The Collaborative Care PrTNER Study (PrTNER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Substance Use; Substance Use Disorders; AIDS
• Intervention / Treatment: Behavioral: CC PrTNER

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).

• Study Type: Interventional
• Enrollment (Estimated): 275
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renata Sanders, MD; Phone Number: 215-590-5633; Email: sandersr2@chop.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Not yet recruiting
      • Johns Hopkins Center for Adolescent and Young Adult Health
      • Contact: Christopher Hammond, MD; Phone Number: 410-550-0048; Email: chammo20@jhmi.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Recruiting
      • Children's Hospital of Philadelphia
      • Principal Investigator: Marne Castillo, PhD, MEd
      • Principal Investigator: Nadia Dowshen, MD, MSHP
      • Contact: Bevin Gwiazdowski, MSW; Phone Number: 215-840-6813; Email: gwiazdowsb@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP uptake at 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)	12 months
HIV virologic suppression at 12 months	Viral load < 20 copies/mL from baseline to 12 months	12 months
Number of days of past-28-day non-tobacco drug/alcohol use	Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP persistence	Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months	12 months
Sustained viral suppression	Duration of time participants are virally suppressed from baseline to 12 months	12 months
Uptake of HIV Antiretroviral therapy (ART) treatment	Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months	12 months
Mean number of negative urine drug screens (UDS)	Mean number of negative UDS at 12 months	12 months
Substance-related problems	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	12 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute on Drug Abuse (NIDA); Johns Hopkins University; Baltimore City Health Department
• Investigators: Principal Investigator: Renata Sanders, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: HIV; peer coaches; PrEP; adolescents; AIDS; community health worker; alcohol use; preexposure prophylaxis; Substance use; drug use; young male; young men; young males; Substances use disorder; adolescent males
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Chemically-Induced Disorders; Drinking Behavior; Slow Virus Diseases; HIV Infections; Behavior; Alcohol Drinking; Substance-Related Disorders; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 23-021859; R01DA059022 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be shared between sites and made available to other NIH funded researchers upon approval of written official request and shared via applicable Johns Hopkins University Data Transfer Agreements. No data will be released that would allow the identification of any respondent, unless written informed permission for this is obtained.

Data will also be shared with key stakeholders throughout the study, between sites, and made available to study participants after the analysis is completed. We will summarize and present findings in a summary report, webinar, and in a face-to-face meeting at each site once analyses are completed. The summary report will be emailed to participants, including, adolescents, providers, and community partners about the findings of the work. As part of the Center for AIDS Research (CFAR) Initiatives, we will share our findings and data, when appropriate, with the Baltimore and Philadelphia CFARs and Ryan White sites.

• IPD Sharing Time Frame: Data will be shared between sites and with key stakeholders throughout the study. At the conclusion of the study data will be made available to participants.
• IPD Sharing Access Criteria: Applicable Johns Hopkins University Data Transfer Agreements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No