We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
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|ClinicalTrials.gov Identifier: NCT03551938|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Relationship skills session for YMSM couples||Not Applicable|
Young (15-24 years old) gay, bisexual and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the US, despite stable or declining rates of infection among other groups. HIV prevention and research efforts in the US have continued to target MSM as individuals, largely focusing on messages that encourage the uptake of prevention efforts and reducing sexual risk. Recently, there has been growing interest in structural interventions to reduce HIV risk, tackling social, economic and cultural factors that place MSM in contexts of risk. However, despite socio-ecological theory postulating the importance of individual, dyadic and social influences on HIV risk, there has been a dearth of intervention efforts focused at the dyadic level.
We Prevent seeks to intervene on relationship communication skills as a pathway to HIV prevention during the critical period of adolescence. The proposed activities will develop and test a relationship skills focused HIV prevention intervention for young YMSM aged 15-19 as an addition to the current Couples HIV Testing and Counseling (CHTC). At home STI test kits will also be sent in Phases II and III at baseline and each follow-up.
Phase I of the project includes collection of data from two groups of participants: 1) 40 YMSM in in-depth interviews and 10 YMSM in cognitive interviews and 2) 10 Technical Experts (TEG), for a total sample of 60 research participants.
Phase II will consist of a one-arm pilot test of the intervention condition with 20 YMSM and their partners (total 40 participants). Participants will complete a Baseline, and 3-month assessment.
Phase III involves a pilot two-arm prospective RCT in which 160 YMSM and their partners (320 participants) will complete a Baseline assessment and then complete assessments every 3 months for 9 months.
Recruitment of all participants is in all 50 states and will be conducted through popular social media sites (e.g. Facebook). All interviews will be conducted through the HIPAA video-conferencing platform, VSee.
Phases I and II: To develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention for 15-19 year old YMSM and their partners.
Phase III: To conduct a randomized controlled trial (RCT) comparing the efficacy of the adapted intervention for YMSM versus a control condition, which is CHTC alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||ATN 157 -We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples|
|Actual Study Start Date :||June 28, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
No Intervention: Control
Receive only the standard Couples HIV Testing and Counseling (CHTC) Session.
Receive one 45-minute Relationship skills session for YMSM couples (the intervention) before receiving the standard Couples HIV Testing and Counseling (CHTC) Session.
Behavioral: Relationship skills session for YMSM couples
Relationship skills session as an addition to the current CHTC intervention for 15-19 year old YMSM and their partners.
- HIV Testing [ Time Frame: At baseline, at 3 months, at 6 months, and at 9 months. ]The proportion of YMSM tested for HIV 2 or more times, at least 3 months apart, in the 9-month follow-up period.
- PrEP Awareness and Intentions [ Time Frame: At baseline, at 3 months, at 6 months, and at 9 months. ]Knowledge of PrEP, willingness to use PrEP, and uptake of PrEP. PrEP willingness will be measured with an existing 8-item scale (α=.84) developed for YMSM to gauge likelihood of PrEP use across different conditions (e.g., partner types; experiencing potential side effects).
- Sexual Risk Behavior [ Time Frame: At baseline, at 3 months, at 6 months, and at 9 months. ]Anal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
- STIs and STI Testing [ Time Frame: At baseline, at 3 months, at 6 months, and at 9 months. ]The proportion of YMSM tested for STIs at least once in the 9-month follow-up period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551938
|Contact: Matthew Rosso, MPHemail@example.com|
|Contact: Oksana Kutsa, BSfirstname.lastname@example.org|
|United States, Michigan|
|Center for Sexuality and Health Disparities||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact 734-615-0149 email@example.com|
|Principal Investigator: Rob Stephenson, PhD|
|Principal Investigator:||Rob Stephenson, PhD||University of Michigan|
|Principal Investigator:||Kristi Gamarel, PhD||University of Michigan|