PopART / HPTN 071 is a large community-randomised trial that will be carried out in Zambia and South Africa to measure the impact of a universal HIV test-and-treat intervention on population-level HIV incidence.
HIV prevalence and incidence remain at a very high level in many parts of Southern Africa and there is an urgent need for more effective prevention measures. Mathematical models have shown that universal voluntary HIV counselling and testing, with the offer of immediate antiretroviral treatment (ART) for those testing HIV-positive, has the potential to achieve substantial reductions in HIV incidence at population level. Testing the effectiveness of this strategy, in combination with proven preventive interventions, is a key global health priority.
The trial will be carried out by a multi-national research consortium, led by the London School of Hygiene and Tropical Medicine in collaboration with the following institutions:
- Imperial College London
- Desmond Tutu TB Centre, University of Stellenbosch, South Africa
- ZAMBART, Zambia
- HIV Prevention Trials Network (HPTN) including the HPTN/CORE at FHI360, the HPTN Network Laboratory at Johns Hopkins University and the HPTN Statistical and Data Management Center at the University of Washington.
Within the two study countries, the design and delivery of the intervention will be carried out in close partnership with the Ministries of Health, PEPFAR and local implementing agencies.
A total of 21 communities (12 in Zambia and 9 in South Africa) will be selected for study. The cluster or community for the purposes of this trial will be defined as the catchment population of a local health unit (through which the intervention will be delivered). These 21 communities will be grouped into 7 matched triplets (4 in Zambia and 3 in South Africa).
In each matched triplet, one community will be randomly selected to receive the full PopART intervention (Arm A), a second community will receive the full PopART intervention except that ART will be offered according to current national guidelines (Arm B) and the third will act as a control community and will receive standard of care (Arm C). Within each country, communities will be matched based on the best available estimates of HIV prevalence, with the aim of minimizing the between-community variance in baseline HIV incidence within matched triplets.
It is expected that the trial will be carried out over a 5-year period from January 2013 to December 2017.
The PopART intervention includes the following HIV prevention methods:
- Offering universal voluntary HIV testing, delivered in the home by community health workers
- Referring people who are HIV positive to HIV care at their local health centre
- Offering immediate antiretroviral therapy (ART) irrespective of CD4-count, with potential benefits for the individual who has HIV and to prevent their partner(s) acquiring HIV
- Referring men who test HIV negative to professional medical male circumcision providers
- Promoting treatment for pregnant women with HIV, to prevent them from passing HIV to their babies
- Strengthening the treatment of sexually transmitted at local health centres
- Providing condoms in the community
To measure the impact of the intervention, a Population cohort consisting of a random sample of 2,500 adults aged 18-44 years will be selected from the general population of each cluster. A baseline survey of the cohort will be carried out at the time the intervention is initiated. Follow-up surveys of the cohort will be carried out after 12, 24 and 36 months and used to measure the impact of the intervention on HIV incidence and other outcomes.
The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), the Bill & Melinda Gates Foundation and the Office of the US Global AIDS Coordinator (OGAC) are providing initial funding for the PopART / HPTN 071 trial.