The PopART trial


 

The PopART trial

The HPTN 071 or PopART trial is a cluster-randomized trial which aims to determine the impact of two community-level combination prevention packages, both of which include universal HIV testing and intensified provision of HIV/ART care,  on population-level HIV incidence.

 Study setting

The trial is being conducted in partnership with the Western Cape department of Health, City of Cape Town Health Directorate, ANOVA Healthcare, Kheth’ Impilo, SACTWU and SCMS, in 9 communities in South Africa and in 12 in Zambia and enrolment started in 2013. In South Africa there are 6 clusters in the Cape Metro Health District and 3 in the Cape Winelands Health District. A cluster or community is defined as the catchment population of a health facility.

Study design

Communities have been randomized to arms A (full intervention prevention package plus ART regardless CD4 count), B (full intervention prevention package plus ART according to government guidelines) or C (standard of care). At each site of the intervention sites, interventions are delivered to the entire community of approximately 40 000 people by a cadre of community workers with referrals to government Primary Health Care (PHC) clinics. Community workers provide clients with condoms, screen and refer relevant clients to government clinics for HIV, TB and STI treatment and voluntary male medical circumcision (VMMC). Primary outcomes (including HIV incidence) will be measured in a randomly selected individual level cohort of 2500 individuals in each community (including the Arm C communities) over 36 months.

There is also an extensive social science component to describe and explain the trial outcomes; inclusive of formative research conducted before intervention implementation and ongoing research throughout the study period. One aspect of this social science component is a large-scale ancillary study called HPTN 071a that aims to investigate the role of stigma on scaled-up HIV prevention delivery. In addition to understanding stigma from the perspective of community members, this ancillary study also investigates the experiences of health care workers in delivering HIV-related services. One component this ancillary is an open-cohort of healthcare workers (including those based at the clinic, those attached to the clinic and delivering services in the community and the cadre of community workers delivering the PopART intervention) who participate in three survey rounds. The first round of this cohort was completed in South Africa in December 2014.

Status

Full funding for the PopART trial was received by May 2013

Formative social science research activities commenced in December 2012, and was completed in mid-2013. The HPTN 071a ancillary study grant was awarded in May 2013.

Activities relating to the main trial, i.e. intervention and population cohort activities were commenced in South Africa in January 2014. By end 2014 more than 52 000 adult clients had consented to the intervention and 15 000 participants had been enrolled for the population cohort. At the completion of the first round of the HPTN 071a ancillary study, 634 healthcare workers were enrolled in the cohort in South Africa. Field activities will continue until mid-2017.

Principal Investigator: Dr. Peter Bock: peterb@sun.ac.za