Substance Use4UsNCT05000866

Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples

A study testing Communication skills training video and Drug use module in people with Substance Use and HIV Infections, run by Hunter College of City University of New York at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 17 to 29 years, men onlyHealthy volunteers can take part
Conditions the study is for: Substance Use, HIV Infections
What is being tested?: Communication skills training video and Drug use module
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 484 participants
Where: 2 sitesUnited States
Study dates: 13 Oct 2021to 24 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

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 17 to 29 years
Men only
Healthy volunteers accepted
Child, Adult

Who may be able to join

· Have a main partner who is another male and have been in a relationship for 3 month or longer
One participant must be between 17 and 29; Main partner can be any age above 17.
One participant must be HIV negative (as confirmed by rapid test)
One participant must have used at least 1 drug in the past 90 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB)
One participant must have engaged in Transmission Risk Behavior (TRB) in the past 90 days
o Defined as Condom-less Anal Sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner
Live in the NYC or Detroit metropolitan area
Speak English

Who cannot join

· Any signs of serious mental illness or cognitive deficit
History of IPV with their main partner and safety concerns in the current relationship.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan
Ann Arbor, Michigan, 48109
Hunter College
New York, New York, 10018

Other trials in United States

About this study

This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.

Conditions: Substance Use, HIV Infections
Being tested: Communication skills training video, Drug use module
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.

Communication skills training videoBehavioural
The communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene.
Drug use moduleBehavioural
The substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals.

Study groups in NCT05000866
Study group	Role	What they receive
CHTC as usual	No intervention	Participants complete the standard Couples HIV Testing and Counseling session (CHTC).
CHTC and communications skills training video	Active comparator	Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together. Receives: Behavioral: Communication skills training video
CHTC and substance use module	Active comparator	Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together. Receives: Behavioral: Drug use module
CHTC, communications skills training and substance use module	Active comparator	Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together. Receives: Behavioral: Communication skills training video; Behavioral: Drug use module

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: 12 months
Urine assay for drug use
Positive urine screen for drug use assessed bi-annually
Measured: 12 months
CAS with casual partners
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
Measured: 12 months
Bacterial STI's
Any chlamydia or gonorrhea diagnosis assessed bi-annually
Measured: 12 months

Secondary outcomes (4)

Binge drinking
Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Measured: 12 months
Syphilis infection
Reactive RPR test assessed bi-annually
Measured: 12 months
PrEP Uptake
self-reported receipt of a PrEP-prescription
Measured: 12 months
PrEP adherence
taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 202124 Jun 2026

First posted11 Aug 2021
Study start13 Oct 2021
Primary completion21 May 2025
Study completion24 Jun 2026

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 two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.
Masking: None (open label)
Enrolment: 484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05000866
Sponsor's protocol ID: R01DA050508
Acronym: 4Us
Status last verified: Oct 2026
First submitted: 7 Apr 2021
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Starks TJ, D Kyre K, B Cowles C, Castiblanco J, Washington C, N Parker J, M Kahle E, Stephenson R. A full-factorial randomized controlled trial of adjunct couples HIV testing and counseling components addressing drug use and communication skills among sexual minority male couples. BMC Public Health. 2021 Nov 24;21(1):2158. doi: 10.1186/s12889-021-12208-3.
PubMed 34819058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
ClinicalTrials.gov ID: NCT05000866
Acronym / sponsor ID: 4Us / R01DA050508
Conditions: Substance Use, HIV Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 484 participants (actual)
Lead sponsor: Hunter College of City University of New YorkUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), University of Michigan
Study start: 13 Oct 2021 (actual)
Primary completion: 21 May 2025 (actual)
Study completion: 24 Jun 2026 (actual)
First posted: 11 Aug 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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4
Model description: This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.

Arm	Type	Receives
CHTC as usual	No intervention	–Participants complete the standard Couples HIV Testing and Counseling session (CHTC).
CHTC and communications skills training video	Active comparator	Behavioral: Communication skills training videoParticipants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together.
CHTC and substance use module	Active comparator	Behavioral: Drug use moduleParticipants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together.
CHTC, communications skills training and substance use module	Active comparator	Behavioral: Communication skills training video, Behavioral: Drug use moduleParticipants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together.

Who may qualify

Ages: 17 to 29 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

· Have a main partner who is another male and have been in a relationship for 3 month or longer
o Defined as Condom-less Anal Sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner

Key exclusion criteria (2 listed)

· Any signs of serious mental illness or cognitive deficit

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
Communication skills training videoThe communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene.	Behavioural	CHTC and communications skills training video, CHTC, communications skills training and substance use module
Drug use moduleThe substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals.	Behavioural	CHTC and substance use module, CHTC, communications skills training and substance use module

Primary outcome

Drug use frequency
Time frame: 12 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: 12 months
Positive urine screen for drug use assessed bi-annually
CAS with casual partners
Time frame: 12 months
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
Bacterial STI's
Time frame: 12 months
Any chlamydia or gonorrhea diagnosis assessed bi-annually

4 secondary outcomes

Binge drinking
Time frame: 12 months
Syphilis infection
Time frame: 12 months
PrEP Uptake
Time frame: 12 months
PrEP adherence
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Derived from this study: PubMed 34819058Starks TJ, D Kyre K, B Cowles C, Castiblanco J, Washington C, N Parker J, M Kahle E, Stephenson R. A full-factorial randomized controlled trial of adjunct couples HIV testing and counseling components addressing drug use and communication skills among sexual minority male couples. BMC Public Health. 2021 Nov 24;21(1):2158. doi: 10.1186/s12889-021-12208-3.
Individual participant dataSharing planned: Undecided

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Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
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Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 2 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Drug use frequency (time frame: 12 months). The study lists 4 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 NCT05000866, 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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.