Clinical trial NCT01900977: Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Universal Test and Treat (UTT)
Combination Prevention
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute of Mental Health (NIMH)
name: National Institute on Drug Abuse (NIDA)
name: Office of the U.S. Global AIDS Coordinator
name: The International Initiative for Impact Evaluation (3ie) with support from Bill & Melinda Gates Foundation
name: London School of Hygiene and Tropical Medicine
name: Imperial College London
name: Zambart
name: Desmond Tutu TB Centre
First posted: 2013-07-17
Enrollment: 48540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: HIV incidence over the first, second, and third years of follow-up
timeFrame: 3 years
measure: ART adherence and viral suppression
timeFrame: 24 months
measure: Herpes Simplex Virus -2 (HSV-2) incidence
timeFrame: 12 months, 24 months, and 36 months
measure: HIV disease progression, retention in care, and death
timeFrame: 3 years
measure: ART toxicity
timeFrame: 3 years
measure: Sexual risk behavior
timeFrame: 3 years
measure: Case notification rate of tuberculosis (TB)
timeFrame: 3 years
measure: HIV-related stigma
timeFrame: 3 years
measure: Uptake of PMTCT
timeFrame: 3 years
measure: Uptake of male circumcision
timeFrame: 3 years
measure: ART screening and uptake
timeFrame: 3 years
measure: HIV testing and retesting
timeFrame: 3 years
measure: Time between HIV diagnosis and initiation of care
timeFrame: 3 years
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Desmund Tutu TB Centre at Stellenbosch University
state: Western Cape
city: Lusaka
country: Zambia
facility: Zambart
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Richard Hayes, BSc, MSc, DSc
role: STUDY_CHAIR
affiliation: Imperial College London
name: Sarah Fidler, MBBS, PhD
role: STUDY_CHAIR
affiliation: London School of Hygiene and Tropical Medicine
name: Helen Ayles, BSc, MBBS, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stellenbosch Univeristy
name: Nulda Beyers, MBChB, FCP, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Stellenbosch
name: Peter Bock, MD, MRCP, MRCGP, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bond V, Hoddinott G, Viljoen L, Simuyaba M, Musheke M, Seeley J. Good Health and Moral Responsibility: Key Concepts Underlying the Interpretation of Treatment as Prevention in South Africa and Zambia Before Rolling Out Universal HIV Testing and Treatment. AIDS Patient Care STDS. 2016 Sep;30(9):425-34. doi: 10.1089/apc.2016.0114.
citation: Hargreaves JR, Stangl A, Bond V, Hoddinott G, Krishnaratne S, Mathema H, Moyo M, Viljoen L, Brady L, Sievwright K, Horn L, Sabapathy K, Ayles H, Beyers N, Bock P, Fidler S, Griffith S, Seeley J, Hayes R; HPTN 071 (PopART) study team. HIV-related stigma and universal testing and treatment for HIV prevention and care: design of an implementation science evaluation nested in the HPTN 071 (PopART) cluster-randomized trial in Zambia and South Africa. Health Policy Plan. 2016 Dec;31(10):1342-1354. doi: 10.1093/heapol/czw071. Epub 2016 Jul 3.
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