Women Focused Encounters for Resilience Independence Strength and Eudaimonia

HIV Infections Clinical Trial

— WE RISE  

Official title:

Women Focused Encounters for Resilience Independence Strength and Eudaimonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216600
• Other study ID #: 808061
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: Leah Burke, MS
• Phone: 6195438207
• Email: lbburke[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Medication Adherence
• Substance Use
• Substance-Related Disorders
• Trauma

Intervention

Behavioral:
• 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

Other:
• Control - list of resources
A local list of resources to access exercise, therapy and social support will be provided.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Diego	APLA Health, By His Stripes Wellness Center, Christie's Place, Sister Love

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	Fitbit data	average step counts in past 2 weeks	Weeks 0, 8, 24 and 48.
Primary	Antiretroviral therapy (ART) adherence by drug levels	All participants will undergo testing for ART in hair samples	Weeks 0, 8, 24 and 48.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Timeline follow back substance use	Recall of substance use in the past week	Weekly during weeks 0-8, 24 and 48.
Secondary	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.