A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM

The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs) living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be texted interactive links to publicly available, online content about PrEP and HIV prevention. Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The material used in the intervention will be consistent with the Information Motivation Behavior (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A small randomized controlled study among 66 new participants in the clinics will examine the preliminary efficacy of the intervention compared to enhanced standard of care on attendance at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile Messaging Intervention will show greater attendance at a PrEP Services Appointment and decreased HIV risk behavior at 4 and 16 weeks.

• PrEP Mobile Messaging Intervention (Behavioral): See group description
• Enhanced Standard of Care (Behavioral): See group description

Primary outcomes

• Number of PrEP Services Appointments Attended-Full Sample [16 weeks]: With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.
• Number of PrEP Services Appointments Attended- Restricted Sample [16 weeks]: With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care. Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.
• Number of Participants Who Received a PrEP Prescription-Full Sample [16 weeks]: Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
• Number of Participants Who Received a PrEP Prescription-Restricted Sample [16 weeks]: Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

Secondary outcomes

• Change in PrEP Knowledge-Full Sample [Baseline, 16 weeks]: Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.
• Change in PrEP Knowledge-Restricted Sample [Baseline, 16 weeks]: Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
• Change in Social Motivational Readiness for PrEP Care-Full Sample [Baseline, 16 weeks]: Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.
• Change in Social Motivational Readiness for PrEP Care-Restricted Sample [Baseline, 16 weeks]: Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
• Change in PrEP Self-efficacy-Full Sample [Baseline, 16 weeks]: Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.
• Change in PrEP Self-efficacy-Restricted Sample [Baseline, 16 weeks]: Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

Sex: Male, ages: 18 Years to 35 Years, accepts healthy volunteers

Inclusion Criteria:

* English speaking
* Black MSM
* Eligible for PrEP
* Visit STI/HIV testing clinics at University of Mississippi Medical Center
* Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment

Exclusion Criteria:

\- Involved in another PrEP or HIV prevention related study

Participant flow

Outcome results

• Number of PrEP Services Appointments Attended-Full Sample (Primary), Mean, visits attended: PrEP Mobile Messaging Intervention 0.58 +/- 0.72; Enhanced Standard of Care 0.55 +/- 0.68
• Number of PrEP Services Appointments Attended- Restricted Sample (Primary), Mean, visits attended: PrEP Mobile Messaging Intervention 0.56 +/- 0.75; Enhanced Standard of Care 0.50 +/- 0.65
• Number of Participants Who Received a PrEP Prescription-Full Sample (Primary), Count of participants, Participants: PrEP Mobile Messaging Intervention 16; Enhanced Standard of Care 17
• Number of Participants Who Received a PrEP Prescription-Restricted Sample (Primary), Count of participants, Participants: PrEP Mobile Messaging Intervention 16; Enhanced Standard of Care 16
• Change in PrEP Knowledge-Full Sample (Secondary), Mean, score on a scale: PrEP Mobile Messaging Intervention 0.50 +/- 0.83; Enhanced Standard of Care 1.00 +/- 1.15
• Change in PrEP Knowledge-Restricted Sample (Secondary), Mean, score on a scale: PrEP Mobile Messaging Intervention 0.55 +/- 0.86; Enhanced Standard of Care 0.83 +/- 1.15
• Change in Social Motivational Readiness for PrEP Care-Full Sample (Secondary), Mean, units on a scale: PrEP Mobile Messaging Intervention -1.00 +/- 3.59; Enhanced Standard of Care 0.29 +/- 4.46
• Change in Social Motivational Readiness for PrEP Care-Restricted Sample (Secondary), Mean, units on a scale: PrEP Mobile Messaging Intervention -1.35 +/- 3.48; Enhanced Standard of Care 0.47 +/- 4.72
• Change in PrEP Self-efficacy-Full Sample (Secondary), Mean, score on a scale: PrEP Mobile Messaging Intervention -0.33 +/- 3.11; Enhanced Standard of Care -0.37 +/- 2.91
• Change in PrEP Self-efficacy-Restricted Sample (Secondary), Mean, score on a scale: PrEP Mobile Messaging Intervention -0.36 +/- 3.23; Enhanced Standard of Care -0.20 +/- 3.21

Adverse events

Time frame: Participants were monitored for adverse events over the duration of the study (4 months).

• Results publication: Rouffiac AE, Whiteley L, Brown L, Mena L, Craker L, Healy M, Haubrick K. A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 20;9(2):e15781. doi: 10.2196/15781. PMID 32130196

• Informed Consent Form (PDF, 2020-05-05)
• Study Protocol and Statistical Analysis Plan (PDF, 2020-11-08)

• Larry K. Brown, M.D., Principal investigator, Rhode Island Hospital
• Laura Whiteley, M.D., Principal investigator, Rhode Island Hospital
• Leandro Mena, M.D., Study director, University of Mississippi Medical Center