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Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

ABSTRACT: Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ?18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ?500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.Same-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease.This study is registered with ClinicalTrials.gov number NCT01900080.

SUBMITTER: Koenig SP

PROVIDER: S-EPMC5526526 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

Koenig Serena P SP Dorvil Nancy N Dévieux Jessy G JG Hedt-Gauthier Bethany L BL Riviere Cynthia C Faustin Mikerlyne M Lavoile Kerlyne K Perodin Christian C Apollon Alexandra A Duverger Limathe L McNairy Margaret L ML Hennessey Kelly A KA Souroutzidis Ariadne A Cremieux Pierre-Yves PY Severe Patrice P Pape Jean W JW

PLoS medicine 20170725 7

<h4>Background</h4>Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.<h4>Methods and findings</h4>We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The ...[more]

PMID: 28742880

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Project description:BackgroundSame-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population.Methods and findingsWe conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.ConclusionsIn patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes.Trial registrationThis study is registered with ClinicalTrials.gov NCT03154320.

Project description:Same-day initiation (SDI) of antiretroviral therapy (ART) has been recommended to improve ART programme outcomes in South Africa since August 2017. This study assessed implementation of SDI over time in two South African districts, describing the characteristics of same-day initiators and evaluating the impact of SDI on retention in ART care. Routine data were analysed for HIV-infected adults who were newly initiating ART in Johannesburg or Mopani Districts between October 2017 and June 2018. Characteristics of same-day ART initiators were compared to later initiators, and losses to follow-up (LTFU) to six months were assessed using Kaplan Meier survival analysis and multivariate logistic regression. The dataset comprised 32 290 records (29 964 from Johannesburg and 2 326 from Mopani). The overall rate of SDI was 40.4% (n = 13 038), increasing from 30.3% in October 2017 to 54.2% in June 2018. Same-day ART initiators were younger, more likely to be female and presented with less advanced clinical disease than those initiating treatment at later times following diagnosis (p<0.001 for all). SDI was associated with disengagement from care: LTFU was 30.1% in the SDI group compared to 22.4%, 19.8% and 21.9% among clients initiating ART 1-7 days, 8-21 days and ≥22 days after HIV diagnosis, respectively (p<0.001). LTFU was significantly more likely among clients in Johannesburg versus Mopani (adjusted odds ratio (aOR) = 1.43, p<0.001) and among same-day versus later initiators (aOR = 1.45, p<0.001), while increasing age reduced LTFU (aOR = 0.97, p<0.001). In conclusion, SDI has increased over time as per national guidelines, but there is serious concern regarding the reduced rate of retention among same-day initiators. Nevertheless, SDI may result in a net programmatic benefit provided that interventions are implemented to support client readiness for treatment and ongoing engagement in ART care, particularly among younger adults in large ART programmes such as Johannesburg.

Project description:BackgroundIn August 2016, Ethiopia endorsed a universal "test and treat" strategy for people living with human immunodeficiency virus (PLHIV) based on World Health Organization recommendation. However, there is limited evidence on the routine application of the same-day "test and treat" recommendation in low-income settings. This study assessed the effect of same-day treatment initiation on individual-level retention at 6- and 12-months follow-up.MethodsA multicenter facility-based retrospective cohort study was conducted to compare retention-in-care between PLHIV who started antiretroviral therapy (ART) on the same-day and those started ART > 7 days following HIV diagnoses. Participants were at least 15 years-old and were newly diagnosed and started on ART between October 2016 and July 2018 in 11 health facilities in the Amhara region of Ethiopia. Multivariable logistic regression controlling for potential confounders and Kaplan-Meier survival analysis were used to assess differences in outcomes between the groups.ResultsIn total, 433 PLHIV started ART on the same-day of diagnosis and 555 PLHIV who started ART > 7 days after HIV diagnosis were included in the study. At 6-months, 82.0% (355) in the same-day group vs 89.4% (496) in the > 7 days group were retained-in-care (absolute risk difference (RD) = 7.4%; 95% confidence interval (CI): 2.9-11.8%). At 12-months, 75.8% (328) in the same-day group vs 82.0% (455) in the > 7 days group were retained-in-care (absolute RD = 6.2%; 95% CI: 1.1, 11.4%). The major drop in retention was in the first 30 days following ART initiation among same-day group. After adjusting for baseline and non-baseline covariates, the same-day group was less likely to be retained-in-care at 6- and 12-months (adjusted risk ratio (RR) = 0.89; 95% CI: 0.87, 0.90 and adjusted RR = 0.86; 95% CI: 0.83, 0.89, respectively).ConclusionsReduced retention-in-care can threaten the benefit of the same-day "test and treat" policy. The policy needs to be implemented cautiously with greater emphasis on assessment and preparation of PLHIV for ART to ensure treatment readiness before starting them on same-day ART and close monitoring of patients during early follow-up periods.

