Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06585631

The Collaborative Care PrTNER Study

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
275 (estimated)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
Male
Age
15 Years – 29 Years
Healthy volunteers
Accepted

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.

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALCC PrTNERParticipants 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.

Timeline

Start date
2025-01-02
Primary completion
2028-06-01
Completion
2028-06-01
First posted
2024-09-05
Last updated
2026-04-14

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06585631. Inclusion in this directory is not an endorsement.