Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06216600

Conditions

HIV Infections

Substance Use

Trauma

Medication Adherence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Acceptance and Commitment Therapy (ACT)

Body weight circuit training

Empathetic social support

Control - list of resources

Study Details

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.

Conditions

HIV Infections

Substance Use

Trauma

Medication Adherence

Study ID

NCT06216600

Start date

Sep 19, 2024

Status verified date

Jan, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Acceptance and Commitment Therapy (ACT)

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

Body weight circuit training

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

Empathetic social support

Study participants will participate in empathetic social support

Control - list of resources

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

Primary outcome measure

  • Antiretroviral therapy (ART) adherence by drug levels [ Time Frame: Weeks 0, 8, 24 and 48. ]

Central Contacts and Locations

Central contacts

Liliana Harkness

619-543-4753lir003@health.ucsd.edu

Helene Le

619-543-3116helenele@health.ucsd.edu

Locations

UC San Diego AntiViral Research Center (AVRC)

Recruiting

San Diego, California, United States, 92103

Contacts

Liliana Harkness

619-543-4753lir003@health.ucsd.edu

Emily Kvitek

619-543-8080ekvitek@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

May 1, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-05-01.