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Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial
- Source :
- The Lancet. Global Health
- Publication Year :
- 2020
-
Abstract
- Summary Background Community-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. Methods We 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. Findings Between 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
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Anti-HIV Agents
Art initiation
030231 tropical medicine
Human immunodeficiency virus (HIV)
HIV Infections
medicine.disease_cause
03 medical and health sciences
South Africa
Young Adult
0302 clinical medicine
Acquired immunodeficiency syndrome (AIDS)
Health care
Medicine
Humans
Uganda
030212 general & internal medicine
Community Health Services
Community based
business.industry
General Medicine
Articles
Middle Aged
medicine.disease
Antiretroviral therapy
Treatment Outcome
Relative risk
Family medicine
Female
business
Viral load
Delivery of Health Care
Subjects
Details
- ISSN :
- 2214109X
- Volume :
- 8
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- The Lancet. Global health
- Accession number :
- edsair.doi.dedup.....2a63aaa545151b583b9d5aee014e1d62