Women Focused Encounters for Resilience Independence Strength and Eudaimonia

NCT06216600 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Substance Use
  • Trauma
  • Medication Adherence

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy (ACT)

Participants will undergo ACT in combination with exercise and social support.

BEHAVIORAL

Body weight circuit training

Participants will learn and undergo body weight circuit training in combination with ACT and social support.

BEHAVIORAL

Empathetic social support

Study participants will participate in empathetic social support

OTHER

Control - list of resources

A local list of resources to access exercise, therapy and social support will be provided.

Sponsors & Collaborators

  • Christie's Place

    collaborator OTHER
  • By His Stripes Wellness Center

    collaborator OTHER
  • Sister Love

    collaborator OTHER
  • APLA Health

    collaborator UNKNOWN
  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Maile Karris, MD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2027-12-31
Completion
2028-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06216600 on ClinicalTrials.gov