HPTN 071

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

HPTN 071 Launches!

Randomization in South Africa   Zambia Randomization Activity
Study Randomization Activities in South Africa and Zambia


What is HPTN 071 (PopART)

 

HPTN 071 (PopART) Population Effects of Antiretroviral Therapy to Reduce HIV Transmission is a research study that will determine the impact of a package of HIV prevention interventions on community-level HIV incidence. These prevention interventions include universal household voluntary HIV counseling and testing, linkage of HIV infected individuals to care and early initiation of antiretroviral therapy (ART) for all those testing HIV-positive. The study will be conducted in 21 communities in the Western Cape of South Africa, and in Zambia.

 

 

 

HPTN 071 (PopART) Study Sites


   
HPTN 071 Study Design Chart

HPTN 071 Study Brochure

HPTN 071 Study Design Chart


 

Protocol Status: Enrolling

Study Summary

Study Purpose: The purpose of this study is to determine the impact of two community-level combination prevention packages, both of which include universal HIV testing and intensified provision of HIV antiretroviral therapy (ART) and care, on population-level HIV incidence.

Study Design: This is a three-arm, cluster-randomized, longitudinal study to be implemented in 21 clusters (communities).

Study Population: The prevention packages will be implemented throughout the communities randomized to the intervention arms. Main study outcomes will be measured in a randomly-selected group drawn from the adult population of the communities: a Population Cohort.

Study Size: The combined population of all 21 clusters is approximately 1.2 million individuals. The interventions will be implemented in 14 of the 21 clusters with a combined population of approximately 800,000 individuals (adults and children) in the intervention arms.

The approximate sizes of the randomly-selected groups for main study outcome assessments are:

    • Population Cohort: 52,500 individuals;
    • Case-Control Studies: 2,400 individuals;
    • Qualitative Studies: about 2,000 individuals;
    • Population Cross-Sectional Survey: 10,500 individuals (if funded) ;
    • TB Survey: about 94,500 individuals (if funded); and
    • PMTCT Survey: about 25,200 individuals (if funded).

 

Study Sites: The study communities in Zambia are spread across 4 provinces and 6 districts. Each community is the catchment population of a government health facility.

    • Chimwemwe and Ndeke in Kitwe District (Copperbelt Province)
    • Chipulukusu and Chifubu in Ndola District (Copperbelt Province)
    • Makululu and Ngungu in Kabwe District (Central Province)
    • Chawama, Chipata and Kanyama in Lusaka District (Lusaka Province)
    • Maramba and Dambwa in Livingstone District (Southern Province)
    • Shampande in Choma District (Southern Province)   

 

The study communities in South Africa are located in the Cape Metro District and Cape Winelands District of the Western Cape Province. As above, the communities are defined by the catchment population of a government health facility.

    • Delft South (Metro District)
    • Kuyasa (Metro District)
    • Luvuyo (Metro District)
    • Town II  (Metro District)
    • Ikhwezi (Metro District)
    • Bloekombos (Metro District)
    • Dalevale (Cape Winelands District)
    • Wellington (Cape Winelands District)
    • Cloetesville (Cape Winelands District)

 

Study Duration: The planned duration of the entire study will be approximately 6 years, with enrollment and follow-up of communities and delivery of the intervention occurring over 4 years. Assessment of the primary outcome (HIV incidence) in the Population Cohort is planned to take place 12, 24, and 36 months after recruitment. Interim evaluation will take place during the first two years of intervention to determine whether to continue with the 36 month follow-up of the Population Cohort and the fourth year of intervention.

Treatment Regimen: 

Arm A - Universal Testing with Immediate ART: 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 immediate eligibility for ART
      • Promotion of male circumcision and prevention of mother to child transmission (PMTCT) services; and
      • 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
    • Treatment of sexually transmitted infections (STIs) and provision of condoms at health units

 

Arm B - 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; and
      • 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.

