Publications by authors named "Joanna Orne-Gliemann"

47 Publications

Couple oriented counselling improves male partner involvement in sexual and reproductive health of a couple: Evidence from the ANRS PRENAHTEST randomized trial.

PLoS One 2021 30;16(7):e0255330. Epub 2021 Jul 30.

Centre Pasteur Cameroon, Epidemiology and Public Health Service, Yaounde, Cameroon.

Background: Male partner involvement (MPI) has been recognized as a priority area to be strengthened in Prevention of Mother to Child Transmission (PMTCT) of HIV. We explored the impact of Couple Oriented Counselling (COC) in MPI in sexual and reproductive health and associated factors.

Method: From February 2009 to October 2011, pregnant women were enrolled at their first antenatal care visit (ANC-1) and followed up until 6 months after delivery in the Mother and Child Center of the Chantal Biya Foundation within the randomized prenahtest multicentric trial. The MPI index was defined using sexual and reproductive health behaviour variables by using multiple correspondence analysis followed by mixed classification. Men were considered as highly involved if they had shared their HIV test results with their partner, had discussed on HIV or condom used, had contributed financially to ANC, had accompanied their wife to ANC or had practiced safe sex. Factors associated to MPI were investigated by the logistic model with GEE estimation approach.

Results: A total of 484 pregnant women were enrolled. The median age of the women was 27 years (IQR: 23-31) and 55.23% had a gestational age greater than 16 weeks at ANC-1. Among them, HIV prevalence was 11.9% (95% CI: 9.0-15.4). The median duration of the women's relationship with their partner was 84 months (IQR: 48-120). MPI index at 6 months after delivery was significantly greater in the COC group than the classical counselling group (14.8% vs 8,82%; p = 0,043; Fig 1). The partners of the women who participated in the COC were more likely to be involved during follow up than others (aOR = 1.45; 95% CI = 1.00-2.10). Partners with no incoming activity (aOR = 2.90; 95% CI = 1.96-4.29), who did not used violence within the couple (aOR = 1.70; 95% CI = 1.07-2.68), and whose partner came early for ANC-1 (aOR = 1.37; 95% CI = 1.00-1.89) were more likely to be involved than others.

Conclusion: MPI remains low in stable couples and COC improves partner involvement. Our findings also support the need of strengthening outreach towards "stable" couples and addressing barriers. This could go a long way to improve PMTCT outcomes in Cameroon.

Trial Registration: PRENAHTEST, NCT01494961. Registered 15 December 2011-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01494961.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255330PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323939PMC
July 2021

Early ART Initiation Improves HIV Status Disclosure and Social Support in People Living with HIV, Linked to Care Within a Universal Test and Treat Program in Rural South Africa (ANRS 12249 TasP Trial).

AIDS Behav 2021 Apr 18;25(4):1306-1322. Epub 2020 Nov 18.

Aix Marseille Univ, UMR912 - INSERM, IRD, SanteRCom, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Faculté de Médecine, 27 bd Jean Moulin, 13005, Marseille, France.

We investigated the effect of early antiretroviral treatment (ART) initiation on HIV status disclosure and social support in a cluster-randomized, treatment-as-prevention (TasP) trial in rural South Africa. Individuals identified HIV-positive after home-based testing were referred to trial clinics where they were invited to initiate ART immediately irrespective of CD4 count (intervention arm) or following national guidelines (control arm). We used Poisson mixed effects models to assess the independent effects of (a) time since baseline clinical visit, (b) trial arm, and (c) ART initiation on HIV disclosure (n = 182) and social support (n = 152) among participants with a CD4 count > 500 cells/mm at baseline. Disclosure and social support significantly improved over follow-up in both arms. Disclosure was higher (incidence rate ratio [95% confidence interval]: 1.24 [1.04; 1.48]), and social support increased faster (1.22 [1.02; 1.46]) in the intervention arm than in the control arm. ART initiation improved both disclosure and social support (1.50 [1.28; 1.75] and 1.34 [1.12; 1.61], respectively), a stronger effect being seen in the intervention arm for social support (1.50 [1.12; 2.01]). Besides clinical benefits, early ART initiation may also improve psychosocial outcomes. This should further encourage countries to implement universal test-and-treat strategies.
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http://dx.doi.org/10.1007/s10461-020-03101-yDOI Listing
April 2021

Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial).

Trials 2020 Oct 13;21(1):846. Epub 2020 Oct 13.

CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.

Objectives: To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation.

Trial Design: Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial.

Participants: Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib, hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin; Known hypersensitivity to any of the trial drugs or to chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine, ARB; Hepatic porphyria; Liver failure (Child-Pugh stage ≥B); Stage 4 or 5 chronic kidney disease (GFR <30 mL/min/1.73 m²); Dialysis; Hypersentivity to lactose; Lactase deficiency; Abnormalities in galactose metabolism; Malabsorption syndrome; Glucose-6-phosphate dehydrogenase deficiency; Symptomatic hyperuricemia; Ileus; Colitis; Enterocolitis; Chronic hepatitis B virus disease. The trial is being conducted in France in the Bordeaux, Corse, Dijon, Nancy, Paris and Toulouse areas as well as in the Grand Duchy of Luxembourg. Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations.

Intervention And Comparator: The four experimental treatments planned in protocol version 1.2 (April 8, 2020) are: (1) Hydroxychloroquine 200 mg, 2 tablets BID on day 0, 2 tablets QD from day 1 to 9; (2) Imatinib 400 mg, 1 tablet QD from day 0 to 9; (3) Favipiravir 200 mg, 12 tablets BID on day 0, 6 tablets BID from day 1 to 9; (4) Telmisartan 20 mg, 1 tablet QD from day 0 to 9. The comparator is a complex of vitamins and trace elements (AZINC Forme et Vitalité®), 1 capsule BID for 10 days, for which there is no reason to believe that they are active on the virus. In protocol version 1.2 (April 8th, 2020): People in the control arm will receive a combination of vitamins and trace elements; people in the experimental arms will receive hydroxychloroquine, or favipiravir, or imatinib, or telmisartan.

