Study on Non-communicable and Selected Communicable Chronic Comorbidities Among HIV-positive Patients on Anti-retroviral Therapy in Rural Lesotho and Their Association to Virologic Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,754
- 试验地点
- 2
- 主要终点
- Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho
研究概览
简要总结
This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic treatment failure as well as chronic communicable and non-communicable comorbidities among patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to determine prevalence of treatment failure as well as the prevalence of the following comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with treatment failure or a comorbidity or both are followed-up for 12 months.
详细描述
Background
Owing to successful scale-up and decentralization of anti-retroviral therapy (ART) in rural Lesotho, the number of persons infected with HIV who stay alive increased dramatically. The new situation of HIV having turned from a deadly disease into a chronic but manageable condition creates a new challenge to health care providers in rural facilities of the country. Patients on long-time ART may suffer from comorbidities endangering the success of ART and their health and/or from ART-failure due to development of resistance of the virus. The magnitude of the burden of comorbidities as well as ART- failure has not been examined extensively in Lesotho yet.
Objectives of the Study
The study has six major objectives:
- To assess the prevalence of virologic failure and genotype-resistance of HIV among patients on ART in rural Lesotho.
- To assess the prevalence of hepatitis C and hepatitis B among patients on ART in rural facilities in Lesotho
- To assess the prevalence of diabetes mellitus, arterial hypertension and dyslipidaemia among patients on ART in rural facilities in Lesotho
- To assess the prevalence of depression and alcohol use disorder among patients on ART in rural facilities in Lesotho
- To examine associations between chronic comorbidities and virologic outcome among patients on ART in rural Lesotho
- To follow-up patients with virologic failure and/or comorbidity(ies) among patients on ART in rural Lesotho
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •on anti-retroviral therapy ≥ 6 months
- •informed consent given
排除标准
- •on anti-retroviral therapy for < 6 months or documented treatment interruption of ≥ 7 days during the last 3 months
- •children < 16 years without the caretaker who can provide informed consent for study participation
- •patients on second-line anti-retroviral therapy
结局指标
主要结局
Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho
时间窗: at enrollment
The prevalence of the following comorbidities/conditions will be assessed: * Diabetes Mellitus * Arterial Hypertension * Dyslipidemia * Depression * Alcohol use disorder * Hepatitis B * Hepatitis C
Prevalence of virologic failure and genotype resistance patterns among patients on anti-retroviral therapy who were not monitored virologically
时间窗: At enrollment
All patients on first-line ART ≥ 6 months will receive viral load testing. Those with a detectable viral load will receive enhanced adherence counselling and again a viral load measurement 3 months after the initial viral load (as recommended by the consolidated WHO-guidelines). In case of persistent virologic failure (2 times detectable viral load) a genotype resitance testing will be done and patients will be switched to second-line ART. This will allow to validate the WHO algorithm for virologic failure in a remote, resource-limited setting.
次要结局
- 1-year outcomes of patients with comorbidities diagnosed at enrollment(12-18 months after enrollment)
- Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho(at enrollment)
- 1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART(12-18 months after enrollment)
- Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement(enrollment + 3 months)