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

Not Applicable

Completed

• Conditions: HIV Infections; Health Behavior
• Interventions: Behavioral: Mindfulness

• Registration Number: NCT04193605
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Study Start: 2022-02-11
• Primary Completion: 2022-10-12
• Study Completion: 2022-10-12
• Results First Submitted: 2023-12-30
• Results First Submitted QC: 2024-03-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Results First Posted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

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Exclusion Criteria

• Non-English speaking
• Appear temporarily impaired (e.g., intoxicated)
• Not willing to or legally unable to provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Stress Reduction	Mindfulness	MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.

Primary Outcome Measures

Name	Time	Method
Feasibility Intervention Measure	Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.	Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from "1" completely disagree to "5" completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20.

Trial Locations

Locations (1)

UAB School of Nursing; 🇺🇸 Birmingham, Alabama, United States