Main Outcome: The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.

Randomisation: Participants are randomized in a 1:1:1:1:1 ratio to each arm using a web-based randomisation tool. Participants not treated with an ARB or ACEI prior to enrolment are randomized to receive the comparator or one of the four experimental drugs. Participants already treated with an ARB or ACEI are randomized to receive the comparator or one of the experimental drugs except telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir). Randomisation is stratified on ACEI or ARBs treatment at inclusion and on the type of residence (personal home vs. nursing home).

Blinding (masking): This is an open-label trial. Participants, caregivers, investigators and statisticians are not blinded to group assignment.

Numbers To Be Randomised (sample Size): A total of 1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added. Three successive futility interim analyses are planned, when the number of participants reaches 30, 60 and 102 in the control arm. Two efficacy analyses (interim n°3 and final) will be performed successively.

Trial Status: This describes the Version 1.2 (April 8, 2020) of the COVERAGE protocol that was approved by the French regulatory authority and ethics committee. The trial was opened for enrolment on April 15, 2020 in the Nouvelle Aquitaine region (South-West France). Given the current decline of the COVID-19 pandemic in France and its unforeseeable dynamic in the coming months, new trial sites in 5 other French regions and in Luxembourg are currently being opened. A revised version of the protocol was submitted to the regulatory authority and ethics committee on June 15, 2020. It contains the following amendments: (i) Inclusion criteria: age ≥65 replaced by age ≥60; time since first symptoms <3 days replaced by time since first symptoms <5 days; (ii) Withdrawal of the hydroxychloroquine arm (due to external data); (iii) increase in the number of trial sites.

Trial Registration: The trial was registered on Clinical Trials.gov on April 22, 2020 (Identifier: NCT04356495): and on EudraCT on April 10, 2020 (Identifier: 2020-001435-27).

Full Protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
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http://dx.doi.org/10.1186/s13063-020-04619-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7552584PMC
October 2020

Retention-in-care in the PMTCT cascade: definitions matter! Analyses from the INSPIRE projects in Malawi, Nigeria and Zimbabwe.

J Int AIDS Soc 2020 10;23(10):e25609

ISPED, Inserm, Bordeaux Population Health Research Center, UMR 1219, University of Bordeaux, Bordeaux, France.

Introduction: Definitions of retention-in-care in Prevention of Mother-to-Child Transmission of HIV (PMTCT) vary substantially between studies and programmes. Some definitions are based on visits missed/made, others on a minimum total number of visits, or attendance at a final clinic visit at a specific time. An agreed definition could contribute to developing evidence-based interventions for improving retention-in-care. In this paper, we estimated retention-in-care rates according to different definitions, and we quantified and visualized the degree of agreement between definitions.

Methods: We calculated retention in care rates using nine definitions in the six INSPIRE PMTCT intervention studies, conducted in three sub-Saharan African countries between 2013 and 2017. With data from one of the studies (E4E), we estimated the agreement between definitions using Gwet's agreement coefficient (AC1) and concordance. We calculated positive predictive values (PPV) and negative predictive values (NPV) for all definitions considering successively each definition as the reference standard. Finally, we used a Multiple Correspondence Analysis (MCA) to examine clustering of the way different definitions handle retention-in-care.

Results: Retention-in-care rates among 5107 women ranged from 30% to 76% in the complete dataset with Gwet's AC1 being 0.56 [0.53; 0.59] indicating a moderate agreement between all definitions together. Two pairs of definitions with high inner concordance and agreement had either very high PPV or very high NPV, and appeared distinct from the other five definitions on the MCA figures. These pairs of definitions were also the ones resulting in the lowest and highest estimates of retention-in-care. The simplest definition, that only required a final clinic visit to classify women as retained in care, and classified 55% of women as retained in care, had a PPV ranging from 0.7 to 1 and a NPV ranging from 0.69 to 0.98 when excluding the two pairs afore-mentioned; it resulted in a moderate to substantial agreement and a 70% to 90% concordance with all other definitions.

Conclusions: Our study highlights the variability of definitions in estimating retention-in-care. Some definitions are very stringent which may be required in some instances. A simple indicator such as attendance at a single time point may be sufficient for programme planning and evaluation.
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http://dx.doi.org/10.1002/jia2.25609DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543052PMC
October 2020

Test but not treat: Community members' experiences with barriers and facilitators to universal antiretroviral therapy uptake in rural KwaZulu-Natal, South Africa.

PLoS One 2020 24;15(9):e0239513. Epub 2020 Sep 24.

Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.

Introduction: Antiretroviral therapy (ART) has revolutionised the care of HIV-positive individuals resulting in marked decreases in morbidity and mortality, and markedly reduced transmission to sexual partners. However, these benefits can only be realised if individuals are aware of their HIV-positive status, initiated and retained on suppressive lifelong ART. Framed using the socio-ecological model, the present study explores factors contributing to poor ART uptake among community members despite high acceptance of HIV-testing within a Treatment as Prevention (TasP) trial. In this paper we identify barriers and facilitators to treatment across different levels of the socio-ecological framework covering individual, community and health system components.

Methods: This research was embedded within a cluster-randomised trial (ClinicalTrials.gov, number NCT01509508) of HIV treatment as Prevention in rural KwaZulu-Natal, South Africa. Data were collected between January 2013 and July 2014 from resident community members. Ten participants contributed to repeat in-depth interviews whilst 42 participants took part in repeat focus group discussions. Data from individual interviews and focus group discussions were triangulated using community walks to give insights into community members' perception of the barriers and facilitators of ART uptake. We used thematic analysis guided by a socio-ecological framework to analyse participants' narratives from both individual interviews and focus group discussions.

Results: Barriers and facilitators operating at the individual, community and health system levels influence ART uptake. Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions. Other barriers were individual (substance misuse, fear of ART side effects), community (alternative health beliefs). Facilitators cited by participants included individual (expectations of improved health and longer life expectancy following ART, single tablet regimens), community (availability of ART in the community through mobile trial facilities) and health system factors (fast and efficient service provided by friendly staff).

Discussion: We identified multiple barriers to achieving universal ART uptake. To enhance uptake in HIV care services, and achieve the full benefits of ART requires interventions that tackle persistent HIV stigma, and offer people with HIV respectful, convenient and efficient services. These interventions require evaluation in appropriately designed studies.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0239513PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7514038PMC
November 2020

Patient perspectives on interpersonal aspects of healthcare and patient-centeredness at primary health facilities: A mixed methods study in rural Eastern Uganda.

PLoS One 2020 30;15(7):e0236524. Epub 2020 Jul 30.

Department of Public Health-Health Systems and Equity Unit, Institute of Tropical Medicine, Antwerp, Belgium.

Introduction: Patient-centered care (PCC) is an approach to involve patients in health care delivery, to contribute to quality of care, and to strengthen health systems responsiveness. This article aims to highlight patient perspectives by showcasing their perceptions of their experience of PCC at primary health facilities in two districts in Uganda.

Methods: A mixed methods cross-sectional study was conducted in three public and two private primary health care facilities in rural eastern Uganda. In total, 300 patient exit survey questionnaires, 31 semi-structured Interviews (SSIs), 5 Focus Group Discussions (FGDs) and 5 feedback meetings were conducted. Data analysis was guided by a conceptual framework focusing on (1) understanding patients' health needs, preferences and expectations, (2) describing patients perceptions of their care experience according to five distinct PCC dimensions, and (3) reporting patient reported outcomes and their recommendations on how to improve quality of care.

Results: Patient expectations were shaped by their access to the facility, costs incurred and perceived quality of care. Patients using public facilities reported doing so because of their proximity (78.3% in public PHCs versus 23.3% in private PHCs) and because of the free services availed. On the other hand, patients attending private facilities did so because of their perception of better quality of care (84.2% in private PHCs versus 21.7% in public PHCs). Patients expectations of quality care were expressed as the availability of medication, shorter waiting times, flexible facility opening hours and courteous health workers. Analysis of the 300 responses from patients interviewed on their perception of the care they received, pointed to higher normalized scores for two out of the five PCC dimensions considered: namely, exploration of the patient's health and illness experience, and the quality of the relationship between patient and health worker (range 62.1-78.4 out of 100). The qualitative analysis indicated that patients felt that communication with health workers was enhanced where there was trust and in case of positive past experiences. Patients however felt uncomfortable discussing psychological or family matters with health workers and found it difficult to make decisions when they did not fully understand the care provided. In terms of outcomes, our findings suggest that patient enablement was more sensitive than patient satisfaction in measuring the effect of interpersonal patient experience on patient reported outcomes.

Discussion And Conclusion: Our findings show that Ugandan patients have some understanding of PCC related concepts and express a demand for it. The results offer a starting point for small scale PCC interventions. However, we need to be cognizant of the challenges PCC implementation faces in resource constrained settings. Patients' expectations in terms of quality health care are still largely driven by biomedical and technical aspects. In addition, patients are largely unaware of their right to participate in the evaluation of health care. To mitigate these challenges, targeted health education focusing on patients' responsibilities and patient's rights are essential. Last but not least, all stakeholders must be involved in developing and validating methods to measure PCC.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236524PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392339PMC
September 2020

Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa.

J Int AIDS Soc 2019 10;22(10):e25402

School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.

Introduction: The universal test-and-treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa.

Methods: The TasP cluster-randomized trial (2012 to 2016) implemented six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 × 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level.

Results: 8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited.

Conclusions: PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART-initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90-90-90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context-specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH-27-0512-3974 (South African National Clinical Trials Register).
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http://dx.doi.org/10.1002/jia2.25402DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6803817PMC
October 2019

No effect of test and treat on sexual behaviours at population level in rural South Africa.

AIDS 2019 03;33(4):709-722

University Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux, France.

Context: Within the community-randomized ANRS 12249 Treatment-as-Prevention trial conducted in rural South Africa, we analysed sexual behaviours stratified by sex over time, comparing immediate antiretroviral therapy irrespective of CD4+ cell count vs. CD4+-guided antiretroviral therapy (start at CD4+ cell count > 350 cells/μl then >500 cells/μl) arms.

Methods: As part of the 6-monthly home-based trial rounds, a sexual behaviour individual questionnaire was administered to all residents at least 16 years. We considered seven indicators: sexual intercourse in the past month; at least one regular sexual partner in the past 6 months; at least one casual sexual partner in the past 6 months and more than one sexual partner in the past 6 months; condom use at last sex (CLS) with regular partner, CLS with casual partner, and point prevalence estimate of concurrency. We conducted repeated cross-sectional analyses, stratified by sex. Generalized Estimating Equations models were used, including trial arm, trial time, calendar time and interaction between trial arm and trial time.

Results: CLS with regular partner varied between 29-51% and 23-46% for men and women, respectively, with significantly lower odds among women in the control vs. intervention arm by trial end (P < 0.001). CLS with casual partner among men showed a significant interaction between arm and trial round, with no consistent pattern. Women declared more than one partner in the past 6 months in less than 1% of individual questionnaires; among men, rates varied between 5-12%, and odds significantly and continuously declined between calendar rounds 1 and 7 [odds ratio = 4.2 (3.24-5.45)].

Conclusion: Universal Test and Treat was not associated with increased sexual risk behaviours.
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http://dx.doi.org/10.1097/QAD.0000000000002104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373441PMC
March 2019

Retention in Care Trajectories of HIV-Positive Individuals Participating in a Universal Test-and-Treat Program in Rural South Africa (ANRS 12249 TasP Trial).

