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NCT Number: NCT06585631

The Collaborative Care PrTNER Study

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC PrTNER

Behavioral

Participants randomized to CC PrTNER will be assigned a peer coach. They will conduct interviewer-administered behavioral surveys. The surveys provide an in-depth assessment of SU, HIV prevention and care, engagement, and adherence. Behavioral surveys are administered monthly. The coach will discuss with the participant the areas that are flagged by the psychiatrist; provide psychoeducation around areas identified, and work with the participant to identify their health goals and how changes in SU may help feed into self-defined goals. The coach will meet weekly with the consultant addiction psychiatrist who will make a provisional diagnosis and define a treatment plan with clear goals for treatment outcome. Recommendations will be communicated electronically to the HIV or PrEP provider to facilitate implementation. The coach utilizes MI skills to implement the individually tailored to facilitate the adoption and maintenance of health behaviors.

Primary outcomes

  1. PrEP uptake at 12 months

    Time frame: 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)

  2. HIV virologic suppression at 12 months

    Time frame: 12 months

    Viral load < 20 copies/mL from baseline to 12 months

  3. Number of days of past-28-day non-tobacco drug/alcohol use

    Time frame: 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 outcomes

  1. PrEP persistence

    Time frame: 12 months

    Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months

  2. Sustained viral suppression

    Time frame: 12 months

    Duration of time participants are virally suppressed from baseline to 12 months

  3. Uptake of HIV Antiretroviral therapy (ART) treatment

    Time frame: 12 months

    Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months

  4. Mean number of negative urine drug screens (UDS)

    Time frame: 12 months

    Mean number of negative UDS at 12 months

  5. Substance-related problems

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Renata Sanders, MD

CONTACT

[email protected]

215-590-5633

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Baltimore City Health Department
  • Johns Hopkins University
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project

Acronym: PrTNER

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 5, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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