 

Arm C - Standard of Care (Control Arm)

      • 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.
      • Treatment of STIs and provision of condoms at health facilities and other venues in the community.

       

Primary Objectives: 

To measure the impact of the two intervention packages on HIV incidence by enrolling and following a random sample of adults (the Population Cohort) in the trial communities for 3 years.

 

Secondary Objectives: 

    • Measure the impact of the two intervention packages on the following:
      • HIV incidence over the first, second, and third years of follow-up;
      • Community viral load (if funding is identified);
      • ART adherence and viral suppression (if funding is identified);
      • ART drug resistance (if funding is identified);
      • HSV-2 incidence;
      • Uptake of HIV testing and retesting over the entire study period;
      • ART screening and uptake;
      • Time between HIV diagnosis and initiation of care;
      • Retention in care;
      • HIV disease progression and death;
      • ART toxicity based on clinic records;
      • Sexual risk behavior;
      • Case notification rate of tuberculosis;
      • HIV-related stigma;
      • Uptake of PMTCT; and
      • Uptake of male circumcision.
    •  Carry out case-control studies to examine factors related to:
      • Uptake of HIV testing during the first round of home-based testing in Arms A and B;
      • Uptake of immediate treatment in Arm A; and
      • Uptake of HIV testing during the second round of home-based testing in Arms A and B
    • Use qualitative methods to:
      • Assess popular understanding of HIV testing and treatment at study initiation and during implementation;
      • Evaluate the acceptability and functioning of the Community HIV-care Providers (CHiPs) in Arms A and B;
      • Evaluate the acceptability of interventions and barriers to access in Arms A and B;
      • Document the effect of the interventions on social networks, stigma, sexual behavior, alcohol use, gender-based violence, HIV identity, other HIV prevention options and community morale; and
      • Evaluate the process and challenges of community consultation and applying ethical principles.
    • Measure the burden experienced by local health centers due to implementation of the intervention in the community.
    • Measure the incremental cost of the two intervention packages through systematic recording of costs in intervention and control communities
    • Estimate the effectiveness and cost-effectiveness of the intervention packages and alternative packages, both in the chosen study populations and in other populations by fitting mathematical models based on the empirical data from the trial, including data related to cost.

     


     

Protocol Team Member: Ab Schaap get info

Protocol Team Member: Christophe Fraser get info

Protocol Team Member: Deborah Watson-Jones get info

Protocol Team Member: Estelle Piwowar-Manning get info

Protocol Team Member: Ginny Bond get info

Protocol Team Member: Helen Ayles get info

Protocol Team Member: James Hargreaves get info

Protocol Team Member: Kalpana Sabapathy get info

Protocol Team Member: Katharina Hauck get info

Protocol Team Member: Kwame Shanaube get info

Protocol Team Member: Lyn Horn get info

Protocol Team Member: Lynda Marie Emel get info

Protocol Team Member: Megan Baldwin get info

Protocol Team Member: Nathaniel Chishinga get info

Protocol Team Member: Nulda Beyers get info

Protocol Team Member: Peter Bock get info

Protocol Team Member: Rhonda White get info

Protocol Team Member: Sian Floyd get info

Protocol Team Member: Sten H. Vermund get info

Protocol Team Member: Susan Eshleman get info

Protocol Team Member: Tanette Headen get info

Protocol Statistician: Deborah Donnell get info

Protocol Co-Chair: Sarah Fidler get info

Protocol Chair: Richard Hayes get info

DAIDS Medical Officer: David Burns get info

DAIDS Medical Officer: Peter Kim get info

CORE Protocol Specialist: Ayana Moore get info

CORE Protocol Specialist: Sam Griffith get info


Site Target
Enrollment
Cumulative
Enrollment
Implementation
Status
More
Info

Desmond Tutu TB Centre

31744

Cape Town, South Africa

22,500

 

Designated

get more

ZAMBART Clinical Research Site

31743

Lusaka, Zambia

30,000

 

Registered

get more