Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial
| Registry | NCT06148584, acronym TRIM |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 271 (Actual) |
| Sponsor | HIV Prevention Trials Network (Network); collaborators: National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) |
| Conditions | HIV Infections |
| Interventions | General, status-neutral HIV education, HIV self-test kits, Information about where to receive HIV prevention services, Barber-led peer support group education, Facility-based HIV risk reduction counseling, Facility-based HIV testing, Information about facility distributed HIV self-test kits, STI testing (Behavioral, diagnostic test, other) |
| Dates | start 2024-03-13, primary completion 2025-06-30, completion 2025-06-30, first posted 2023-11-28, last updated 2026-10-20 |
| Locations | 1 site in Uganda |
Related Papers Related Patents Related Grants Related Experts
All trials for HIV Infections All trials of General, status-neutral HIV education All trials of HIV self-test kits
-Summary
To test community-based approaches to engage heterosexual men at risk for HIV and specifically to assess the feasibility and acceptability of a barbershop based HIV prevention program.
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+Detailed description
HPTN 111/TRIM is a cluster randomized study to assess the feasibility and acceptability of a barbershop-based HIV prevention program. Eighteen barbershops in Kalangala District, Uganda will be purposively selected to participate in the study and randomized 2:1 to provide the barbershop-based HIV prevention initiative (intervention) or the standard-of-care (control). Individual participants will be enrolled from the barbershops and receive intervention or control services based on their barbershop. The barbershop-based HIV prevention initiative will include barber provided status-neutral HIV education, HIV self-test kits, and information about where to receive HIV prevention services.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Intervention Barbershops Group | Experimental | Behavioral: General, status-neutral HIV education; Diagnostic Test: HIV self-test kits; Other: Information about where to receive HIV prevention services; Behavioral: Barber-led peer support group education; Diagnostic Test: STI testing | Participants recruited from intervention barbershops will receive the barbershop-based HIV prevention initiative. The trained barber will provide the following services during regular haircut services: general, status-neutral HIV education, HIV self-test kits, and information about where to receive HIV prevention services. The barber will also lead peer support group education every two months for clients enrolled in the study.
All participants in both groups will complete study clinic visits for scheduled study procedures which include bio-behavioral data collection, HIV counseling and testing, and STI testing. Participants will be followed for 12 months. |
| Control Barbershops Group | Active comparator | Behavioral: Facility-based HIV risk reduction counseling; Diagnostic Test: Facility-based HIV testing; Other: Information about facility distributed HIV self-test kits; Diagnostic Test: STI testing | Participants recruited from control barbershops will receive standard-of-care HIV prevention services which include facility-based HIV risk reduction counseling and testing and providing information about facility distributed HIV self-test kits.
All participants in both groups will complete study clinic visits for scheduled study procedures which include bio-behavioral data collection, HIV counseling and testing, and STI testing. Participants will be followed for 12 months. |
- General, status-neutral HIV education (Behavioral): General, status-neutral HIV education
- HIV self-test kits (Diagnostic test): HIV self-test kits
- Information about where to receive HIV prevention services (Other): Information about where to receive HIV prevention services
- Barber-led peer support group education (Behavioral): Barber-led peer support group education
- Facility-based HIV risk reduction counseling (Behavioral): Facility-based HIV risk reduction counseling
- Facility-based HIV testing (Diagnostic test): Facility-based HIV testing
- Information about facility distributed HIV self-test kits (Other): Information about facility distributed HIV self-test kits
- STI testing (Diagnostic test): STI testing
+Outcome measures
Primary outcomes
- Participant Responses From Feasibility Survey Question of Barber Qualities: The Barber Was Knowledgeable About HIV and Prevention [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of barber-related qualities at Week 26 and Week 52. Responses to the statement, "The barber was knowledgeable about HIV and prevention," were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Participant Responses From Feasibility Survey Question of Barber Qualities: The Barber Was Knowledgeable About HIV Self-Testing [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of barber-related qualities at Week 26 and Week 52. Responses to the statement, "The barber was knowledgeable about HIV self-testing" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Participant Responses From Feasibility Survey Question of Barber Qualities: The Barber Was Non-Judgmental and Listened to my Thoughts. [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of barber-related qualities at Week 26 and Week 52. Responses to the statement, "The barber was non-judgmental and listened to my thoughts" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Did the Participant Attend a Barber-Led Group Session Since the Last Study Visit? [Week 26, Week 52]: This question was part of the broader objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative. Participants were asked whether they attended a barber-led group session. Some items in the participant feasibility and acceptability survey were conditional on this question and included responses only for those who reported attending group sessions.
- Participant Responses From Feasibility Survey Question of Barber Qualities: Barber-Led Group Sessions Provided a Safe, Comfortable Space to Discuss HIV-Related Topics [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of barber-related qualities at Week 26 and Week 52. Responses to the statement, "Barber-led group sessions provided a safe, comfortable space to discuss HIV-related topics" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week. Note- This feasibility survey question was conditional and included responses only for those who reported attending group sessions.
