Clinical trial NCT04289116: Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Official title: Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
HIV Infections
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Hunter College of City University of New York
name: Oregon Health and Science University
name: Wayne State University
First posted: 2020-02-28
Enrollment: 75
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: HIV Transmission Risk Behavior
timeFrame: 30 days
measure: Bacterial STI infection in the absence of PrEP
timeFrame: 30 days
Secondary outcomes:
measure: Communication skills
timeFrame: 30 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego LGBT Community Center
state: California
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: New York
country: United States
facility: The City University of New York
state: New York
Study officials:
affiliation: City University of New York
name: Tyrel Starks, PhD
role: STUDY_CHAIR
affiliation: University of Rhode Island
name: Sarah W Feldstein Ewing, PhD
role: STUDY_CHAIR
References: