HIV infection remains at a very high level in Zambia. The national HIV prevalence rate among adults 15-49 years currently stands at 14.3% (2007 ZDHS). Although this represents a slight decrease from the 15.6% prevalence observed in the 2001-02 ZDHS, there is still an urgent need to scale up existing prevention efforts to significantly reduce new infections.
HPTN 071 (PopART) is a research study that will find out whether offering a combination of several HIV prevention methods at community level will reduce the number of new HIV infections. It is one of the first studies to evaluate the impact of a “Universal Test and Treat” approach on community-level HIV incidence. The study will determine whether this approach can work on a large community scale, and whether it is possible and affordable to deliver.
12 targeted communities with a high HIV prevalence across three provinces in Zambia and 9 in the Western Cape were chosen in a fair and open ‘public randomisation’ event to which ordinary members of the communities were invited. Each of the selected 21 communities was randomly allocated into three different arms and received different intervention services. (see diagram).
The full PopART Intervention consists of:
- Door-to-door universal HIV counselling and testing with the offer of a immediate ART to all individuals who test positive.
- Voluntary medical male Circumcision
- Promotion of prevention of Mother to Child Transmission fo HIV for pregnant women with HIV
- Condom provision
- Referral of Sexually Transmitted Infections (STI) for treatment at local clinics
- TB Screening
A random sample of 2,500 adults will be selected from each community and followed up for 3 years to measure the impact of the PopART intervention on HIV incidence through a Population Cohort (PC). The study also has several secondary objectives.
The study is being conducted by the NIH funded HIV Prevention Trials Network (HPTN). The study is led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM), in collaboration with Imperial College London, the Zambia AIDS Related Tuberculosis (ZAMBART) Project and the Desmond Tutu TB Centre (DTTC) at Stellenbosch University, South Africa.
The delivery of the intervention is being carried out in close partnership with the Ministry of Health, and the Ministry of Community Development, Maternal and Child Health, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), and their local implementing partners.
The study underwent several approvals, including by Ministry of Health and ethical regulatory bodies. The preparation and planning period for the entire study was approximately 21 months (2012-third quarter 2013).
Initial preparations involved working out complex funding mechanisms and agreements; identifying appropriate PEPFAR partners with whom the study would work with to deliver the intervention; setting up additional infrastructure at the clinics ( Arms A and B) where necessary; employing and training a huge cadre of staff, preparing the selected communities and developing strategies how to effectively engage; conducting intensive coordination and collaborations with various key partners to identify how existing systems could be strengthened.
Rapid formative research (broad brush surveys) was conducted between Nov 2012-Sept 2013 to identify local catalysts and barriers that could influence intervention or research implementation as well as identify key stakeholders.
The study is the most intensive research to be conducted in HIV prevention in Southern Africa; in Zambia it involves 553 study staff of which 414 are Community HIV care Providers (CHiPs) responsible for the door-to-door delivery of the intervention. Enrolment of study participants for the Population Cohort, community and clinic-based interventions began in November 2013 and has continued to date. Regular mobilization activities as well as household visits by uniformed study staff are evident in these communities. Regional (study sites) research laboratories have all been set up. Key coordination and collaborative meetings have continued at all levels.
TIMELINE: The study is being carried out over a 6-year period from 2012 -2017.