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Title
Impact of prevention and treatment interventions on population HIV incidence: Primary results of the community-randomized Ya Tsie Botswana prevention project
Presenter
Moeketsi Joseph Makhema
Authors
M.J. Makhema1, K. Wirth2, M. Pretorius Holme2, T. Gaolathe1, M. Mmalane1, E. Kadima1, U. Chakalisa1, K. Manyake1, A. Mbikiwa1, S. Simon1, R. Letlhogile1, K. Mukokomani1, E. van Widenfelt1, S. Moyo1, K. Bennett3, J. Leidner4, R. Lebelonyane5, M.G. Alwano6, K. Powis1,2,7, S. Dryden-Peterson1,2,8, C. Kgathi1, V. Novitsky2, J. Moore9, P. Bachanas9, W. Abrams6, L. Block9, S. El-Halabi5, T. Marukutira6, L.A. Mills6, H. Bussmann1, L. Okui1, O. John1, R. Shapiro2, V. DeGruttola2, Q. Lei2, R. Wang2, E. Tchetgen Tchetgen2,10, M. Essex1,2, S. Lockman1,2,8
Institutions
1Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana, 2Harvard T.H. Chan School of Public Health, Boston, United States, 3Bennett Statistical Consulting, Inc., Ballston Lake, United States, 4Goodtables Data Consulting, LLC, Norman, United States, 5Botswana Ministry of Health, Gaborone, Botswana, 6Centers for Disease Control and Prevention, Gaborone, Botswana, 7Massachusetts General Hospital, Boston, United States, 8Brigham and Women's Hospital, Boston, United States, 9U.S. Centers for Disease Control and Prevention, Atlanta, United States, 10The Wharton School, University of Pennsylvania, Philadelphia, United States

Background: Antiretroviral therapy(ART) markedly reduces incidence in known HIV-discordant relationships. However, the impact of expanded access to HIV testing/counseling(HTC), ART, and male circumcision(MC) on community HIV incidence is unknown, particularly in settings with both high HIV prevalence and high baseline ART coverage such as Botswana.
Methods: The Ya Tsie Botswana Prevention Project was a pair-matched community-randomized trial that evaluated the impact of prevention interventions on HIV incidence in 30 rural/semi-urban communities throughout Botswana, from 2013-2018. Fifteen communities were randomized to receive community-wide HTC, linkage-to-care, earlier ART initiation, and enhanced MC services, and 15 communities received standard of care. Universal ART became standard of care in both arms mid-2016. A random sample of ~20% of households in each community was selected, and HIV-uninfected 16-64 year-old residents of these households enrolled in a longitudinal HIV incidence cohort (HIC) that underwent ~annual HTC. We compared HIV incidence by randomized arm over ~30 months. The pre-specified primary analysis used a permutation test of inverse variance weighted average of log- transformed incidence ratios from pair-specific, interval-censored Cox proportional hazards models (PHM); 95% CIs were obtained using standard pair-stratified Cox PHM for interval censored data. P-values are two-sided.
Results: Among 12,610 participants, at baseline 29% were HIV-infected, 72% of whom were already on ART (97% of individuals on ART had HIV-1 RNA< 400copies/mL). We enrolled 8,974 HIV-uninfected individuals in the HIC (4,487/arm), with median age 29 years (60% female). The median duration of follow-up was 29 months, and 95% of participants in each arm re-tested for HIV at >1 follow-up visit. 57 HIC participants in the intervention arm (annualized HIV incidence: 0.59%) and 90 in the control arm (annualized HIV incidence: 0.92%) acquired HIV. The HIV incidence ratio was 0.69 (P=0.09) in intervention vs. standard-of-care communities in the primary weighted-average Cox PHM. The pair-stratified Cox PHM produced 95%CI of 0.46-0.90 (incidence ratio=0.65, P=0.01).
Conclusions: We observed a 30% reduction in community HIV incidence with expanded HTC, linkage, ART, and MC campaigns. Importantly, our findings demonstrate that it is possible to reduce HIV incidence in high-HIV-prevalence settings that have already approached the ambitious UNAIDS 90-90-90 targets, by further increasing coverage.


Figure 1A-B
[Figure 1A-B]