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

Not Applicable

Completed

• Conditions: HIV/AIDS; HIV Infections
• Interventions: Behavioral: We Test; Behavioral: IHTC

• Registration Number: NCT04289116
• Lead Sponsor: Florida State University

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.

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
We Test	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.
Individual HIV Testing and Counseling	IHTC	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Communication skills	30 days	Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 120

Trial Locations

Locations (3)

San Diego LGBT Community Center; 🇺🇸 San Diego, California, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

The City University of New York; 🇺🇸 New York, New York, United States