J Acquir Immune Defic Syndr 2019 04;80(4):375-385

INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé, Traitement de l'Information Médicale, Aix Marseille University, Marseille, France.

Objective: To study retention in care (RIC) trajectories and associated factors in patients eligible for antiretroviral therapy (ART) in a universal test-and-treat setting (TasP trial, South Africa, 2012-2016).

Design: A cluster-randomized trial whereby individuals identified HIV positive after home-based testing were invited to initiate ART immediately (intervention) or following national guidelines (control).

Methods: Exiting care was defined as ≥3 months late for a clinic appointment, transferring elsewhere, or death. Group-based trajectory modeling was performed to estimate RIC trajectories over 18 months and associated factors in 777 ART-eligible patients.

Results: Four RIC trajectory groups were identified: (1) group 1 "remained" in care (reference, n = 554, 71.3%), (2) group 2 exited care then "returned" after [median (interquartile range)] 4 (3-9) months (n = 40, 5.2%), (3) group 3 "exited care rapidly" [after 4 (4-6) months, n = 98, 12.6%], and (4) group 4 "exited care later" [after 11 (9-13) months, n = 85, 10.9%]. Group 2 patients were less likely to have initiated ART within 1 month and more likely to be male, young (<29 years), without a regular partner, and to have a CD4 count >350 cells/mm. Group 3 patients were more likely to be women without social support, newly diagnosed, young, and less likely to have initiated ART within 1 month. Group 4 patients were more likely to be newly diagnosed and aged 39 years or younger.

Conclusions: High CD4 counts at care initiation were not associated with a higher risk of exiting care. Prompt ART initiation and special support for young and newly diagnosed patients with HIV are needed to maximize RIC.
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http://dx.doi.org/10.1097/QAI.0000000000001938DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6410969PMC
April 2019

Linkage to primary care after home-based blood pressure screening in rural KwaZulu-Natal, South Africa: a population-based cohort study.

BMJ Open 2018 12 6;8(12):e023369. Epub 2018 Dec 6.

Population Health and Primary Care, University of East Anglia, Norwich, UK.

Objectives: The expanding burden of non-communicable diseases (NCDs) globally will require novel public health strategies. Community-based screening has been promoted to augment efficiency of diagnostic services, but few data are available on the downstream impact of such programmes. We sought to assess the impact of a home-based blood pressure screening programme on linkage to hypertension care in rural South Africa.

Setting: We conducted home-based blood pressure screening withinin a population cohort in rural KwaZulu-Natal, using the WHO Stepwise Approach to Surveillance (STEPS) protocol.

Participants: Individuals meeting criteria for raised blood pressure (≥140 systolic or ≥90 diastolic averaged over two readings) were referred to local health clinics and included in this analysis. We defined linkage to care based on self-report of presentation to clinic for hypertension during the next 2 years of cohort observation. We estimated the population proportion of successful linkage to care with inverse probability sampling weights, and fit multivariable logistic regression models to identify predictors of linkage following a positive hypertension screen.

Results: Of 11 694 individuals screened, 14.6% (n=1706) were newly diagnosed with elevated pressure. 26.9% (95% CI 24.5% to 29.4%) of those sought hypertension care in the following 2 years, and 38.1% (95% CI 35.6% to 40.7%) did so within 5 years. Women (adjusted OR (aOR) 2.41, 95% CI 1.68 to 3.45), those of older age (aOR 11.49, 95% CI 5.87 to 22.46, for 45-59 years vs <30) and those unemployed (aOR 1.71, 95% CI 1.10 to 2.65) were more likely to have linked to care.

Conclusions: Linkage to care after home-based identification of elevated blood pressure was rare in rural South Africa, particularly among younger individuals, men and the employed. Improved understanding of barriers and facilitators to NCD care is needed to enhance the effectiveness of blood pressure screening in the region.
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http://dx.doi.org/10.1136/bmjopen-2018-023369DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6286496PMC
December 2018

"If you are here at the clinic, you do not know how many people need help in the community": Perspectives of home-based HIV services from health care workers in rural KwaZulu-Natal, South Africa in the era of universal test-and-treat.

PLoS One 2018 9;13(11):e0202473. Epub 2018 Nov 9.

Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France.

Background: Limited engagement in clinic-based care is affecting the HIV response. We explored the field experiences and perceptions of local health care workers regarding home-based strategies as opportunities to improve the cascade of care of people living with HIV in rural South Africa as part of a Universal Test-and-Treat approach.

Methods: In Hlabisa sub-district, home-based HIV services, including rapid HIV testing and counselling, and support for linkage to and retention in clinic-based HIV care, were implemented by health care workers within the ANRS 12249 Treatment-as-Prevention (TasP) trial. From April to July 2016, we conducted a mixed-methods study among health care workers from the TasP trial and from local government clinics, using self-administrated questionnaires (n = 90 in the TasP trial, n = 56 in government clinics), semi-structured interviews (n = 13 in the TasP trial, n = 5 in government clinics) and three focus group discussions (n = 6-10 health care workers of the TasP trial per group). Descriptive statistics were used for quantitative data and qualitative data were analysed thematically.

Results: More than 90% of health care workers assessed home-based testing and support for linkage to care as feasible and acceptable by the population they serve. Many health care workers underlined how home visits could facilitate reaching people who had slipped through the cracks of the clinic-based health care system and encourage them to successfully access care. Health care workers however expressed concerns about the ability of home-based services to answer the HIV care needs of all community members, including people working outside their home during the day or those who fear HIV-related stigmatization. Overall, health care workers encouraged policy-makers to more formally integrate home-based services in the local health system. They promoted reshaping the disease-specific and care-oriented services towards more comprehensive goals.

Conclusion: Because home-based services allow identification of people early during their infection and encourage them to take actions leading to viral suppression, HCWs assessed them as valuable components within the panel of UTT interventions, aiming to reach the 90-90-90 UNAIDS targets, especially in the rural Southern African region.

Trial Registration: The registration number of the ANRS 12249 TasP trial on ClinicalTrials.gov is NCT01509508.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0202473PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6226311PMC
April 2019

The impact of population dynamics on the population HIV care cascade: results from the ANRS 12249 Treatment as Prevention trial in rural KwaZulu-Natal (South Africa).

J Int AIDS Soc 2018 07;21 Suppl 4:e25128

ISPED, Inserm, Bordeaux Population Health Research Center, Université de Bordeaux, Bordeaux, France.

Introduction: The universal test and treat strategy (UTT) was developed to maximize the proportion of all HIV-positive individuals on antiretroviral treatment (ART) and virally suppressed, assuming that it will lead to a reduction in HIV incidence at the population level. The evolution over time of the cross-sectional HIV care cascade is determined by individual longitudinal trajectories through the HIV care continuum and underlying population dynamics. The purpose of this paper is to quantify the contribution of each component of population change (in- and out-migration, HIV seroconversion, ageing into the cohort and definitive exit such as death) on the HIV care cascade in the context of the ANRS 12249 Treatment as Prevention (TasP) cluster-randomized trial, investigating UTT in rural KwaZulu-Natal, South Africa, between 2012 and 2016.

Methods: HIV test results and information on clinic visits, ART prescriptions, viral load and CD4 count, migration and deaths were used to calculate residency status, HIV status and HIV care status for each individual on a daily basis. Position within the HIV care continuum was considered as a score ranging from 0 (undiagnosed) to 4 (virally suppressed). We compared the cascade score of each individual joining or leaving the population of resident adults living with HIV with the average score of their cluster at the time of entry or exit. Then, we computed the contribution of each entry or exit on the average cascade score and their annualized total contribution, by component of change.

Results: While the average cascade score increased over time in all clusters, that increase was constrained by population dynamics. Permanent exits and ageing into the people living with HIV cohort had a marginal effect. Both in-migrants and out-migrants were less likely to be retained at each step of the HIV care continuum. However, their overall impact on the cross-sectional cascade was limited as the effect of in- and out-migration balanced each other. The contribution of HIV seroconversions was negative in all clusters.

Conclusions: In a context of high HIV incidence, the continuous flow of newly infected individuals slows down the efforts to increase ART coverage and population viral suppression, ultimately attenuating any population-level impact on HIV incidence.

Clinical Trial Number: NCT01509508 (clinicalTrials.gov)/DOH-27-0512-3974 (South African National Clinical Trials Register).
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http://dx.doi.org/10.1002/jia2.25128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6053480PMC
July 2018

Comparative assessment of five trials of universal HIV testing and treatment in sub-Saharan Africa.

J Int AIDS Soc 2018 01;21(1)

Inserm, Bordeaux Population Health Research Center, UMR 1219, University Bordeaux, Bordeaux, France.

Design: Universal voluntary HIV counselling and testing followed by prompt initiation of antiretroviral therapy (ART) for all those diagnosed HIV-infected (universal test and treat, UTT) is now a global health standard. However, its population-level impact, feasibility and cost remain unknown. Five community-based trials have been implemented in sub-Saharan Africa to measure the effects of various UTT strategies at population level: BCPP/YaTsie in Botswana, MaxART in Swaziland, HPTN 071 (PopART) in South Africa and Zambia, SEARCH in Uganda and Kenya and ANRS 12249 TasP in South Africa. This report describes and contrasts the contexts, research methodologies, intervention packages, themes explored, evolution of study designs and interventions related to each of these five UTT trials.

Methods: We conducted a comparative assessment of the five trials using data extracted from study protocols and collected during baseline studies, with additional input from study investigators. We organized differences and commonalities across the trials in five categories: trial contexts, research designs, intervention packages, trial themes and adaptations.

Results: All performed in the context of generalized HIV epidemics, the trials highly differ in their social, demographic, economic, political and health systems settings. They share the common aim of assessing the impact of UTT on the HIV epidemic but differ in methodological aspects such as study design and eligibility criteria for trial populations. In addition to universal ART initiation, the trials deliver a wide range of biomedical, behavioural and structural interventions as part of their UTT strategies. The five studies explore common issues, including the uptake rates of the trial services and individual health outcomes. All trials have adapted since their initiation to the evolving political, economic and public health contexts, including adopting the successive national recommendations for ART initiation.

Conclusions: We found substantial commonalities but also differences between the five UTT trials in their design, conduct and multidisciplinary outputs. As empirical literature on how UTT may improve efficiency and quality of HIV care at population level is still scarce, this article provides a foundation for more collaborative research on UTT and supports evidence-based decision making for HIV care in country and internationally.
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http://dx.doi.org/10.1002/jia2.25048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5810333PMC
January 2018

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

Lancet HIV 2018 03 30;5(3):e116-e125. Epub 2017 Nov 30.

University of Bordeaux, ISPED, INSERM, Bordeaux Population Health Research Center, UMR 1219, Bordeaux, France. Electronic address:

Background: 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.