- Participant-assessed Feasibility Scores Related to Barber Qualities Survey Question/Statement: The Barber Was Knowledgeable About HIV and Prevention [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the barber qualities statement, "The Barber Was Knowledgeable About HIV and Prevention" Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Feasibility Scores Related to Barber Qualities Survey Question/Statement: The Barber Was Knowledgeable About HIV Self-Testing [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the barber qualities statement, "The barber was knowledgeable about HIV self-testing" Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Feasibility Scores Related to Barber Qualities Survey Question/Statement: The Barber Was Non-Judgmental and Listened to my Thoughts [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the barber qualities statement, "The barber was non-judgmental and listened to my thoughts" Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Feasibility Scores Related to Barber Qualities Survey Question/Statement: Barber-Led Group Sessions Provided a Safe, Comfortable Space to Discuss HIV-Related Topics [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the barber qualities statement, "Barber-led group sessions provided a safe, comfortable space to discuss HIV-related topics" Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation). Note- This feasibility survey question scores was conditional and only scored for those who reported attending group sessions.
- Participant-assessed Feasibility Score of Barber Qualities (Village-Level) [0-52 Weeks]: Consistent with the primary objective to evaluate feasibility and acceptability of a barbershop-based HIV prevention initiative, the endpoint assessed among intervention participants was participant-assessed feasibility scores related to barber qualities. Survey items were statements or questions with five-level Likert responses scored from -2 (least supportive) to +2 (most supportive), with higher scores indicating greater support. Scores were calculated at each visit. Final scores were obtained by averaging within participants and then across villages, producing village-level means while weighting participants equally within villages and villages equally regardless of size. The confidence intervals were estimated using nonparametric bootstrap resampling of villages with replacement.
- Participant Responses From Feasibility Survey Question of Participant Experience: I Have More Knowledge for HIV Prevention and Care Services After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of participant experience at Week 26 and Week 52. Responses to the question/statement "I feel that I have more knowledge for HIV prevention and care services after talking with my barberer" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Participant Responses From Feasibility Survey Question of Participant Experience: I Feel That I Have More Knowledge About HIV Testing After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of participant experience at Week 26 and Week 52. Responses to the question/statement "I feel that I have more knowledge about HIV testing after talking with my barber" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Participant Responses From Feasibility Survey Question of Participant Experience: I Feel That I Have More Knowledge About PrEP After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of participant experience at Week 26 and Week 52. Responses to the question/statement "I feel that I have more knowledge about PrEP after talking with my barber" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Participant Responses From Feasibility Survey Question of Participant Experience: I Feel That I Have More Knowledge About PEP After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of participant experience at Week 26 and Week 52. Responses to the question/statement "I feel that I have more knowledge about PEP after talking with my barber" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Participant Responses From Feasibility Survey Question of Participant Experience: I Feel That I Have More Knowledge About Safe Male Circumcision After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from feasibility surveys of participant experience at Week 26 and Week 52. Responses to the question/statement "I feel that I have more knowledge about safe male circumcision after talking with my barber" were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents responses from the corresponding assessment week.
- Participant-assessed Feasibility Scores Related to Participant Experience Survey Question/Statement: I Feel That I Have More Knowledge for HIV Prevention and Care Services After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the participant experience statement, "I feel that I have more knowledge for HIV prevention and care services after talking with my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Feasibility Scores Related to Participant Experience Survey Question/Statement: I Feel That I Have More Knowledge About HIV Testing After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the participant experience statement, "I feel that I have more knowledge about HIV testing after talking with my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Feasibility Scores Related to Participant Experience Survey Question/Statement: I Feel That I Have More Knowledge About PrEP After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the participant experience statement, "I feel that I have more knowledge about PrEP after talking with my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Feasibility Scores Related to Participant Experience Survey Question/Statement: I Feel That I Have More Knowledge About PEP After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the participant experience statement, "I feel that I have more knowledge about PEP after talking with my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Feasibility Scores Related to Participant Experience Survey Question/Statement: I Feel That I Have More Knowledge About Safe Male Circumcision After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed feasibility scores related to the participant experience statement, "I feel that I have more knowledge about safe male circumcision after talking with my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant Feasibility Score of Participant Experience (Village-Level) [0-52 Weeks]: Consistent with the primary objective to evaluate feasibility and acceptability of a barbershop-based HIV prevention initiative, the endpoint assessed among intervention participants was participant-assessed feasibility scores related to participant experience. Survey items were statements or questions with five-level Likert responses scored from -2 (least supportive) to +2 (most supportive), with higher scores indicating greater support. Scores were calculated at each visit. Final scores were obtained by averaging within participants and then across villages, producing village-level means while weighting participants equally within villages and villages equally regardless of size. The confidence intervals were estimated using nonparametric bootstrap resampling of villages with replacement.
