search
Back to results

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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relationship skills session for YMSM partnered-individuals and couples
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV, telehealth, HIV testing, YMSM, couples

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Sexuality and Health Disparities

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Sexual Risk Behavior
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

HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale .Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no).
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
HIV Testing
Self-reported HIV testing in the past 3 months
HIV Testing
Self-reported HIV testing in the past 3 months
HIV Testing
Self-reported HIV testing in the past 3 months
STI Testing
Any self-reported STI testing in the past 3 months
STI Testing
Any self-reported STI testing in the past 3 months
STI Testing
Any self-reported STI testing in the past 3 months

Full Information

First Posted
May 15, 2018
Last Updated
May 24, 2023
Sponsor
University of Michigan
Collaborators
University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03551938
Brief Title
We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
Official Title
ATN 157 -We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan
Collaborators
University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV, telehealth, HIV testing, YMSM, couples

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relationship skills session for YMSM partnered-individuals and couples
Intervention Description
Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
Primary Outcome Measure Information:
Title
Sexual Risk Behavior
Description
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Time Frame
The number of participants who report sexual risk behavior at 3 months.
Title
Sexual Risk Behavior
Description
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Time Frame
The number of participants who report sexual risk behavior at 6 months.
Title
Sexual Risk Behavior
Description
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Time Frame
The number of participants who report sexual risk behavior at 9 months.
Secondary Outcome Measure Information:
Title
HIV Communication
Description
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale .Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Time Frame
Mean at 3 months
Title
HIV Communication
Description
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Time Frame
Mean at 6 months
Title
HIV Communication
Description
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Time Frame
Mean at 9 months
Title
PrEP Use
Description
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no).
Time Frame
The number of participants at 3 months
Title
PrEP Use
Description
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Time Frame
The number of participants at 6 months
Title
PrEP Use
Description
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Time Frame
The number of participants at 9 months
Title
HIV Testing
Description
Self-reported HIV testing in the past 3 months
Time Frame
The number of participants at 3-months
Title
HIV Testing
Description
Self-reported HIV testing in the past 3 months
Time Frame
The number of participants at 6 months
Title
HIV Testing
Description
Self-reported HIV testing in the past 3 months
Time Frame
The number of participants at 9 months
Title
STI Testing
Description
Any self-reported STI testing in the past 3 months
Time Frame
The number of participants at 3 months
Title
STI Testing
Description
Any self-reported STI testing in the past 3 months
Time Frame
The number of participants at 6 months
Title
STI Testing
Description
Any self-reported STI testing in the past 3 months
Time Frame
The number of participants at 9 months

10. Eligibility

Sex
All
Gender Based
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
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Stephenson, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristi Gamarel, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Sexuality and Health Disparities
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30602433
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs