WeTestATN156: Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM

Sponsor

Florida State University (Other)

Overall Status

Completed

CT.gov ID

NCT04289116

Collaborator

Hunter College of City University of New York (Other), Oregon Health and Science University (Other), Wayne State University (Other)

Enrollment

Locations

Arms

28.3

Actual Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS HIV Infections	Behavioral: We Test Behavioral: IHTC	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM

Actual Study Start Date :

Jan 20, 2020

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: We Test 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.	Behavioral: We Test 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.
Active Comparator: Individual HIV Testing and Counseling 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.	Behavioral: IHTC Individual HIV Testing and Counseling

Arm

Intervention/Treatment

Experimental: We Test

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.

Behavioral: We Test

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.

Active Comparator: Individual HIV Testing and Counseling

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.

Behavioral: IHTC

Individual HIV Testing and Counseling

Outcome Measures

Primary Outcome Measures

HIV Transmission Risk Behavior [30 days]
Self-reported Condomless anal sex in the absence of PrEP
Bacterial STI infection in the absence of PrEP [30 days]
APTIMA (TMA RNA test) for Urine and Rectal samples

Secondary Outcome Measures

Communication skills [30 days]
Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 120

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 24 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego LGBT Community Center	San Diego	California	United States	92103
2	Wayne State University	Detroit	Michigan	United States	48202
3	The City University of New York	New York	New York	United States	10018

Sponsors and Collaborators

Florida State University
Hunter College of City University of New York
Oregon Health and Science University
Wayne State University

Investigators

Study Chair: Tyrel Starks, PhD, The City University of New York
Study Chair: Sarah W Feldstein Ewing, PhD, University of Rhode Island

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sylvie Naar, Principal Investigator, Florida State University

ClinicalTrials.gov Identifier:

NCT04289116

Other Study ID Numbers:

MOD00000199

First Posted:

Feb 28, 2020

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Jul 7, 2022