Abstract
SummaryBackgroundCommunity-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART.MethodsWe did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992.FindingsBetween May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07–1·29; psuperiority=0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98–1·19; pnon-inferiority=0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16–1·55; psuperiority<0·0001) as did the hybrid approach (66%, RR 1·19, 1·02–1·40; psuperiority=0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275–452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events.InterpretationIn high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load.FundingThe Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.
Highlights
Of the 37 million people estimated to be living with HIV globally, approximately 62% are on life-saving antiretroviral therapy (ART) and 53% are virally suppressed.[1]
Evidence before this study the proportion of people living with HIV who know their status has increased, approaching the UNAIDS goal of 90%, the proportion of people living with HIV who have started lifesaving antiretroviral therapy (ART) and met the gold-standard metric of success, viral suppression, lags behind by about a third, among men
Before this study, randomised trials had not tested the effectiveness of community-based ART initiation, monitoring, and resupply; an innovative approach to overcome barriers associated with accessing clinic-based services such as clinic hours and transport costs
Summary
Of the 37 million people estimated to be living with HIV globally, approximately 62% are on life-saving antiretroviral therapy (ART) and 53% are virally suppressed.[1]. A systematic review and meta-analysis from 2019 evaluated the effectiveness of community-based HIV initiatives in achieving the UNAIDS 90-90-90 targets; 90% of people living with HIV knowing their status, 90% of those starting ART, and 90% of those reaching viral suppression. Another study evaluated the effect of starting ART at the clinic and transferring stable clients to decentralised medication delivery and adherence clubs (a hybrid clinic-community approach) on viral suppression compared with remaining at the clinic. They found no decrease in viral suppression with this clinic-community hybrid approach, showing the effectiveness of community ART refills. Comprehensive community-based services have the potential to close the gap in ART coverage for different demographics
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