NCT06585631 · Children's Hospital of Philadelphia
The Collaborative Care PrTNER Study
(PrTNER)
What this study is about
A randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
CC PrTNER
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 outcome measures
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)
HIV virologic suppression at 12 months
Time frame: 12 months
Viral load \< 20 copies/mL from baseline to 12 months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- Baltimore, Maryland
- Philadelphia, Pennsylvania
Collaborators
Johns Hopkins University, Baltimore City Health Department, National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations