The HPTN071 (PopART) trial


 

The HPTN 071 or PopART study 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. The study is being conducted in 9 communities in South Africa and 12 in Zambia. Communities were 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). Following changes to ART guidelines during the study, Arm A and B both offered ART regardless of CD4 count from Oct 2016 onwards. Despite this change the study is still well powered to evaluate the primary outcome, HIV incidence. At each of the arm A and B sites, interventions were delivered to the entire community by a cadre of Community HIV-care providers (CHiPs) with referrals to government Primary Health Care (PHC) clinics. CHiPs provided clients with condoms, screen and refer relevant clients to government clinics for HIV, TB and STI treatment and voluntary male medical circumcision (VMMC).

Field work for PopART began in January 2014. The study concluded the final annual round of the CHiPs intervention in December 2017.  PC follow up will be completed in June 2018. The primary findings of the study will be reported early 2019. Between January 2018 and end June 2019 there will be extensive consultation with stakeholders and dissemination of study results as part of a planned exit from study communities and clinics.

Primary outcomes are measured in a randomly selected individual level cohort of approximately 2000 individuals in each community (including the Arm C communities) over 36 months referred to as the population cohort (PC). The HPTN071 Population Cohort (PC) is currently in its 3rd round (PC 36) of study participant follow up.

CHiPs intervention progress:

  • By the end of 2017 for the third annual round for both South Africa and Zambia 152,454 households had been visited by CHiPs
  • 168,556 individuals accepted HIV testing among those eligible for HIV testing

PC progress

  • PC 0: 18 633 participants were enrolled
  • PC12: 12 821 PC assessment visits were completed
  • Of the PC assessment visits completed for PC12, 3256 rapid tests were completed
  • PC 24: 15 344 PC assessment visits were completed
  • Of the PC assessment visits completed for PC24, 3 029 rapid tests were completed
  • As of 31st January 2018, 53.9% (n=8269) of population cohort assessment visits had been completed.

Data collection in the population cohort is scheduled to end on the 30th June 2018. Data cleaning and analysis will continue thereafter until the PopART results are disseminated early 2019. Dissemination will involve the announcement of primary results to all HPTN 071 (PopART) stakeholders, as well as a number of community level disseminations in HPTN 071 (PopART) communities in South Africa.

Within PopART 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.  Refer to DTTC social science component for summaries on qualitative work conducted for this trial.