Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216600
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-01-11
Brief Title:
Women Focused Encounters for Resilience Independence Strength and Eudaimonia
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Women Focused Encounters for Resilience Independence Strength and Eudaimonia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WE RISE
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 therapyACT exercise social support to address the substance abuse violence and AIDSHIV 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
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 US 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 Abuse Violencetrauma and HIVAIDS SAVA syndemic is proposed to primarily contribute to gender-based differences in HIV outcomesTo meaningful address SAVA requires interventions that focus on each epidemic and transdiagnostic processes shared mediators including mood depressionanxiety 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 andor 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 11 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 eg 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
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 andor 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 11 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None