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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Connecticut
Liberations Program, Inc
RECRUITING
Bridgeport
Recovery Network of Programs, Inc
TERMINATED
Bridgeport
Apex Community Care. Inc.
TERMINATED
Danbury
APT
RECRUITING
New Haven
Greater Hartford Harm Reduction Coalition- SWAN
RECRUITING
New Haven
Massachusetts
Stanley Street Treatment and Resource Center
RECRUITING
Fall River
Contact Information
Primary
June-Marie C Weiss, MA, MEd
junemarie.weiss@yale.edu
203-737-3347
Time Frame
Start Date: 2021-10-04
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 526
Treatments
No_intervention: Treatment as Usual (TAU)
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. They will receive standard care as provided by the community-based organization and by their medical provider.
Experimental: Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)
Participants randomized to Compass will also receive a health handout on HIV risk reduction approaches. They will also 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).
Authors
Albana Lame
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Yale University

This content was sourced from clinicaltrials.gov