NCT05855655Completed
Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3
Developing and Testing Internet-Based Mindfulness Intervention to Reduce Minority Stress and Promote HIV-Related Behavioral Health Among Young Adult Sexual Minority Men: Aim 3, A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 4 May 2023
- Start date
- 8 Apr 2023
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Brown University
- Diseases
- HIV
- NCT number
- NCT05855655
What you commit to
- Study type: Interventional
- Participants enrolled: 68
- From 8 Apr 2023 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant cognitive impairment
- Currently symptomatic and untreated bipolar disorder
Other
- Psychosis
- Imminent suicidal risk
Who the study is looking for
- 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
Age in the registry: 18 years to 34 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brown University Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.