CompletedNot Applicable

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

United States68 participantsStarted 2023-04-08

Plain-language 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.

Who can participate

Age range18 Years – 34 Years

SexMALE

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Inclusion Criteria: * 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 Exclusion Criteria: Participants will be excluded from the study if they are determined to have symptoms that would prevent them from giving meaningful consent or participate in study activities including any of the following criteria: * Significant cognitive impairment * Psychosis * Currently symptomatic and untreated bipolar disorder * Imminent suicidal risk

What they're measuring

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

Timeframe: 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

Timeframe: 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

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

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

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

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

Timeframe: During intervention period (10 weeks)

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

Timeframe: Post-intervention (week 10)

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

Trial details

NCT IDNCT05855655

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Results submitted2025-10-22

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