Opioid-use DisorderCoMPASSNCT04738825
Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
A study testing Contingency Management with stepped care to PrEP adherence and support services (CoMPASS) in people with Opioid-use Disorder and HIV Prevention Program, run by Yale University at 6 sites in United States.
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 have injected drugs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, HIV Prevention Program
- What is being tested?
- Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Oct 2021to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- Have kidney disease (a contraindication to PrEP)
- Aim 3:
- 1. Non-English speaking
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Recovery Network of Programs, Inc
Bridgeport, Connecticut, 06484
Liberations Program, Inc
Bridgeport, Connecticut, 06604
Apex Community Care. Inc.
Danbury, Connecticut, 06810
Stanley Street Treatment and Resource Center
Fall River, Massachusetts, 02720
Connecticut Harm Reduction Alliance (GHHRC and SWAN)
New Haven, Connecticut, 06511
The APT Foundation (Legion and Long Wharf)
New Haven, Connecticut, 06519
About this study
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. .
Read the detailed 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 have injected drugs in their lifetime. 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.
- Conditions
- Opioid-use Disorder, HIV Prevention Program
- Being tested
- Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)
- Keywords
- People who inject drugs, Pre-exposure prophylaxis (PrEP), Medications for opioid use disorder, Opioid use disorder, HIV prevention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained PrEP adherence
Determined by tenofovir-diphosphate levels by dried blood spot testing or objective confirmation.
Measured: 24 weeks
Secondary outcomes (9)
Sustained PrEP adherence
Determined by tenofovir-diphosphate levels by dried blood spot testing or objective confirmation.
Measured: 12 weeks
Recent PrEP adherence
Self-report adherence confirmed by the presence of tenofovir in urine sample or objective confirmation.
Measured: 12 weeks
Recent PrEP adherence
Self-report adherence confirmed by the presence of tenofovir in urine sample or objective confirmation.
Measured: 24 weeks
HIV Risk Behaviors
Self-reported HIV risk behaviors
Measured: 12 weeks
HIV Risk Behaviors
Self-reported HIV risk behaviors
Measured: 24 weeks
Engagement in opioid use disorder-related care
Self report of engagement in opioid use disorder-related care
Measured: 12 weeks
Engagement in opioid use disorder-related care
Self report of engagement in opioid use disorder-related care
Measured: 24 weeks
Extra medical opioid use
Self reported extra medical opioid use
Measured: 12 weeks
Extra medical opioid use
Self reported extra medical opioid use
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start4 Oct 2021
- Primary completion31 Jul 2026
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- E. Jennifer Edelman, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738825
- Sponsor's protocol ID
- 2000029351
- Other IDs
- R01DA051871
- Acronym
- CoMPASS
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39710733Sung 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.
PubMed 36460267
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
- ClinicalTrials.gov ID
- NCT04738825
- Acronym / sponsor ID
- CoMPASS / 2000029351
- Conditions
- Opioid-use Disorder, HIV Prevention Program
- Keywords
- People who inject drugs, Pre-exposure prophylaxis (PrEP), Medications for opioid use disorder, Opioid use disorder, HIV prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Detailed 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 have injected drugs in their lifetime. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS) |
Primary outcome
Sustained PrEP adherence
Time frame: 24 weeks
Determined by tenofovir-diphosphate levels by dried blood spot testing or objective confirmation.
9 secondary outcomes
Sustained PrEP adherence
Time frame: 12 weeks
Recent PrEP adherence
Time frame: 12 weeks
Recent PrEP adherence
Time frame: 24 weeks
HIV Risk Behaviors
Time frame: 12 weeks
HIV Risk Behaviors
Time frame: 24 weeks
Engagement in opioid use disorder-related care
Time frame: 12 weeks
Engagement in opioid use disorder-related care
Time frame: 24 weeks
Extra medical opioid use
Time frame: 12 weeks
Extra medical opioid use
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 39710733Pickering 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.
- Derived from this study: PubMed 36460267Sung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Jennifer Edelman, MD, MHS principal investigator
Yale University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management with stepped care to PrEP adherence and support services (CoMPASS) in people with Opioid-use Disorder and HIV Prevention Program, run by Yale University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained PrEP adherence (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.