NCT04738825

Brief 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. .

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2021May 2027

First Submitted

Initial submission to the registry

January 29, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4.7 years

First QC Date

January 29, 2021

Last Update Submit

May 5, 2026

Conditions

Opioid-use DisorderHIV Prevention Program

Keywords

People who inject drugsPre-exposure prophylaxis (PrEP)Medications for opioid use disorderOpioid use disorderHIV prevention

Outcome Measures

Primary Outcomes (1)

  • Sustained PrEP adherence

    Determined by tenovifir-diphosphate levels by dried blood spot testing.

    24 weeks

Secondary Outcomes (8)

  • Sustained PrEP adherence

    12 weeks

  • Recent PrEP adherence

    12 weeks

  • HIV Risk Behaviors

    12 weeks

  • HIV Risk Behaviors

    24 weeks

  • Engagement in opioid use disorder-related care

    12 weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Sexually transmitted infection and HIV acquisition

    12 months

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

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.

Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)

EXPERIMENTAL

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).

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

Interventions

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

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).

Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Recovery Network of Programs, Inc

Bridgeport, Connecticut, 06484, United States

Location

Liberations Program, Inc

Bridgeport, Connecticut, 06604, United States

Location

Apex Community Care. Inc.

Danbury, Connecticut, 06810, United States

Location

Greater Hartford Harm Reduction Coalition- SWAN

New Haven, Connecticut, 06511, United States

Location

APT

New Haven, Connecticut, 06519, United States

Location

Stanley Street Treatment and Resource Center

Fall River, Massachusetts, 02720, United States

Location

Related Publications (2)

  • Pickering E, Viera A, Sung ML, Davidson D, Bailey G, Buchelli M, Jenkins M, Kolakowski J, Maier L, Edelman EJ, Rash CJ. Readiness to implement contingency management to promote PrEP initiation and adherence among people who inject drugs: results from a multi-site implementation survey. Addict Sci Clin Pract. 2024 Dec 23;19(1):97. doi: 10.1186/s13722-024-00503-4.

    PMID: 39710733DERIVED

  • Sung ML, Viera A, Esserman D, Tong G, Davidson D, Aiudi S, Bailey GL, Buchanan AL, Buchelli M, Jenkins M, John B, Kolakowski J, Lame A, Murphy SM, Porter E, Simone L, Paris M, Rash CJ, Edelman EJ. Contingency Management and Pre-Exposure Prophylaxis Adherence Support Services (CoMPASS): A hybrid type 1 effectiveness-implementation study to promote HIV risk reduction among people who inject drugs. Contemp Clin Trials. 2023 Feb;125:107037. doi: 10.1016/j.cct.2022.107037. Epub 2022 Nov 30.

    PMID: 36460267DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • E. Jennifer Edelman, MD, MHS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Aims 1 and 2: Randomized controlled trial to evaluate the effectiveness of contingency management with stepped care to PrEP adherence and support services (Compass) compared to treatment as usual. Aim 3: Implementation-focused process evaluation to gain information on implementation of the intervention from perspectives of participants as well as front-line providers and staff
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 4, 2021

Study Start

October 4, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(6)