Testing the Efficacy of Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Depressive Symptoms
研究概览
简要总结
Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years or greater
- •Living in a county with a score of .4 or higher on the index of relative rurality (IRR)
- •Living in Alabama, Arkansas, Delaware, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia
- •Living with HIV
- •Has a telephone at home
- •Able to provide informed consent
排除标准
- •Not meeting eligibility criteria described above
结局指标
主要结局
Depressive Symptoms
时间窗: 4, 8, and 12 month follow-ups
Depressive symptoms during the past 2 weeks will be self-reported via completion of the 9-item Patient Health Questionnaire-9 (PHQ-9). The calculated scale range is 0-27, with higher scores indicating more depressive symptoms.
Antiretroviral Treatment Medication Adherence
时间窗: 4, 8, and 12 month follow-ups
Recent (past 30 day) antiretroviral treatment adherence will be self-reported using the 3-item Wilson Medication Adherence Scale. The calculated scale range is 0-100, with higher scores indicating more consistent medication adherence.
Viral Suppression
时间窗: 4 and 12 month follow-ups
HIV viral load will be assessed using self-collected dried blood spot (DBS) samples, with samples collecting using HemaSpot devices. Viral suppression will be defined as a measured viral load less than or equal to 839 copies/mL.
Health-Related Quality of Life
时间窗: 4, 8, and 12 month follow-ups
Health-related quality of life will be self-reported using the 31-item World Health Organization Quality of Life Brief Assessment for PLH (WHOQOL-HIV BREF). The calculated scale range is 0-100, with higher scores indicating better quality of life. Composite scores will be calculated in line with Walsh et al., 2024.
次要结局
- Accessing Needed Social and Medical Services(4, 8, and 12 month follow-ups)
- Structural Barriers(4, 8, and 12 month follow-ups)
- HIV Treatment Adherence Self-Efficacy(4, 8, and 12 month follow-ups)
- Loneliness(4, 8, and 12 month follow-ups)
- Internalized HIV Stigma(4, 8, and 12 month follow-ups)
- General Self-Efficacy(4, 8, and 12 month follow-ups)
- Social Support(4, 8, and 12 month follow-ups)
研究者
Jennifer Walsh
Associate Professor
Medical College of Wisconsin