We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
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|ClinicalTrials.gov Identifier: NCT03551938|
Recruitment Status : Active, not recruiting
First Posted : June 11, 2018
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Relationship skills session for YMSM partnered-individuals and 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 15-24 as an addition to the current HIV Counseling, Testing, and Referrals (CTR) and Couples HIV Testing and Counseling (CHTC). At home STI test kits will also be sent in Phases II and III at baseline and one follow up.
Phase I of the project included collection of data from two groups of participants: 1) 30 YMSM in in-depth interviews and 8 YMSM in cognitive interviews and 2) 7 Technical Experts (TEG), for a total sample of 45 research participants.
Phase II consisted of a one-arm pilot test of the intervention condition with 6 YMSM dyads (total 12 participants). Participants completed a Baseline and 1-month follow-up assessment.
Phase III involves a pilot two-arm prospective RCT in which 320 YMSM 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 platforms, VSee and Zoom.
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 15-24 year old YMSM versus a control condition, which is CTR or CHTC alone.
|Study Type :||Interventional (Clinical Trial)|
|Actual 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 :||August 2021|
|Estimated Study Completion Date :||December 2021|
No Intervention: Control
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Behavioral: Relationship skills session for YMSM partnered-individuals and couples
Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 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.
- Relationship Dynamic [ Time Frame: At baseline, at 3 months, at 6 months, and at 9-months ]Relationship satisfaction, commitment, trust, experiences of relational closeness, and intimate partner violence.
- 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.
- 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).
- 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.
- Mechanisms of Change [ Time Frame: At baseline, at 3 months, at 6 months, and at 9 months. ]Risk communication with their partner, preferences for sexual health outcomes, any sexual agreement the couple may have, and general communication
- Psychosocial [ Time Frame: At baseline, at 3 months, at 6 months, and at 9 months. ]Perception of individual HIV risk, perceived chance of success in life, anticipated HIV stigma, everyday discrimination, family acceptance, depression and anxiety symptoms, and substance use
- Study satisfaction [ Time Frame: At 3 months, at 6 months, and at 9 months. ]Satisfaction with the study, and feedback on the relationship-skills addition to CTR and CHTC
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
|United States, Michigan|
|Center for Sexuality and Health Disparities|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Rob Stephenson, PhD||University of Michigan|
|Principal Investigator:||Kristi Gamarel, PhD||University of Michigan|