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      HIV treatment eligibility expansion and timely antiretroviral treatment initiation following enrollment in HIV care: A metaregression analysis of programmatic data from 22 countries

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          Abstract

          Background

          The effect of antiretroviral treatment (ART) eligibility expansions on patient outcomes, including rates of timely ART initiation among those enrolling in care, has not been assessed on a large scale. In addition, it is not known whether ART eligibility expansions may lead to “crowding out” of sicker patients.

          Methods and findings

          We examined changes in timely ART initiation (within 6 months) at the original site of HIV care enrollment after ART eligibility expansions among 284,740 adult ART-naïve patients at 171 International Epidemiology Databases to Evaluate AIDS (IeDEA) network sites in 22 countries where national policies expanding ART eligibility were introduced between 2007 and 2015. Half of the sites included in this analysis were from Southern Africa, one-third were from East Africa, and the remainder were from the Asia-Pacific, Central Africa, North America, and South and Central America regions. The median age of patients enrolling in care at contributing sites was 33.5 years, and the median percentage of female patients at these clinics was 62.5%. We assessed the 6-month cumulative incidence of timely ART initiation (CI-ART) before and after major expansions of ART eligibility (i.e., expansion to treat persons with CD4 ≤ 350 cells/μL [145 sites in 22 countries] and CD4 ≤ 500 cells/μL [152 sites in 15 countries]). Random effects metaregression models were used to estimate absolute changes in CI-ART at each site before and after guideline expansion. The crude pooled estimate of change in CI-ART was 4.3 percentage points (95% confidence interval [CI] 2.6 to 6.1) after ART eligibility expansion to CD4 ≤ 350, from a baseline median CI-ART of 53%; and 15.9 percentage points (pp) (95% CI 14.3 to 17.4) after ART eligibility expansion to CD4 ≤ 500, from a baseline median CI-ART of 57%. The largest increases in CI-ART were observed among those newly eligible for treatment (18.2 pp after expansion to CD4 ≤ 350 and 47.4 pp after expansion to CD4 ≤ 500), with no change or small increases among those eligible under prior guidelines (CD4 ≤ 350: −0.6 pp, 95% CI −2.0 to 0.7 pp; CD4 ≤ 500: 4.9 pp, 95% CI 3.3 to 6.5 pp). For ART eligibility expansion to CD4 ≤ 500, changes in CI-ART were largest among younger patients (16–24 years: 21.5 pp, 95% CI 18.9 to 24.2 pp). Key limitations include the lack of a counterfactual and difficulty accounting for secular outcome trends, due to universal exposure to guideline changes in each country.

          Conclusions

          These findings underscore the potential of ART eligibility expansion to improve the timeliness of ART initiation globally, particularly for young adults.

          Abstract

          In a large-scale analysis, Olga Tymejczyk and colleagues study antiretroviral therapy initiation in people with HIV infection accompanying secular changes in treatment eligibility.

          Author summary

          Why was this study done?
          • In 2009 and 2013, the World Health Organization (WHO) recommended that HIV patients with CD4 counts ≤350 and ≤500 cells/μL, respectively, initiate antiretroviral treatment (ART).

          • The expansion of ART eligibility criteria has the potential to increase ART initiation rates, especially among healthier patients; however, it could also lead to “crowding out” of persons with more advanced disease and lower rates of ART initiation among these patients.

          • While many countries have adopted WHO guidelines, the impact of ART eligibility expansions on timely ART initiation has not been studied on a large scale.

          What did the researchers do and find?
          • We examined the changes in timely ART initiation after national ART eligibility criteria were expanded to CD4 ≤ 350 and/or CD4 ≤ 500 in 22 countries, using data on 284,740 adult ART-naïve patients at 171 sites in the International Epidemiology Databases to Evaluate AIDS (IeDEA) network.

          • Site-level cumulative incidence of ART initiation (CI-ART) within 6 months of enrollment increased by 4.3 percentage points after national ART eligibility expansion to CD4 ≤ 350 and by 15.9 percentage points after expansion to CD4 ≤ 500.

