Clinical trial NCT05855655: Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Minority Stress
Mental Health Wellness 1
Keywords: Mindfulness-based intervention
Sexual minority
LGBTQ
HIV prevention
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-05-11
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Impact of Mindfulness-Based Queer Resilience intervention on HIV/STI testing: home testing
timeFrame: 6 months
measure: Impact of Mindfulness-Based Queer Resilience intervention on HIV/STI testing: self report
timeFrame: 6 months
measure: Impact of Mindfulness-Based Queer Resilience intervention on sexual risk behaviors
timeFrame: 6 months
measure: Impact of Mindfulness-Based Queer Resilience intervention on safe sex behaviors
timeFrame: 6 months
measure: Feasibility of online Mindfulness-Based Queer Resilience as measured by recruitment rates
timeFrame: 3 months
measure: Feasibility of online Mindfulness-Based Queer Resilience as measured by retention rates
timeFrame: 3 months
measure: Feasibility of online Mindfulness-Based Queer Resilience as measured by engagement: Enactment of treatment skills
timeFrame: 3 months
measure: Acceptability of online Mindfulness-Based Queer Resilience as measured by the Client Satisfaction Questionnaire
timeFrame: 3 months
measure: Acceptability of online Mindfulness-Based Queer Resilience as measured by a session evaluation form
timeFrame: 3 months
measure: Acceptability of online Mindfulness-Based Queer Resilience as measured by semi-structured qualitative exit interview
timeFrame: 3 months
Secondary outcomes:
measure: Fingernail cortisol levels
timeFrame: 6 months
measure: Depression symptoms: PHQ-9
timeFrame: 6 months
measure: Depression symptoms: BDI-II
timeFrame: 6 months
measure: Anxiety symptoms
timeFrame: 6 months
measure: Perceived stress
timeFrame: 6 months
measure: Loneliness
timeFrame: 6 months
measure: Mindfulness
timeFrame: 6 months
measure: Self compassion
timeFrame: 6 months
measure: Emotion regulation difficulties
timeFrame: 6 months
measure: Queer community belonging
timeFrame: 6 months
measure: PrEP willingness and adherence
timeFrame: 6 months
measure: Sleep
timeFrame: 6 months
measure: Internalized Stigma/Homophobia
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Shufang Sun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: