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

N/ACompletedNCT01900977

HIV Prevention Trials Network48,540 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

48,540

Interventions

Universal Testing with immediate ARTOTHER

• Combination prevention package including: o House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with immediate eligibility for ART; Promotion of male circumcision and prevention of mother to child transmission (PMTCT) services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and prevention of mother-to-child transmission of HIV services available in the community; and Treatment of sexually transmitted infections (STIs) and provision of condoms at health units

Universal Testing with ART eligibility according to National GuidelinesOTHER

Combination prevention package including: House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with ART eligibility according to national guidelines; Promotion of male circumcision and PMTCT services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and PMTCT services available in the community; and Treatment of STIs and provision of condoms at health units.

Standard of CareOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Secondary Outcomes

HIV incidence over the first, second, and third years of follow-up

Time frame: 3 years

ART adherence and viral suppression

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)

Time frame: 24 months

Herpes Simplex Virus -2 (HSV-2) incidence

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

Time frame: 12 months, 24 months, and 36 months

HIV disease progression, retention in care, and death

Time frame: 3 years

ART toxicity

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

Time frame: 3 years

Sexual risk behavior

o Self-reported sexual risk behavior at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort

Time frame: 3 years

Case notification rate of tuberculosis (TB)

* 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

Time frame: 3 years

HIV-related stigma

* 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

Time frame: 3 years

Uptake of PMTCT

* 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

Time frame: 3 years

Uptake of male circumcision

* 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

Time frame: 3 years

ART screening and uptake

* 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

Time frame: 3 years

HIV testing and retesting

* 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 frame: 3 years

Time between HIV diagnosis and initiation of care

* 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)

Time frame: 3 years

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes