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

Opioid-use Disorder Clinical Trial

— CoMPASS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04738825
• Other study ID #: 2000029351
• Secondary ID: R01DA051871
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: June-Marie C Weiss, MA, MEd
• Phone: 203-737-3347
• Email: junemarie.weiss[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 526
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention Program
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Contingency 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).

Locations

Country	Name	City	State
United States	Liberations Program, Inc	Bridgeport	Connecticut
United States	Recovery Network of Programs, Inc	Bridgeport	Connecticut
United States	Apex Community Care. Inc.	Danbury	Connecticut
United States	Stanley Street Treatment and Resource Center	Fall River	Massachusetts
United States	APT	New Haven	Connecticut
United States	Greater Hartford Harm Reduction Coalition- SWAN	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sexually transmitted infection and HIV acquisition	State surveillance data	12 months
Primary	Sustained PrEP adherence	Determined by tenovifir-diphosphate levels by dried blood spot testing.	24 weeks
Secondary	Sustained PrEP adherence	Determined by tenovifir-diphosphate levels by dried blood spot testing. .	12 weeks
Secondary	Recent PrEP adherence	Self-report adherence confirmed by the presence of tenofivir in urine sample.	12 weeks
Secondary	HIV Risk Behaviors	Self-reported HIV risk behaviors	12 weeks
Secondary	HIV Risk Behaviors	Self-reported HIV risk behaviors	24 weeks
Secondary	Engagement in opioid use disorder-related care	Self report of engagement in opioid use disorder-related care	12 weeks
Secondary	Engagement in opioid use disorder-related care	Self report of engagement in opioid use disorder-related care	24 weeks
Secondary	Extra medical opioid use	Self reported extra medical opioid use	12 weeks
Secondary	Extra medical opioid use	Self reported extra medical opioid use	24 weeks