Recruiting

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06585631

Conditions

HIV

Substance Use Disorders

Substance Use

AIDS

Eligibility Criteria

Sex: Male

Age: 15 - 29

Healthy Volunteers: Accepted

Interventions

CC PrTNER

Study Details

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 aged 15 to 29 through engagement in SU treatment.

Conditions

HIV

Substance Use Disorders

Substance Use

AIDS

Study ID

NCT06585631

Start date

Jan 2, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 15 - 29

Healthy Volunteers: Accepted

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

Enrollment

275 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • PrEP uptake at 12 months [ Time Frame: 12 months ]
  • HIV virologic suppression at 12 months [ Time Frame: 12 months ]
  • Number of days of past-28-day non-tobacco drug/alcohol use [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Renata Sanders, MD

215-590-5633sandersr2@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Bevin Gwiazdowski, MSW

215-840-6813gwiazdowsb@chop.edu

Principal Investigator:

Marne Castillo, PhD, MEd

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • HIV
  • AIDS
  • Substance use
  • Substances use disorder
  • drug use
  • alcohol use
  • preexposure prophylaxis
  • PrEP
  • peer coaches
  • community health worker
  • young men
  • adolescents
  • young male
  • young males
  • adolescent males

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-05-18.