Status:
RECRUITING
The Collaborative Care PrTNER Study
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Johns Hopkins University
Baltimore City Health Department
Conditions:
HIV
Substance Use Disorders
Eligibility:
MALE
15-24 years
Phase:
NA
Brief Summary
A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophyla...
Detailed Description
The Collaborative Care (CC) PrTNER is a multi-component intervention developed by members of the research team specifically for YBLMSM aged 15 to 24 who are at-risk for or living with HIV. This model ...
Eligibility Criteria
Inclusion
- Aim 1:
- 15-24 years old;
- Cisgender male;
- Self-identified Black/African American race or Latino/Hispanic ethnicity;
- Report prior oral/anal sex with another male;
- At-risk for HIV (condomless anal sex or positive sexually transmitted infection (STI) in last 6 months);
- 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:
- 15-24 years old;
- Cisgender male;
- Self-identified Black/African American race or Latino/Hispanic ethnicity;
- Report prior oral/anal sex with another 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
- Aim 2:
- Participants will be excluded if they are:
- Assigned female sex at birth
- Identify as transgender
- Outside the age criteria (\<15 or \>24 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 oral or anal sex;
- Unable to read or write in English,
- Plan to move in the next 12 months.
Key Trial Info
Start Date :
January 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06585631
Start Date
January 2 2025
End Date
June 1 2028
Last Update
August 29 2025
Active Locations (2)
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1
Johns Hopkins Center for Adolescent and Young Adult Health
Baltimore, Maryland, United States, 21205
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146