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Clinical Trials/NCT04289116
NCT04289116
Completed
Not Applicable

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

Florida State University2 sites in 1 country71 target enrollmentJanuary 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Florida State University
Enrollment
71
Locations
2
Primary Endpoint
HIV Transmission Risk Behavior
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2020
End Date
May 31, 2022
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sylvie Naar

Principal Investigator

Florida State University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

HIV Transmission Risk Behavior

Time Frame: baseline, month 3, month 6

Self-reported Condomless anal sex with a casual partner

Secondary Outcomes

  • Communication Skills(baseline, month 3, month 6)

Study Sites (2)

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