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

NCT03551938 | Completed Results

• 2 other identifiers: FWA000048015U19HD089881-04
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV, telehealth, HIV testing, YMSM, couples

Outcome Measures

Primary Outcomes (3)

• 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.

  The number of participants who report sexual risk behavior at 3 months.

• 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.

  The number of participants who report sexual risk behavior at 6 months.

• 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.

  The number of participants who report sexual risk behavior at 9 months.

Secondary Outcomes (12)

• HIV Communication

  Mean at 3 months

• HIV Communication

  Mean at 6 months

• HIV Communication

  Mean at 9 months

• PrEP Use

  The number of participants at 3 months

• PrEP Use

  The number of participants at 6 months

Study Arms (2)

Control

NO INTERVENTION

Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.

Intervention

EXPERIMENTAL

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

Interventions

Relationship skills session for YMSM partnered-individuals and couples BEHAVIORAL

Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.

Intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• University of North Carolina, Chapel Hill: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Center for Sexuality and Health Disparities

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 30602433 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Family Characteristics

Condition Hierarchy (Ancestors)

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Rob Stephenson
• Organization: University of Michigan

rbsteph@med.umich.edu

734-763-1188

Study Officials

• Rob Stephenson, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Kristi Gamarel, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 11, 2018
• Study Start: June 28, 2018
• Primary Completion: July 13, 2021
• Study Completion: August 20, 2021
• Last Updated: June 18, 2023
• Results First Posted: June 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)