Methods: We did a phase 4, open-label, cluster randomised trial of 22 communities in rural KwaZulu-Natal, South Africa. We included individuals residing in the communities who were aged 16 years or older. The clusters were composed of aggregated local areas (neighbourhoods) that had been identified in a previous study in the Hlabisa subdistrict. The study statisticians randomly assigned clusters (1:1) with MapInfo Pro (version 11.0) to either the control or intervention communities, stratified on the basis of antenatal HIV prevalence. We offered residents repeated rapid HIV testing during home-based visits every 6 months for about 4 years in four clusters, 3 years in six clusters, and 2 years in 12 clusters (58 cluster-years) and referred HIV-positive participants to trial clinics for ART (fixed-dose combination of tenofovir, emtricitabine, and efavirenz) regardless of CD4 cell count (intervention) or according to national guidelines (initially ≤350 cells per μL and <500 cells per μL from January, 2015; control). Participants and investigators were not masked to treatment allocation. We used dried blood spots once every 6 months provided by participants who were HIV negative at baseline to estimate the primary outcome of HIV incidence with cluster-adjusted Poisson generalised estimated equations in the intention-to-treat population after 58 cluster-years of follow-up. This study is registered with ClinicalTrials.gov, number NCT01509508, and the South African National Clinical Trials Register, number DOH-27-0512-3974.

Findings: Between March 9, 2012, and June 30, 2016, we contacted 26 518 (93%) of 28 419 eligible individuals. Of 17 808 (67%) individuals with a first negative dried blood spot test, 14 223 (80%) had subsequent dried blood spot tests, of whom 503 seroconverted after follow-up of 22 891 person-years. Estimated HIV incidence was 2·11 per 100 person-years (95% CI 1·84-2·39) in the intervention group and 2·27 per 100 person-years (2·00-2·54) in the control group (adjusted hazard ratio 1·01, 95% CI 0·87-1·17; p=0·89). We documented one case of suicidal attempt in a woman following HIV seroconversion. 128 patients on ART had 189 life-threatening or grade 4 clinical events: 69 (4%) of 1652 in the control group and 59 (4%) of 1367 in the intervention group (p=0·83).

Interpretation: The absence of a lowering of HIV incidence in universal test and treat clusters most likely resulted from poor linkage to care. Policy change to HIV universal test and treat without innovation to improve health access is unlikely to reduce HIV incidence.

Funding: ANRS, GiZ, and 3ie.
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http://dx.doi.org/10.1016/S2352-3018(17)30205-9DOI Listing
March 2018

Couples HIV counselling and couple relationships in India, Georgia and the Dominican Republic.

BMC Public Health 2017 Nov 25;17(1):901. Epub 2017 Nov 25.

INSERM UMR 1219 - Bordeaux Population Health Research Center, Bordeaux, France.

Background: Couples HIV counseling and testing is essential for combination HIV prevention, but its uptake remains very low. We aimed to evaluate factors associated with couples HIV counseling uptake in India, Georgia and the Dominican Republic, as part of the ANRS 12127 Prenahtest intervention trial.

Methods: Pregnant women ≥15 years, attending their first antenatal care (ANC) session between March and September 2009, self-reporting a stable partner, and having received couple-oriented post-test HIV counseling (trial intervention) were included. Individuals and couple characteristics associated with the acceptability of couples HIV counseling were assessed using multivariable logistic regression for each study site.

Results: Among 711 women included (232, 240 and 239 in the Dominican Republic, Georgia and India, respectively), the uptake of couples HIV counseling was 9.1% in the Dominican Republic, 13.8% in Georgia and 36.8% in India. The uptake of couples HIV counseling was associated with women having been accompanied by their partner to ANC, and never having used a condom with their partner in the Dominican Republic; with women having been accompanied by their partner to ANC in India; with women having a higher educational level than their partner and having ever discussed HIV with their partner in Georgia.

Conclusion: Couple HIV counseling uptake was overall low. Strategies adapted to local socio-cultural contexts, aiming at improving women's education level, or tackling gender norms to facilitate the presence of men in reproductive health services, should be considered.

Trial Registration: ClinicalTrials.gov Identifier: NCT01494961 . Registered December 15, 2011. (Retrospectively registered).
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http://dx.doi.org/10.1186/s12889-017-4901-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5702196PMC
November 2017

Implementing universal HIV treatment in a high HIV prevalence and rural South African setting - Field experiences and recommendations of health care providers.

PLoS One 2017 20;12(11):e0186883. Epub 2017 Nov 20.

Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux, France.

Background: We aimed to describe the field experiences and recommendations of clinic-based health care providers (HCP) regarding the implementation of universal antiretroviral therapy (ART) in rural KwaZulu-Natal, South Africa.

Methods: In Hlabisa sub-district, the local HIV programme of the Department of Health (DoH) is decentralized in 18 clinics, where ART was offered at a CD4 count ≤500 cells/μL from January 2015 to September 2016. Within the ANRS 12249 TasP trial, implemented in part of the sub-district, universal ART (no eligibility criteria) was offered in 11 mobile clinics between March 2012 and June 2016. A cross-sectional qualitative survey was conducted in April-July 2016 among clinic-based nurses and counsellors providing HIV care in the DoH and TasP trial clinics. In total, 13 individual interviews and two focus groups discussions (including 6 and 7 participants) were conducted, audio-recorded, transcribed, and thematically analyzed.

Results: All HCPs reported an overall good experience of delivering ART early in the course of HIV infection, with most patients willing to initiate ART before being symptomatic. Yet, HCPs underlined that not feeling sick could challenge early ART initiation and adherence, and thus highlighted the need to take time for counselling as an important component to achieve universal ART. HCPs also foresaw logistical challenges of universal ART, and were especially concerned about increasing workload and ART shortage. HCPs finally recommended the need to strengthen the existing model of care to facilitate access to ART, e.g., community-based and integrated HIV services.

Conclusions: The provision of universal ART is feasible and acceptable according to HCPs in this rural South-African area. However their experiences suggest that universal ART, and more generally the 90-90-90 UNAIDS targets, will be difficult to achieve without the implementation of new models of health service delivery.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695789PMC
December 2017

Patterns of Attendance at Mother Support Groups in Zimbabwe. The EPAZ Trial (2014-2016).

