HIV InfectionsWE RISENCT06216600
Women Focused Encounters for Resilience Independence Strength and Eudaimonia
A study testing Acceptance and Commitment Therapy (ACT), Body weight circuit training and Empathetic social support in people with HIV Infections and Substance Use, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Substance Use, Trauma
- What is being tested?
- Acceptance and Commitment Therapy (ACT), Body weight circuit training and Empathetic social support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a woman
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, 92103
Liliana Harkness, 619-543-4753, lir003@health.ucsd.edu
Emily Kvitek, 619-543-8080, ekvitek@health.ucsd.edu
About this study
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.
Read the detailed description
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.
- Conditions
- HIV Infections, Substance Use, Trauma, Medication Adherence
- Being tested
- Acceptance and Commitment Therapy (ACT), Body weight circuit training, Empathetic social support, Control - list of resources
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Wounds and Injuries, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
Participants will undergo ACT in combination with exercise and social support.
Body weight circuit trainingBehavioural
Participants will learn and undergo body weight circuit training in combination with ACT and social support.
Empathetic social supportBehavioural
Study participants will participate in empathetic social support
Control - list of resourcesOther
A local list of resources to access exercise, therapy and social support will be provided.
| Study group | Role | What they receive |
|---|---|---|
| WE RISE Intervention | Experimental | Participants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Body weight circuit training; Behavioral: Empathetic social support |
| Control | Active comparator | Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support. Receives: Other: Control - list of resources |
| Observational | Experimental | Observational study of participants undergoing WE RISE adapted for sustainability. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Body weight circuit training; Behavioral: Empathetic social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral therapy (ART) adherence by drug levels
All participants will undergo testing for ART in hair samples
Measured: Weeks 0, 8, 24 and 48.
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: Weeks 0, 8, 24 and 48.
Timeline follow back substance use
Recall of substance use in the past week
Measured: 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.
Measured: Weeks 0, 8, 24 and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start19 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type 1 hybrid study randomizing particpants 1:1 to either WE RISE or control (list of resources). Followed by one arm observational study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Christie's Place, By His Stripes Wellness Center, Sister Love, APLA Health
- Responsible party
- Principal investigator, Maile Young Karris, University of California, San Diego
- Investigators
- Maile Karris, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216600
- Sponsor's protocol ID
- 808061
- Acronym
- WE RISE
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Focused Encounters for Resilience Independence Strength and Eudaimonia
- ClinicalTrials.gov ID
- NCT06216600
- Acronym / sponsor ID
- WE RISE / 808061
- Conditions
- HIV Infections, Substance Use, Trauma, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Christie's Place, By His Stripes Wellness Center, Sister Love, APLA Health
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Type 1 hybrid study randomizing particpants 1:1 to either WE RISE or control (list of resources). Followed by one arm observational study.
| Arm | Type | Receives |
|---|---|---|
| WE RISE Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Body weight circuit training, Behavioral: Empathetic social supportParticipants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot. |
| Control | Active comparator | Other: Control - list of resourcesParticipants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support. |
| Observational | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Body weight circuit training, Behavioral: Empathetic social supportObservational study of participants undergoing WE RISE adapted for sustainability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is a woman
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)Participants will undergo ACT in combination with exercise and social support. | Behavioural | Observational, WE RISE Intervention |
| Body weight circuit trainingParticipants will learn and undergo body weight circuit training in combination with ACT and social support. | Behavioural | Observational, WE RISE Intervention |
| Empathetic social supportStudy participants will participate in empathetic social support | Behavioural | Observational, WE RISE Intervention |
| Control - list of resourcesA local list of resources to access exercise, therapy and social support will be provided. | Other | Control |
Primary outcome
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
5 secondary outcomes
Antiretroviral therapy (ART) adherence by visual analog scale
Time frame: Weeks 0, 8, 24 and 48.
Generalized Anxiety Disorder-7
Time frame: Weeks 0, 8, 24 and 48.
Patient Health Questionnaire - 9
Time frame: Weeks 0, 8, 24 and 48.
Timeline follow back substance use
Time frame: Weekly during weeks 0-8, 24 and 48.
International trauma questionnaire
Time frame: Weeks 0, 8, 24 and 48.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maile Karris, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT), Body weight circuit training and Empathetic social support in people with HIV Infections and Substance Use, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liliana Harkness (619-543-4753, lir003@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiretroviral therapy (ART) adherence by drug levels (time frame: Weeks 0, 8, 24 and 48.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.