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

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.

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Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UAB School of Nursing

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness

Behavioral

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.

Primary outcomes

Feasibility Intervention Measure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Dec 10, 2019
Registry last updated: Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed