Substance UseCHPNCT06307977
Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
A study testing Couples Health Project in people with Substance Use and HIV Infections, run by Hunter College of City University of New York at 3 sites in United States.
Trial summary
This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use, HIV Infections
- What is being tested?
- Couples Health Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 May 2024to Feb 2029
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a main partner who is another cisgender male and have been in a relationship for 3 month or longer
- Index participant must be between 18 and 55; Main partner can be any age 18 and older
- One participant must be HIV negative (as confirmed by rapid test)
- One participant must have used at least 1 drug in the past 30 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)
- Index participant must have engaged in TRB in the past 30 days- Defined as CAS with a casual partner, or a serodiscordant or non-monogamous main partner
- Live in the United States
- Speak and read English
Who cannot join
- Any signs of serious mental illness or cognitive deficit
- Current suicidal/homicidal ideations
- History of IPV with their main partner and safety concerns in the current relationship.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Active, not recruiting
University of Virginia
Charlottesville, Virginia, 22904
- Active, not recruiting
Wayne State University
Detroit, Michigan, 48201
- Recruiting
Hunter College
New York, New York, 10018
Tyrel J Starks, 212-206-7919, tstarks@hunter.cuny.edu
Demetria Cain, 212-206-7919, dcain@prideresearch.org
About this study
This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).
- Conditions
- Substance Use, HIV Infections
- Being tested
- Couples Health Project
- Medical subject headings
- Substance-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Health ProjectBehavioural
Also called CHP
A 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: CHTC as usual | No intervention | Participants complete the standard Couples HIV Testing and Counseling session (CHTC). |
| Behavioral: Couples Health Project | Active comparator | A three-session intervention for couples addressing couples communication skills, substance use, sexual agreements. The intervention also includes couples HIV testing and counseling in the final session. Receives: Behavioral: Couples Health Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use Frequency
Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments
Measured: 9 Months
Urine assay for drug use
Positive urine screen for drug use assessed bi-annually
Measured: 9 Months
CAS with casual partners
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments in the absence of adequate PrEP coverage
Measured: 9 Months
Secondary outcomes (3)
Bacterial sexually transmitted infections
Any chlamydia or gonorrhea diagnosis
Measured: 9 Months
Binge Drinking
Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Measured: 9 Months
PrEP Uptake
self-reported receipt of a PrEP-prescription
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 May 2024
- Primary completionJan 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tyrel Starks, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307977
- Sponsor's protocol ID
- R01DA059272
- Acronym
- CHP
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Starks TJ, Hillesheim JR, Castiblanco J, Robles G, S Ingersoll K, Outlaw AY, Cain D. A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the Couples Health Project. BMC Public Health. 2024 Nov 19;24(1):3216. doi: 10.1186/s12889-024-20719-y.
PubMed 39563247
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
- ClinicalTrials.gov ID
- NCT06307977
- Acronym / sponsor ID
- CHP / R01DA059272
- Conditions
- Substance Use, HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 May 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Mar 2024 (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.
This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).
| Arm | Type | Receives |
|---|---|---|
| No Intervention: CHTC as usual | No intervention | –Participants complete the standard Couples HIV Testing and Counseling session (CHTC). |
| Behavioral: Couples Health Project | Active comparator | Behavioral: Couples Health ProjectA three-session intervention for couples addressing couples communication skills, substance use, sexual agreements. The intervention also includes couples HIV testing and counseling in the final session. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have a main partner who is another cisgender male and have been in a relationship for 3 month or longer
- Index participant must be between 18 and 55; Main partner can be any age 18 and older
- One participant must be HIV negative (as confirmed by rapid test)
- One participant must have used at least 1 drug in the past 30 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)
- Index participant must have engaged in TRB in the past 30 days- Defined as CAS with a casual partner, or a serodiscordant or non-monogamous main partner
Key exclusion criteria (3 listed)
- Any signs of serious mental illness or cognitive deficit
- Current suicidal/homicidal ideations
- History of IPV with their main partner and safety concerns in the current relationship.
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 |
|---|---|---|
| Couples Health ProjectAlso: CHPA 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention | Behavioural | Behavioral: Couples Health Project |
Primary outcome
Drug use Frequency
Time frame: 9 Months
Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments
Urine assay for drug use
Time frame: 9 Months
Positive urine screen for drug use assessed bi-annually
CAS with casual partners
Time frame: 9 Months
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments in the absence of adequate PrEP coverage
3 secondary outcomes
Bacterial sexually transmitted infections
Time frame: 9 Months
Binge Drinking
Time frame: 9 Months
PrEP Uptake
Time frame: 9 months
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 17 Sep 2026.
- Derived from this study: PubMed 39563247Starks TJ, Hillesheim JR, Castiblanco J, Robles G, S Ingersoll K, Outlaw AY, Cain D. A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the Couples Health Project. BMC Public Health. 2024 Nov 19;24(1):3216. doi: 10.1186/s12889-024-20719-y.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples Health Project in people with Substance Use and HIV Infections, run by Hunter College of City University of New York at 3 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Contact Tyrel J Starks, PHD (212-206-7919, tstarks@hunter.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug use Frequency (time frame: 9 Months). The study lists 3 primary outcomes in all. 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 NCT06307977, which also lists 1 linked publication.
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 17 Sep 2026.