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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Acceptance and Commitment Therapy (ACT) — BEHAVIORAL
    Participants will undergo ACT in combination with exercise and social support.
  • Body weight circuit training — BEHAVIORAL
    Participants will learn and undergo body weight circuit training in combination with ACT and social support.
  • Empathetic social support — BEHAVIORAL
    Study participants will participate in empathetic social support
  • Control - list of resources — OTHER
    A 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 Intervention
    Participants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot.
  • Active Comparator: Control
    Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.
  • Experimental: Observational
    Observational 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

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego AntiViral Research Center (AVRC)San DiegoCalifornia92103
Liliana Harkness
619-543-4753
Emily Kvitek
619-543-8080

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