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

The University of Alabama at Birmingham

Status: Completed

Conditions: Health Behavior; HIV Infections

Treatments: Behavioral: Mindfulness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04193605

K23AT010567 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Mindfulness Based Stress Reduction

Active Comparator group

Description:

MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.

Treatment:

Behavioral: Mindfulness

Standard of Care

No Intervention group

Description:

The control condition will continue receiving usual care or standard of care.