Project description:BackgroundDespite antiretroviral therapy (ART) being widely available, HIV continues to cause substantial illness and premature death in low-and-middle-income countries. High rates of loss to follow-up after HIV diagnosis can delay people starting ART. Starting ART within seven days of HIV diagnosis (rapid ART initiation) could reduce loss to follow-up, improve virological suppression rates, and reduce mortality.ObjectivesTo assess the effects of interventions for rapid initiation of ART (defined as offering ART within seven days of HIV diagnosis) on treatment outcomes and mortality in people living with HIV. We also aimed to describe the characteristics of rapid ART interventions used in the included studies.Search methodsWe searched CENTRAL, the Cochrane Database of Systematic Reviews, MEDLINE, Embase, and four other databases up to 14 August 2018. There was no restriction on date, language, or publication status. We also searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform, and websites for unpublished literature, including conference abstracts.Selection criteriaWe included randomized controlled trials (RCTs) that compared rapid ART versus standard care in people living with HIV. Children, adults, and adolescents from any setting were eligible for inclusion.Data collection and analysisTwo review authors independently assessed the eligibility of the studies identified in the search, assessed the risk of bias and extracted data. The primary outcomes were mortality and virological suppression at 12 months. We have presented all outcomes using risk ratios (RR), with 95% confidence intervals (CIs). Where appropriate, we pooled the results in meta-analysis. We assessed the certainty of the evidence using the GRADE approach.Main resultsWe included seven studies with 18,011 participants in the review. All studies were carried out in low- and middle-income countries in adults aged 18 years old or older. Only one study included pregnant women.In all the studies, the rapid ART intervention was offered as part of a package that included several cointerventions targeting individuals, health workers and health system processes delivered alongside rapid ART that aimed to facilitate uptake and adherence to ART.Comparing rapid ART with standard initiation probably results in greater viral suppression at 12 months (RR 1.18, 95% CI 1.10 to 1.27; 2719 participants, 4 studies; moderate-certainty evidence) and better ART uptake at 12 months (RR 1.09, 95% CI 1.06 to 1.12; 3713 participants, 4 studies; moderate-certainty evidence), and may improve retention in care at 12 months (RR 1.22, 95% CI 1.11 to 1.35; 5001 participants, 6 studies; low-certainty evidence). Rapid ART initiation was associated with a lower mortality estimate, however the CIs included no effect when compared to standard of care (RR 0.72, 95% CI 0.51 to 1.01; 5451 participants, 7 studies; very low-certainty evidence). It is uncertain whether rapid ART has an effect on modification of ART treatment regimens as data are lacking (RR 7.89, 95% CI 0.76 to 81.74; 977 participants, 2 studies; very low-certainty evidence). There was insufficient evidence to draw conclusions on the occurrence of adverse events.Authors' conclusionsRCTs that include initiation of ART within one week of diagnosis appear to improve outcomes across the HIV treatment cascade in low- and middle-income settings. The studies demonstrating these effects delivered rapid ART combined with several setting-specific cointerventions. This highlights the need for pragmatic research to identify feasible packages that assure the effects seen in the trials when delivered through complex health systems.

