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Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples (4Us)

Primary Purpose

Substance Use, HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication skills training video
Drug use module
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use

Eligibility Criteria

17 Years - 29 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • · 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

Exclusion Criteria:

  • · Any signs of serious mental illness or cognitive deficit

    • History of IPV with their main partner and safety concerns in the current relationship.

Sites / Locations

  • University of Michigan
  • Hunter CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

CHTC as usual

CHTC and communications skills training video

CHTC and substance use module

CHTC, communications skills training and substance use module

Arm Description

Participants complete the standard Couples HIV Testing and Counseling session (CHTC).

Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together.

Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together.

Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2021
Last Updated
May 10, 2023
Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA), University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05000866
Brief Title
Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
Acronym
4Us
Official Title
Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA), University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, HIV Infections

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHTC as usual
Arm Type
No Intervention
Arm Description
Participants complete the standard Couples HIV Testing and Counseling session (CHTC).
Arm Title
CHTC and communications skills training video
Arm Type
Active Comparator
Arm Description
Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together.
Arm Title
CHTC and substance use module
Arm Type
Active Comparator
Arm Description
Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together.
Arm Title
CHTC, communications skills training and substance use module
Arm Type
Active Comparator
Arm Description
Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together.
Intervention Type
Behavioral
Intervention Name(s)
Communication skills training video
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Drug use module
Intervention Description
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.
Primary Outcome Measure Information:
Title
Drug use frequency
Description
Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments
Time Frame
12 months
Title
Urine assay for drug use
Description
Positive urine screen for drug use assessed bi-annually
Time Frame
12 months
Title
CAS with casual partners
Description
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
Time Frame
12 months
Title
Bacterial STI's
Description
Any chlamydia or gonorrhea diagnosis assessed bi-annually
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Binge drinking
Description
Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Time Frame
12 months
Title
Syphilis infection
Description
Reactive RPR test assessed bi-annually
Time Frame
12 months
Title
PrEP Uptake
Description
self-reported receipt of a PrEP-prescription
Time Frame
12 months
Title
PrEP adherence
Description
taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
Time Frame
12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Both partners in the couple must identify as male.
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: · 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 Exclusion Criteria: · Any signs of serious mental illness or cognitive deficit History of IPV with their main partner and safety concerns in the current relationship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tyrel J Starks
Phone
212-206-7919
Email
tstarks@hunter.cuny.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Cowles
Phone
212-206-7919
Email
ccowles@hunter.cuny.edu
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Stephenson, PhD
Phone
734-615-0149
Email
rbsteph@umich.edu
Facility Name
Hunter College
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Cowles, MPH
Phone
212-206-7919
Email
ccowles@hunter.cuny.edu
First Name & Middle Initial & Last Name & Degree
Tyrel J Starks, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34819058
Citation
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.
Results Reference
derived

Learn more about this trial

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

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