          • At the individual level, increases were greatest among patients 16–24 years old at enrollment and those newly eligible for ART. No change or small improvements in CI-ART were also observed among patients already eligible for ART before eligibility expansion.

          • At the site level, sites with the lowest initial levels of CI-ART experienced the greatest increases following guideline expansions.

          What do these findings mean?
          • Overall, ART eligibility expansions were followed by appreciable improvements in timely ART initiation.

          • Many clinics can support ART initiation among newly eligible patients with less advanced disease without negatively affecting ART initiation rates among those with more advanced disease.

          • These findings illustrate the potential of ART eligibility expansion to improve the timeliness of ART initiation and patient outcomes along the care cascade globally, particularly for younger adults, in support of the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets, thereby reducing morbidity, mortality, and onward HIV transmission.

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          Most cited references 22

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          Systematic Review of HIV Transmission between Heterosexual Serodiscordant Couples where the HIV-Positive Partner Is Fully Suppressed on Antiretroviral Therapy

          Background The risk of sexual HIV transmission in serodiscordant couples when the HIV-positive partner has full virologic suppression on combination antiretroviral therapy (cART) is debated. This study aims to systematically review observational studies and randomized controlled trials (RCTs), evaluating rates of sexual HIV transmission between heterosexual serodiscordant couples when the HIV-positive partner has full suppression on cART. Methods and Findings We searched major bibliographic databases to November 2012 for relevant observational studies and RCTs without language restrictions. Conference proceedings, key journals and bibliographies were also searched. Studies reporting HIV transmission rates, cART histories and viral loads of the HIV-positive partners were included. Two reviewers extracted methodologic characteristics and outcomes. Of 20,252 citations, 3 studies met all eligibility criteria with confirmed full virologic suppression in the HIV-positive partner. We included 3 additional studies (2 cohort studies, 1 RCT) that did not confirm viral suppression in the HIV-positive partner at transmission in a secondary meta-analysis. Methodologic quality was reasonable. The rate of transmission in the 3 studies confirming virologic suppression was 0 per 100 person-years (95% CI = 0–0.05), with low heterogeneity (I2 = 0%). When we included the 3 studies that did not confirm virologic suppression, the rate of transmission was 0.14 per 100 person-years (95%CI = 0.04–0.31) (I2 = 0%). In a sensitivity analysis including all 6 studies, the rate of transmission was 0 per 100 person-years (95%CI = 0–0.01) after omitting all transmissions with known detectable or unconfirmed viral loads, as full suppression in these cases was unlikely. Limitations included lack of data on same-sex couples, type of sexual intercourse (vaginal vs. anal), direction of HIV transmission, exact viral load at the time of transmission, sexually transmitted infections (STI) rates, and extent of condom use. Conclusions Our findings suggest minimal risk of sexual HIV transmission for heterosexual serodiscordant couples when the HIV-positive partner has full viral suppression on cART with caveats regarding information on sexual intercourse type, STIs, and condom use. These findings have implications when counseling heterosexual serodiscordant couples on sexual and reproductive health. More research is needed to explore HIV transmission risk between same-sex couples.
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            A universal testing and treatment intervention to improve HIV control: One-year results from intervention communities in Zambia in the HPTN 071 (PopART) cluster-randomised trial

