Women Focused Encounters for Resilience Independence Strength and Eudaimonia
NCT ID: NCT06216600
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-09-19
2028-05-31
Brief Summary
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* 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 th eintervention.
Detailed Description
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The goal of this proposal is to evaluate and implement WE RISE for WLWH across four sites in Ending the HIV Epidemic (EHE) jurisdictions (San Diego, CA; Charlotte, NC; Atlanta, GA and Los Angeles, CA). This study is guided by a study advisory board (SAB) of 12 women living with and/or otherwise affected by HIV.
At each site peers will be trained at the University of California San Diego (UCSD) to provide ACT, exercise and social support thorugh didactic and experiential experiences and a workbook that guides them through the intervention. WE RISE delivery will be monitored by experts at UCSD and peers provided feedback through 6 months to encourage the devleopment of mastery.
The first phase of WE RISE is a type 1 hybrid study that will involve randomizing participants 1:1 to the WE RISE intervention or a local curated list of resources that focus on providing HIV care, therapy, exercise and social support. All participants in this phase will undergo assessments (HIV adherence, trauma symptoms, substance use, depression, anxiety, loneliness and others) at weeks 0, 8 (end of interveniton), 24 and 48. All participants in this arm will also receive a Fitbit to track objective activity (e.g. step counts).
This phase will pursue the following Aims:
Aim 1: Evaluate short (week 8) and longer term (weeks 12, 24) effectiveness of WE RISE on HIV (↑ ART adherence, ↑ continuous viral suppression), trauma (↓ trauma symptoms), substance use (↓ days and amount of substance use) and transdiagnostic factors such as mood (↓depression, ↓anxiety), stigma and loneliness.
Aim 2: Document the WE RISE implementation process by characterizing reach, effectiveness, adoption, implementation and maintenance (RE-AIM) by site for 24 weeks.
Phase 2 of WE RISE is an observational study that will focus on sustainability of WE RISE once research funding is completed. We will encourage our partnering community based organizations to adapt WE RISE as they see fit to enable them to continue to provide the intervention. Participants will undergo the same assessment schedule as in phase 1. In this phase, the study team will continue to observe and document the intervention for adaptations made and persistence of intervention fidelity.
This phase will focus on Aim 3.
Aim 3: Transcreate alternate or additional IS that address site specific barriers and facilitators to optimize the effectiveness, maintenance and broader dissemination of WE RISE at 24 weeks while documenting the implementation process (RE-AIM) and site-specific adaptations using the Framework for Recording Adaptations and Modifications-Enhanced (FRAME) through 48 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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WE RISE Intervention
Participants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot.
Acceptance and Commitment Therapy (ACT)
Participants will undergo ACT in combination with exercise and social support.
Body weight circuit training
Participants will learn and undergo body weight circuit training in combination with ACT and social support.
Empathetic social support
Study participants will participate in empathetic social support
Control
Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.
Control - list of resources
A local list of resources to access exercise, therapy and social support will be provided.
Observational
Observational study of participants undergoing WE RISE adapted for sustainability.
Acceptance and Commitment Therapy (ACT)
Participants will undergo ACT in combination with exercise and social support.
Body weight circuit training
Participants will learn and undergo body weight circuit training in combination with ACT and social support.
Empathetic social support
Study participants will participate in empathetic social support
Interventions
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Acceptance and Commitment Therapy (ACT)
Participants will undergo ACT in combination with exercise and social support.
Body weight circuit training
Participants will learn and undergo body weight circuit training in combination with ACT and social support.
Empathetic social support
Study participants will participate in empathetic social support
Control - list of resources
A local list of resources to access exercise, therapy and social support will be provided.
Eligibility Criteria
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Inclusion Criteria
2. Able to read and understand English
3. Able to participate in a low intensity exercise program
4. HIV-seropositive
5. At risk substance use (any illegal or unprescribed drug), tobacco, marijuana or alcohol use (four or more drinks in one day or 8 or more in one week).
6. Reports missing more ART doses than previous months, or \> 5 in a month, or has a detectable HIV viral load
7. Experienced interpersonal violence
8. Able and willing to provide informed consent
9. Confirmed COVID-19 vaccinated x 2 or willingness to wear a mask during inperson interactions.
Exclusion Criteria
2. Enrolled in hospice
3. Not willing or not able to comply with study advisory board group participation agreement.
18 Years
FEMALE
Yes
Sponsors
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Christie's Place
OTHER
By His Stripes Wellness Center
OTHER
Sister Love
OTHER
APLA Health
UNKNOWN
University of California, San Diego
OTHER
Responsible Party
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Maile Young Karris
Associate Professor
Principal Investigators
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Maile Karris, MD
Role: PRINCIPAL_INVESTIGATOR
UCSD
Locations
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UC San Diego AntiViral Research Center (AVRC)
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Liliana Harkness
Role: primary
Emily Kvitek
Role: backup
Other Identifiers
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808061
Identifier Type: -
Identifier Source: org_study_id