Project description:Background and objectiveDevelopment of clear and effective discrete-choice experiment surveys is an important step toward ensuring accurate and usable preference results. Pretest interviews and pilot testing are common in the development of discrete-choice experiments, and it is important for researchers to report details of survey changes resulting from patient feedback elicited in pilot work. This paper details pilot testing of an online discrete-choice experiment to elicit preferences for long-acting antiretroviral therapies among patients with HIV.MethodsThe survey included an introduction to hypothetical treatment options, descriptions of attributes, comprehension questions, instructions for completing a discrete-choice experiment, a discrete-choice experiment with 17 choice tasks, and questions about personal characteristics. We piloted the survey with 50 respondents over ten waves. Each wave incorporated design improvements based on observations made during the previous wave. Respondents completed the online survey while screen sharing with a researcher, allowing interactive discussion. We developed a scheme for assessing and categorizing the survey changes.ResultsChanges to the pilot were categorized by ways they impacted aspects of the discrete-choice experiment or the likely quality of resulting data. The four categories of impact are: understanding of attributes, underlying discrete-choice experiment and understanding of the choice question, collection of individual characteristics hypothesized to affect preference, and changes that improved clarity and usability of the survey without directly affecting the other categories (e.g., survey navigation and instructional clarity, formatting changes).ConclusionsDetailed attention to the respondent experience in this large pilot allowed survey improvements that will likely reduce ambiguity, ensure more accurate capture of patient preferences and, ultimately, improve product development for long-acting antiretroviral therapies.

Project description:INTRODUCTION:Many prevention of mother-to-child HIV transmission programmes across Africa initiate HIV-infected (HIV positive) pregnant women on lifelong antiretroviral therapy (ART) on the first day of antenatal care ("same-day" initiation). However, there are concerns that same-day initiation may limit patient preparation before starting ART and contribute to subsequent non-adherence, disengagement from care and raised viral load. We examined if same-day initiation was associated with viral suppression and engagement in care during pregnancy. METHODS:Consecutive ART-eligible pregnant women making their first antenatal care (ANC) visit at a primary care facility in Cape Town, South Africa were enrolled into a prospective cohort between March 2013 and June 2014. Before July 2013, ART eligibility was based on CD4 cell count ≤350 cells/μL ("Option A"), with a 1 to 2 week delay from the first ANC visit to ART initiation for patient preparation; thereafter all women were eligible regardless of CD4 cell count ("Option B+") and offered ART on the same day as first ANC visit. Women were followed with viral load testing conducted separately from routine ART services, and engagement in ART services was measured using routinely collected clinic, pharmacy and laboratory records through 12 months postpartum. RESULTS:Among 628 HIV-positive women (median age, 28 years; median gestation at ART start, 21 weeks; 55% newly diagnosed with HIV), 73% initiated ART same-day; this proportion was higher under Option B+ versus Option A (85% vs. 20%). Levels of viral suppression (viral load <50 copies/mL) at delivery (74% vs. 82%) and 12 months postpartum (74% vs. 71%) were similar under same-day versus delayed initiation respectively. Findings were consistent when viral suppression was defined at <1000 copies/mL, after adjustment for demographic/clinical measures and across subgroups of age, CD4 and timing of HIV diagnosis. Time to first viral rebound following initial suppression did not differ by timing of ART initiation nor did engagement in care through 12 months postpartum (same-day = 73%, delayed = 73%, p = 0.910). CONCLUSIONS:These data suggest that same-day ART initiation during pregnancy is not associated with lower levels of engagement in care or viral suppression through 12 months post-delivery in this setting, providing reassurance to ART programmes implementing Option B+.

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Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

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Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

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