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

NCT04289116 | Completed Results DMC

• 1 other identifier: ATN 156
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV/AIDS; HIV Infections

Outcome Measures

Primary Outcomes (1)

• HIV Transmission Risk Behavior

  Self-reported Condomless anal sex with a casual partner

  baseline, month 3, month 6

Secondary Outcomes (1)

• Communication Skills

  baseline, month 3, month 6

Study Arms (3)

We Test - Index Participants

EXPERIMENTAL

Each participant 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

Individual HIV Testing and Counseling - Index Participants

ACTIVE COMPARATOR

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 Counseling and Testing - Partner Participants

ACTIVE COMPARATOR

Referred partner who participates in Individual HIV Testing and Counseling with their partner.

Behavioral: IHTC

Interventions

We Test BEHAVIORAL

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.

We Test - Index Participants

IHTC BEHAVIORAL

Individual HIV Testing and Counseling

Individual Counseling and Testing - Partner Participants; Individual HIV Testing and Counseling - Index Participants

Eligibility Criteria

• Age: 15 Years - 24 Years
• Gender Eligibility Details: Identifies as male, nonbinary, genderqueer or gender nonconforming.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• Hunter College of City University of New York: collaborator
• Oregon Health and Science University: collaborator
• Wayne State University: collaborator

Study Sites (2)

Wayne State University

Detroit, Michigan, 48202, United States

Location

The City University of New York

New York, New York, 10018, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Sylvie Naar, PhD; Distinguished Endowed Professor
• Organization: Florida State University

sylvie.naar@med.fsu.edu

18506442334

Study Officials

• Tyrel Starks, PhD

  City University of New York

  STUDY CHAIR

• Sarah W Feldstein Ewing, PhD

  University of Rhode Island

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 28, 2020
• Study Start: January 20, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)