The Collaborative Care PrTNER Study
Purpose
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 aged 15 to 29 through engagement in SU treatment.
Conditions
- HIV
- Substance Use Disorders
- Substance Use
- AIDS
Eligibility
- Eligible Ages
- Between 15 Years and 29 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Young men will be randomized (1:1) to intervention vs. SOC for each aim, using a computer-stratified randomization to yield balanced randomization between younger (15-19, 20-24) & older (25-29) age groups and based on substance use risk as determined by their screener questionnaire. A separate stratum will be defined for each combination of covariates (age group and substance use risk) and participants will be randomized. Participants will sign a release of medical information for HIV/SU/Mental Health Disorders outcomes. Visits occur at baseline (time 0), 3, 6, 9, and 12 months. Participants will complete an interviewer-administered, electronic baseline and quarterly surveys followed by the collection of samples for biologic measures. Survey assess individual, interpersonal, multi-level barriers to HIV prevention care and treatment in the community, and structural levels. The survey will identify varying severity of hazardous/harmful substance use and co-existing mental health needs.
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals. |
|
|
No Intervention Standard of Care |
The participant's provider will receive an electronic alert in real time of the participant's positive screen for SU and a list of area substance treatment resources. The provider at their discretion will provide counseling or initiate a referral to in-clinic or community-based resources for SU assessment and treatment. Each of our clinical sites has case management resources for counseling and support for linkage to co-located SU treatment or community-based resources for inpatient or outpatient SU treatment as indicated at the discretion of the HIV/PrEP provider. SOC arm participants will not be assigned a coach. Study visit surveys and sample collection at baseline, 3, 6, 9, and 12 months are identical for intervention and SOC arm participants. Research personnel will make no attempts to provide brief intervention, motivational interviewing (MI), or case management. |
|
Recruiting Locations
Philadelphia, Pennsylvania 19146
More Details
- NCT ID
- NCT06585631
- Status
- Recruiting
- Sponsor
- Children's Hospital of Philadelphia
Detailed Description
The Collaborative Care (CC) PrTNER is a multi-component intervention developed by members of the research team specifically for young men aged 15 to 29 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).