- Participant Responses From Intervention Acceptability Survey Question: How Satisfied Are You With the HIV Information Provided by Your Barber? [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the question: "How satisfied are you with the HIV information provided by your barber?" Responses were measured using a Likert scale with the following options: Very dissatisfied, Dissatisfied, Neutral, Satisfied, and Very satisfied. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question: How Comfortable Were You Discussing HIV and Other Health Related Topics With Your Barber? [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the question: "How comfortable were you discussing HIV and other health related topics with your barber?" Responses were measured using a Likert scale with the following options: Very Uncomfortable, Somewhat Uncomfortable, Neutral, Somewhat Comfortable and Very Comfortable. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: I am Comfortable Seeking HIV Prevention/Treatment Services After Talking With my Barber. [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "I am comfortable seeking HIV prevention/treatment services after talking with my barber" Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: I Felt Uncomfortable With the Idea of Taking an HIV Self-Test Kit From my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "I felt uncomfortable with the idea of taking an HIV self-test kit from my barber". Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: I Liked Being Able to Get an HIV Self-Test Kit From my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "I liked being able to get an HIV self-test kit from my barber". Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: Talking to my Barber About HIV Topics and Receiving a Haircut Was Too Time Consuming [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "Talking to my barber about HIV topics and receiving a haircut was too time consuming". Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: I Worried About Other People in the Shop Hearing my Barber Talking to me About HIV [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "I worried about other people in the shop hearing my barber talking to me about HIV". Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: I Worried That I Might Experience Stigma Going to the Barber Who Talks About HIV [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "I worried that I might experience stigma going to the barber who talks about HIV". Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: It Allowed me to Think Positively About Seeking/Using HIV Prevention/Treatment Medications. [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "It allowed me to think positively about seeking/using HIV prevention/treatment medications". Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week.
- Participant Responses From Intervention Acceptability Survey Question/Statement: Group Sessions Were Useful in Improving my Knowledge of HIV Prevention/Treatment Services [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant responses from acceptability survey of intervention acceptability at Week 26 and Week 52. This section included the statement: "Group sessions were useful in improving my knowledge of HIV prevention/treatment services". Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represents participant responses for a given assessment week. Only participants who reported attending group sessions were asked this question at each visit.
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: How Satisfied Are You With the HIV Information Provided by Your Barber? [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability question, "How satisfied are you with the HIV information provided by your barber?" Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: How Comfortable Were You Discussing HIV and Other Health Related Topics With Your Barber? [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability question, "How Comfortable Were You Discussing HIV and Other Health Related Topics With Your Barber?" Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: I am Comfortable Seeking HIV Prevention/Treatment Services After Talking With my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, "I am comfortable seeking HIV prevention/treatment services after talking with my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: Talking to my Barber About HIV Topics and Receiving a Haircut Was Too Time Consuming [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, "Talking to my barber about HIV topics and receiving a haircut was too time consuming". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: I Felt Uncomfortable With the Idea of Taking an HIV Self-Test Kit From my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, "I felt uncomfortable with the idea of taking an HIV self-test kit from my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: I Liked Being Able to Get an HIV Self-Test Kit From my Barber [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, " I liked being able to get an HIV self-test kit from my barber". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: I Worried About Other People in the Shop Hearing my Barber Talking to me About HIV [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, " I worried about other people in the shop hearing my barber talking to me about HIV". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: I Worried That I Might Experience Stigma Going to the Barber Who Talks About HIV [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, " I worried that I might experience stigma going to the barber who talks about HIV". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: Talking to Barber Allowed me to Think Positively About HIV Prevention/Treatment Medications [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, "Talking to barber allowed me to think positively about HIV prevention/treatment medications". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation).
- Participant-assessed Acceptability Scores Related to Intervention Acceptability Survey Question/Statement: Group Sessions Were Useful in Improving my Knowledge of HIV Prevention/Treatment Services [Week 26 and Week 52]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among participants in the intervention group: participant-assessed acceptability scores related to participant intervention acceptability statement, "Group sessions were useful in improving my knowledge of HIV prevention/treatment services". Responses, measured on a five-level Likert scale, were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section includes summary measures of participant scores at each visit, reported as mean (standard deviation). This section included responses only for participants reported attending group sessions.
- Participant-assessed Acceptability Scores Related to Participant Intervention Acceptability (Village-level) [0-52 Weeks]: Consistent with the primary study objective to evaluate feasibility and acceptability of a barbershop-based HIV prevention initiative, this endpoint was assessed among participants in the intervention group as participant-assessed acceptability scores related to intervention acceptability. Survey items comprised statements/questions with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive) to +2 (most supportive), with higher scores indicating greater support. Scores were calculated at each visit. For derived scores, responses were averaged within participants and then within villages to obtain village-level means, weighting participants equally within villages and villages equally regardless of size. Confidence intervals were estimated using nonparametric bootstrap resampling of villages with replacement.
- Barber Responses From the Feasibility Survey Question of Delivering the Intervention: How Easy Was it to Provide HIV Prevention Information to Your Clients While Giving a Haircut? [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility question, "How easy was it to provide HIV prevention information to your clients while giving a haircut?", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Very difficult, Somewhat difficult, Neither easy nor difficult, Somewhat easy, and Very easy. Each row represented the responses to an individual survey question for a given assessment week.
