Women Focused Encounters for Resilience Independence Strength and Eudaimonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Diego
About this trial
The goal of this combination Type 1 hybrid and observational study is to evaluate the impact of a peer delivered intervention of acceptance and commitment therapy (ACT) + exercise + social support to address the substance (ab)use, violence, and AIDS/HIV (SAVA) to improve medication adherence for women living with HIV (WLWH). This intervention will be implemented by community based organizations that focus on WLWH across four counties. The main question it aims to answer are:
* Will peer provision of ACT, exercise, and social support improve medication adherence for WLWH? * Will community based organizations be able to sustain the intervention after research is completed, and what changes will need to be made to sustain the intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is a woman
Able to read and understand English
Able to participate in a low intensity exercise program
HIV-seropositive
Disqualifiers
Unwilling to participate in video record sessions (used to evaluate the quality of the intervention)
Enrolled in hospice
Not willing or not able to comply with study advisory board group participation agreement.
Trial design
Design model
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy (ACT)
BehavioralParticipants will undergo ACT in combination with exercise and social support.
Body weight circuit training
BehavioralParticipants will learn and undergo body weight circuit training in combination with ACT and social support.
Empathetic social support
BehavioralStudy participants will participate in empathetic social support
Control - list of resources
Other interventionA local list of resources to access exercise, therapy and social support will be provided.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: WE RISE InterventionExperimental treatment 3 interventions
Group B: ControlActive comparator 1 intervention
Group C: ObservationalExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Antiretroviral therapy (ART) adherence by drug levels
All participants will undergo testing for ART in hair samples
Time frame
Weeks 0, 8, 24 and 48.Secondary outcomes
1
Antiretroviral therapy (ART) adherence by visual analog scale
Self reported measure of adherence on a scale (score range 0 to 100 higher scores indicate higher adherence)
Time frame
Weeks 0, 8, 24 and 48.2
Generalized Anxiety Disorder-7
Measure of anxiety (score range 0 to 21, sum of items, 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety)
Time frame
Weeks 0, 8, 24 and 48.3
Patient Health Questionnaire - 9
Measure of depression (score range 0-27, sum of items, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression)
Time frame
Weeks 0, 8, 24 and 48.4
Timeline follow back substance use
Recall of substance use in the past week
Time frame
Weekly during weeks 0-8, 24 and 48.Other outcomes
1
HIV Stigma Scale 12-short form
Evaluates HIV stigma (scale ranges 12-48, sum of all items, higher scores indicate higher internalization of stigma)
Time frame
Weeks 0, 8, 24 and 48.2
Loneliness (UCLA-3 item)
Three item question about loneliness (range 1-9, score is sum of all items, higher score indicates higher loneliness)
Time frame
Weeks 0, 8, 24 and 48.3
Fitbit data
average step counts in past 2 weeks
Time frame
Weeks 0, 8, 24 and 48.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
Christie's Place
Collaborator
By His Stripes Wellness Center
Collaborator
Sister Love
Collaborator
APLA Health
Collaborator
Source ClinicalTrials.gov