J Acquir Immune Defic Syndr 2017 06;75 Suppl 2:S216-S223

*INSERM U1219-Centre Inserm Bordeaux Population Health, Université de Bordeaux, Bordeaux, France; †Université de Bordeaux, ISPED, Centre INSERM U1219-Bordeaux Population Health, Bordeaux, France; ‡Organization for Public Health Interventions and Development, Harare, Zimbabwe; §Clinical Research Centre, Africa University, Mutare, Zimbabwe; ‖University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe; ¶North West University, School of Basic Sciences, Vanderbijlpark, South Africa; #Family AIDS Caring Trust, Mutare, Zimbabwe; and **Mutare Provincial Hospital, Mutare, Zimbabwe.

Background: In Southern Africa, groups of mothers living with HIV successfully provide peer psychosocial support during pregnancy and early childhood. We report patterns of attendance at Mother Support Groups (MSGs) sessions among women and mothers living with HIV in rural Zimbabwe.

Methods: In the Elimination of Pediatric AIDS cluster-randomized trial, MSGs were established in 14 health facilities in Mutare and Makoni districts. Patterns of attendance at MSG sessions were categorized by calendar attendance from delivery to 6-month postpartum using a Dynamic Time Warping clustering method. Baseline characteristics of women and postpartum MSG attendance patterns were described. Linkages between these patterns and 12-month postpartum retention in care were explored using mixed-effects models.

Results: Most women (88%) attended at least 1 MSG session between enrollment and 6-month postpartum. Two patterns of postpartum MSG attendance, "Regular Attendance" and "Non-Regular Attendance," were readily identified. Being older than 32 (P = 0.01), booking for antenatal care before 22 weeks gestational age (P = 0.02), and being on antiretroviral therapy at first antenatal care booking (P = 0.01) were significantly associated with "Regular Attendance." "Regular Attendance" at MSG sessions during the 6-month postpartum period was significantly associated with better retention in care at 12 months, compared with "Non-Regular Attendance" (P < 0.01).

Discussion: Women living with HIV attended MSG sessions. However, few attended regularly. Younger and newly diagnosed women were less likely to attend postpartum MSG sessions or remain in care at 12 months postpartum. Peer support models should consider specific needs of these women, especially in rural areas, in order for MSGs to contribute to improve maternal and child health outcomes.
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http://dx.doi.org/10.1097/QAI.0000000000001348DOI Listing
June 2017

Impact of Facility-Based Mother Support Groups on Retention in Care and PMTCT Outcomes in Rural Zimbabwe: The EPAZ Cluster-Randomized Controlled Trial.

J Acquir Immune Defic Syndr 2017 06;75 Suppl 2:S207-S215

*Ministry of Health and Child Care, Mutare, Zimbabwe; †Family AIDS Caring Trust, Mutare, Zimbabwe; ‡INSERM U1219-Centre Inserm Bordeaux Population Health, Université de Bordeaux, Bordeaux, France; §Université de Bordeaux, ISPED, Centre INSERM U1219-Bordeaux Population Health, Bordeaux, France; ‖Clinical Research Centre, Africa University, Mutare, Zimbabwe; ¶North West University, School of Basic Sciences, South Africa; #University of Zimbabwe, College of Health Sciences Harare, Zimbabwe; and **Organization for Public Health Interventions and Development, Harare, Zimbabwe.

Background: Prevention of mother-to-child transmission elimination goals are hampered by low rates of retention in care. The Eliminating Paediatric AIDS in Zimbabwe project assessed whether mother support groups (MSGs) improve rates of retention in care of HIV-exposed infants and their HIV-positive mothers, and maternal and infant outcomes.

Methods: The study involved 27 rural clinics in eastern Zimbabwe. MSGs were established in 14 randomly selected clinics and met every 2 weeks coordinated by volunteer HIV-positive mothers. MSG coordinators provided health education and reminded mothers of MSG meetings by cell phone. Infant retention in care was defined as "12 months postpartum point attendance" at health care visits of HIV-exposed infants at 12 months of age. We also measured regularity of attendance and other program indicators of HIV-positive mothers and their HIV-exposed infants.

Results: Among 507 HIV-positive pregnant women assessed as eligible, 348 were enrolled and analyzed (69%) with mothers who had disclosed their HIV status being overrepresented. In the intervention arm, 69% of infants were retained in care at 12 months versus 61% in the control arm, with no statistically significant difference. Retention and other program outcomes were systematically higher in the intervention versus control arm, suggesting trends toward positive health outcomes with exposure to MSGs.

Discussion: We were unable to show that facility-based MSGs improved retention in care at 12 months among HIV-exposed infants. Selective enrollment of mothers more likely to be retained-in-care may have contributed to lack of effect. Methods to increase the impact of MSGs on retention including targeting of high-risk mothers are discussed.
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June 2017

Patterns of HIV Care Clinic Attendance and Adherence to Antiretroviral Therapy Among Pregnant and Breastfeeding Women Living With HIV in the Context of Option B+ in Zimbabwe.

J Acquir Immune Defic Syndr 2017 06;75 Suppl 2:S198-S206

*Clinton Health Access Initiative, Harare, Zimbabwe; †Clinton Health Access Initiative, Boston, MA; ‡Université de Bordeaux, ISPED, Centre INSERM U1219 Bordeaux Population Health, Bordeaux, France; §AIDS and TB Unit, Ministry of Health Department, Ministry of Health and Child Care, Harare, Zimbabwe; and ‖Sigma3 Services, Nyon, Switzerland.

Background: Consistent use of antiretroviral therapy (ART) during pregnancy and breastfeeding reduces the likelihood of mother-to-child HIV transmission. All pregnant and breastfeeding women living with HIV in Zimbabwe are offered ART with same-day initiation regardless of CD4 count (Option B+). We investigated patterns of clinic attendance and adherence to ART among HIV-infected pregnant women in Zimbabwe.