- Barber Responses From the Feasibility Survey Question of Delivering the Intervention: How Comfortable Were You Discussing HIV and Other Health Related Topics With Your Clients? [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility question, "How comfortable were you discussing HIV and other health-related topics with your clients?", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Very uncomfortable, Somewhat uncomfortable, Neutral, Somewhat comfortable, and Very comfortable. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question of Delivering the Intervention: I Felt Comfortable Providing HIV Prevention Information to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt comfortable providing HIV prevention information to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row in the dataset represents responses for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Uncomfortable With the Idea of Giving HIV Self-Test Kits to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt uncomfortable with the idea of giving HIV self-test kits to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Was Uncomfortable Talking About HIV With a Client in Presence of Other Clients in the Shop [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I was uncomfortable talking about HIV with a client in presence of other clients in the shop", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: Felt Comfortable Providing Information About HIV Prevention/Treatment Services to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "felt comfortable providing information about HIV prevention/treatment services to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Comfortable Providing Information About HIV Testing to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt comfortable providing information about HIV testing to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Comfortable Providing Information About PrEP to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt comfortable providing information about PrEP to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Comfortable Providing Information About PEP to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt comfortable providing information about PEP to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Comfortable Providing Information About Safe Male Circumcision to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt comfortable providing information about safe male circumcision to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt That I Was Able to Answer the Questions my Clients Had About HIV [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt that I was able to answer the questions my clients had about HIV", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Did Barber Lead a Group Session Since the Last Study Visit? [Week 13, Week 26, Week 39, Week 52, Week 65]: This question was part of the broader objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative. Barbers were asked whether they led a group session since the last study visit. Some items in the barber feasibility and acceptability survey were conditional on this question and included responses only for those who reported conducting the group sessions.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Comfortable Leading the Group Sessions With my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt comfortable leading the group sessions with my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week. This question was asked to barbers who led the group sessions.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Knowledgeable About the Topics we Discussed During the Group Session [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, "I felt knowledgeable about the topics we discussed during the group session", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week. This question was asked to barbers who led the group sessions.
- Barber Responses From the Feasibility Survey Question/Statement of Delivering the Intervention: I Felt Confident Leading a Group of my Clients in Discussing HIV Infection [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the feasibility survey of delivering the intervention. Responses to the feasibility statement, " I felt confident leading a group of my clients in discussing HIV infection", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week. This question was asked to barbers who led the group sessions.
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question: How Easy Was it to Provide HIV Prevention Information to Your Clients While Giving a Haircut? [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey question, "How Easy Was it to Provide HIV Prevention Information to Your Clients While Giving a Haircut?" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question: How Comfortable Were You Discussing HIV and Other Health Related Topics With Your Clients? [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey question, "How Comfortable Were You Discussing HIV and Other Health Related Topics With Your Clients?" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: I Felt Comfortable Providing HIV Prevention Information to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, "I felt comfortable providing HIV prevention information to my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: I Felt Uncomfortable With the Idea of Giving HIV Self-Test Kits to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, " I felt uncomfortable with the idea of giving HIV self-test kits to my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: I Was Uncomfortable Talking About HIV With a Client in Presence of Other Clients in the Shop [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, " I was uncomfortable talking about HIV with a client in presence of other clients in the shop" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: Felt Comfortable Providing Information About HIV Prevention/Treatment Services to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, "felt comfortable providing information about HIV prevention/treatment services to my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement:I Felt Comfortable Providing Information About HIV Testing to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, "I felt comfortable providing information about HIV testing to my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement:I Felt Comfortable Providing Information About PrEP to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, "I felt comfortable providing information about PrEP to my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement:I Felt Comfortable Providing Information About PEP to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, "I felt comfortable providing information about PEP to my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement:I Felt Comfortable Providing Information About Safe Male Circumcision to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, "I felt comfortable providing information about safe male circumcision to my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: I Felt That I Was Able to Answer the Questions my Clients Had About HIV [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, " I felt that I was able to answer the questions my clients had about HIV" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: I Felt Comfortable Leading the Group Sessions With my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, " I felt comfortable leading the group sessions with my clients" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation). This question was asked to barbers who led the group sessions.
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: I Felt Knowledgeable About the Topics we Discussed During the Group Session [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, " I felt knowledgeable about the topics we discussed during the group session" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation). This question was asked to barbers who led the group sessions.
- Barber-assessed Feasibility Scores Related to the Feasibility of Delivering the Intervention Question/Statement: I Felt Confident Leading a Group of my Clients in Discussing HIV Information [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed feasibility scores related to feasibility survey statement, " I felt confident leading a group of my clients in discussing HIV information" Feasibility survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation). This question was asked to barbers who led the group sessions.
- Barber-assessed Feasibility Scores About Delivering the Intervention (Village-level) [0-65 Weeks]: Consistent with the primary study objective to evaluate feasibility and acceptability of a barbershop-based HIV prevention initiative, this endpoint was assessed among barbers in the intervention group as barber-assessed feasibility scores related to intervention delivery. Survey items comprised statements/questions with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive) to +2 (most supportive), with higher scores indicating greater support. Scores were calculated at each visit. For derived scores, responses were averaged within barbers and then within villages to obtain village-level means, weighting barbers equally within villages and villages equally regardless of size. Confidence intervals were estimated using nonparametric bootstrap resampling of villages with replacement.
- Barber Responses From the the Acceptability Survey Question/Statement of Delivering the Intervention?: I Felt That my Clients Appreciated Discussing HIV Prevention Information With me [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the acceptability survey of delivering the intervention. Responses to the acceptability statement, "I felt that my clients appreciated discussing HIV prevention information with me", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the the Acceptability Survey Question/Statement of Delivering the Intervention?: I Like Being Able to Give HIV Self-Test Kits to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the acceptability survey of delivering the intervention. Responses to the acceptability statement, "I like being able to give HIV self-test kits to my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the the Acceptability Survey Question/Statement of Delivering the Intervention?: I am Worried That People Don't Want to Come to my Shop Because They Don´t Want to Hear About HIV [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the acceptability survey of delivering the intervention. Responses to the acceptability statement, "I am worried that people don't want to come to my shop because they don´t want to hear about HIV", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the the Acceptability Survey Question/Statement of Delivering the Intervention?: I Enjoyed Providing HIV Information & Discussing Other Health Related Topics With my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the acceptability survey of delivering the intervention. Responses to the acceptability statement, "I enjoyed providing HIV information \& discussing other health related topics with my clients", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week.
- Barber Responses From the the Acceptability Survey Question/Statement of Delivering the Intervention?: I Felt That my Clients Appreciated Attending the Barber-Led Group Sessions [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the acceptability survey of delivering the intervention. Responses to the acceptability statement, "I felt that my clients appreciated attending the barber-led group sessions", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week. This question was asked to barbers who led the group sessions.
- Barber Responses From the the Acceptability Survey Question/Statement of Delivering the Intervention?: I Felt That the Barber-Led Group Sessions Were Useful for my Clients to Learn More About HIV [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber responses from the acceptability survey of delivering the intervention. Responses to the acceptability statement, "I felt that the barber-led group sessions were useful for my clients to learn more about HIV", were collected at Weeks 13, 26, 39, 52, and 65. Responses were measured using a Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, and Strongly agree. Each row represented an individual survey response for a given assessment week. This question was asked to barbers who led the group sessions.
- Barber-assessed Acceptability Scores Related to Acceptability of Delivering the Intervention Question/Statement: I Felt That my Clients Appreciated Discussing HIV Prevention Information With me [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed acceptability scores related to acceptability survey statement, "I felt that my clients appreciated discussing HIV prevention information with me". Acceptability survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. For each question, responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Acceptability Scores Related to Acceptability of Delivering the Intervention Question/Statement: I Like Being Able to Give HIV Self-Test Kits to my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed acceptability scores related to acceptability survey statement, " I like being able to give HIV self-test kits to my clients". Acceptability survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. For each question, responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Acceptability Scores Related to Acceptability of Delivering the Intervention Question/Statement: I Worried That People Don't Want to Come to my Shop Because They Don´t Want to Hear About HIV [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed acceptability scores related to acceptability survey statement, " I worried that people don't want to come to my shop because they don´t want to hear about HIV". Acceptability survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. For each question, responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Acceptability Scores Related to Acceptability of Delivering the Intervention Question/Statement: I Enjoyed Providing HIV Information & Discussing Other Health Related Topics With my Clients [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed acceptability scores related to acceptability survey statement, " I enjoyed providing HIV information \& discussing other health related topics with my clients". Acceptability survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. For each question, responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation).
- Barber-assessed Acceptability Scores Related to Acceptability of Delivering the Intervention Question/Statement: I Felt That my Clients Appreciated Attending the Barber-Led Group Sessions [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed acceptability scores related to acceptability survey statement, " I felt that my clients appreciated attending the barber-led group sessions". Acceptability survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. For each question, responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation). This question was asked to barbers who led the group sessions.
- Barber-assessed Acceptability Scores Related to Acceptability of Delivering the Intervention Question/Statement: I Felt That the Barber-Led Group Sessions Were Useful for my Clients to Learn More About HIV [Week 13, Week 26, Week 39, Week 52, Week 65]: Consistent with the primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following endpoint was assessed among barbers in the intervention group: barber-assessed acceptability scores related to acceptability survey statement, " I felt that the barber-led group sessions were useful for my clients to learn more about HIV". Acceptability survey questions comprised statements or questions about delivering the intervention, with responses measured on a five-level Likert scale. For each question, responses were scored from -2 (least supportive of the intervention) to +2 (most supportive of the intervention), with higher scores indicating greater support. Scores were calculated at each visit. This section included summary measures of barber scores at each visit, reported as mean (standard deviation). This question was asked to barbers who led the group sessions.
- Barber-assessed Acceptability Scores About Delivering the Intervention (Village-level) [0-65 Weeks]: Consistent with the primary study objective to evaluate feasibility and acceptability of a barbershop-based HIV prevention initiative, this endpoint was assessed among barbers in the intervention group as barber-assessed acceptability scores related to intervention delivery. Survey items comprised statements/questions with responses measured on a five-level Likert scale. Responses were scored from -2 (least supportive) to +2 (most supportive), with higher scores indicating greater support. Scores were calculated at each visit. For derived scores, responses were averaged within barbers and then within villages to obtain village-level means, weighting barbers equally within villages and villages equally regardless of size. Confidence intervals were estimated using nonparametric bootstrap resampling of villages with replacement.
- Total Number of Times Clients Contacted About the Study. [0- 52 Week]: Consistent with this primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following outcome measure is reported: Total number of times clients contacted about the study. The total number of daily client contacts are reported by barbershops. Barbershops were de-identified and replaced with dummy names: Barbershop 1- Barbershop 19.
- Total Number of Client Referrals [0- 52 Week]: Consistent with this primary study objective to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following outcome measure is reported: Total number of client referrals reported by barbershops. Barbershops were de-identified and replaced with dummy names: Barbershop 1- Barbershop 19.
- Total Number of Clients Enrolled Per Week [0- 52 Week]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following outcome measure is reported: total number of clients enrolled per week. It is calculated by the total number of participants divided by the total number of weeks of enrollment at the barbershops. Barbershops were de-identified and replaced with dummy names: Barbershop 1- Barbershop 19.
- Total Number of Participants Enrolled Per Client Visit [0- 52 Week]: Consistent with the primary study objective of evaluating the feasibility and acceptability of a barbershop-based HIV prevention initiative, the following outcome measure is reported: total number of participants enrolled per client visit. It was calculated by the total number of participants divided by the total number of times a barber reported talking to clients about the study at the barbershops. Barbershops were de-identified and replaced with dummy names: Barbershop 1- Barbershop 19.
- Participant Visit Completion at Week 26 and Week 52 [Week 26, Week 52]: This is part of a broad primary objective to evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative. Visit completion (percent of participants attending visits within the allowable window) is summarized overall and by arm for each scheduled visit.
- Barber Visit Completion at Quarterly Visits. [Week 13, Week 26, Week 39, Week 52, Week 65]: This is part of broad primary objectivev to Evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. Note that barbers in the intervention arm attended the quarterly visits and those who were in the control arm only completed week 13 visit.
- Did the Participant Attend the Barbershop They Were Recruited From Since the Last Study Visit? [Week 26, Week 52]: This is part of broader primary objective to evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. Those participants who answered "Yes" to the question "Did the participant attend the barbershop they were recruited from since the last study visit?" are reported.
- How Many Times Did the Participant Attend Their Recruiting Barbershop for a Haircut Since the Last Study Visit? [Week 26, Week 52]: This is part of broad primary objective to evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. Those participants who answered "Yes" to the question "Did the participant attend the barbershop they were recruited from since the last study visit?" were considered for the question "How many times did the participant attend their recruiting barbershop for a haircut since the last study visit?". Summary statistics including mean and standard deviation are reported.
- The Last Time the Participant Went to the Recruiting Barbershop for a Haircut, Approximately How Long Did the Participant Spend at the Shop? [Week 26, Week 52]: This is part of broad primary objectivev to Evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. Those participants who answered "Yes" to the question "Did the participant attend the barbershop they were recruited from since the last study visit?" are considered for the question "The last time the participant went to the recruiting barbershop for a haircut, approximately how long did the participant spend at the shop?. The time is reported in minutes and summary statistics including mean and standard deviation are reported for each study visit.
- HIV-related Services the Participants Received From a Barber During Their Most Recent Haircut at the Recruiting Shop [Week 26, Week 52]: This is part of broad primary objective to evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. Those participants who answered "Yes" to the question "Did the participant attend the barbershop they were recruited from since the last study visit?" were considered for the following question: What HIV-related services did you receive from a barber from their recruiting barbershop since tthe ast study visit? (Mark all that apply)". Participants could choose multiple options from the following options: HIV education, HIV prevention referral information, HIV treatment referral information, HIV self-test kit information, HIV self-test kits to take home, None, Other (specify).
- Whether Participants Received Any Intervention Services From Any Barber at Haircuts Between Enrollment and Week 52 [0-52 Weeks]: This is part of broader primary objective to evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative.
The patient-level outcome, "Whether participants received any intervention services from a barber at haircuts between enrollment and Week 52" was derived from the question: "Did the participant attend the barbershop from which they were recruited since the last study visit?" Participants who responded "Yes" at either the Week 26 or Week 52 visit were classified as having received intervention services during the period from enrollment to Week 52.
- Whether Participants Attended Any Barber-led Group Session Between Enrollment and Week 52 [0-52 Weeks]: This is part of broad primary objective to evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. "Whether participants attended any barber-led group session between enrollment and Week 52" was derived from the question: "Did the participant attend a barber-led group session since the last study visit?" Participants who responded "Yes" at either the Week 26 or Week 52 visit were classified as having attended any barber-led group session between enrollment and Week 52. Participants reporting attending the barber-led group sessions between enrollment and week 52 are reported here.
- Average Number of Participant Reported Visits to the Recruiting Barbershop (Village-Level) [0-52 Weeks]: This is part of broader primary objective to evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. "Average number of visits to the recruiting barbershop (average of counts from Week 26 and Week 52)" was calculated from visit-level question "How Many Times Did the Participant Attend Their Recruiting Barbershop for a Haircut Since the Last Study Visit?" by averaging the counts from week 26 and week 52.
- Average Time Spent at the Shop for the Participant's Last Haircut (Village-level) [0-52 Weeks]: This is part of broader primary objective to evaluate the Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative. "Average time spent at the shop for the participant's last haircut (average of times from Week 26 and Week 52)" is calculated from visit-level question "The last time they went to the recruiting barbershop for a haircut, approximately how long did the participant spend at the shop? Include waiting time." by averaging the times from week 26 and week 52.
- Total Number of Barber Reported Client Visits (Village-level) [0-65 weeks]: This is part of the broad primary objective to evaluate the Feasibility and Acceptability of a barbershop-based HIV Prevention Initiative. Information about client visits is collected every time a participating client visits the barbershop from the barber logs; this information will be summarized at the level of data collection, equally weighting each client visit. Descriptive statistics are based on village-level data in the intervention group.
