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      Towards 90-90: Findings after two years of the HPTN 071 (PopART) cluster-randomized trial of a universal testing-and-treatment intervention in Zambia

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          Abstract

          Background

          HPTN071(PopART) is a 3-arm community-randomised study in 21 peri-urban/urban communities in Zambia and the Western Cape of South Africa, with high HIV prevalence and high mobility especially among young adults. In Arm A communities, from November 2013 community HIV care providers (CHiPs) have delivered the “PopART” universal-test-and-treat (UTT) package in annual rounds, during which they visit all households and offer HIV testing. CHiPs refer HIV-positive (HIV+) individuals to routine HIV clinic services, where universal ART (irrespective of CD4 count) is offered, with re-visits to support linkage to care. The overall goal is to reduce population-level adult HIV incidence, through achieving high HIV testing and treatment coverage.

          Methods and findings

          The second annual round was June 2015-October 2016. Included in analysis are all individuals aged ≥15 years who consented to participate, with extrapolation to the total population. Our three main outcomes are (1) knowledge of HIV+ status (2) ART coverage, by the end of Round 2 (R2) and compared with the start of R2, and (3) retention on ART on the day of consenting to participate in R2. We used “time-to-event” methods to estimate the median time to start ART after referral to care. CHiPs visited 45,631 households during R2, ~98% of the estimated total across the four communities, and for 94% (43,022/45,631) consent was given for all household members to be listed on the CHiPs’ electronic register; 120,272 individuals aged ≥15 years were listed, among whom 64% of men (37,265/57,901) and 86% (53,516/62,371) of women consented to participate in R2. We estimated there were 6,521 HIV+ men and 10,690 HIV+ women in the total population of visited households; and that ~80% and ~90% of HIV+ men and women respectively knew their HIV+ status by the end of R2, fairly similar across age groups but lower among those who did not participate in Round 1 (R1). Among those who knew their HIV+ status, ~80% of both men and women were on ART by the end of R2, close to 90% among men aged ≥45 and women aged ≥35 years, but lower among younger adults, those who were resident in R1 but did not participate in R1, and those who were newly resident in the area of the community in which they were living in R2. Overall ART coverage was ~65% among HIV+ men and ~75% among HIV+ women, compared with the cumulative 90–90 target of 81%. Among those who reported ever taking ART, 93% of men and 95% of women self-reported they were on ART and missed 0 pills in the last 3 days. The median time to start ART after referral to care was ~6 months in R2, similar across the age range 25–54 years, compared with ~9.5 months in R1. The two main limitations to our findings were that a comparison with control-arm communities cannot be made until the end of the study; and that to extrapolate to the total population, assumptions were required about individuals who were resident, but did not participate, in R2.

          Conclusions

          Overall coverage against the 90–90 targets was high after two years of intervention, but was lower among men, individuals aged 18–34 years, and those who did not participate in R1. Our findings reflect the relative difficulties for CHiPs to contact men at home, compared with women, and that it is challenging to reach high levels of testing and treatment coverage in communities with substantial mobility and in-migration. The shortened time to start ART after referral to care in R2, compared with R1, was likely attributable to multiple factors including an increased focus of the CHiPs on linkage to care; increasing community acceptance and understanding of the CHiPs, and of ART and UTT, with time; increased coordination with the clinics to facilitate linkage; and clinic improvements.

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          Most cited references9

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          Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial

          Universal antiretroviral therapy (ART), as per the 2015 WHO recommendations, might reduce population HIV incidence. We investigated the effect of universal test and treat on HIV acquisition at population level in a high prevalence rural region of South Africa.
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            Community-based strategies to strengthen men’s engagement in the HIV care cascade in sub-Saharan Africa

            Monica Sharma and colleagues discuss evidence-based approaches to improving HIV services for men in sub-Saharan Africa.
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              Combination HIV Prevention and HIV Incidence in Uganda

