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

Study Overview
=================
Brief 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). Primary outcomes are HIV and STI testing and self-reported sexual risk behaviors. Secondary outcomes are stress biomarker (fingernail cortisol levels), psychological health, minority stress and coping. The study will examine recruitment and retention, number of sessions attended, self-reported at-home practice of mindfulness, completion of assessment, and acceptability of the intervention.

Detailed Description
-----------------
In 2017, gay, bisexual, and other men who have sex with men (MSM) made up 70% of new HIV infections in the U.S., and young adult MSM (age 18-34; YMSM) account for the majority of HIV cases. YMSM also experience prevalent, often co-occurring mental health issues, including depression, anxiety, and substance use, creating a syndemic condition surrounding HIV risk and suboptimal HIV testing. A key driver of such disparities experienced by YMSM is minority stress. Experiences of identity-based discrimination lead to internalized stigma and maladaptive coping (e.g., emotion dysregulation, avoidant coping, impulsivity) The downstream effects of minority stress are poor mental health (depression and anxiety), increased sexual risk, and lack of engagement in key health services such as HIV testing due to anxiety related to identity disclosure to providers and anticipation of stigmatizing encounters. Recent evidence also suggests discrimination exposure is linked to heightened physiological stress response (cortisol level) that represents depletion of coping resources and increased risk for development of stress-linked psychological disorders (depression, anxiety). Therefore, reducing minority stress represents a promising transdiagnostic approach to reduce the burden of HIV and mental health issues experienced by YMSM. Research suggests that Mindfulness-Based Interventions (MBIs) target mechanisms relevant to minority stress, including self-acceptance, emotional dysregulation, and avoidant coping. Therefore, as an individual-level intervention, MBIs may serve as an innovative HIV prevention intervention by lowering the syndemic risk among YMSM through reducing psychological symptoms, improving coping, and enhancing HIV-related behavioral health. However, no evidence-based MBIs have been tested for HIV prevention, and clinical and research evidence suggests further adaptation is warranted to improve its relevance and optimize engagement for YMSM. This study aims to develop an internet-delivered MBI to address minority stress and its negative HIV-related health consequences experienced by YMSM. Specifically, the researchers propose to adapt, refine, and pilot-test an evidence-based MBI, Mindfulness-based Stress Reduction (MBSR), to promote mental and sexual health and HIV testing engagement among distressed, high-risk YMSM. Aims 1-3 will support the subsequent production and evaluation of the adapted intervention. To maximize reach, scalability, and availability to a population that experience challenges seeking in-person counseling and health services, the intervention will also be adapted for internet-based delivery. Aim 1. (Previously Completed) Adapt MBSR for distressed, high-risk YMSM using internet delivery, guided by the ADAPT-ITT model. Researchers conducted iterative phases of formative research including online-based focus groups with YMSM, solicitation of feedback from stakeholders, and revision of intervention protocols. This process resulted in the first-draft of an internet-delivered, mindfulness-based intervention protocol for use with YMSM, known as Mindfulness-Based Queer Resilience (MBQR). Aim 2. (Previously Completed - see ClinicalTrials.gov ID: NCT05540652) Refine intervention protocol by administering adapted materials to distressed, high-risk YMSM (n=18) through internet-based open pilot and gather feedback. Following integration of feedback, this process will result in a finalized protocol of an internet-delivered, mindfulness-based intervention protocol for YMSM. Aim 3. (This is the focus of this Clinical Trial Registration) Examine the feasibility and acceptability of the internet-delivered mindfulness-based intervention (iMBI), called Mindfulness-based Queer Resilience (MBQR), for HIV prevention. Researchers 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). They will 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). Primary outcomes are HIV and STI testing and self-reported sexual risk behaviors. Secondary outcomes are stress biomarker (fingernail cortisol levels), psychological health, minority stress and coping. The study will examine recruitment and retention, number of sessions attended, self-reported at-home practice of mindfulness, completion of assessment, and acceptability of the intervention.

Official Title
-----------------
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

