RecruitingNot ApplicableNCT04738825

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

Sponsor

Yale University

Enrollment

526 participants

Start Date

Oct 4, 2021

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder HIV Prevention Program

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 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

Min Age: 18 Years

Inclusion Criteria11

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 their lifetime
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 phone or use of a household member's phone
Provide written informed consent
Aim 3:
Currently employed at one of the participating study sites
Willing to complete a web-based survey

Exclusion Criteria9

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

Interventions

BEHAVIORALContingency Management with stepped care to PrEP adherence and support services (CoMPASS)

Participants will receive contingency management sessions (n=9). Participants who do not demonstrate PrEP adherence by week 12 will be "stepped up" to receive PrEP adherence and support services (n=5).