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OpenTrials
Completed

NCT Number: NCT04289116

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

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.

Completed

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Key information

Age range

15 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University, Detroit, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

IHTC

Behavioral

Individual HIV Testing and Counseling

Primary outcomes

  1. HIV Transmission Risk Behavior

    Time frame: baseline, month 3, month 6

    Self-reported Condomless anal sex with a casual partner

Secondary outcomes

  1. Communication Skills

    Time frame: baseline, month 3, month 6

    Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

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

Registry information

Acronym: WeTestATN156

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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