Women Focused Encounters for Resilience Independence Strength and Eudaimonia
Part of paid clinical trials in San Diego, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT06216600
- Status
- Recruiting
Conditions
- HIV Infections
- Medication Adherence
- Substance Use
- Trauma
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- 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 — OTHERA local list of resources to access exercise, therapy and social support will be provided.
Study Details
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.
Key Dates
- Start date
- Sep 19, 2024
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2027
- Completion
- May 31, 2028
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: WE RISE InterventionParticipants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot.
- Active Comparator: ControlParticipants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.
- Experimental: ObservationalObservational study of participants undergoing WE RISE adapted for sustainability.
Primary Outcome Measure
Antiretroviral therapy (ART) adherence by drug levels [ Time Frame: Weeks 0, 8, 24 and 48. ]
Central Contacts
- Liliana Harkness619-543-4753
- Helene Le619-543-3116
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC San Diego AntiViral Research Center (AVRC) | San Diego | California | 92103 |
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