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Can rewards and support keep drug users HIV-Free?

NCT ID NCT04738825

Prevention Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 6 times

Summary

This study tests a 24-week program called CoMPASS that uses rewards (contingency management) and extra support to help people who inject drugs take PrEP consistently for HIV prevention. About 526 participants with opioid use disorder will be enrolled. Those who don't stick with PrEP after 12 weeks get stepped up to more intensive adherence support. The goal is to see if this approach improves PrEP use and reduces HIV risk behaviors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Contingency management with stepped care to PrEP adherence and support services (CoMPASS)
What this could lead to
If it works, this could provide an effective way to help people who inject drugs stay on PrEP and lower their HIV risk.
What could go wrong
This is a behavioral intervention study, not a drug trial, so results may vary by individual. The program is complex and may be hard to scale in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 526 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

opiate dependence HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV prevention program Opioid use disorder

Contacts and locations

Locations

  • Apex Community Care. Inc.

    Danbury, Connecticut, 06810, United States

  • Connecticut Harm Reduction Alliance (GHHRC and SWAN)

    New Haven, Connecticut, 06511, United States

  • Liberations Program, Inc

    Bridgeport, Connecticut, 06604, United States

  • Recovery Network of Programs, Inc

    Bridgeport, Connecticut, 06484, United States

  • Stanley Street Treatment and Resource Center

    Fall River, Massachusetts, 02720, United States

  • The APT Foundation (Legion and Long Wharf)

    New Haven, Connecticut, 06519, United States

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