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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS, HIV Infections

Intervention / Treatment
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* Behavioral: We Test
* Behavioral: IHTC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: We Test<br>Each participant or couple 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<br>* 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.<br>|
| Active Comparator: Individual HIV Testing and Counseling<br>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<br>* Individual HIV Testing and Counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Transmission Risk Behavior | Self-reported Condomless anal sex in the absence of PrEP | 30 days | 
| Bacterial STI infection in the absence of PrEP | APTIMA (TMA RNA test) for Urine and Rectal samples | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication skills | Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 120 | 30 days |