Conditions
-----------------
Hiv, Minority Stress, Mental Health Wellness 1

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Based Queer Resilience (MBQR)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The methodological approach includes a 2-arm trial of MBQR vs. a health education control group, with up to n=30 per arm (total Aim 3 sample size = up to 60 participants enrolled and randomized). The study is intended to evaluate the impacts of MBQR on the specified outcomes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Queer Resilience (MBQR)<br>MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. In addition to the 10 weekly sessions there is an all-day retreat (6hrs) that takes place around week 6. The participants also meet one-on-one with the instructor(s) at the beginning and middle of class for a 30-minute welcome call and check in. | Behavioral: Mindfulness-Based Queer Resilience (MBQR)<br>* This work aims to develop an internet-delivered MBI to address minority stress and its negative HIV-related health consequences experienced by young men who have sex with men (YMSM). This aim will examine the feasibility and acceptability of the internet-delivered mindfulness-based intervention (iMBI), called Mindfulness-based Queer Resilience (MBQR), for HIV prevention. The study 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).<br>|
| Active Comparator: Health Education<br>The online Health Education course is a self-paced program that can be largely completed independently (no group meeting, no all-day) by control group participants. The ten weekly modules are estimated to take around 30 to 90 minutes each to complete and consist of readings, videos, infographics, and other related activities (e.g., reflections, quizzes). Participants randomized to the control will be offered an optional MBQR-hybrid course after the 6-month follow-up assessment is complete. MBQR-hybrid is an online-based mindfulness course asynchronously facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. Participants will also have the option of participating in weekly live 1-hour sessions. MBQR-hybrid is designed to be completed within a 3-months time frame (10 modules that can be paced to complete in a 10-14 weeks time frame). | Behavioral: Mindfulness-Based Queer Resilience (MBQR)<br>* This work aims to develop an internet-delivered MBI to address minority stress and its negative HIV-related health consequences experienced by young men who have sex with men (YMSM). This aim will examine the feasibility and acceptability of the internet-delivered mindfulness-based intervention (iMBI), called Mindfulness-based Queer Resilience (MBQR), for HIV prevention. The study 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of MBQR intervention on HIV/STI testing: home testing | A primary aim of the study is to evaluate the impact of MBQR on HIV/STI testing through self-administered home testing kits provided at no cost to participants at baseline, post-intervention, and 6 months follow up. At baseline, participants will participate in rapid oral HIV testing. Kits will be mailed to participants and with be completed at home on Zoom with study research assistants available for guidance and testing counseling (as needed). At post-intervention and 6 month follow-up, participants will be asked to complete more comprehensive home HIV/STI testing. | 6 months | 
| Impact of MBQR intervention on HIV/STI testing: self report | A primary aim of the study is to evaluate the impact of MBQR on HIV/STI testing through self-report measures adminisiterd via Qualtrics. At baseline, post-intervention, and 6-month follow up, all participants will be invited to complete an intervention assessment via Qualtrics. This assessment contains a HIV/STI status and testing experience questionnaire. | 6 months | 
| Impact of MBQR intervention on sexual risk behaviors | A primary aim of the study is to evaluate the impact of MBQR on sexual risk behaviors. This primary outcome will be assessed via the Sexual Risk Behaviors Scale, which is adapted from Emory University's American Men's Internet Survey. At baseline, mid-intervention (week 5), post-intervention, and 6-month follow up, participants will complete an intervention assessment via Qualtrics. This assessment will contain the Sexual Risk Behaviors Scale. | 6 months | 
| Impact of MBQR intervention on safe sex behaviors | A primary aim of the study is to evaluate the impact of MBQR on safe sex behaviors. This primary outcome will be assessed via the Safe Sex Self-Efficacy Scale (SSES). Participants will respond to 13 items using a five item Likert scale (1=Not at all confident, 2=Not very confident, 3=Somewhat confident, 4=Very confident, 5=Extremely confident). Scores may range from 13-65. At baseline, post-intervention, and 6-month follow up, participants will complete an intervention assessment via Qualtrics. This assessment will contain the Safe Sex Self-Efficacy Scale (SSES). | 6 months | 
| Feasibility of online MBQR as measured by recruitment rates | A primary aim of the study is to evaluate feasibility and acceptability of MBQR. Feasibility will be assessed via three measures. One measure of feasibility will be participant recruitment rates. See other primary outcomes for other measures used. | 3 months | 
| Feasibility of online MBQR as measured by retention rates | A primary aim of the study is to evaluate feasibility and acceptability of MBQR. Feasibility will be assessed via three measures. One measure of feasibility will be participant retention rates (i.e., as measured by attendance and attrition). See other primary outcomes for other measures used. | 3 months | 
| Feasibility of online MBQR as measured by engagement: Enactment of treatment skills | A primary aim of the study is to evaluate feasibility and acceptability of MBQR. Feasibility will be assessed via three measures. One measure of feasibility will be engagement (i.e, enactment of treatment skills), which will be assessed by home practice completion. | 3 months | 
| Acceptability of online MBQR as measured by the Client Satisfaction Questionnaire | A primary aim of the study is to evaluate feasibility and acceptability of MBQR. Acceptability will be assessed using three measures. One such measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Scores for the CSQ-8 range from 8 to 32, with higher values indicating higher satisfaction. See other primary outcomes for other measures used. | 3 months | 
| Acceptability of online MBQR as measured by a session evaluation form | The primary aim of the study is to evaluate feasibility and acceptability of MBQR. Acceptability will be assessed using three measures. One such measure of acceptability will be via a session evaluation form that provides both qualitative and quantitative feedback on the study intervention. See other primary outcomes for other measures used. | 3 months | 
