We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples

• ClinicalTrials.gov Identifier: NCT03551938
• Recruitment Status: Completed
• First Posted: June 11, 2018
• Last Update Posted: June 28, 2022
• Sponsor: University of Michigan
• Collaborator: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): Robert Stephenson, University of Michigan

Study Description

Brief Summary:

We Prevent seeks to develop and pilot test a developmentally-appropriate relationship skills session as an addition to the current Couples HIV Testing and Counseling (CHTC) intervention for young gay, bisexual and other men who have sex with men (YMSM). This project involves three phases to develop and pilot test the intervention. Phase I collected brief quantitative survey data, in-depth qualitative interview data, and cognitive interview data from YMSM and feedback from a technical expert group (TEG) to develop and refine the two-session intervention. Phase II involved conducting a one-arm pilot of the intervention condition to further refine the intervention content with a sample of 12 YMSM (6 dyads). Phase III involves conducting a randomized controlled trial (RCT) comparing the relationship-focused intervention to a control condition, which is HIV Testing, Counseling, and Referrals (CTR) alone with a sample of 320 YMSM.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS	Behavioral: Relationship skills session for YMSM partnered-individuals and couples	Not Applicable

Detailed Description:

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.

Specific Aims:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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
• Actual Primary Completion Date: July 13, 2021
• Actual Study Completion Date: August 20, 2021

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
Experimental: Intervention; 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.

Outcome Measures

Primary Outcome Measures :

1. Sexual Risk Behavior [ Time Frame: The number of participants who report sexual risk behavior at 3 months. ]
   Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
2. Sexual Risk Behavior [ Time Frame: The number of participants who report sexual risk behavior at 6 months. ]
   Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
3. Sexual Risk Behavior [ Time Frame: The number of participants who report sexual risk behavior at 9 months. ]
   Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.

Secondary Outcome Measures :

1. HIV communication [ Time Frame: Means at 3 months ]
   The 9-item Couples Efficacy to Reduce HIV Threat scale
2. HIV Communication [ Time Frame: Means at 6 months ]
   The 9-item Couples Efficacy to Reduce HIV Threat Scale
3. HIV communication [ Time Frame: Means at 9 months ]
   The 9-item Couples Efficacy to Reduce HIV Threat Scale
4. PrEP Use [ Time Frame: The number of participants at 3 months ]
   Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
5. PrEP Use [ Time Frame: The number of participants at 6 months ]
   Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
6. PrEP Use [ Time Frame: The number of participants at 9 months ]
   Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
7. HIV Testing [ Time Frame: The number of participants at 3-months ]
   Self-reported HIV testing in the past 3 months
8. HIV Testing [ Time Frame: The number of participants at 6 months ]
   Self-reported HIV testing in the past 3 months
9. HIV Testing [ Time Frame: The number of participants at 9 months ]
   Self-reported HIV testing in the past 3 months
10. STI Testing [ Time Frame: The number of participants at 3 months ]
    Any self-reported STI testing in the past 3 months
11. STI Testing [ Time Frame: The number of participants at 6 months ]
    Any self-reported STI testing in the past 3 months
12. STI Testing [ Time Frame: The number of participants at 9 months ]
    Any self-reported STI testing in the past 3 months

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cisgender men (assigned male sex at birth and currently identifies as male) OR transgender men (assigned female at birth and identifies as male or transgender man
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Ages 15 to 24 years (inclusive) at time of screening
• Current U.S. resident
• Sufficient age for sexual consent in the current state of residence (assessed at both the individual and dyadic level)
• Self-identify that they are in an emotional and sexual relationship with another male
• Cisgender men (assigned male sex at birth and currently identifies as male) OR transgender men (assigned female at birth and identifies as male or transgender man
• Self-reports that they engaged in any kind of sexual activity (oral, vaginal, anal) in their lifetime
• Has access to computer/personal device/smart phone with internet access
• Self-report being HIV negative or unknown serostatus
• Speak and read English

Exclusion Criteria:

• Younger than age for consent without parental permission in the current state of residence
• Assigned female sex at birth and currently identifies as something other than male or transgender man
• Assigned male sex at birth but identifies as gender other than male or transgender man
• Aged 14 years or younger or 25 or older at the time of screening
• HIV-positive
• Not currently in an emotional and/or sexual relationship with another male
• Does not speak or read English
• Reports intimate partner violence in the past 6 months

Contacts and Locations

Locations

United States, Michigan

Center for Sexuality and Health Disparities

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Rob Stephenson, PhD; University of Michigan
• Principal Investigator: Kristi Gamarel, PhD; University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gamarel KE, Darbes LA, Hightow-Weidman L, Sullivan P, Stephenson R. The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 2;8(1):e10370. doi: 10.2196/10370.

• Responsible Party: Robert Stephenson, Professor & Chair, School of Nursing, University of Michigan
• ClinicalTrials.gov Identifier: NCT03551938
• Other Study ID Numbers: FWA00004801
• First Posted: June 11, 2018
• Last Update Posted: June 28, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Stephenson, University of Michigan:

HIV, telehealth, HIV testing, YMSM, couples

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases