Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- NCDs and NCD risk factors in the study population by time on ART
研究概览
简要总结
For national antiretroviral therapy (ART) programs, the most important health system goals in reducing morbidity and mortality among HIV-infection patients are to initiate treatment as early as eligibility criteria allow and to achieve the highest possible long-term retention of patients on ART. In South Africa, cohort data have consistently found high attrition among ART patients, with the combined cumulative outcomes of death and loss to follow up averaging 25-40% over the first five years after ART initiation. Like many other middle income countries, South Africa also faces very high rates of non-communicable diseases (NCDs) and NCD risks. Despite this, there are virtually no studies looking at interactions between ART and NCDs, and none that have considered the effect of NCDs and NCD risk factors on achieving the second health system goal mentioned above: long term retention on ART.
详细描述
The main RapIT study focuses on rapid initiation of ART, with short-term (6-month) attrition from treatment and viral suppression as the primary outcomes. In this supplemental study, we will evaluate the role of NCDs and NCD risk factors on long-term retention on ART, with outcomes including mortality, loss to follow up, viral suppression and immunologic improvement, and physical functioning, ability to perform normal daily activities, and economic productivity among patients already on ART. The study will enroll up to 400 adult patients already on ART for ≥ 12 months at the RapIT study site. At enrollment, consented subjects will be screened for elevated levels of several NCD risk factors including body mass index; glucose using HbA1c levels; blood pressure and cholesterol; as well as signs of abnormalities in hepatic, renal, and lung function. A medical history will be taken, and a questionnaire will gather information about chronic pain, alcohol use, smoking, physical functioning, ability to perform normal daily activities, and economic productivity. Referral for further NCD diagnosis and care will be offered as needed. Existing electronic medical records will be accessed to obtain retrospective data since ART initiation and to follow subjects prospectively for up to 24 months after the enrollment screening is completed. Six months after enrollment, subjects with NCDs or at high risk of NCDs will be re-screened at a routine ART medication pickup visit to assess uptake of referral and whether risks, conditions, or outcomes have changed. The study will help identify reasons for poor outcomes on ART and point to interventions that will help achieve the overall goals of the national ART program.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ART patients >35 years old.
- •Initiated ART at least 12 months prior to study enrollment.
- •Presenting at study clinic for a routine ART monitoring visit.
排除标准
- •Pregnant or within first six months post-partum.
- •Already enrolled in the RapIT study or another research study.
- •Stated intention to transfer care to another location during the next 12 months.
- •Not physically or emotionally able to participate in the study, in the opinion of the investigators.
- •Not willing or able to provide written informed consent to participate in the study.
- •Previously enrolled in the same study.
结局指标
主要结局
NCDs and NCD risk factors in the study population by time on ART
时间窗: Baseline
The outcomes for primary objective 1 will be NCDs and NCD risk factors in the study population by time on ART, including diabetes, cardiovascular disease, respiratory conditions, hypertension, obesity, and behavioral risks such as smoking and alcohol use.
次要结局
- Uptake of NCD care(6 months)
- HIV treatment outcomes(Baseline)
- Changes in NCD risks or prevalence(6 months)