Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT05855655
Status
Completed

Conditions

  • Hiv
  • Mental Health Wellness 1
  • Minority Stress

Eligibility Criteria

Sex
MALE
Age
18 Years - 34 Years
Healthy Volunteers
Accepted

Interventions

  • Mindfulness-Based Queer Resilience (MBQR) — BEHAVIORAL
    This work aims to develop an internet-delivered MBI to address minority stress and its negative HIV-related health consequences experienced by young men who have sex with men (YMSM). This aim will examine the feasibility and acceptability of the internet-delivered mindfulness-based intervention (iMBI), called "Mindfulness-based Queer Resilience (MBQR)", for HIV prevention. The study will enroll and randomize a sample of 60 distressed, high-risk YMSM into one of two groups: MBQR intervention (n=30) or active control condition (n=30).

Study Details

The overall aim of the research study is to develop and test a mindfulness-based program for young adult gay, bisexual, and queer men at risk for HIV (Brown University IRB approved protocol #2004002698). Researchers have completed Aims 1 and 2 of the broader study. Aim 1 used qualitative, community engaged methods, along with a quantitative online survey, to inform intervention development with the study population. Aim 2 involved seeking feedback on the developed mindfulness program through an open-pilot with 18 participants from the same study population (young adult gay, bisexual, and queer men at risk for HIV). The next phase of the intervention development (Aim 3 - registered here) will enroll and randomize a sample of 60 distressed, high-risk YMSM into one of two groups: MBQR intervention (n=30) or active control condition (n=30). Researchers aim to over-enroll YMSM of color (e.g., Black/Latinx YMSM) and anticipate the group to include approximately 50-60% Black/Latinx YMSM (or YMSM of color). Outcomes of feasibility and acceptability include rates of recruitment and retention, number of sessions attended, self-reported at-home practice of mindfulness, completion of assessment, and exit interviews.

Key Dates

Start date
Apr 8, 2023
Status verified
Oct 2025
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Mindfulness-Based Queer Resilience (MBQR)
    MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. In addition to the 10 weekly sessions there is an all-day retreat (6hrs) that takes place around week 6. The participants also meet one-on-one with the instructor(s) at the beginning and middle of class for a 30-minute welcome call and check in.
  • Active Comparator: Health Education
    The online Health Education course is a self-paced program that can be largely completed independently (no group meeting, no all-day) by control group participants. The ten weekly modules are estimated to take around 30 to 90 minutes each to complete and consist of readings, videos, infographics, and other related activities (e.g., reflections, quizzes).

Primary Outcome Measure

Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates [ Time Frame: During recruitment period of study, up to 2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02912-

Find similar trials in Providence, RI

By condition
HIV
By specialty
Infectious disease
By research site
Brown University· Providence, RI

Related Studies