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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193605
• Other study ID #: K23AT010567
• Secondary ID: K23AT010567
• Status: Completed
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: October 12, 2022

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• HIV Infections

Intervention

Behavioral:
• Mindfulness
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.

Locations

Country	Name	City	State
United States	UAB School of Nursing	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Intervention Measure	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.	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.