Sex, UnsafeNCT03125915

Addressing Substance Use Through CVCT

A study testing Communication skills training video, substance use module and Couples HIV Testing and Counseling in people with Sex, Unsafe and Drug Use, run by Hunter College of City University of New York at 1 site 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 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Sex, Unsafe, Drug Use
What is being tested?: Communication skills training video, substance use module and Couples HIV Testing and Counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2014to 1 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Both members of the couple:
are born male and current male gender identity;
identify as gay, bisexual or same-sex attracted;
read English at 8th grade level or better;
have access to the Internet;
agree to audio and video recording of intervention sessions;

Show all 12Show fewer

At least one member of the couple:
reports the use of any drug listed on the DAST-10 in the previous 30 days.
s identified as HIV negative during screening and baseline assessments.
The couple
has been together for at least 3 months;
has engaged in oral or anal sex with one another in the past 3 months;

Who cannot join

At baseline either member of the couple reports intimate partner violence (IPV), which is defined as serious physical or sexual violence that occurs outside the context of consensual bondage or sado-masochistic sexual play, which results in concerns about safety.
At the first in-person meeting, staff will be empowered to deem the couple ineligible for the intervention if they identify inconsistencies between information provided in the eligibility screener and the in-person meeting (e.g., discrepancies in age or duration of relationship) or any issues that might hinder participation (e.g., attending meeting high or drunk). The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hunter College
New York, New York, 10018

Other trials in United States

About this study

Official title: Addressing Substance Use Through Couples Voluntary Counseling and Testing (CVCT)

The proposed study developed and tested two adjunct components for use in Couples HIV Testing and Counseling (CHTC) with gay-male couples: a communication skills training video and a substance use agreement module. Phase I of the study involved the creation of intervention materials and Phase II was comprised of a small randomized controlled trial comparing the additive effects of the novel components to CHTC as usual.

Read the detailed description

Phase I: Utilizing formative qualitative data on the correspondence of sexual agreements, drug use, and sexual risk behavior, the study team created two adjunct intervention components:

Communication skills training videos: The team produced a brief (20-minute) communication skills training video. The video includes 4 scenes in which a gay couple is depicted discussing HIV risk, sexual agreements, or drug use. The scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays the use of more effective interpersonal communication and a more adaptive outcome.

Substance use agreement module: The team developed a structured activity to assist couples in clarifying their understanding and goals around substance use. The module includes the completion of a calendar detailing recent substance use and structured debriefing questions.

Phase II: A randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of novel intervention components will be conducted. The trial involves 70 couples (n = 140 individuals). Half of the couples are randomized to complete the drug calendar (the other half do not). Half of the couples are randomized to view communication skills training videos, the other half do not. The result is four intervention conditions:

CHTC as usual
CHTC + communication skills training videos
CHTC + substance use module
CHTC + communication skills training videos + substance use calendar

Participants complete a baseline assessment (either online or in person) prior to their intervention session. All intervention sessions are completed with both members of the couple together. Follow-up assessments are completed individually online at 1, 3, and 6 months post-intervention.

Conditions: Sex, Unsafe, Drug Use
Being tested: Communication skills training video, substance use module, Couples HIV Testing and Counseling
Keywords: couples HIV testing; drug intervention; communication skills
Medical subject headings: Unsafe Sex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Communication skills training videoBehavioural
This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.
substance use moduleBehavioural
Also called drug calendar
This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.
Couples HIV Testing and CounselingBehavioural
Also called (CHTC)
CHTC delivered as per the CDC protocol.

Study groups in NCT03125915
Study group	Role	What they receive
CHTC as usual	Active comparator	Participants receive couples HIV testing and counseling following the CDC approved protocol. Receives: Behavioral: Couples HIV Testing and Counseling
CHTC + communication skills videos	Experimental	The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol. Receives: Behavioral: Communication skills training video; Behavioral: Couples HIV Testing and Counseling
CHTC + substance use module	Experimental	The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results. Receives: Behavioral: substance use module; Behavioral: Couples HIV Testing and Counseling
CHTC + video + substance use module	Experimental	The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity. Receives: Behavioral: Communication skills training video; Behavioral: substance use module; Behavioral: Couples HIV Testing and Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Respondents Reporting Any Drug Use
The outcome measure is a dichotomous variable indicating whether or not each participant reported any drug use in the in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated the use of any drugs at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.
Measured: 30 days prior to assessment
Condomless Anal Sex With Casual Partners
The outcome measure is a dichotomous variable indicating whether or not each participant indicated the occurrence of any insertive or receptive condomless anal sex (CAS) with a casual partner in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated any CAS with a casual partner at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.
Measured: 30 days prior to assessment
Drug Abuse Screening Test-10 Total Scores
The scale assesses the number of drug use related problems experienced by the participant in the 30 days prior to the assessment. Higher scores indicate a greater number of drug use related problems. Note, assessments were conducted at 1, 3, and 6 months post intervention.
Measured: 30 days prior to assessment

Timeline

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

1 Apr 20141 Feb 2018

First posted24 Apr 2017
Study start1 Apr 2014
Primary completion1 Feb 2018
Study completion1 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Sex, UnsafeStudies 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: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: The study tests two independent variables in a fully-crossed factorial design. Half of the couples complete a substance use module during their CHTC session (half do not); half view communication skills training videos (half do not).
Masking: Single blind
Who is masked: Care provider
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03125915
Sponsor's protocol ID: R34DA036419
Other IDs: R34DA036419
Status last verified: Mar 2021
First submitted: 20 Apr 2017
Last updated: 15 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Starks TJ, Robles G, Bosco SC, Doyle KM, Dellucci TV. Relationship functioning and substance use in same-sex male couples. Drug Alcohol Depend. 2019 Aug 1;201:101-108. doi: 10.1016/j.drugalcdep.2019.04.009. Epub 2019 May 23.
PubMed 31203148
Starks TJ, Doyle KM, Shalhav O, John SA, Parsons JT. An Examination of Gay Couples' Motivations to Use (or Forego) Pre-exposure Prophylaxis Expressed During Couples HIV Testing and Counseling (CHTC) Sessions. Prev Sci. 2019 Jan;20(1):157-167. doi: 10.1007/s11121-018-0892-7.
PubMed 29651646
Starks TJ, Pawson M, Stephenson R, Sullivan P, Parsons JT. Dyadic Qualitative Analysis of Condom Use Scripts Among Emerging Adult Gay Male Couples. J Sex Marital Ther. 2018 Apr 3;44(3):269-280. doi: 10.1080/0092623X.2017.1359713. Epub 2017 Aug 25.
PubMed 28745559
Starks TJ, Dellucci TV, Gupta S, Robles G, Stephenson R, S Sullivan P, Parsons JT. A Pilot Randomized Trial of Intervention Components Addressing Drug Use in Couples HIV Testing and Counseling (CHTC) with Male Couples. AIDS Behav. 2019 Sep;23(9):2407-2420. doi: 10.1007/s10461-019-02455-2.
PubMed 30887190

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 Sex, Unsafe trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Addressing Substance Use Through Couples Voluntary Counseling and Testing (CVCT)
ClinicalTrials.gov ID: NCT03125915
Acronym / sponsor ID: R34DA036419
Conditions: Sex, Unsafe, Drug Use
Keywords: couples HIV testing; drug intervention; communication skills
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Hunter College of City University of New YorkUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Apr 2014 (actual)
Primary completion: 1 Feb 2018 (actual)
Study completion: 1 Feb 2018 (actual)
First posted: 24 Apr 2017 (actual)
Results: Posted 26 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Phase I: Utilizing formative qualitative data on the correspondence of sexual agreements, drug use, and sexual risk behavior, the study team created two adjunct intervention components:

CHTC as usual
CHTC + communication skills training videos
CHTC + substance use module
CHTC + communication skills training videos + substance use calendar

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (care provider)
Number of arms: 4
Model description: The study tests two independent variables in a fully-crossed factorial design. Half of the couples complete a substance use module during their CHTC session (half do not); half view communication skills training videos (half do not).

