Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM (WeTestATN156)
Primary Purpose
HIV/AIDS, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
We Test
IHTC
Sponsored by
About this trial
This is an interventional other trial for HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
- At least one partner must be HIV-negative or status unknown
- THE INDEX PARTNER must be 15-24 years old
- YMSM under age 18 MUST HAVE AN AGE CONCORDANT PARTNER TO PARTICIPATE IN THIS STUDY, I.E., MINORS may only participate in the study with a partner within 2 years of age OF THE MINOR SUBJECT'S AGE. THE AGE CONCORDANT PARTNER MUST BE AT LEAST FIFTEEN YEARS OLD.
- INDEX PARTNER MUST BE SEXUALLY ACTIVE (ANY ACTIVITY THAT COULD LEAD TO ORGASM)
- CURRENTLY SEEING SOMEONE, DATING, EXPERIMENTING WITH RELATIONSHIPS OR IN A RELATIONSHIP
- HAVE HAD SEX, HOOKED UP WITH OR MADE OUT WITH THAT PERSON
- Both partners must be able to communicate in English.
- LIVE IN OR NEAR NEW YORK CITY OR DETROIT OR SAN DIEGO
- GENDER IDENTITY AS MALE OR nonbinary, GENDERQUEER, agender OR GENDER NONCOMFORMING
Exclusion Criteria:
- Unstable, serious psychiatric symptoms
- Current suicidal/homicidal ideation
- Current or prior Intimate Partner Violence (IPV) on the part of either relationship partner
- IF EITHER PARTICIPATING PARTNER FELT PRESSURED OR COERCED TO PARTICIPATE IN THE STUDY OR FELT ANYONE MADE THEM FEEL THEY HAD TO PARTICIPATE IN THEY STUDY WHEN THEY DID NOT WANT TO.
Sites / Locations
- San Diego LGBT Community Center
- Wayne State University
- The City University of New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
We Test
Individual HIV Testing and Counseling
Arm Description
Each participant or couple will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
Outcomes
Primary Outcome Measures
HIV Transmission Risk Behavior
Self-reported Condomless anal sex in the absence of PrEP
Bacterial STI infection in the absence of PrEP
APTIMA (TMA RNA test) for Urine and Rectal samples
Secondary Outcome Measures
Communication skills
Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 120
Full Information
NCT ID
NCT04289116
First Posted
February 14, 2020
Last Updated
July 5, 2022
Sponsor
Florida State University
Collaborators
Hunter College of City University of New York, Oregon Health and Science University, Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT04289116
Brief Title
Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Acronym
WeTestATN156
Official Title
Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
Hunter College of City University of New York, Oregon Health and Science University, Wayne State University
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
The purpose of this study is to compare different ways to deliver the couples HIV Testing and Counseling (CHTC) intervention that is suited for adolescents and young adults.
Detailed Description
Investigators will conduct a comparative effectiveness trial (CET) of CHTC for adolescent-age (15-24 years) same-sex male couples. This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the individual or couple together and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. Youth will be randomized to receive one of two conditions: Condition 1: watch videos on ACT, participate in Communication Skills Training (MI-CST), and complete an individual HIV test, or if participating as a couple will receive CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HIV Infections
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At baseline participants will be randomized to one of two conditions: Condition 1: MI-CST + observation of ACT videos + CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
We Test
Arm Type
Experimental
Arm Description
Each participant or couple will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
Arm Title
Individual HIV Testing and Counseling
Arm Type
Active Comparator
Arm Description
Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
Intervention Type
Behavioral
Intervention Name(s)
We Test
Intervention Description
This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.
Intervention Type
Behavioral
Intervention Name(s)
IHTC
Intervention Description
Individual HIV Testing and Counseling
Primary Outcome Measure Information:
Title
HIV Transmission Risk Behavior
Description
Self-reported Condomless anal sex in the absence of PrEP
Time Frame
30 days
Title
Bacterial STI infection in the absence of PrEP
Description
APTIMA (TMA RNA test) for Urine and Rectal samples
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Communication skills
Description
Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 120
Time Frame
30 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Identifies as male, nonbinary, genderqueer or gender nonconforming.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one partner must be HIV-negative or status unknown
THE INDEX PARTNER must be 15-24 years old
YMSM under age 18 MUST HAVE AN AGE CONCORDANT PARTNER TO PARTICIPATE IN THIS STUDY, I.E., MINORS may only participate in the study with a partner within 2 years of age OF THE MINOR SUBJECT'S AGE. THE AGE CONCORDANT PARTNER MUST BE AT LEAST FIFTEEN YEARS OLD.
INDEX PARTNER MUST BE SEXUALLY ACTIVE (ANY ACTIVITY THAT COULD LEAD TO ORGASM)
CURRENTLY SEEING SOMEONE, DATING, EXPERIMENTING WITH RELATIONSHIPS OR IN A RELATIONSHIP
HAVE HAD SEX, HOOKED UP WITH OR MADE OUT WITH THAT PERSON
Both partners must be able to communicate in English.
LIVE IN OR NEAR NEW YORK CITY OR DETROIT OR SAN DIEGO
GENDER IDENTITY AS MALE OR nonbinary, GENDERQUEER, agender OR GENDER NONCOMFORMING
Exclusion Criteria:
Unstable, serious psychiatric symptoms
Current suicidal/homicidal ideation
Current or prior Intimate Partner Violence (IPV) on the part of either relationship partner
IF EITHER PARTICIPATING PARTNER FELT PRESSURED OR COERCED TO PARTICIPATE IN THE STUDY OR FELT ANYONE MADE THEM FEEL THEY HAD TO PARTICIPATE IN THEY STUDY WHEN THEY DID NOT WANT TO.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyrel Starks, PhD
Organizational Affiliation
The City University of New York
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarah W Feldstein Ewing, PhD
Organizational Affiliation
University of Rhode Island
Official's Role
Study Chair
Facility Information:
Facility Name
San Diego LGBT Community Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
The City University of New York
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently, there is no plan to share the study data at this time; however, the study team is currently in the process of developing a plan to share data, while protecting the privacy and confidentiality of participants.
Learn more about this trial
Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
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