Women Focused Encounters for Resilience Independence Strength and Eudaimonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Antiretroviral therapy (ART) adherence by drug levels
研究概览
简要总结
The goal of this combination Type 1 hybrid and observational study is to evaluate the impact of a peer delivered intervention of acceptance and commitment 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 the intervention.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Study investigators and outcomes assessors will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to read and understand English
- •Able to participate in a low intensity exercise program
- •HIV-seropositive
- •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).
- •Reports missing more ART doses than previous months, or > 5 in a month, or has a detectable HIV viral load
- •Experienced interpersonal violence
- •Able and willing to provide informed consent
排除标准
- •Unwilling to participate in video record sessions (used to evaluate the quality of the intervention)
- •Enrolled in hospice
- •Not willing or not able to comply with study advisory board group participation agreement.
研究组 & 干预措施
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.
干预措施: Body weight circuit training (Behavioral)
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.
干预措施: Empathetic social support (Behavioral)
Control
Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.
干预措施: Control - list of resources (Other)
Observational
Observational study of participants undergoing WE RISE adapted for sustainability.
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
Observational
Observational study of participants undergoing WE RISE adapted for sustainability.
干预措施: Body weight circuit training (Behavioral)
Observational
Observational study of participants undergoing WE RISE adapted for sustainability.
干预措施: Empathetic social support (Behavioral)
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.
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
结局指标
主要结局
Antiretroviral therapy (ART) adherence by drug levels
时间窗: Weeks 0, 8, 24 and 48.
All participants will undergo testing for ART in hair samples
次要结局
- Generalized Anxiety Disorder-7(Weeks 0, 8, 24 and 48.)
- Patient Health Questionnaire - 9(Weeks 0, 8, 24 and 48.)
- Antiretroviral therapy (ART) adherence by visual analog scale(Weeks 0, 8, 24 and 48.)
- Timeline follow back substance use(Weekly during weeks 0-8, 24 and 48.)
- International trauma questionnaire(Weeks 0, 8, 24 and 48.)
研究者
Maile Young Karris
Associate Professor
University of California, San Diego