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From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).
Published: July 2019
AI Article Synopsis
Article Abstract
Background: Universal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health.
Methods: We randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only).
Results: A total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39).
Conclusions: Universal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.).
