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

HIV Infections Clinical Trial

— WeTestATN156  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289116
• Other study ID #: MOD00000199
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• HIV/AIDS

Intervention

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.
• IHTC
Individual HIV Testing and Counseling

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan
United States	The City University of New York	New York	New York
United States	San Diego LGBT Community Center	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
Florida State University	Hunter College of City University of New York, Oregon Health and Science University, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Transmission Risk Behavior	Self-reported Condomless anal sex in the absence of PrEP	30 days
Primary	Bacterial STI infection in the absence of PrEP	APTIMA (TMA RNA test) for Urine and Rectal samples	30 days
Secondary	Communication skills	Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 120	30 days