Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services (CoMPASS)

  • STATUS
    Recruiting
  • End date
    May 31, 2026
  • participants needed
    526
  • sponsor
    Yale University
Updated on 11 May 2022
Accepts healthy volunteers

Summary

The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to promote HIV prevention among individuals with opioid use disorder who inject drugs. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .

Description

Consistent with a Hybrid Effectiveness-Implementation Type 1 design, this is a multi-site randomized clinical trial designed to evaluate the effectiveness of Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS) vs. treatment as usual (TAU) on HIV risk reduction among individuals with opioid use disorder (OUD) who inject drugs. The study will be conducted in community-based settings serving individuals with opioid use disorder to assess the effectiveness of CoMPASS on promoting: sustained PrEP adherence (primary outcome) and HIV risk behaviors, engagement in opioid use disorder-related care, opioid use (secondary outcomes); and sexually transmitted infections and HIV (exploratory). Participants randomized to CoMPASS will first receive contingency management and have the potential to earn prizes for making progress towards initiation of and consistent adherence to HIV pre-exposure prophylaxis (PrEP) and engagement in OUD-related care. Individuals who do not demonstrate PrEP adherence (based on self-report, confirmed by urine testing for tenofovir metabolites at week 12), will be "stepped up" to PrEP Adherence and Support Services (PASS). The intervention is 24 weeks in duration. Participants randomized to TAU will receive a health handout on HIV risk reduction approaches, including PrEP and OUD-related care, and where to access such services.

To inform future implementation efforts, factors relevant for scale-up in parallel (e.g., completion of study visits, attitudes regarding the intervention among front-line staff) will be assessed.

Details
Condition Opioid-use Disorder, HIV Prevention Program
Treatment Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)
Clinical Study IdentifierNCT04738825
SponsorYale University
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aims 1 and 2
Receive or willing to receive care at one of the participating study sites
Have a recent negative HIV test with no concern for acute HIV
Report injection drug use in the past 6 months
Meet PrEP eligibility criteria by either a) sharing of injection or drug preparation equipment; b) sexual risk behaviors (i.e. condomless sex or STI) in the past 6 months
Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder
Have a cell phone or use of a household member's cell phone
Provide written informed consent
Aim 3
Currently employed at one of the participating study sites
Willing to complete a web-based survey

Exclusion Criteria

Aims 1 and 2
Currently prescribed PrEP
Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive
Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.)
Inability to provide at least one collateral contact for a friend or family member
Non-English speaking (for sites without Spanish-speaking staff)
Have kidney disease (a contraindication to PrEP)
Aim 3
Non-English speaking
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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