Today, the New England Journal of Medicine (NEJM) published the primary results from the HPTN 071 (PopART) study, the largest of four studies conducted in sub-Saharan Africa that tested whether a universal test-and-treat (UTT) strategy can lower the incidence of HIV at a community level. Findings from HPTN 071 (PopART) show that delivery of a combination prevention intervention that included household-based HIV testing, coupled with antiretroviral therapy provided according to local guidelines, resulted in 30 percent lower incidence of HIV infection than the standard of care, a statistically significant effect. The results from two of the other major UTT studies: Ya Tsie (also called the Botswana Combination Prevention Project or BCPP) and Sustainable East Africa Research in Community Health (SEARCH) were also published in NEJM today. In 2017, results of the first UTT study (the TASP Study) which was conducted in South Africa was published in Lancet HIV. The TASP and SEARCH studies did not show an effect on HIV incidence, while the Ya Tsie study showed a 30 percent decrease in HIV incidence that was not statistically significant.
“Taken together with the findings of the other studies, HPTN 071 (PopART) provides key evidence that a universal test and treat strategy can reduce the incidence of new HIV infections, even in settings with generalized HIV epidemics,” said Myron Cohen, MD, HPTN co-principal investigator and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “But these results also demonstrate the challenges of getting the maximal benefit of treatment as prevention, the magnitude of treatment coverage needed, and the need to find hard to reach people and link them to appropriate care.”
HPTN 071 (PopART), conducted from 2013 through 2018, involved more than one million people living in 21 communities in South Africa and Zambia. The study was designed to measure the effects of two HIV combination prevention strategies that offered HIV testing to people in their homes annually, with linkage to HIV care and treatment at a local health facility for those living with HIV; both were compared to standard of care. The two strategies differed only in that one strategy (Arm B) offered ART according to local treatment guidelines whereas the other (Arm A) offered ART to anyone living with HIV. Approximately midway through the trial, local guidelines changed to also offer ART to anyone living with HIV, so the interventions were identical for the latter half of the trial period. While the findings in Arm B compared to standard of care communities showed a decrease in HIV incidence by 30 percent, there was no significant change noted in HIV incidence in Arm A compared to standard of care (7 percent decrease in incidence). The reasons for the failure to see an effect in Arm A remain unclear.
Some important points of comparison and contrast among the four UTT studies are:
- The PopART communities were large urban or peri-urban communities whereas the other trials were in smaller rural communities.
- HIV incidence was measured in a separately recruited random sample of the study communities in HPTN 071 (PopART) and Ya Tsie/BCPP, while in the TASP and SEARCH, HIV incidence was measured through follow-up of community members who participated in the intervention.
- In HPTN 071 (PopART) and Ya Tsie/BCPP, the control communities did not receive any additional intervention beyond standard of care, while SEARCH and TasP control communities received enhanced community-wide HIV services, particularly for HIV testing and linkage to care, probably explaining the lack of observed difference between the intervention and control arms.
- Investigators in the three published studies in the NEJM were successful in the scale-up of HIV testing and HIV treatment with significant effects on viral load suppression at community levels.
Results from HPTN 071 (PopART) provide key information for policymakers and program managers in sub-Saharan Africa as they aim to expand HIV programs overall and UTT specifically. The study also helps inform the design of future studies using a UTT intervention.
“Each of the four UTT studies offers critical lessons in terms of the importance of every step of the HIV testing and treatment cascade in order to garner the benefits of UTT,” said Wafaa El-Sadr MD, MPH, MPA, HPTN co-principal investigator, global director for ICAP at Columbia University and professor of epidemiology and medicine. “The studies also highlight the need to scale-up primary prevention to achieve epidemic control.”
HPTN 071 (PopART) was conducted by the HIV Prevention Trials Network (HPTN) and led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM) in collaboration with Imperial College London, the University of Oxford, the Zambia AIDS Related Tuberculosis (ZAMBART) Project and the Desmond Tutu TB Centre (DTTC) at Stellenbosch University, South Africa. The study was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) with primary funding from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Additional funding was provided by the International Initiative for Impact Evaluation (3ie) with support from the Bill & Melinda Gates Foundation, as well as by NIAID, the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH).