The Collaborative Care PrTNER Study
PrTNER
2 other identifiers
interventional
275
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Jan 2025
Typical duration for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2024
CompletedFirst Posted
Study publicly available on registry
September 5, 2024
CompletedStudy Start
First participant enrolled
January 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 14, 2026
April 1, 2026
3.4 years
September 3, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
PrEP persistence
12 months
Sustained viral suppression
12 months
Uptake of HIV Antiretroviral therapy (ART) treatment
12 months
Mean number of negative urine drug screens (UDS)
12 months
Substance-related problems
12 months
Study Arms (2)
Intervention
EXPERIMENTALParticipants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals.
Standard of Care
NO INTERVENTIONThe 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
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.
Eligibility Criteria
You may qualify if:
- Aim 1:
- 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:
- 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
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- Johns Hopkins Universitycollaborator
- Baltimore City Health Departmentcollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
Johns Hopkins Center for Adolescent and Young Adult Health
Baltimore, Maryland, 21205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renata Sanders, MD
Children's Hospital of Philadelphia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2024
First Posted
September 5, 2024
Study Start
January 2, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- Access Criteria
- Applicable Johns Hopkins University Data Transfer Agreements
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.