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

This study is currently recruiting participants.
Verified April 2014 by HIV Prevention Trials Network
Sponsor:
Collaborators:
Office of the U.S. Global AIDS Coordinator
Bill and Melinda Gates Foundation
London School of Hygiene and Tropical Medicine
Imperial College London
Zambart
Desmond Tutu HIV Centre
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT01900977
First received: July 2, 2013
Last updated: April 3, 2014
Last verified: April 2014

July 2, 2013
April 3, 2014
September 2013
February 2017   (final data collection date for primary outcome measure)
HIV incidence in members of the Population Cohort (PC) over three years of follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
HIV incidence over three years of follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01900977 on ClinicalTrials.gov Archive Site
  • HIV incidence over the first, second, and third years of follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • ART adherence and viral suppression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months, 24 months, and 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • ART toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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)
  • HIV incidence over the first, second, and third years of follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    HIV diagnosis at 12 months, 24 months, and 36 months among those who were HIV-uninfected at enrollment in the Population Cohort
  • ART adherence and viral suppression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months, 24 months, and 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • ART toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • 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)
Not Provided
Not Provided
 
Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART)
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
  • Other: Universal Testing with immediate ART

    • 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
  • Other: Universal Testing with ART eligibility according to National Guidelines

    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 Name: PopART Intervention
  • Other: Standard of Care
  • Active Comparator: Arm A Universal Testing w/Immediate ART
    Intervention: Other: Universal Testing with immediate ART
  • Active Comparator: Arm B ART according to National Guidelines
    Intervention: Other: Universal Testing with ART eligibility according to National Guidelines
  • 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.

    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52500
April 2017
February 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 44 Years
Yes
Contact: Sam Griffith 919.544.7040 ext 11571 sgriffith@fhi360.org
Contact: Ayana Moore, PhD 919.544.7040 ext 11244 amoore@fhi360.org
South Africa,   Zambia
 
NCT01900977
HPTN 071, 11865
Yes
HIV Prevention Trials Network
HIV Prevention Trials Network
  • 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
  • Bill and Melinda Gates Foundation
  • London School of Hygiene and Tropical Medicine
  • Imperial College London
  • Zambart
  • Desmond Tutu HIV Centre
Study Chair: Richard Hayes, BSc, MSc, DSc London School of Hygiene and Tropical Medicine
Study Chair: Sarah Fidler, MBBS, PhD Imperial College London
Principal Investigator: Helen Ayles, BSc, MBBS, MSc, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Nulda Beyers, MBChB, FCP, MSc, PhD Stellenbosch Univeristy
HIV Prevention Trials Network
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP