Collaborative care program for young Black and Latino men at risk for HIV
The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project
This study tests a new support program to help young Black and Latino men at risk for HIV start taking prevention medication and manage their substance use better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 15 Years to 29 Years |
| Sex | Male |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06585631 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention aimed at increasing the initiation of preexposure prophylaxis (PrEP) and reducing viral load among young Black and Latino men who have sex with men, aged 15 to 24. The intervention integrates substance use treatment with HIV care, utilizing a collaborative care model that includes feedback from a psychiatrist and support from a peer coach. Participants will be randomly assigned to assess the effectiveness of this multi-component approach in addressing both HIV risk and substance use behaviors.
Who should consider this trial
Good fit: Ideal candidates are young Black or Latino cisgender males aged 15 to 24 who are at-risk for HIV or living with HIV and have moderate-to-high risk substance use behaviors.
Not a fit: Patients who do not identify as Black or Latino, are older than 24, or do not have moderate-to-high risk substance use behaviors may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve HIV prevention and treatment outcomes for young Black and Latino men who have sex with men.
How similar studies have performed: Other studies have shown success with integrated care models for HIV prevention and treatment, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Aim 1: * 15-24 years old; * Cisgender male; * History of condomless sex; * Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2, * Living in Philadelphia, PA or Baltimore, MD, and surrounding areas; * Able to read and write in English Aim 2: * 15-29 years old; * Cisgender male; * Living with a diagnosis of HIV; * CRAFFT score ≥2, * Living in Philadelphia, PA or Baltimore, MD, and surrounding areas; * Able to read and write in English Aim 3 • All randomized study participants will be included in Aim 3. Exclusion Criteria: Aim 2: * Participants will be excluded if they are: * Assigned female sex at birth * Identify as transgender * Outside the age criteria (\<15 or \>29 years old) * Cognitively unable to complete study requirements * Living outside of the two geographic areas * Do not screen positive for SU * No prior substance use history * No prior condomless sex; * Unable to read or write in English, * Plan to move in the next 12 months.
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Center for Adolescent and Young Adult Health — Baltimore, Maryland, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Renata Sanders, MD — Children's Hospital of Philadelphia
- Study coordinator: Renata Sanders, MD
- Email: sandersr2@chop.edu
- Phone: 215-590-5633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.