Arm	Type	Receives
CHTC as usual	Active comparator	Behavioral: Couples HIV Testing and CounselingParticipants receive couples HIV testing and counseling following the CDC approved protocol.
CHTC + communication skills videos	Experimental	Behavioral: Communication skills training video, Behavioral: Couples HIV Testing and CounselingThe couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.
CHTC + substance use module	Experimental	Behavioral: substance use module, Behavioral: Couples HIV Testing and CounselingThe couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results.
CHTC + video + substance use module	Experimental	Behavioral: Communication skills training video, Behavioral: substance use module, Behavioral: Couples HIV Testing and CounselingThe couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

are born male and current male gender identity;
identify as gay, bisexual or same-sex attracted;
read English at 8th grade level or better;
have access to the Internet;
agree to audio and video recording of intervention sessions;

Key exclusion criteria (2 listed)

At baseline either member of the couple reports intimate partner violence (IPV), which is defined as serious physical or sexual violence that occurs outside the context of consensual bondage or sado-masochistic sexual play, which results in concerns about safety.
At the first in-person meeting, staff will be empowered to deem the couple ineligible for the intervention if they identify inconsistencies between information provided in the eligibility screener and the in-person meeting (e.g., discrepancies in age or duration of relationship) or any issues that might hinder participation (e.g., attending meeting high or drunk). The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses.

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 videoThis video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.	Behavioural	CHTC + communication skills videos, CHTC + video + substance use module
substance use moduleAlso: drug calendarThis activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.	Behavioural	CHTC + substance use module, CHTC + video + substance use module
Couples HIV Testing and CounselingAlso: (CHTC)CHTC delivered as per the CDC protocol.	Behavioural	CHTC + communication skills videos, CHTC + substance use module, CHTC + video + substance use module, CHTC as usual

Primary outcome

Proportion of Respondents Reporting Any Drug Use
Time frame: 30 days prior to assessment
The outcome measure is a dichotomous variable indicating whether or not each participant reported any drug use in the in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated the use of any drugs at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.
Condomless Anal Sex With Casual Partners
Time frame: 30 days prior to assessment
The outcome measure is a dichotomous variable indicating whether or not each participant indicated the occurrence of any insertive or receptive condomless anal sex (CAS) with a casual partner in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated any CAS with a casual partner at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.
Drug Abuse Screening Test-10 Total Scores
Time frame: 30 days prior to assessment
The scale assesses the number of drug use related problems experienced by the participant in the 30 days prior to the assessment. Higher scores indicate a greater number of drug use related problems. Note, assessments were conducted at 1, 3, and 6 months post intervention.

Results and safety

Results posted to the registry on 26 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHTC as Usual	32	32
CHTC + Communication Skills Videos	40	40
CHTC + Substance Use Module	34	34
CHTC + Video + Substance Use Module	34	34

Primary outcome: Proportion of Respondents Reporting Any Drug Use

Time frame: 30 days prior to assessment. Count of participants. Unit: Participants

Measure	CHTC as Usual n = 32	CHTC + Communication Skills Videos n = 40	CHTC + Substance Use Module n = 34	CHTC + Video + Substance Use Module n = 34
1 month follow-up	25	26	18	17
3 month follow-up	20	17	28	15
6 month follow-up	15	31	15	17

CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: -3.62 (95% CI -6.78 to -0.46), p = .03, multi-leve latent growth curve
CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: -1.67 (95% CI -4.10 to 0.76), p = .18, multi-level latent growth curve
CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: -0.35 (95% CI -2.50 to 1.80), p = 0.75, multi-level latent growth curve

Population analysed: Intent to treat analysis conducted using latent growth curve modeling to examine between-group differences in follow-up rates of drug use and trajectories of use over the follow-up period.

