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

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.

Conditions

• HIV

Interventions

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

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

Standard of Care

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Office of the U.S. Global AIDS Coordinator

  collaborator UNKNOWN

• Bill and Melinda Gates Foundation

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Zambart

  collaborator OTHER

• Desmond Tutu TB Centre

  collaborator OTHER

• HIV Prevention Trials Network

  lead NETWORK

Principal Investigators

• Richard Hayes, BSc, MSc, DSc · London School of Hygiene and Tropical Medicine

• Sarah Fidler, MBBS, PhD · Imperial College London

• Helen Ayles, BSc, MBBS, MSc, PhD · London School of Hygiene and Tropical Medicine

• Nulda Beyers, MBChB, FCP, MSc, PhD · Stellenbosch Univeristy

• Peter Bock, MD, MRCP, MRCGP, MPH, PhD · University of Stellenbosch

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2018-07-07

Completion

2018-07-07

Countries

• South Africa
• Zambia

Study Locations