Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART)

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: Universal Testing with ART eligibility according to National Guidelines; Other: Universal Testing with immediate ART; Other: Standard of Care

• Registration Number: NCT01900977
• Lead Sponsor: HIV Prevention Trials Network

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-17
• Study Start: 2014-01
• Primary Completion: 2018-07-07
• Study Completion: 2018-07-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48540

Inclusion Criteria

1. Population Cohort

   1. 18 - 44 years of age
   2. Able and willing to provide informed consent
   3. Residing within catchment area of a designated local health unit and intending to remain so for the next three years
   4. Residing in a randomly selected household

2. Case-Control Study 1 Inclusion Criteria:

   1. At least 18 years of age
   2. Able and willing to provide informed consent
   3. Resident in the cluster during the first round of testing
   4. Visited by a CHiP team and offered testing during the first round of home-based testing

3. Case-Control Study 2 Inclusion Criteria:

   1. At least 18 years of age
   2. Able and willing to provide informed consent
   3. Resident in the cluster during the first round of testing
   4. Tested HIV-infected in CHiP home-based testing, or HIV-infected and disclosed that they were previously diagnosed as HIV-infected to CHiP team

4. Case-Control Study 3 Inclusion Criteria:

   1. At least 18 years of age
   2. Able and willing to provide informed consent
   3. Resident in the cluster during the second round of testing
   4. Visited by a CHiP team and offered testing during the second round of home-based testing

Exclusion Criteria

1. Population Cohort Exclusion Criteria:

   1. Current or planned enrollment in another HIV treatment, prevention, or Pre-Exposure Prophylaxis (PrEP) study
   2. Current, planned or prior enrollment in an HIV vaccine study
   3. 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.

2. Case-Control Study 1 Exclusion Criteria:

   1. Individuals belonging to the Population Cohort or other case-control studies
   2. Individuals known to be HIV-infected after testing elsewhere.

3. Case-Control Study 2 Exclusion Criteria:

   1. Individuals enrolled in the Population Cohort or other case-control studies
   2. HIV-infected individuals already on ART before study commences

4. Case-Control Study 3 Exclusion Criteria:

   1. Known HIV infected from CHiP data.
   2. Individuals belonging to the Population Cohort or other case-control studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B ART according to National Guidelines	Universal Testing with ART eligibility according to National Guidelines	-
Arm A Universal Testing w/Immediate ART	Universal Testing with immediate ART	-
Standard of Care	Standard of Care	Includes: Strengthening of HIV testing and ART services according to national guidelines at health facilities and other venues; Strengthening of male circumcision and PMTCT services available at health facilities and other venues in the community; and Treatment of STIs and provision of condoms at health facilities and other venues in the community.

Primary Outcome Measures

Name	Time	Method
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.	3 years

Secondary Outcome Measures

Name	Time	Method
HIV incidence over the first, second, and third years of follow-up	3 years
ART adherence and viral suppression	24 months	HIV viral load at 24 months in HIV-infected members of the Population Cohort who initiated HIV care and ART after commencement of the PopART intervention in the community (if funding available)
Herpes Simplex Virus -2 (HSV-2) incidence	12 months, 24 months, and 36 months	Incident HSV-2 infections at 12 months, 24 months, and 36 months for all individuals in the Population Cohort who were HSV-2-uninfected at enrollment
HIV disease progression, retention in care, and death	3 years
ART toxicity	3 years	ART safety and clinical events among Population Cohort participants initiating ART after commencement of the PopART intervention in the community, measured using routine health center data, and; ART safety and clinical events among health center attendees who initiated ART after commencement of the PopART intervention in the community, measured using routine health center data
Sexual risk behavior	3 years	o Self-reported sexual risk behavior at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort
Case notification rate of tuberculosis (TB)	3 years	* Case notification rates of bacteriologically-confirmed TB diagnosed among the general population of patients seeking care at health centers as recorded by health centers; * TB mortality among TB cases in the community as recorded by health centers
HIV-related stigma	3 years	* Self-reported data on stigma indicators at enrollment, 12 months, 24 months, and 36 months in the Population Cohort; * Qualitative interviews in selected members of the general population in Arms A, B, and
Uptake of PMTCT	3 years	* Self-reported use of services for PMTCT at Enrollment, 12 months, 24 months, and 36 months among HIV-infected women in the Population Cohort who had been pregnant in the prior 12 months; * Uptake of PMTCT services at health centers; * Uptake of PMTCT as indicated in data collected in households by CHiPs
Uptake of male circumcision	3 years	* Self-reported circumcision status/uptake at Enrollment, 12 months, 24 months, and 36 months of men in the Population Cohort; * Uptake of circumcision in the community as indicated in health center data; * Uptake of circumcision as indicated in data collected in households by CHiPs
ART screening and uptake	3 years	* The proportion of Population Cohort members, identified as HIV-infected who screen for ART eligibility, and who subsequently initiate ART; * Proportion of community members, identified as HIV-infected in data from CHiP teams, who screen for ART eligibility, and who subsequently initiate ART, as indicated in health center data
HIV testing and retesting	3 years	* Self-reported recent HIV testing at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort; * The number of adults (16 years and older) in the household and the number of HIV tests performed as indicated in data from CHiP teams and health centers
Time between HIV diagnosis and initiation of care	3 years	* The proportion of Population Cohort members initiating HIV care within 3 months of a positive HIV diagnosis; * The proportion of community members initiating HIV care within 3 months of HIV diagnosis as indicated in data from CHiP teams (provision of HIV positive result) and health center data (date of care initiation)

Trial Locations

Locations (2)

Desmund Tutu TB Centre at Stellenbosch University; 🇿🇦 Cape Town, Western Cape, South Africa

Zambart; 🇿🇲 Lusaka, Zambia