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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV/AIDS
• Intervention / Treatment: Behavioral: We Test; Behavioral: IHTC

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • San Diego LGBT Community Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University
  • New York
    • New York, New York, United States, 10018
      • The City University of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication skills	Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 120	30 days

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: Wayne State University; Oregon Health and Science University; Hunter College of City University of New York
• Investigators: Study Chair: Tyrel Starks, PhD, The City University of New York; Study Chair: Sarah W Feldstein Ewing, PhD, University of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: MOD00000199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No