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Recruiting NCT06585631

The Collaborative Care PrTNER Study

No phase Interventional HIV Substance Use Disorders Substance Use AIDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CC PrTNER.
Who it may be relevant to
Registry conditions: HIV, Substance Use Disorders, Substance Use, AIDS. Basic parameters: 15 years — 29 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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 S

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • PrEP persistence [Time frame: 12 months]
  • Sustained viral suppression [Time frame: 12 months]
  • Uptake of HIV Antiretroviral therapy (ART) treatment [Time frame: 12 months]
  • Mean number of negative urine drug screens (UDS) [Time frame: 12 months]
  • Substance-related problems [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 2 centers
  • Johns Hopkins Center for Adolescent and Young Adult Health — Baltimore
  • Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT06585631 · 23-021859 · R01DA059022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