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

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Florida State University

Status

Completed

Conditions

HIV Infections
HIV/AIDS

Treatments

Behavioral: IHTC
Behavioral: We Test

Study type

Interventional

Funder types

Other

Identifiers

NCT04289116
ATN 156

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

Male

Ages

15 to 24 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

71 participants in 3 patient groups

We Test - Index Participants
Experimental group
Description:
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.
Treatment:
Behavioral: We Test
Individual HIV Testing and Counseling - Index Participants
Active Comparator group
Description:
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.
Treatment:
Behavioral: IHTC
Individual Counseling and Testing - Partner Participants
Active Comparator group
Description:
Referred partner who participates in Individual HIV Testing and Counseling with their partner.
Treatment:
Behavioral: IHTC

Trial documents
3

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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