The Collaborative Care PrTNER Study

Not Applicable

Recruiting

• Conditions: HIV; Substance Use Disorders; Substance Use; AIDS
• Interventions: Behavioral: CC PrTNER

• Registration Number: NCT06585631
• Lead Sponsor: Children's Hospital of Philadelphia

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 prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young Black and Latino men who have sex with men (YBLMSM) aged 15 to 24 through engagement in SU treatment.

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 moves beyond the individual to consider the broader context in which, substance use (SU), and HIV risk are (re)produced.

Enhanced models that integrate SU treatment into HIV and PrEP primary care services (using a collaborative care approach that incorporates feedback from a psychiatrist and support from a peer coach) are needed to address the nuance of substance use in this population. We, therefore, are proposing to conduct a randomized trial to evaluate an integrated collaborative care model (CC PrTNER).

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-05
• Study Start: 2025-01-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 275

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	CC PrTNER	Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals.

Primary Outcome Measures

Name	Time	Method
PrEP uptake at 12 months	12 months	PrEP uptake from baseline to 12 month survey. Biomedical assessment of PrEP use at 12 months, Intraerythrocytic Tenofovir-Diphosphate (TVF-DP) from dried blood spot (DBS) \>700 fmol/punch (oral PrEP), 2+ on-time injections of Long-acting injectable cabotegravir (CAB-LA)
HIV virologic suppression at 12 months	12 months	Viral load \< 20 copies/mL from baseline to 12 months
Number of days of past-28-day non-tobacco drug/alcohol use	12 months	Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
PrEP persistence	12 months	Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months
Sustained viral suppression	12 months	Duration of time participants are virally suppressed from baseline to 12 months
Uptake of HIV Antiretroviral therapy (ART) treatment	12 months	Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months
Mean number of negative urine drug screens (UDS)	12 months	Mean number of negative UDS at 12 months
Substance-related problems	12 months	Substance-related problems as defined by Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), and Severity of Dependence Scale (SDS scores) from baseline to 12 months

Trial Locations

Locations (2)

Johns Hopkins Center for Adolescent and Young Adult Health; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States