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 range

18 Years – 34 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

Trial details

NCT IDNCT05855655

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Results submitted2025-10-22

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