              BACKGROUND To assess the impact of combination HIV prevention (CHP) on HIV incidence, we analyzed the association between HIV incidence and scale-up of antiretroviral therapy (ART) and medical male circumcision in Rakai, Uganda. Changes in population-level viral load suppression and sexual behaviors were also examined. METHODS Between 1999 and 2016, data were collected through 12 surveys from 30 communities in the Rakai Community Cohort Study, an open population-based cohort of persons aged 15-49 years. We assessed HIV incidence trends based on observed seroconversion data, self-reported ART and male circumcision coverage, viral load suppression, and sexual behaviors. RESULTS In total, 33,937 study participants contributed 103,011 person-visits (HIV prevalence ~13%). Follow-up of 17,870 HIV-negative persons contributed 94,427 person-years with 931 seroconversions. ART was introduced in 2004; by 2016 coverage was 69% (72% in women vs. 61% in men, p<0.001). HIV viral load suppression among all HIV-positive persons increased from 42% in 2009 to 75% by 2016 (p<0.001). Male circumcision coverage increased from 15% in 1999 to 59% by 2016 (p<0.001). Persons 15-19 years reporting n 71 ever having sex increased from 30% to 55% (p<0.0001). HIV incidence declined by 42% in 2016 relative to the pre-CHP period prior to 2010 (1.17/100 py to 0.66/100 py; adjIRR:0.58: 95%CI: 0.45-0.76); declines were greater in men (adjIRR=0.46; 95%CI: 0.29-0.73) than women (adjIRR=0.68, 95%CI: 0.50-0.94). CONCLUSIONS In this longitudinal study, HIV incidence significantly declined with CHP scale-up, providing empiric evidence that HIV control interventions can have substantial population-level impact. However, additional efforts are needed to overcome gender disparities and achieve HIV elimination.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: Writing – original draft
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                10 August 2018
                2018
                : 13
                : 8
                : e0197904
                Affiliations
                [1 ] Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom
                [2 ] Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom
                [3 ] Zambart, University of Zambia School of Medicine, Lusaka, Zambia
                [4 ] FHI 360, HIV Prevention Trials Network, Durham, North Carolina, United States of America
                [5 ] Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa
                [6 ] HIV Clinical Trials Unit, Imperial College London, London, United Kingdom
                University of California, Berkeley, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                ¶ Membership of the HPTN 071 (PopART) Study Team is provided in the Acknowledgments.

                Author information
                http://orcid.org/0000-0002-8615-7601
                http://orcid.org/0000-0002-5959-526X
                http://orcid.org/0000-0001-6029-9372
                http://orcid.org/0000-0003-3211-6078
                http://orcid.org/0000-0002-1729-9892
                Article
                PONE-D-17-35882
                10.1371/journal.pone.0197904
                6086421
                30096139
                8d53ba2b-53a7-4ebc-a451-a778c478c6aa
                © 2018 Floyd et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 5 October 2017
                : 10 May 2018
                Page count
                Figures: 6, Tables: 3, Pages: 22
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100000002, National Institutes of Health;
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100009054, U.S. President’s Emergency Plan for AIDS Relief;
                Award Recipient :
                Funded by: International Initiative for Impact Evaluation (3ie)
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000865, Bill and Melinda Gates Foundation;
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award Recipient :
                HPTN 071 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under Cooperative Agreements UM1-AI068619, UM1-AI068617, and UM1-AI068613, with funding from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Additional funding is provided by the International Initiative for Impact Evaluation (3ie) with support from the Bill & Melinda Gates Foundation, as well as by NIAID, the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH), all part of the U.S. National Institutes of Health (NIH). The funders had no role in data collection, data analysis, or the decision to publish this manuscript. 3ie reviewed and provided non-binding comments on the draft manuscript prior to journal submission. The trial sponsor, NIH, reviewed and approved the original design of the HPTN 071 study and approves all changes to the study protocol. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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                The authors have provided in the S1 Data and S2 Data supporting information files aggregate data that can be used to replicate the main analyses presented in this paper. These aggregate data comprise counts of relevant indicators stratified by gender, community, age-group, and participation and residency in the first year of intervention. The protocol that the ethics committees approved specifies that intervention data can only be shared in aggregate form. For queries related to these data, please contact the corresponding author, Sian Floyd ( sian.floyd@ 123456lshtm.ac.uk ), or the senior data manager at ZAMBART ( ab@ 123456zambart.org.zm ).

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