NCT06216600 Women Focused Encounters for Resilience Independence Strength and Eudaimonia
| NCT ID | NCT06216600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-09-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Is a woman 2. Able to read and understand English 3. Able to participate in a low intensity exercise program 4. HIV-seropositive 5. 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). 6. Reports missing more ART doses than previous months, or \> 5 in a month, or has a detectable HIV viral load 7. Experienced interpersonal violence 8. Able and willing to provide informed consent Exclusion Criteria: 1. Unwilling to participate in video record sessions (used to evaluate the quality of the intervention) 2. Enrolled in hospice 3. Not willing or not able to comply with study advisory board group participation agreement.
Contact & Investigator
Maile Karris, MD
PRINCIPAL INVESTIGATOR
UCSD
Frequently Asked Questions
Who can join the NCT06216600 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06216600 currently recruiting?
Yes, NCT06216600 is actively recruiting participants. Contact the research team at lir003@health.ucsd.edu for enrollment information.
Where is the NCT06216600 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06216600 clinical trial?
NCT06216600 is sponsored by University of California, San Diego. The principal investigator is Maile Karris, MD at UCSD. The trial plans to enroll 300 participants.
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