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

NCT03551938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2023-06-18

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Rob Stephenson, PhD · University of Michigan

  • Kristi Gamarel, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2021-07-13
Completion
2021-08-20

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551938 on ClinicalTrials.gov