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

NCT05855655 | Completed Results

• 2 other identifiers: 2004002698-BK23AT011173
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hiv; Minority Stress; Mental Health Wellness 1

Keywords

Mindfulness-based intervention; Sexual minority; LGBTQ; HIV prevention

Outcome Measures

Primary Outcomes (7)

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility will be assessed via three measures. One measure of feasibility will be participant recruitment rates. The recruitment rate will be calculated by comparing the total number of participants screened eligible to those who were successfully enrolled in the study. See other primary outcomes for other measures used.

  During recruitment period of study, up to 2 months

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: HIV/STI Testing Submission

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility will be assessed via three measures. One measure of feasibility will be participant retention rates, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., HIV/STI testing submission) is reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used.

  Baseline, Post-intervention (week 10), and 6-month Follow-up

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Nail Sample Submission

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility will be assessed via three measures. One measure of feasibility will be participant retention rates, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., nail sample submission for cortisol level testing) is reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used.

  Baseline, Post-intervention (week 10), and 6-month Follow-up

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Survey Submission

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility will be assessed via three measures. One measure of feasibility will be participant retention rates, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., post-intervention and 6-month follow-up survey submission) are reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used.

  Baseline, Post-intervention (week 10), and 6-month Follow-up

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Engagement

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility will be assessed via three measures. One measure of feasibility will be engagement with the MBQR program (i.e, adherence to the prescribed intervention), which will be assessed by class attendance data. The average number of sessions that participants attended the MBQR sessions is reported here.

  During intervention period (10 weeks)

• Acceptability of Online Mindfulness-Based Queer Resilience as Measured by the Client Satisfaction Questionnaire

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Acceptability will be assessed using three measures. One such measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Participants rated each item on a four-point Likert scale. Total scores for the CSQ-8 range from 8 to 32, with higher values indicating higher satisfaction. See other primary outcomes for other measures used.

  Post-intervention (week 10)

• Acceptability of Online Mindfulness-Based Queer Resilience as Measured by a Session Evaluation Form

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Acceptability will be assessed using three measures. One such measure of acceptability will be via a session evaluation form that provides both qualitative and quantitative feedback on the study intervention using 10 questions, rated on a four-point Likert scale, and 6 free response questions. The quantitative data is reported here. Total scores range from 10 to 40, with higher values indicating higher satisfaction. See other primary outcomes for other measures used.

  Post-intervention (week 10)

Study Arms (2)

Mindfulness-Based Queer Resilience (MBQR)

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Queer Resilience (MBQR)

Health Education

ACTIVE COMPARATOR

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).

Behavioral: Mindfulness-Based Queer Resilience (MBQR)

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).

Health Education; Mindfulness-Based Queer Resilience (MBQR)

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Assigned male at birth,
• Being 18 to 34 of age,
• Identify as a cisgender man or nonbinary,
• Reside in the United States,
• Can read and speak English,
• Engaged in condomless anal sex with another man in past 6 months,
• Endorse distress, measured by the PHQ-9 and GAD-7,
• Possess a devise (phone, tablet, computer) that allows for online conferencing.
• HIV-negative at time of screening

You may not qualify if:

• Significant cognitive impairment
• Psychosis
• Currently symptomatic and untreated bipolar disorder
• Imminent suicidal risk

Sponsors & Collaborators

• Brown University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Results Point of Contact

• Title: Shufang Sun
• Organization: Brown University

shufang_sun@brown.edu

401-863-5735

Study Officials

• Shufang Sun, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The methodological approach includes a 2-arm trial of MBQR vs. a health education control group, with up to n=30 per arm (total Aim 3 sample size = up to 60 participants enrolled and randomized). The study is intended to evaluate the acceptability and feasibility of MBQR.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 11, 2023
• Study Start: April 8, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Fall 2024

Locations

US (1)