Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART): A Cluster-randomized Trial of the Impact of a Combination Prevention Package on Population-level HIV Incidence in Zambia and South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48,540
- 试验地点
- 3
- 主要终点
- HIV incidence measured over 3 years in the Population Cohort, with the primary analysis including HIV incidence measured between Months 12 and 36 of the study.
研究概览
简要总结
PopART is a community randomized trial that is investigating whether a community-wide combination HIV prevention package including annual home-based HIV testing, active referral and the offer of immediate ART for those testing HIV-positive, along with the promotion of proven HIV prevention methods (such as voluntary medical male circumcision, prevention of mother to child transmission and condom use), will help to prevent transmission and substantially reduce new HIV infections. The study is being conducted in 21 communities in Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total population of approximately 1.2 million individuals.
详细描述
HIV Prevention Trials Network (HPTN) 071 (PopART) will investigate the impact on HIV incidence of universal voluntary HIV counseling and testing (with referral to care) provided to a community through a house-to-house campaign, in combination with early ART for individuals who are HIV-positive, and other proven preventive interventions. The design of HPTN 071 (PopART) will allow the study team to distinguish between the impact of universal testing with referral for HIV care in accordance with national guidelines, and the impact of universal testing with referral for early ART initiation for those with HIV infection. In addition, HPTN 071 (PopART) will determine if a program of universal voluntary testing, including early ART initiation, is feasible and acceptable when delivered on a large scale to entire communities. Evaluating the effectiveness of universal voluntary HIV counseling and testing with the offer of early ART is a key global health priority.
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 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Population Cohort
- •18 - 44 years of age
- •Able and willing to provide informed consent
- •Residing within catchment area of a designated local health unit and intending to remain so for the next three years
- •Residing in a randomly selected household
- •Case-Control Study 1 Inclusion Criteria:
- •At least 18 years of age
- •Able and willing to provide informed consent
- •Resident in the cluster during the first round of testing
- •Visited by a CHiP team and offered testing during the first round of home-based testing
- •Case-Control Study 2 Inclusion Criteria:
- •At least 18 years of age
- •Able and willing to provide informed consent
- •Resident in the cluster during the first round of testing
- •Tested HIV-infected in CHiP home-based testing, or HIV-infected and disclosed that they were previously diagnosed as HIV-infected to CHiP team
- •Case-Control Study 3 Inclusion Criteria:
- •At least 18 years of age
- •Able and willing to provide informed consent
- •Resident in the cluster during the second round of testing
- •Visited by a CHiP team and offered testing during the second round of home-based testing
排除标准
- •Population Cohort Exclusion Criteria:
- •Current or planned enrollment in another HIV treatment, prevention, or Pre-Exposure Prophylaxis (PrEP) study
- •Current, planned or prior enrollment in an HIV vaccine study
- •Anything that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- •Case-Control Study 1 Exclusion Criteria:
- •Individuals belonging to the Population Cohort or other case-control studies
- •Individuals known to be HIV-infected after testing elsewhere.
- •Case-Control Study 2 Exclusion Criteria:
- •Individuals enrolled in the Population Cohort or other case-control studies
- •HIV-infected individuals already on ART before study commences
- •Case-Control Study 3 Exclusion Criteria:
- •Known HIV infected from CHiP data.
- •Individuals belonging to the Population Cohort or other case-control studies
结局指标
主要结局
HIV incidence measured over 3 years in the Population Cohort, with the primary analysis including HIV incidence measured between Months 12 and 36 of the study.
时间窗: 3 years
次要结局
- HIV incidence over the first, second, and third years of follow-up(3 years)
- ART adherence and viral suppression(24 months)
- Herpes Simplex Virus -2 (HSV-2) incidence(12 months, 24 months, and 36 months)
- HIV disease progression, retention in care, and death(3 years)
- ART toxicity(3 years)
- Sexual risk behavior(3 years)
- Case notification rate of tuberculosis (TB)(3 years)
- HIV-related stigma(3 years)
- Uptake of PMTCT(3 years)
- Uptake of male circumcision(3 years)
- ART screening and uptake(3 years)
- HIV testing and retesting(3 years)
- Time between HIV diagnosis and initiation of care(3 years)