Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV

Study Overview
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Brief Summary
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The investigator propose to culturally adapt the mindfulness-based stress reduction (MSBR) intervention for Black/African American women living with HIV (WLWH) to reduce stress and enhance HIV self-care behaviors and viral load (VL) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by Black WLWH in the US. Specifically, the investigator aims to 1) culturally adapt the MBSR intervention for Black WLWH using ADAPT-ITT; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted MBSR intervention for Black WLWH. The investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.

Official Title
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Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV

Conditions
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HIV Infections, Health Behavior

Intervention / Treatment
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* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cisgender females HIV seropositive 18 years of age or older English speaking An active patient at the local HIV ambulatory clinic in Alabama. Exclusion Criteria: Non-English speaking Appear temporarily impaired (e.g., intoxicated) Not willing to or legally unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Based Stress Reduction<br>MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview. | Behavioral: Mindfulness<br>* The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.<br>|
| No Intervention: Standard of Care<br>The control condition will continue receiving usual care or standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence will be measured by the single-item antiretroviral therapy question. Higher scores indicate better ART adherence. | Immediately post-intervention or 8 weeks. | 
| Perceived Stress | Perceived stress will be measures using the perceived stress scale (PSS), with higher scores indicating higher perceived stress. | Immediately post-intervention or 8 weeks. | 
| Mental Distress | Mood will be assessed using the PHQ-8. Higher scores are indicate increased symptom severity. | Immediately post-intervention or 8 weeks. | 
| Physical | Physical symptoms will measured by the AIDS Clinical Trial group HIV symptom index. A higher score indicate more symptoms. | Immediately post-intervention or 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social support | Social support will be measured using the abbreviated medical outcome study social support scale (MOS4). Higher scores indicate higher social support. | Immediately post-intervention or 8 weeks. | 
| Mindfulness | Mindfulness will be measured using the five facet mindfulness scale (FFMQ-SF) with higher scores indicating more mindfulness. | Immediately post-intervention or 8 weeks. |