N/A
Completed N=68
Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3
HIV · Minority Stress · Mental Health Wellness 1
Source: ClinicalTrials.gov NCT05855655 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates — 68 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates |
68 | — |
| PRIMARY Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: HIV/STI Testing Submission |
34; 34; 26; 29; 27; 28 | — |
| PRIMARY Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Nail Sample Submission |
30; 28; 23; 26; 23; 24 | — |
| PRIMARY Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Survey Submission |
34; 34; 33; 31; 28; 32 | — |
| PRIMARY Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Engagement |
7.18 | — |
| PRIMARY Acceptability of Online Mindfulness-Based Queer Resilience as Measured by the Client Satisfaction Questionnaire |
26.61; 18.25 | — |
| PRIMARY Acceptability of Online Mindfulness-Based Queer Resilience as Measured by a Session Evaluation Form |
33.27; 26.22 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05855655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.