Clinical trial NCT06216600: Women Focused Encounters for Resilience Independence Strength and Eudaimonia
Official title: Women Focused Encounters for Resilience Independence Strength and Eudaimonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Substance Use
Trauma
Medication Adherence
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Christie's Place
name: By His Stripes Wellness Center
name: Sister Love
name: APLA Health
First posted: 2024-01-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antiretroviral therapy (ART) adherence by drug levels
timeFrame: Weeks 0, 8, 24 and 48.
Secondary outcomes:
measure: Antiretroviral therapy (ART) adherence by visual analog scale
timeFrame: Weeks 0, 8, 24 and 48.
measure: Generalized Anxiety Disorder-7
timeFrame: Weeks 0, 8, 24 and 48.
measure: Patient Health Questionnaire - 9
timeFrame: Weeks 0, 8, 24 and 48.
measure: Timeline follow back substance use
timeFrame: Weekly during weeks 0-8, 24 and 48.
measure: International trauma questionnaire
timeFrame: Weeks 0, 8, 24 and 48.
Other outcomes:
measure: HIV Stigma Scale 12-short form
timeFrame: Weeks 0, 8, 24 and 48.
measure: Loneliness (UCLA-3 item)
timeFrame: Weeks 0, 8, 24 and 48.
measure: Fitbit data
timeFrame: Weeks 0, 8, 24 and 48.
Locations:
city: San Diego
country: United States
facility: UC San Diego AntiViral Research Center (AVRC)
state: California
Study officials:
affiliation: UCSD
name: Maile Karris, MD
role: PRINCIPAL_INVESTIGATOR
References: