Exploring the Consequences of Food Insecurity and Harnessing the Power of Peer Navigation and mHealth to Reduce Food Insecurity and Cardiometabolic Comorbidities Among Persons With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
研究概览
简要总结
The objectives of this study are to better understand how FI (food insecurities) contributes to the development of cardiometabolic comorbidities among PWH (People with HIV) and to test a novel bilingual FI intervention designed to reduce these comorbidities among food insecure PWH. The PI and staff will conduct this study in partnership with the Wake Forest Infectious Diseases Specialty Clinic, one of the largest Ryan White-funded clinics in North Carolina, which serves more than 2,000 PWH annually from a predominantly rural catchment area that includes South Central Appalachia. This area has high rates of both FI and HIV.
详细描述
The proposed study the team has created a conceptually integrated, mixed methods study that includes
- Longitudinal data collection to explore the difference in the prevalence and incidence of cardiometabolic comorbidities between food secure and insecure PWH
- Implementation and evaluation of the weCare/Secure intervention designed to improve insulin sensitivity among food insecure PWH with prediabetes or Type 2 diabetes (T2DM)
- Semi-structured individual in-depth interviews to understand the effect of the intervention on FI and insulin sensitivity among participants in an randomized controlled trial (RCT) trial
- Broad dissemination of study findings to inform both research and clinical practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic
- •be living with HIV
- •≥18 years of age
- •provide informed consent
排除标准
- •unable to speak English or Spanish
- •have cognitive impairment that would prevent participation
研究组 & 干预措施
Usual Care
There is no peer navigation within usual care.
干预措施: Usual Care (Other)
weCare/Secure
The weCare intervention is based on the social cognitive and empowerment theories and social support and is currently designed to reduce missed HIV care appointments and increase viral suppression among PWH who are newly diagnosed or out of care through the use of peer navigation and mHealth
干预措施: weCare/Secure (Behavioral)
结局指标
主要结局
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
时间窗: Month 36
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
时间窗: Baseline
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
时间窗: Month 12
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
时间窗: Month 24
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
次要结局
未报告次要终点