Health Behavior, HIV Infections
Conditions
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.
Interventions
BEHAVIORALMindfulness
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Based Stress Reduction MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.
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. | 24 |
| Standard of Care The control condition will continue receiving usual care or standard of care. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Mindfulness Based Stress Reduction |
|---|---|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 7.5 | 47.1 years STANDARD_DEVIATION 9.3 | 46.8 years STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 48 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 48 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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.
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.
Population: Participants in the standard of care did not receive the intervention. Therefore, data was not collected or analyzed on these participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Feasibility Intervention Measure | 18 units on a scale | Standard Deviation 2.4 |