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Completed

NCT Number: NCT01900977

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

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.

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Key information

Conditions

HIV

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Universal Testing with immediate ART

Other
  • 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

Other names: PopART Intervention, UTT

Universal Testing with ART eligibility according to National Guidelines

Other

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.

Other names: PopART Intervention

Standard of care

Other

Primary outcomes

  1. 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

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

    Time frame: 3 years

  2. ART adherence and viral suppression

    Time frame: 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)

  3. Herpes Simplex Virus -2 (HSV-2) incidence

    Time frame: 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

  4. HIV disease progression, retention in care, and death

    Time frame: 3 years

  5. ART toxicity

    Time frame: 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

  6. Sexual risk behavior

    Time frame: 3 years

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

  7. Case notification rate of tuberculosis (TB)

    Time frame: 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

  8. HIV-related stigma

    Time frame: 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

  9. Uptake of PMTCT

    Time frame: 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

  10. Uptake of male circumcision

    Time frame: 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

  11. ART screening and uptake

    Time frame: 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

  12. HIV testing and retesting

    Time frame: 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

  13. Time between HIV diagnosis and initiation of care

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

HIV Prevention Trials Network

Network

Collaborators

  • Bill and Melinda Gates Foundation
  • Desmond Tutu TB Centre
  • Imperial College London
  • London School of Hygiene and Tropical Medicine
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)
  • Office of the U.S. Global AIDS Coordinator
  • Zambart

Registry information

Official study title

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

Acronym: PopART

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 17, 2013
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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