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Randomized Controlled Trial
. 2019 Jul 18;381(3):230-242.
doi: 10.1056/NEJMoa1812281.

Universal Testing, Expanded Treatment, and Incidence of HIV Infection in Botswana

Joseph Makhema  1 , Kathleen E Wirth  1 , Molly Pretorius Holme  1 , Tendani Gaolathe  1 , Mompati Mmalane  1 , Etienne Kadima  1 , Unoda Chakalisa  1 , Kara Bennett  1 , Jean Leidner  1 , Kutlo Manyake  1 , Atang M Mbikiwa  1 , Selebaleng V Simon  1 , Rona Letlhogile  1 , Kutlwano Mukokomani  1 , Erik van Widenfelt  1 , Sikhulile Moyo  1 , Refeletswe Lebelonyane  1 , Mary G Alwano  1 , Kathleen M Powis  1 , Scott L Dryden-Peterson  1 , Coulson Kgathi  1 , Vlad Novitsky  1 , Janet Moore  1 , Pamela Bachanas  1 , William Abrams  1 , Lisa Block  1 , Shenaaz El-Halabi  1 , Tafireyi Marukutira  1 , Lisa A Mills  1 , Connie Sexton  1 , Elliot Raizes  1 , Simani Gaseitsiwe  1 , Hermann Bussmann  1 , Lillian Okui  1 , Oaitse John  1 , Roger L Shapiro  1 , Sherri Pals  1 , Haben Michael  1 , Michelle Roland  1 , Victor DeGruttola  1 , Quanhong Lei  1 , Rui Wang  1 , Eric Tchetgen Tchetgen  1 , M Essex  1 , Shahin Lockman  1
Affiliations
Randomized Controlled Trial

Universal Testing, Expanded Treatment, and Incidence of HIV Infection in Botswana

Joseph Makhema et al. N Engl J Med. .

Abstract

Background: The feasibility of reducing the population-level incidence of human immunodeficiency virus (HIV) infection by increasing community coverage of antiretroviral therapy (ART) and male circumcision is unknown.

Methods: We conducted a pair-matched, community-randomized trial in 30 rural or periurban communities in Botswana from 2013 to 2018. Participants in 15 villages in the intervention group received HIV testing and counseling, linkage to care, ART (started at a higher CD4 count than in standard care), and increased access to male circumcision services. The standard-care group also consisted of 15 villages. Universal ART became available in both groups in mid-2016. We enrolled a random sample of participants from approximately 20% of households in each community and measured the incidence of HIV infection through testing performed approximately once per year. The prespecified primary analysis was a permutation test of HIV incidence ratios. Pair-stratified Cox models were used to calculate 95% confidence intervals.

Results: Of 12,610 enrollees (81% of eligible household members), 29% were HIV-positive. Of the 8974 HIV-negative persons (4487 per group), 95% were retested for HIV infection over a median of 29 months. A total of 57 participants in the intervention group and 90 participants in the standard-care group acquired HIV infection (annualized HIV incidence, 0.59% and 0.92%, respectively). The unadjusted HIV incidence ratio in the intervention group as compared with the standard-care group was 0.69 (P = 0.09) by permutation test (95% confidence interval [CI], 0.46 to 0.90 by pair-stratified Cox model). An end-of-trial survey in six communities (three per group) showed a significantly greater increase in the percentage of HIV-positive participants with an HIV-1 RNA level of 400 copies per milliliter or less in the intervention group (18 percentage points, from 70% to 88%) than in the standard-care group (8 percentage points, from 75% to 83%) (relative risk, 1.12; 95% CI, 1.09 to 1.16). The percentage of men who underwent circumcision increased by 10 percentage points in the intervention group and 2 percentage points in the standard-care group (relative risk, 1.26; 95% CI, 1.17 to 1.35).

Conclusions: Expanded HIV testing, linkage to care, and ART coverage were associated with increased population viral suppression. (Funded by the President's Emergency Plan for AIDS Relief and others; Ya Tsie ClinicalTrials.gov number, NCT01965470.).

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Figures

Figure 1.
Figure 1.
Map of the 15 Matched Community Pairs in Botswana.
Figure 2.
Figure 2.. Trial Randomization and Outcomes in the HIV-Incidence Cohort.
Shown are data on randomization and outcomes in the standard-care group (Panel A) and the intervention group (Panel B).
Figure 3.
Figure 3.. Kaplan–Meier Estimates of the Time to Seroconversion among Participants without HIV Infection and Subgroup Analysis of HIV Incidence.
Panel A shows the estimated cumulative probability of seroconversion among 8974 HIV-negative participants. The inset shows the same data on an enlarged y axis. The shaded areas indicate 95% confidence intervals, and tick marks indicate censored data. Panel B shows a forest plot of HIV incidence ratios for key subgroups. I bars indicate 95% confidence intervals.
See this image and copyright information in PMC

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