- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551938
We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
ATN 157 -We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Center for Sexuality and Health Disparities
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The number of participants who report sexual risk behavior at 3 months.
|
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.
|
The number of participants who report sexual risk behavior at 6 months.
|
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.
|
The number of participants who report sexual risk behavior at 9 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
The number of participants at 6 months
|
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)
|
The number of participants at 9 months
|
HIV Testing
Time Frame: The number of participants at 3-months
|
Self-reported HIV testing in the past 3 months
|
The number of participants at 3-months
|
HIV Testing
Time Frame: The number of participants at 6 months
|
Self-reported HIV testing in the past 3 months
|
The number of participants at 6 months
|
HIV Testing
Time Frame: The number of participants at 9 months
|
Self-reported HIV testing in the past 3 months
|
The number of participants at 9 months
|
STI Testing
Time Frame: The number of participants at 3 months
|
Any self-reported STI testing in the past 3 months
|
The number of participants at 3 months
|
STI Testing
Time Frame: The number of participants at 6 months
|
Any self-reported STI testing in the past 3 months
|
The number of participants at 6 months
|
STI Testing
Time Frame: The number of participants at 9 months
|
Any self-reported STI testing in the past 3 months
|
The number of participants at 9 months
|
HIV Communication
Time Frame: Mean at 3 months
|
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).
|
Mean at 3 months
|
HIV Communication
Time Frame: Mean at 6 months
|
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).
|
Mean at 6 months
|
HIV Communication
Time Frame: Mean at 9 months
|
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).
|
Mean at 9 months
|
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).
|
The number of participants at 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristi Gamarel, PhD, University of Michigan
- Principal Investigator: Rob Stephenson, PhD, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- FWA00004801
- 5U19HD089881-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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