            Background The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets require that, by 2020, 90% of those living with HIV know their status, 90% of known HIV-positive individuals receive sustained antiretroviral therapy (ART), and 90% of individuals on ART have durable viral suppression. The HPTN 071 (PopART) trial is measuring the impact of a universal testing and treatment intervention on population-level HIV incidence in 21 urban communities in Zambia and South Africa. We report observational data from four communities in Zambia to assess progress towards the UNAIDS targets after 1 y of the PopART intervention. Methods and findings The PopART intervention comprises annual rounds of home-based HIV testing delivered by community HIV-care providers (CHiPs) who also support linkage to care, ART retention, and other services. Data from four communities in Zambia receiving the full intervention (including immediate ART for all individuals with HIV) were used to determine proportions of participants who knew their HIV status after the CHiP visit; proportions linking to care and initiating ART following referral; and overall proportions of HIV-infected individuals who knew their status (first 90 target) and the proportion of these on ART (second 90 target), pre- and post-intervention. We are not able to assess progress towards the third 90 target at this stage of the study. Overall, 121,130 adults (59,283 men and 61,847 women) were enumerated in 46,714 households during the first annual round (December 2013 to June 2015). Of the 45,399 (77%) men and 55,703 (90%) women consenting to the intervention, 80% of men and 85% of women knew their HIV status after the CHiP visit. Of 6,197 HIV-positive adults referred by CHiPs, 42% (95% CI: 40%–43%) initiated ART within 6 mo and 53% (95% CI: 52%–55%) within 12 mo. In the entire population, the estimated proportion of HIV-positive adults who knew their status increased from 52% to 78% for men and from 56% to 87% for women. The estimated proportion of known HIV-positive individuals on ART increased overall from 54% after the CHiP visit to 74% by the end of the round for men and from 53% to 73% for women. The estimated overall proportion of HIV-positive adults on ART, irrespective of whether they knew their status, increased from 44% to 61%, compared with the 81% target (the product of the first two 90 targets). Coverage was lower among young men and women than in older age groups. The main limitation of the study was the need for assumptions concerning knowledge of HIV status and ART coverage among adults not consenting to the intervention or HIV testing, although our conclusions were robust in sensitivity analyses. Conclusions In this analysis, acceptance of HIV testing among those consenting to the intervention was high, although linkage to care and ART initiation took longer than expected. Knowledge of HIV-positive status increased steeply after 1 y, almost attaining the first 90 target in women and approaching it in men. The second 90 target was more challenging, with approximately three-quarters of known HIV-positive individuals on ART by the end of the annual round. Achieving higher test uptake in men and more rapid linkage to care will be key objectives during the second annual round of the intervention. Trial registration ClinicalTrials.gov NCT01900977
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              Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial.

              In Africa, up to 30% of HIV-infected patients who are clinically eligible for antiretroviral therapy (ART) do not start timely treatment. We assessed the effects of an intervention targeting prevalent health systems barriers to ART initiation on timing and completeness of treatment initiation.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: Academic Editor
                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                23 March 2018
                March 2018
                : 15
                : 3
                Affiliations
                [1 ] Institute for Implementation Science in Population Health, City University of New York, New York, New York, United States of America
                [2 ] Graduate School of Public Health and Health Policy, City University of New York, New York, New York, United States of America
                [3 ] R.M. Fairbanks School of Public Health, Indiana University, Indianapolis, Indiana, United States of America
                [4 ] Indiana University School of Medicine, Indianapolis, Indiana, United States of America
                [5 ] Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
                [6 ] Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
                [7 ] National Hospital of Tropical Diseases, Hanoi, Vietnam
                [8 ] Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
                [9 ] Bordeaux School of Public Health, Bordeaux, France
                [10 ] Rwanda Military Hospital, Kigali, Rwanda
                [11 ] World Health Organization, Geneva, Switzerland
                University of Southampton, UNITED KINGDOM
                Author notes

                I have read the journal's policy and the authors of this manuscript have the following competing interests: KA has served on Scientific Advisory Boards for HIV and Cardiovascular Disease for Gilead Sciences and serves on the Scientific Advisory Board for TrioHealth.

                ¶ Membership of the IeDEA Collaboration is provided in S3 Text.

                Article
                PMEDICINE-D-17-03092
                10.1371/journal.pmed.1002534
                5865713
                29570723
                © 2018 Tymejczyk 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.

