Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth

• NCM4HIV (Behavioral): Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring, PrEP eligibility screening,PrEP/nPEP services (labs, medication), healthcare planning/coordination, MI counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health
• Usual Care (Behavioral): Participant will receive usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling, substance use treatment referrals, PrEP/nPEP referrals

Primary outcomes

• Number of Participants Who Use Preventive Prophylaxis (PrEP) [baseline]
• Number of Participants Who Use Preventive Prophylaxis (PrEP) [At completion of the 3-month intervention (Month 3)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Preventive Prophylaxis (PrEP) [3 months after intervention (Month 6)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Preventive Prophylaxis (PrEP) [6 months after intervention (Month 9)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Preventive Prophylaxis (PrEP) [9 months after intervention (Month 12)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) [baseline]
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) [At completion of the 3-month intervention (Month 3)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) [3 months after intervention (Month 6)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) [6 months after intervention (Month 9)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) [9 months after intervention (Month 12)]: Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey [baseline]: An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey [At completion of the 3-month intervention (Month 3)]: An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.\\ Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey [3 months after intervention (Month 6)]: An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey [6 months after intervention (Month 9)]: An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey [9 months after intervention (Month 12)]: An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) [Baseline]: Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) [At completion of the 3-month intervention (Month 3)]: Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) [3 months after intervention (Month 6)]: Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) [6 months after intervention (Month 9)]: Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) [9 months after intervention (Month 12)]: Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Secondary outcomes

• Mental Health as Measured by the Brief Symptom Index-18 [baseline]: The Brief Symptom Inventory 18 (BSI-18) consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.
• Mental Health as Measured by the Brief Symptom Index-18 [At completion of the 3-month intervention (Month 3)]: The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.
• Mental Health as Measured by the Brief Symptom Index-18 [3 months after intervention (Month 6)]: The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.
• Mental Health as Measured by the Brief Symptom Index-18 [6 months after intervention (Month 9)]: The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.
• Mental Health as Measured by the Brief Symptom Index-18 [9 months after intervention (Month 12)]: The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.
• Housing Status [baseline]: Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
• Housing Status [At completion of the 3-month intervention (Month 3)]: Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
• Housing Status [3 months after intervention (Month 6)]: Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
• Housing Status [6 months after intervention (Month 9)]: Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
• Housing Status [9 months after intervention (Month 12)]: Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
• Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II [At completion of the 3-month intervention (Month 3), 3 months after intervention (Month 6), 6 months after intervention (Month 9), 9 months after intervention (Month 12)]: An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) [baseline]: The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression
• Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) [At completion of the 3-month intervention (Month 3)]: The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) [3 months after intervention (Month 6)]: The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) [6 months after intervention (Month 9)]: The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) [9 months after intervention (Month 12)]: The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
• Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II [baseline]: An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported.

Sex: All, ages: 16 Years to 25 Years

Inclusion Criteria

* youth engaged in high-risk sexual activity or intravenous drug use
* speak English
* homeless
* not planning to move out of the metro area during the study

Exclusion Criteria:

* youth with very low literacy
* severe acute mental symptoms

Participant flow

Outcome results

• Number of Participants Who Use Preventive Prophylaxis (PrEP) (Primary), Count of participants, Participants: NCM4HIV 20; Usual Care 18
• Number of Participants Who Use Preventive Prophylaxis (PrEP) (Primary), Count of participants, Participants: NCM4HIV 55; Usual Care 21
• Number of Participants Who Use Preventive Prophylaxis (PrEP) (Primary), Count of participants, Participants: NCM4HIV 37; Usual Care 17
• Number of Participants Who Use Preventive Prophylaxis (PrEP) (Primary), Count of participants, Participants: NCM4HIV 45; Usual Care 17
• Number of Participants Who Use Preventive Prophylaxis (PrEP) (Primary), Count of participants, Participants: NCM4HIV 42; Usual Care 12
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) (Primary), Count of participants, Participants: NCM4HIV 6; Usual Care 14
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) (Primary), Count of participants, Participants: NCM4HIV 7; Usual Care 4
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) (Primary), Count of participants, Participants: NCM4HIV 6; Usual Care 4
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) (Primary), Count of participants, Participants: NCM4HIV 10; Usual Care 3
• Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) (Primary), Count of participants, Participants: NCM4HIV 6; Usual Care 5
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey (Primary), Count of participants, Participants: NCM4HIV 86; Usual Care 34
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey (Primary), Count of participants, Participants: NCM4HIV 81; Usual Care 36
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey (Primary), Count of participants, Participants: NCM4HIV 64; Usual Care 41
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey (Primary), Count of participants, Participants: NCM4HIV 84; Usual Care 23
• Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey (Primary), Count of participants, Participants: NCM4HIV 74; Usual Care 34
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) (Primary), Count of participants, Participants: NCM4HIV 63; Usual Care 24
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) (Primary), Count of participants, Participants: NCM4HIV 43; Usual Care 19
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) (Primary), Count of participants, Participants: NCM4HIV 32; Usual Care 13
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) (Primary), Count of participants, Participants: NCM4HIV 44; Usual Care 24
• Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) (Primary), Count of participants, Participants: NCM4HIV 38; Usual Care 18
• 17 more outcome measures not shown.

Adverse events

Time frame: up to 1 year

Serious adverse events by term

• Results publication: Fernandez-Sanchez H, Jones J, Arandhara U, Padhye N, Nyamathi A, Lightfoot M, Quadri Y, Paul M, Businelle MS, Maria DS. Prevalence and characteristics of sex trafficking among youth experiencing homelessness: A cross-sectional study. PLoS One. 2026 Aug 26;21(8):e0357091. doi: 10.1371/journal.pone.0357091. eCollection 2026. PMID 42647548
• Results publication: Maria DS, Nyamathi A, Lightfoot M, Paul M, Quadri Y, Padhye N, Businelle M, Fernandez-Sanchez H, Jones JT. Results of a Randomized Wait-List Controlled Trial of CAYA: A Nurse Case Management HIV Prevention Intervention for Youth Experiencing Homelessness. AIDS Behav. 2025 Feb;29(2):613-625. doi: 10.1007/s10461-024-04544-3. Epub 2024 Nov 12. PMID 39531116
• Results publication: Santa Maria DM, Padhye N, Ostrosky-Zeichner L, Grimes CZ, Nyamathi A, Lightfoot M, Quadri Y, Paul ME, Jones JT. COVID-19 Vaccination Uptake, Infection Rates, and Seropositivity Among Youth Experiencing Homelessness in the United States. Nurs Res. 2024 Sep-Oct 01;73(5):373-380. doi: 10.1097/NNR.0000000000000747. Epub 2024 May 10. PMID 38809559

• Study Protocol and Statistical Analysis Plan (PDF, 2021-03-09)
• Informed Consent Form (PDF, 2021-03-09)

• Diane Santa Maria, DrPH, Principal investigator, The University of Texas Health Science Center, Houston