BACKGROUND:A universal testing and treatment strategy is a potential approach to reduce the incidence of human immunodeficiency virus (HIV) infection, yet previous trial results are inconsistent. METHODS:In the HPTN 071 (PopART) community-randomized trial conducted from 2013 through 2018, we randomly assigned 21 communities in Zambia and South Africa (total population, approximately 1 million) to group A (combination prevention intervention with universal antiretroviral therapy [ART]), group B (the prevention intervention with ART provided according to local guidelines [universal since 2016]), or group C (standard care). The prevention intervention included home-based HIV testing delivered by community workers, who also supported linkage to HIV care and ART adherence. The primary outcome, HIV incidence between months 12 and 36, was measured in a population cohort of approximately 2000 randomly sampled adults (18 to 44 years of age) per community. Viral suppression (<400 copies of HIV RNA per milliliter) was assessed in all HIV-positive participants at 24 months. RESULTS:The population cohort included 48,301 participants. Baseline HIV prevalence was 21% or 22% in each group. Between months 12 and 36, a total of 553 new HIV infections were observed during 39,702 person-years (1.4 per 100 person-years; women, 1.7; men, 0.8). The adjusted rate ratio for group A as compared with group C was 0.93 (95% confidence interval [CI], 0.74 to 1.18; P = 0.51) and for group B as compared with group C was 0.70 (95% CI, 0.55 to 0.88; P = 0.006). The percentage of HIV-positive participants with viral suppression at 24 months was 71.9% in group A, 67.5% in group B, and 60.2% in group C. The estimated percentage of HIV-positive adults in the community who were receiving ART at 36 months was 81% in group A and 80% in group B. CONCLUSIONS:A combination prevention intervention with ART provided according to local guidelines resulted in a 30% lower incidence of HIV infection than standard care. The lack of effect with universal ART was unanticipated and not consistent with the data on viral suppression. In this trial setting, universal testing and treatment reduced the population-level incidence of HIV infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 071 [PopArt] ClinicalTrials.gov number, NCT01900977.).
The New England journal of medicine
207 - 218
From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).
HPTN 071 (PopART) Study Team