NCT06216600 · University of California, San Diego
Women Focused Encounters for Resilience Independence Strength and Eudaimonia
(WE RISE)
What this study is about
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).
View original scientific description
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.
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.
Primary outcome measures
Antiretroviral therapy (ART) adherence by drug levels
Time frame: Weeks 0, 8, 24 and 48.
All participants will undergo testing for ART in hair samples
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- San Diego, California
Collaborators
Christie's Place, By His Stripes Wellness Center, Sister Love, APLA Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations