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

NCT04738825

Active Not RecruitingNA

Sponsor: Yale University

Conditions: Opioid-use Disorder, HIV Prevention Program

Interventions: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)

Countries: United States

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 have injected drugs in their lifetime. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Aims 1 and 2:

1. Receive or willing to receive care at one of the participating study sites
2. Have a recent negative HIV test with no concern for acute HIV
3. Report injection drug use in their lifetime
4. 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
5. Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder
6. Have a phone or use of a household member's phone
7. Provide written informed consent

Aim 3:

1. Currently employed at one of the participating study sites
2. Willing to complete a web-based survey

Exclusion criteria:

Aims 1 and 2:

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

Aim 3:

1\. Non-English speaking

Locations (6)

Bridgeport, Connecticut, United States
Bridgeport, Connecticut, United States
Danbury, Connecticut, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
Fall River, Massachusetts, United States