Women Focused Encounters for Resilience Independence Strength and Eudaimonia

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.

• Antiretroviral therapy (ART) adherence by visual analog scale [Срок оценки: Weeks 0, 8, 24 and 48.]
• Generalized Anxiety Disorder-7 [Срок оценки: Weeks 0, 8, 24 and 48.]
• Patient Health Questionnaire - 9 [Срок оценки: Weeks 0, 8, 24 and 48.]
• Timeline follow back substance use [Срок оценки: Weekly during weeks 0-8, 24 and 48.]
• International trauma questionnaire [Срок оценки: Weeks 0, 8, 24 and 48.]