The Collaborative Care PrTNER Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06585631
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
15 Years - 29 Years
Healthy Volunteers
Accepted

Interventions

  • CC PrTNER — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 2, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
275 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

PrEP uptake at 12 months [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Adolescent and Young Adult HealthBaltimoreMaryland21205
Christopher Hammond, MD
[email protected]
410-550-0048
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146
Bevin Gwiazdowski, MSW
[email protected]
215-840-6813
Marne Castillo, PhD, MEd (PRINCIPAL_INVESTIGATOR)
Nadia Dowshen, MD, MSHP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
HIVSubstance use disorder
By specialty
Infectious diseaseBehavioral healthAddiction medicine
By research site
Johns Hopkins Center for Adolescent and Young Adult Health· Baltimore, MDChildren's Hospital of Philadelphia· Philadelphia, PA

Related Studies