Women Focused Encounters for Resilience Independence Strength and Eudaimonia
WE RISE
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Sep 2024
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedStudy Start
First participant enrolled
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
May 1, 2026
January 1, 2026
3.3 years
January 11, 2024
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Antiretroviral therapy (ART) adherence by drug levels
All participants will undergo testing for ART in hair samples
Weeks 0, 8, 24 and 48.
Secondary Outcomes (5)
Antiretroviral therapy (ART) adherence by visual analog scale
Weeks 0, 8, 24 and 48.
Generalized Anxiety Disorder-7
Weeks 0, 8, 24 and 48.
Patient Health Questionnaire - 9
Weeks 0, 8, 24 and 48.
Timeline follow back substance use
Weekly during weeks 0-8, 24 and 48.
International trauma questionnaire
Weeks 0, 8, 24 and 48.
Other Outcomes (3)
HIV Stigma Scale 12-short form
Weeks 0, 8, 24 and 48.
Loneliness (UCLA-3 item)
Weeks 0, 8, 24 and 48.
Fitbit data
Weeks 0, 8, 24 and 48.
Study Arms (3)
WE RISE Intervention
EXPERIMENTALParticipants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot.
Control
ACTIVE COMPARATORParticipants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.
Observational
EXPERIMENTALObservational study of participants undergoing WE RISE adapted for sustainability.
Interventions
Participants will undergo ACT in combination with exercise and social support.
Participants will learn and undergo body weight circuit training in combination with ACT and social support.
Study participants will participate in empathetic social support
A local list of resources to access exercise, therapy and social support will be provided.
Eligibility Criteria
You may qualify if:
- Is a woman
- Able to read and understand English
- Able to participate in a low intensity exercise program
- HIV-seropositive
- 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).
- Reports missing more ART doses than previous months, or \> 5 in a month, or has a detectable HIV viral load
- Experienced interpersonal violence
- Able and willing to provide informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christie's Placecollaborator
- By His Stripes Wellness Centercollaborator
- Sister Lovecollaborator
- APLA Healthcollaborator
- University of California, San Diegolead
Study Sites (1)
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, 92103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maile Karris, MD
UCSD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Study investigators and outcomes assessors will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 11, 2024
First Posted
January 22, 2024
Study Start
September 19, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
May 31, 2028
Last Updated
May 1, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available within 6-12 months of entry for the duration of the above mentioned databases.
- Access Criteria
- Access is dependent on the parent databases policy at the time of request.
Deidentified data (e.g. data alone without any possible identifying information) will be shared wit the NIMH data archive and the Sociostructural Implementation Science Coordination Initiative Hub for other researchers to access and use as per funding requirements.