| Acceptability of online MBQR as measured by semi-structured qualitative exit interview | The primary aim of the study is to evaluate feasibility and acceptability of MBQR. Acceptability will be assessed using three measures. One such measure of acceptability will be via a semi-structured qualitative exit interview conducted with one-on-one with study participants via a videoconferencing platform (i.e., Zoom). Interviews will be transcribed and coded for analysis. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fingernail cortisol levels | This secondary outcome will be assessed by providing participants with a fingernail collection kit from which a cortisol bio-sample (i.e., nail trimmings) can be used to assess participant cortisol stress levels during the study. Participants will submit bio-samples via a nail collection kit at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Depression symptoms: PHQ-9 | This secondary outcome will be assessed via the 9-item Patient Health Questionnaire (PHQ-9). Participants will respond to each item using a four item Likert scale (0=Not at all, 1=Several days, 2=More than half the days, 3=Nearly every day). Scores range from 0-27 with cut points indicating minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27) depression. Since the questionnaire relies on patient self-report, all responses should be verified by a clinician. Participants will complete the PHQ-9 at baseline, weekly during the intervention, at post-intervention, and at 6-month follow up. | 6 months | 
| Depression symptoms: BDI-II | This secondary outcome will be assessed via the 21-item Beck Depression Inventory II (BDI-II). Each item is rated on a 4-point Likert-type scale ranging from 0 to 3, based on the severity in the last two weeks. Total scores range from 0 to 63 with higher scores suggesting higher levels of depression symptomology; Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.. Participants will complete the BDI-II at baseline, post-intervention, and at 6-month follow up. | 6 months | 
| Anxiety symptoms | This secondary outcome will be assessed using the 7-item, self-reported Generalized Anxiety Disorder Assessment (GAD-7). Participants will report on anxiety symptoms using a four item Likert scale (0=Not at all, 1=Several days, 2=More than half the days, 3=Nearly every day). Scores range from 0-21, with scores of 5, 10, and 15 serving as cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Since the questionnaire relies on patient self-report, all responses should be verified by a clinician. Participants will complete the GAD-7 at baseline, weekly during the intervention, at post-intervention, and at 6-month follow up. | 6 months | 
| Perceived stress | This secondary outcome will be assessed using the 10-item, self-reported Perceived Stress Scale (PSS-10). Participants will report on thoughts and feeling during the past month using a five item Likert scale (0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Very Often). Scores may range from 0-40. Participants will complete the PSS-10 at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Loneliness | This secondary outcome will be assessed using the 20-item, self-reported UCLA Loneliness Scale. Participants will respond to 20 items on a four point Likert scale (1=Never, 2=Rarely, 3=Sometimes, 4=Sometimes). Scores may range from 20-80. Participants will complete the UCLA Loneliness Scale at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Mindfulness | This secondary outcome will be assessed using the Mindful Attention Awareness Scale (MAAS). Participants will respond to 15 items on a six point Likert scale (1=Almost Always, 2=Very Frequently, 3=Somewhat Frequently, 4=Somewhat Infrequently, 5=Very Infrequently, 6=Almost Never). Scores range from 15 to 90 with higher scores reflecting higher levels of dispositional mindfulness. Participants will complete the MAAS at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Self compassion | This secondary outcome will be assessed using the 26-item validated Self-Compassion Scale (SCS); Participants indicate how they typically act towards themselves in difficult times using a 5-point Likert scale with 1 being Almost Never to 5 being Almost Always. The total self-compassion score is calculated by reverse scoring the negative sub-scale items - self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3, 4 = 2, 5 = 1) then computing a total mean. Researchers can choose to analyze their data either by using individual sub-scale sores or by using a total score. Participants will complete the SCS at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Emotion regulation difficulties | This secondary outcome will be assessed using the Difficulties in Emotion Regulation Short Form Scale (DERS-SF). The DERS-SF is an 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1-5, with 1 being (almost never [0-10%]); 2 (sometimes [11-35%]); 3 (about half the time [36-65%]); 4 (most of the time [66-90%]); and 5 being (almost always [91-100%]). Higher scores indicate more difficulty in emotion regulation. Participants will complete the DERS-SF at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Queer community belonging | This secondary outcome will be assessed using the nine-item Queer Community Belonging scale. Participants rate nine items on a five point Likert scale (1=not at all or never, 2=almost never or occasionally, 3=some of the time, 4=most of the time, 5=all of the time). Scores may range from 9-40. Participants will complete the self-report scale at baseline, post-intervention, and 6-month follow up. | 6 months | 
| PrEP willingness and adherence | This secondary outcome will be assessed using a five-item Pre-Exposure Prophylaxis (PrEP) history and willingness questionnaire. Additionally, participants will complete a six item PrEP adherence self-efficacy questionnaire. Participants will complete the self-report questionnaires at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Sleep | This secondary outcome will be assessed using the Brief Pittsburgh Sleep Inventory (PSI-SF). The PSI-SF is an 10-item self-report measure a participant's usual sleep habits during the past month. Participants will complete the PSI-SF at baseline, post-intervention, and 6-month follow up. | 6 months | 
| Internalized Stigma/Homophobia | Internalized Stigma/Homophobia will be assessed using the self-report 9-item Internalized Homophobia Scale (IHS) that measures perceived and experienced stigma in the past 12 months using a four point scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often). Scores range from 9 to 36 with higher scores indicating higher internalized stigma. Participants will complete the IHS at baseline, post-intervention, and 6-month follow up. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness-based intervention, Sexual minority, LGBTQ, HIV prevention