                Page count
                Figures: 2, Tables: 3, Pages: 19
                Product
                Funding
                Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases [ www.niaid.nih.gov] of the National Institutes of Health under Award Numbers U01AI096299 (OT, EB, JDS, RW, DN; IeDEA Central Africa) and U01AI069924 (EZ, NA; IeDEA Southern Africa); the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development [ www.nichd.nih.gov], the National Cancer Institute [ www.cancer.gov], and the National Institute of Mental Health [ www.nimh.nih.gov] under Award Number U01AI069919 (FD; IeDEA West Africa); the National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Drug Abuse [ www.drugabuse.gov], the National Cancer Institute, and the National Institute of Mental Health under Award Number U01AI069911 (CY, KWK; IeDEA East Africa); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, and the Office of the Director, the National Institutes of Health [ www.nih.gov/institutes-nih/nih-office-director], under Award Number U01AI069923 (Caribbean, Central and South America network for HIV epidemiology [CCASAnet]; BCR); and the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute of Mental Health, and the National Institute on Drug Abuse, under Award Number U01AI069907 (KVN; TREAT Asia HIV Observational Database, an initiative of TREAT Asia, a program of amfAR, The Foundation for AIDS Research [ www.amfar.org]. The Kirby Institute is funded by the Australian Government Department of Health and Ageing [ www.health.gov.au]). Additionally, this work was supported by National Institutes of Health grants U01AI069918, F31DA037788, G12MD007583, K01AI093197, K23EY013707, K24AI065298, K24AI118591, K24DA000432, KL2TR000421, M01RR000052, N01CP01004, N02CP055504, N02CP91027, P30AI027757, P30AI027763, P30AI027767, P30AI036219, P30AI050410, P30AI094189, P30AI110527, P30MH62246, R01AA016893, R01CA165937, R01DA011602, R01DA012568, R24AI067039, U01AA013566, U01AA020790, U01AI031834, U01AI034989, U01AI034993, U01AI034994, U01AI035004, U01AI035039, U01AI035040, U01AI035041, U01AI035042, U01AI037613, U01AI037984, U01AI038855, U01AI038858, U01AI042590, U01AI068634, U01AI068636, U01AI069432, U01AI069434, U01AI103390, U01AI103397, U01AI103401, U01AI103408, U01DA03629, U01DA036935, U01HD032632, U10EY008057, U10EY008052, U10EY008067, U24AA020794,U54MD007587, UL1RR024131, UL1TR000004, UL1TR000083, UL1TR000454, UM1AI035043, Z01CP010214 and Z01CP010176; contracts CDC-200-2006-18797 and CDC-200-2015-63931 from the Centers for Disease Control and Prevention, USA [ www.cdc.gov]; contract 90047713 from the Agency for Healthcare Research and Quality [ www.ahrq.gov], USA; contract 90051652 from the Health Resources and Services Administration [ www.hrsa.gov], USA; grants CBR-86906, CBR-94036, HCP-97105 and TGF-96118 from the Canadian Institutes of Health Research, Canada [ www.cihr-irsc.gc.ca]; Ontario Ministry of Health and Long Term Care [ www.health.gov.on.ca]; and the Government of Alberta, Canada [ www.alberta.ca]. Additional support was provided by the National Cancer Institute, National Institute for Mental Health and National Institute on Drug Abuse (KA). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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                Custom metadata
                Complete data for this study cannot be posted in a supplemental file or a public repository because of legal and ethical restrictions. The Principles of Collaboration under which the IeDEA multiregional collaboration was founded and the regulatory requirements of the different countries' IRBs require the submission and approval of a project concept sheet by the IeDEA Executive Committee and the principal investigators from participating regions. All datasets provided by IeDEA are deidentified according to HIPAA Safe Harbor guidelines, with the exception of dates in some of the regions. Disclosure of a person's HIV status can be highly stigmatizing, and since reidentification of deidentified datasets may be possible when they are combined with publicly available datasets (see work of Dr. Latanya Sweeney), IeDEA promotes the signing of a Data Use Agreement before HIV clinical data can be released. To request data, readers may contact IeDEA for consideration and instructions by filling out the online form available at www.iedea.org/home/who-we-are and completing the application at www.iedea.org/wp-content/uploads/2017/05/IeDEA_Multiregional_Concept_Application_Form_August_2016.docx.

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