An interventional study of Acceptance and Commitment Therapy (ACT) and Body weight circuit training in HIV Infections, Substance Use and Trauma, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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:
In the U.S. women living with HIV (WLWH) are less likely to engage in HIV care, be on antiretroviral therapy (ART), and achieve sustained viral suppression compared to men. The Substance (Ab)use, Violence/trauma, and HIV/AIDS (SAVA) syndemic is proposed to primarily contribute to gender-based differences in HIV outcomes.To meaningful address SAVA requires interventions that focus on each epidemic and transdiagnostic processes (shared mediators) including mood (depression/anxiety), negative beliefs and thoughts about HIV, and loneliness. The Women focused Encounters for Resilience, Independence, Strength, and Eudaimonia (WE RISE) intervention addresses SAVA by employing peer navigator (PN) delivered group-based acceptance and commitment therapy (ACT) + exercise + empathetic social support.
The goal of this proposal is to evaluate and implement WE RISE for WLWH across four sites in Ending the HIV Epidemic (EHE) jurisdictions (San Diego, CA; Charlotte, NC; Atlanta, GA and Los Angeles, CA). This study is guided by a study advisory board (SAB) of 12 women living with and/or otherwise affected by HIV.
At each site peers will be trained at the University of California San Diego (UCSD) to provide ACT, exercise and social support through didactic and experiential experiences and a workbook that guides them through the intervention. WE RISE delivery will be monitored by experts at UCSD and peers provided feedback through 6 months to encourage the development of mastery.
The first phase of WE RISE is a type 1 hybrid study that will involve randomizing participants 1:1 to the WE RISE intervention or a local curated list of resources that focus on providing HIV care, therapy, exercise and social support. All participants in this phase will undergo assessments (HIV adherence, trauma symptoms, substance use, depression, anxiety, loneliness and others) at weeks 0, 8 (end of intervention), 24 and 48. All participants in this arm will also receive a Fitbit to track objective activity (e.g. step counts).
This phase will pursue the following Aims:
Aim 1: Evaluate short (week 8) and longer term (weeks 12, 24) effectiveness of WE RISE on HIV (↑ ART adherence, ↑ continuous viral suppression), trauma (↓ trauma symptoms), substance use (↓ days and amount of substance use) and transdiagnostic factors such as mood (↓depression, ↓anxiety), stigma and loneliness.
Aim 2: Document the WE RISE implementation process by characterizing reach, effectiveness, adoption, implementation and maintenance (RE-AIM) by site for 24 weeks.
Phase 2 of WE RISE is an observational study that will focus on sustainability of WE RISE once research funding is completed. We will encourage our partnering community based organizations to adapt WE RISE as they see fit to enable them to continue to provide the intervention. Participants will undergo the same assessment schedule as in phase 1. In this phase, the study team will continue to observe and document the intervention for adaptations made and persistence of intervention fidelity.
This phase will focus on Aim 3.
Aim 3: Transcreate alternate or additional IS that address site specific barriers and facilitators to optimize the effectiveness, maintenance and broader dissemination of WE RISE at 24 weeks while documenting the implementation process (RE-AIM) and site-specific adaptations using the Framework for Recording Adaptations and Modifications-Enhanced (FRAME) through 48 weeks.
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 300 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
Participants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot.
Behavioral: Acceptance and Commitment Therapy (ACT) · Behavioral: Body weight circuit training · Behavioral: Empathetic social support
Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.
Other: Control - list of resources
Observational study of participants undergoing WE RISE adapted for sustainability.
Behavioral: Acceptance and Commitment Therapy (ACT) · Behavioral: Body weight circuit training · Behavioral: Empathetic social support
Participants will undergo ACT in combination with exercise and social support.
Participants will learn and undergo body weight circuit training in combination with ACT and social support.
Study participants will participate in empathetic social support
A local list of resources to access exercise, therapy and social support will be provided.
Antiretroviral therapy (ART) adherence by drug levels
All participants will undergo testing for ART in hair samples
Time frame: Weeks 0, 8, 24 and 48.
Antiretroviral therapy (ART) adherence by visual analog scale
Self reported measure of adherence on a scale (score range 0 to 100 higher scores indicate higher adherence)
Time frame: Weeks 0, 8, 24 and 48.
Generalized Anxiety Disorder-7
Measure of anxiety (score range 0 to 21, sum of items, 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety)
Time frame: Weeks 0, 8, 24 and 48.
Patient Health Questionnaire - 9
Measure of depression (score range 0-27, sum of items, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression)
Time frame: Weeks 0, 8, 24 and 48.
Timeline follow back substance use
Recall of substance use in the past week
Time frame: Weekly during weeks 0-8, 24 and 48.
International trauma questionnaire
Provides two components of scoring and interpretation: 1) categorical scoring for the diagnosis of post traumatic stress disorder, PTSD (two or more question 1 or 2, two or more question 3 or 4, two of more question 5 or 6, two or more question 7,8,9) and complex post traumatic stress disorder, CPTSD (two or more question 10 or 11, two or more questions 12 or 13, two or more questions 14 or 15, two or more questions 16,17,18). 2) Dimensional scores from 0 to 24 (higher scores indicate higher symptom severity) are also presented for the two subscales. For PTSD sum items 1 to 6, for disturbances of self organization sum items 10 to 15.
Time frame: Weeks 0, 8, 24 and 48.
HIV Stigma Scale 12-short form
Evaluates HIV stigma (scale ranges 12-48, sum of all items, higher scores indicate higher internalization of stigma)
Time frame: Weeks 0, 8, 24 and 48.
Loneliness (UCLA-3 item)
Three item question about loneliness (range 1-9, score is sum of all items, higher score indicates higher loneliness)
Time frame: Weeks 0, 8, 24 and 48.
Fitbit data
average step counts in past 2 weeks
Time frame: Weeks 0, 8, 24 and 48.
Plan to share: Yes — Deidentified data (e.g. data alone without any possible identifying information) will be shared wit the NIMH data archive and the Sociostructural Implementation Science Coordination Initiative Hub for other researchers to access and use as per funding requirements.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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University of California, San Diego