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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: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:BACKGROUND:Despite 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. OBJECTIVES:To 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 METHODS:We 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 CRITERIA:We 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 ANALYSIS:Two 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 RESULTS:We 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' CONCLUSIONS:RCTs 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/?L ("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+.

Project description:BackgroundThe Human Immunodeficiency Virus /Acquired Immune Deficiency Syndrome (HIV/AIDS) is not just a medical problem but its social impact is increasingly affecting its effective management. The fear of HIV-stigma constitutes a major barrier to HIV testing, prevention, uptake and adherence to antiretroviral therapy (ART). We aimed to quantify HIV-related stigma, and identify the factors associated with high HIV-related stigma among persons living with HIV and AIDS (PLHIVA) and on ART.MethodsA hospital-based cross sectional analytic survey targeting PLHIVA on ART at the HIV-day care unit of the Bamenda Regional Hospital of Cameroon was conducted from February to April 2016. A total of 308 eligible and willing participants were consecutively included in the survey. Data were collected using a pretested questionnaire designed from the Berger HIV stigma scale and analyzed using Epi info 3.5.4.ResultsThe mean age of the 308 participants was 40.1±10.2 years. The mean overall HIV/AIDS related stigma score was 88.3?±?18.80 which corresponds to a moderate level of stigma according to the Berger stigma scale. Further analysis revealed that most participants suffered from moderate forms of the different subtypes of stigma including: personalized (49.8%), disclosure (66.4%), negative self-image (50.0%) and public attitude (52.1%) stigmatization. It was estimated that 62.7% (95% confidence interval [CI]?=?57.8-68.9%) of the participants lived with high levels of HIV-related stigma. After controlling for gender, religion, age and occupation, level of education below tertiary (Adjusted Odds Ratio [AOR]?=?0.70 [95% CI?=?0.44-0.91]; p?=?0.036) and a duration from diagnosis below 5 years (AOR?=?1.74 [95% CI?=?1.01-3.00]; p?=?0.046) were significantly associated with high HIV-related stigma.ConclusionAbout three out of every five PLHIVA receiving ART in Bamenda Regional Hospital still experience high levels of HIV-related stigma. This occurs more frequently in participants with low educational status, and who may have known their HIV status for less than 5 years. Anti-HIV-stigma programs in the North West Region need strengthening with intensified psychosocial follow-up of newly diagnosed cases.

Dataset Information

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

Publications

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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