Testing a Multi-Component Intervention 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
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Proportion of Participants With HIV Viral Load ≥832 Copies/mL (HemaSpot DBS)
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 pilot test four intervention components designed to improve care engagement and medication adherence to determine their impact on health outcomes and quality of life among rural, older PLH. The four intervention components, adapted from evidence-based interventions and delivered remotely, are: (1) counselor-facilitated peer social support, (2) HIV stigma reduction, (3) strengths-based case management, and (4) individually-tailored technology use optimization. The investigators hypothesize that components will be acceptable to participants, will be feasible to administer remotely, and will show preliminary impact on (1) the proportion of participants that have viral suppression and (2) health-related quality of life. 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
- •Age 50 years or greater
- •Living in a zip code classified as a "Small and Isolated Small Rural Town" area by Rural-Urban Commuting Area Codes (RUCAs), and/or in a county classified as rural based on RUCAs, and/or in a county with a score of .4 or higher on the index of relative rurality (IRR)
- •Living in Alabama, Arkansas, Georgia, Kentucky, Mississippi, Missouri, Oklahoma, South Carolina, or Tennessee
- •Living with HIV
- •Indicates willingness to participate in support groups
- •Indicates willingness to self-collect a dried blood spot sample
- •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
Proportion of Participants With HIV Viral Load ≥832 Copies/mL (HemaSpot DBS)
时间窗: 3 months following enrollment/baseline survey
Proportion of participants with HIV viral load ≥832 copies/mL, as measured through use of HemaSpot dried blood spot (DBS) testing. At baseline and follow-up, participants were sent dried blood spot (DBS) kits by mail to complete self-collection of blood samples for HIV viral load testing. Following specimen collection, participants placed the filled HemaSpot container into the shipping envelope, which sent the specimen directly to the clinical laboratory for testing. HemaSpot devices with sufficient blood volume were tested using Abbott m2000 RealTime HIV-1 dried blood spot (DBS) quantitative assay, with 832 copies/mL limit of detection. DBS viral load results were classified in three categories: 1. Detected and quantifiable at ≥832 copies/mL; 2. Detected and non-quantifiable, estimated between \<832 and \>300 copies/mL; and 3. Not detected, estimated to be \<300 copies/mL.
Health-Related Quality of Life
时间窗: 3 months following enrollment/baseline survey
Based on full scale scores from the 31-item WHOQOL-HIV BREF (O'Connell \& Skevington, 2012), with scores ranging from 0 to 100. Higher scores indicate higher (better) quality of life. Quality of life was assessed with 31 items from the WHOQOL-HIV BREF (O'Connell \& Skevington, 2012). Domains assessed include physical health; psychological health; level of independence; social relationships; environmental health; and personal beliefs. Additionally, two individual items focus on overall quality of life and general health. Domain scores were created as described by the WHO, and we created a composite quality of life score by equally weighting the 6 domains, overall quality of life item, and general health item. The composite score was rescaled such that overall scores ranged from 0 to 100, with higher scores indicating better health-related quality of life.
次要结局
- Medication Adherence(3 months following enrollment/baseline survey)
- Depressive Symptoms(3 months following enrollment/baseline survey)
研究者
Jennifer Walsh
Associate Professor
Medical College of Wisconsin