CompletedNot Applicable

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

United States19 participantsStarted 2022-08-08

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 Aim 1 of the broader study, which was to use qualitative, community engaged methods, along with a quantitative online survey, to inform intervention development with the study population. The next phase of the intervention development (Aim 2 - registered here), involves 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).

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 years of age * Identify as a cisgender man * Reside in the United States * Can read and speak in English * Engaged in condomless anal sex with another man in the past 6-months * Endorse distress, measured by the PHQ-9 and GAD-7 * Possess a device (phone, tablet, computer) that allows for online conferencing * HIV-negative or status unknown (self-report) Exclusion Criteria: Participants will be excluded from the study if they are determined to have symptoms preventing them from giving meaningful consent or study activities such as: * Significant cognitive impairment * Psychosis * Imminent suicidal risk * Substance abuse

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: Baseline

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

Timeframe: Through study completion, an average of 2 months

Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Session Attendance and Home Practice Completion

Timeframe: Through intervention completion, an average of 2 months

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

Timeframe: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)

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

Timeframe: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)

Trial details

NCT IDNCT05540652

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-15

Results submitted2025-10-02

View on ClinicalTrials.gov More HIV trials

Plain-language summary

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.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Through study completion, an average of 2 months

Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Session Attendance and Home Practice Completion

Timeframe: Through intervention completion, an average of 2 months

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

Timeframe: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)

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

Timeframe: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)