Primary outcome: Condomless Anal Sex With Casual Partners

Time frame: 30 days prior to assessment. Count of participants. Unit: Participants

Measure	CHTC as Usual n = 32	CHTC + Communication Skills Videos n = 40	CHTC + Substance Use Module n = 34	CHTC + Video + Substance Use Module n = 34
1 month follow-up	3	3	3	1
3 month follow-up	0	5	6	2
6 month follow-up	3	4	10	3

CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: 0.05 (95% CI -2.30 to 2.41), p = 0.90, multi-level latent growth curve
CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: 0.26 (95% CI -2.23 to 2.75), p = 0.78, multi-level latent growth curve
CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: -1.18 (95% CI -4.86 to 2.51), p = 0.53, multi-level latent growth curve

Population analysed: n reported is number retained at each wave

Primary outcome: Drug Abuse Screening Test-10 Total Scores

Time frame: 30 days prior to assessment. Mean (Standard Deviation). Unit: score on a scale

Measure	CHTC as Usual n = 32	CHTC + Communication Skills Videos n = 40	CHTC + Substance Use Module n = 34	CHTC + Video + Substance Use Module n = 34
1 month follow-up	2.52 (2.04)	1.70 (1.75)	1.16 (1.39)	1.06 (1.18)
3 month follow-up	1.98 (2.01)	1.53 (1.42)	1.40 (1.85)	0.71 (0.90)
6 month follow-up	1.76 (2.12)	1.70 (1.56)	1.25 (1.73)	0.84 (1.00)

CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: -0.75 (95% CI -1.39 to -0.11), p = 0.02, multi-level latent growth curve
CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: -0.49 (95% CI -1.07 to 0.09), p = 0.10, multi-level latent growth curve
CHTC as Usual vs CHTC + Communication Skills Videos vs CHTC + Substance Use Module vs CHTC + Video + Substance Use Module: Beta: -0.15 (95% CI -0.77 to 0.47), p = 0.63, multi-level latent growth curve

Population analysed: n reported is the number retained at each follow-up wave.

Adverse events

Time frame: Adverse events were monitored for a period of 6 months from baseline to final assessment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHTC as Usual	0 of 32 (0%)	0 of 32 (0%)	0 of 32
CHTC + Communication Skills Videos	0 of 40 (0%)	0 of 40 (0%)	0 of 40
CHTC + Substance Use Module	0 of 34 (0%)	0 of 34 (0%)	0 of 34
CHTC + Video + Substance Use Module	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Limitations and caveats (from the sponsor): The design does not permit inferences about effects of components delivered independently of CHTC. The sample was recruited in a major metropolitan area and at relatively lower risk for HIV infection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31203148Starks TJ, Robles G, Bosco SC, Doyle KM, Dellucci TV. Relationship functioning and substance use in same-sex male couples. Drug Alcohol Depend. 2019 Aug 1;201:101-108. doi: 10.1016/j.drugalcdep.2019.04.009. Epub 2019 May 23.
Background: PubMed 29651646Starks TJ, Doyle KM, Shalhav O, John SA, Parsons JT. An Examination of Gay Couples' Motivations to Use (or Forego) Pre-exposure Prophylaxis Expressed During Couples HIV Testing and Counseling (CHTC) Sessions. Prev Sci. 2019 Jan;20(1):157-167. doi: 10.1007/s11121-018-0892-7.
Background: PubMed 28745559Starks TJ, Pawson M, Stephenson R, Sullivan P, Parsons JT. Dyadic Qualitative Analysis of Condom Use Scripts Among Emerging Adult Gay Male Couples. J Sex Marital Ther. 2018 Apr 3;44(3):269-280. doi: 10.1080/0092623X.2017.1359713. Epub 2017 Aug 25.
Results publication: PubMed 30887190Starks TJ, Dellucci TV, Gupta S, Robles G, Stephenson R, S Sullivan P, Parsons JT. A Pilot Randomized Trial of Intervention Components Addressing Drug Use in Couples HIV Testing and Counseling (CHTC) with Male Couples. AIDS Behav. 2019 Sep;23(9):2407-2420. doi: 10.1007/s10461-019-02455-2.
Individual participant dataSharing planned: Undecided

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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.

Tyrel J Starks, PhD principal investigator

Hunter College, CUNY

1 site 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 12 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Respondents Reporting Any Drug Use (time frame: 30 days prior to assessment). 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 NCT03125915, which also lists 4 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 15 Apr 2021.