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Trial record 2 of 1761 for:    relationship | HIV | United States

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03551938
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Robert Stephenson, University of Michigan

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

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


Contacts
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Contact: Matthew Rosso, MPH 734-647-7260 mtrosso@umich.edu
Contact: Catherine Washington, BS 734-647-8826 washicat@umich.edu

Locations
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United States, Michigan
Center for Sexuality and Health Disparities Recruiting
Ann Arbor, Michigan, United States, 48109
Contact    734-615-0149    rbsteph@med.umich.edu   
Principal Investigator: Rob Stephenson, PhD         
Sponsors and Collaborators
University of Michigan
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Rob Stephenson, PhD University of Michigan
Principal Investigator: Kristi Gamarel, PhD University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases