Women Focused Encounters for Resilience Independence Strength and Eudaimonia (WE RISE)

The goal of this combination Type 1 hybrid and observational study is to evaluate the impact of a peer delivered intervention of acceptance and comittment 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 th eintervention.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Trauma; Medication Adherence; Substance Use
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Body weight circuit training; Behavioral: Empathetic social support; Other: Control - list of resources

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), HIV stigma, 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 thorugh 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 devleopment 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 interveniton), 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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah Burke, MS; Phone Number: 6195438207; Email: lbburke@health.ucsd.edu
• Study Contact Backup: Name: Helene Le; Phone Number: 619-543-3116; Email: avrcregulatory@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Recruiting
      • University of California San Diego
      • Contact: Leah Burke; Phone Number: 619-543-8080; Email: lbuburke@health.ucsd.edu
      • Contact: Lily Harkness; Email: lir003@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Is female sex at birth (cis-women)
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
9. Confirmed COVID-19 vaccinated x 2 or willingness to wear a mask during inperson interactions.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
Active Comparator: Control; Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.	Other: Control - list of resources; A local list of resources to access exercise, therapy and social support will be provided.
Experimental: Observational; Observational study of participants undergoing WE RISE adapted for sustainability.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral therapy (ART) adherence by drug levels	All participants will undergo testing for ART in hair samples	Weeks 0, 8, 24 and 48.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline follow back substance use	Recall of substance use in the past week	Weekly during 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)	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)	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)	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.	Weeks 0, 8, 24 and 48.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitbit data	average step counts in past 2 weeks	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)	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)	Weeks 0, 8, 24 and 48.

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Christie's Place; APLA Health; Sister Love; By His Stripes Wellness Center
• Investigators: Principal Investigator: Maile Karris, MD, UCSD

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 808061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available within 6-12 months of entry for the duration of the above mentioned databases.
• IPD Sharing Access Criteria: Access is dependent on the parent databases policy at the time of request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No