- Percentage of Visits That Included Delivery of the Intervention, Including Any of the Following: HIV Education, HIV Self-test Information, HIV Self-test Kits, or HIV Prevention/Care Referral (Village-level). [0-52 Weeks]: This is part of the broader primary objective to evaluate the Feasibility and Acceptability of a barbershop-based HIV Prevention Initiative. Percentage of client visits with delivery of at least one intervention (HIV education, HIV self-test information, HIV self-test kits, or HIV prevention/care referral) for the barbers in the intervention group were derived from the number of client visits and number of visits with intervention delivery in that visit. Descriptive statistics are based on village-level data in the intervention group.
- Total Number of HIV Self-test Kits Distributed (Village-level) [0-65 weeks]: This is part of the broader primary objective to evaluate the Feasibility and Acceptability of a barbershop-based HIV Prevention Initiative. The number of HIV self-test kits recorded in barber logs were summarized at the village level for intervention-group barbers.
- Frequency of Group Sessions Held (Village-level) [0-65 weeks]: This is part of the broad primary objective to evaluate the Feasibility and Acceptability of a barbershop-based HIV Prevention Initiative. The number of group sessions held and recorded in group session logs will be summarized at the village level for intervention-group barbers.
Secondary outcomes
- Number of Times Participants Tested for HIV Since Last Study Visit (Visit-level) [Week 26, Week 52]: Consistent with the secondary objective to compare completion of self-initiated HIV testing between the intervention and control groups, the number of times participants tested for HIV since the last study visit was collected. For each visit, summary statistics included the median and interquartile range.
- Use of HIV Self-test Kit to Test for HIV(Visit-level) [Week 26, Week 52]: Consistent with the secondary objective to compare completion of self-initiated HIV testing between intervention and control groups, information about use of HIV self-test kit was collected. For those who tested for HIV at least once, use of an HIV self-test was reported at each visit.
- Number and Percentage of Participants Tested for HIV Between Enrollment and Week 26 [0-Week 26]: Consistent with the secondary objective to compare completion of self-initiated HIV testing between intervention and control groups, the number of times participants tested for HIV since the last study visit was collected. For this outcome, participants were categorized as having self-initiated HIV testing if they reported testing for HIV one or more times between enrollment and Week 26. The data table reports the number and percent of participants who met this definition.
- Number and Percentage of Participants Tested for HIV Between Week 26 and Week 52 [Week 26-Week 52]: Consistent with the secondary objective to compare completion of self-initiated HIV testing between intervention and control groups, the number of times participants tested for HIV since the last study visit was collected. For this outcome, participants were categorized as having self-initiated HIV testing if they reported testing for HIV one or more times between Week 26 and Week 52. The data table reports the number and percent of participants who met this definition.
- Number and Percentage of Participants Tested for HIV Between All Study Visits [0-Week 52]: Consistent with the secondary objective to compare completion of self-initiated HIV testing between intervention and control groups, the number of times participants tested for HIV since the last study visit was collected. For this outcome, participants were categorized as having self-initiated HIV testing if they reported testing for HIV one or more times between enrollment and Week 52 (Participants who tested >=1 times between the two time periods: enrollment-week 26 and week 26-week 52). The data table reports the number and percent of participants who met this definition.
- HIV Status of the Main Partner [Week 26, Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' main partner (HIV status) was collected. HIV status is categorized into: HIV positive, HIV negative, I don't know and Missing.
- Total Number of Sexual Partners in the Last Three Months [Week 26, Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' sexual partners was collected. Total number of sexual partners in the last three months were calculated by adding number of non-main partners, plus one if the participant has a main partner.
- Total Number of New Sexual Partners in the Last Three Months [Week 26, Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' sexual partners was collected. The sexual partners were considered "new" if participants had not had sex with them in the past year.
- Number of Sexual Partners With Unknown HIV Status in the Last Three Months [Week 26, Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' sexual partners was collected. Question about the number of partners with unknown HIV status was collected each visit. This was summarized at the visit level.
- Did the Participant Use a Condom the Last Time They Had Vaginal Sex With a Partner? [Week 26, Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' sexual behavior was collected. For participants with a main partner and no other partners, the answer is "Yes" if they answered "Yes" to "Did you use a condom the last time you had vaginal sex with your main partner?". For participants with a main partner as well as other partners, the answer is "Yes" if they answered "Yes" to both "Did you use a condom the last time you had vaginal sex with your main partner?" and "Did you use a condom the last time you had sex with someone other than your main partner?". For participants without a main partner, the answer is "Yes" if they answered "Yes" to "Did you use a condom the last time you had sex with someone other than your main partner?". If none of the previous conditions are met, then the answer is "No".
- Among Participants Who Ever Had a Main Partner, Whether Participants Ever Had a Main Partner With Unknown HIV Status at Week 26 or Week 52 [0-Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' main partner (HIV status) was collected. If the participant did not know whether their main partner was HIV positive or negative at any of the week 26 or week 52 visits, then they are considered to have reported unknown status of the main partner.
- Average Number of Total Sexual Partners From the Three Months Prior to Week 26 and Three Months Prior to Week 52. [0-Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' sexual behavior was collected. The number of sexual partners were averaged across week 26 and week 52 visits.
- Whether Participants Ever Reported Condomless Sex at Their Last Sexual Encounter From Week 26 or Week 52 [0-Week 52]: Consistent with the secondary objective to evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, information about participants' main partner (HIV status) was collected. If the participant did not report using condom at their last sexual encounter at week 26 or week 52 visits, then they considered to have had a condomless sex.
- Did Participant Circumcise Between Enrollment and Week 52? [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported circumcision was collected. The participant who reported a new circumcision at week 26 or week 52 are summarized by arm.
- Whether Participants Ever Went to a Health Facility to Get PEP Between Enrollment and Week 52 [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PEP or use of PEP carewas collected. The participant who reported visiting health facility to get PEP at week 26 or week 52 are summarized by arm (between enrollment and week 52).
- Whether Participants Ever Got a PEP Prescription Between Enrollment and Week 52 [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PEP or use of PEP carewas collected. For the participants who reported visiting health facility to get PEP at week 26 or week 52, whether they got any prescription is summarized by arm (between enrollment and week 52).
- Whether Participants Ever Used PEP Between Enrollment and Week 52 (HIV Prevention Service Questionnaire) [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PEP or use of PEP carewas collected. Participants who ever used PEP at week 26 or week 52,is summarized by arm (between enrollment and week 52). Note that this question was part of the HIV prevention services questionnaire, which included questions about PEP and PrEP.
- Whether Participants Ever Reported Using PEP in the Past Three Months on the ACASI [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PEP or use of PEP carewas collected. Participants who ever reported using PEP in past 3 months are summarized by arm (between enrollment and week 52). This question was part of the ACASI interview and focused on participants´ sexual behavior.
- Whether Participants Ever Went to a Health Facility to Get PrEP Between Enrollment and Week 52 [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PrEP or use of PrEP care was collected. The participant who reported visiting health facility to get PrEP at week 26 or week 52 are summarized by arm (between enrollment and week 52).
- Whether Participants Ever Got a PrEP Prescription Between Enrollment and Week 52 [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PrEP or use of PrEP care was collected. For the participants who reported visiting health facility to get PrEP at week 26 or week 52, whether they got any prescription is summarized by arm (between enrollment and week 52).
- Whether Participants Ever Used PrEP Between Enrollment and Week 52 (HIV Prevention Service Questionnaire) [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PrEP or use of PrEP care was collected. Participants who ever used PrEP at week 26 or week 52,is summarized by arm (between enrollment and week 52). Note that this question was part of the HIV prevention services questionnaire, which included questions about PEP and PrEP.
- Whether Participants Ever Reported Using PrEP in the Past Three Months on the ACASI [0-Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about self-reported refererral to PrEP or use of PrEP care was collected. Participants who ever reported using PrEP in past 3 months are summarized by arm (between enrollment and week 52). This question was part of the ACASI interview and focused on participants´ sexual behavior.
- Self-reported Interest in Long Acting PrEP [Week 52]: Consistent with the secondary objective to compare interest in or use of HIV prevention services between intervention and control groups, information about interest in long-acting PrEP was collected. participants were asked "How interested would you be in taking long-acting injectable PrEP? at week 52, which participants answered with very uninterested, somewhat uninterested, neutral, somewhat interested or very interested. These answers were converted into binary outcome indicating whether participants were interested (somewhat interested or very interested) vs. not interested (very uninterested, somewhat uninterested, neutral). Participants who were interested are reported.
+Eligibility
Sex: Male, ages: 16 Years to any, accepts healthy volunteers
Inclusion Criteria:
Persons who identify as a heterosexual male and meet all of the following criteria are eligible for inclusion in this study:
1. Age ≥ 16 years
a. Any participants 16-17 years old will be enrolled following the Uganda National Council for Science and Technology (UNCST) guidelines for mature and emancipated minors
2. Able and willing to provide informed consent
3. Behaviorally vulnerable to HIV, based on self-report of at least one of the following in the last three months:
1. Had condomless sex with a person of unknown HIV status or a person living with HIV
2. Had more than one sexual partner
4. HIV negative per Ugandan Ministry of Health guidelines and the Study-specific Procedures (SSP) Manual
5. Is a regular customer at a participating barbershop as defined in the SSP Manual
Exclusion Criteria:
Persons who meet any of the following criteria will be excluded from this study:
1. Not planning to stay in the study catchment area in the next 12 months
2. Any other condition that in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Participants who report sex with other men will not be excluded from this study so long as they meet the inclusion and exclusion criteria listed above.
+Locations (1)
| Facility | City | Country | Status |
|---|
| MU-JHU Research Collaboration (MUJHU CARE LTD) CRS | Kampala | Uganda | |
+Publications
- Results publication: Scoville C, Gati Mirembe B, Voldal E, Maena J, Etima J, Harris-Wisecarver J, Rukundo I, Ssemere H, Kemigisha D, Nakyanzi T, Nakalega R, Conserve DF, Albano M, Dyer M, Piwowar-Manning E, Spiegel H, Nakabiito C, Mujugira A, Donnell D, Lukyamuzi Z. Feasibility and Acceptability of Barbershop-Based HIV Prevention Among Heterosexual Men in Kalangala Islands, Uganda: Protocol for a Cluster Randomized Trial (HPTN 111). JMIR Res Protoc. 2026 Apr 17;15:e87612. doi: 10.2196/87612. PMID 41996694
+Study documents
+Investigators
- Zubair Lukyamuzi, MBChB, MPH, Study chair, Makerere University, Johns Hopkins University Collaboration (MU-JHU)
- Brenda Gati Mirembe, MBChB, MscEpi, Study chair, Makerere University, Johns Hopkins University Collaboration (MU-JHU)
+Funding
NIH grants: UM1AI068619-17