Methods: The Evidence for Elimination cluster-randomized trial evaluating point-of-care CD4 testing included 1150 HIV-infected ART-naive women attending antenatal care between January 2014 and June 2015. Thirty-two primary care facilities were randomized between 2 arms. In this secondary analysis of Evidence for Elimination data collected from routine clinic records, we classified women by number of pills dispensed, and estimated adherence from the ratio of pills to days since ART initiation (Medication Possession Ratio, adherent if ≥95%) or the period when they stopped receiving medication.

Results: Two-thirds (67.7%) were still receiving medication 1 year after initiation; less than half of the cohort (39.1%) were adherent. Younger women, newly diagnosed with HIV, and/or first presenting to antenatal care in their third trimester were more likely to drop from care or be nonadherent 360 days after ART initiation.

Conclusion: Adherence to ART is suboptimal particularly among young, newly diagnosed, and/or late presenting patients. Interventions that target these groups, as well as provide additional support to all women who are newly diagnosed, may improve Option B+ ART care. More information is needed about the barriers to ART care among late presenters and teenagers.
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http://dx.doi.org/10.1097/QAI.0000000000001347DOI Listing
June 2017

Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial.

PLoS Med 2016 Aug 9;13(8):e1002107. Epub 2016 Aug 9.

Centre INSERM U1219 Bordeaux Population Health, Université de Bordeaux, Bordeaux, France.

Background: The 2015 WHO recommendation of antiretroviral therapy (ART) for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART.

Methods And Findings: Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults) and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl) contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y) was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm), of whom 9,927 (77.0%) were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%), including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status). Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5%) visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218) initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196) had a CD4 count ≤ 350 cells/μl at first visit, of whom 92.8% initiated ART within 3 mo. Regarding attitudes about ART, 93% (8,802/9,460) of participants agreed with the statement that they would want to start ART as soon as possible if HIV-positive. Estimated baseline HIV prevalence was 30.5% (2,028/6,656) (95% CI 25.0%, 37.0%). HIV prevalence, uptake of home-based HIV testing, linkage to care within 6 mo, and initiation of ART within 3 mo in those with CD4 count ≤ 350 cells/μl did not differ significantly between the intervention and control clusters. Selection bias related to noncontact could not be entirely excluded.

Conclusions: Home-based HIV testing was well received in this rural population, although men were less easily contactable at home; immediate ART was acceptable, with good viral suppression and retention. However, only about half of HIV-positive people accessed care within 6 mo of being identified, with nearly two-thirds accessing care by 12 mo. The observed delay in linkage to care would limit the individual and public health ART benefits of universal testing and treatment in this population.

Trial Registration: ClinicalTrials.gov NCT01509508.
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http://dx.doi.org/10.1371/journal.pmed.1002107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4978506PMC
August 2016

Men, masculinity, and engagement with treatment as prevention in KwaZulu-Natal, South Africa.

AIDS Care 2016 ;28 Suppl 3:74-82

e Africa Centre for Population Health , University of KwaZulu Natal , Mtubatuba , South Africa.

Men's poorer engagement with healthcare generally and HIV care specifically, compared to women, is well-described. Within the HIV public health domain, interest is growing in universal test and treat (UTT) strategies. UTT strategies refer to the expansion of antiretroviral therapy (ART) in order to reduce onward transmission and incidence of HIV in a population, through a "treatment as prevention" (TasP). This paper focuses on how masculinity influences engagement with HIV care in the context of an on-going TasP trial. Data were collected in January-November 2013 using 20 in-depth interviews, 10 of them repeated thrice, and 4 focus group discussions, each repeated four times. Analysis combined inductive and deductive approaches for coding and the review and consolidation of emerging themes. The accounts detailed men's unwillingness to engage with HIV testing and care, seemingly tied to their pursuit of valued masculinity constructs such as having strength and control, being sexually competent, and earning income. Articulated through fears regarding getting an HIV-positive diagnosis, observations that men preferred traditional medicine and that primary health centres were not welcoming to men, descriptions that men used lay measures to ascertain HIV status, and insinuations by men that they were removed from HIV risk, the indisposition to HIV care contrasted markedly with an apparent readiness to test among women. Gendered tensions thus emerged which were amplified in the context where valued masculinity representations were constantly threatened. Amid the tensions, men struggled with disclosing their HIV status, and used various strategies to avoid or postpone disclosing, or disclose indirectly, while women's ability to access care readily, use condoms, or communicate about HIV appeared similarly curtailed. UTT and TasP promotion should heed and incorporate into policy and health service delivery models the intrapersonal tensions, and the conflict, and poor and indirect communication at the micro-relational levels of couples and families.
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http://dx.doi.org/10.1080/09540121.2016.1178953DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5096677PMC
July 2017

Factors associated with antiretroviral treatment initiation amongst HIV-positive individuals linked to care within a universal test and treat programme: early findings of the ANRS 12249 TasP trial in rural South Africa.

AIDS Care 2016 ;28 Suppl 3:39-51

c Africa Centre for Population Health , University of KwaZulu-Natal , Somkhele , South Africa.

Prompt uptake of antiretroviral treatment (ART) is essential to ensure the success of universal test and treat (UTT) strategies to prevent HIV transmission in high-prevalence settings. We describe ART initiation rates and associated factors within an ongoing UTT cluster-randomized trial in rural South Africa. HIV-positive individuals were offered immediate ART in the intervention arm vs. national guidelines recommended initiation (CD4≤350 cells/mm(3)) in the control arm. We used data collected up to July 2015 among the ART-eligible individuals linked to TasP clinics before January 2015. ART initiation rates at one (M1), three (M3) and six months (M6) from baseline visit were described by cluster and CD4 count strata (cells/mm(3)) and other eligibility criteria: ≤100; 100-200; 200-350; CD4>350 with WHO stage 3/4 or pregnancy; CD4>350 without WHO stage 3/4 or pregnancy. A Cox model accounting for covariate effect changes over time was used to assess factors associated with ART initiation. The 514 participants had a median [interquartile range] follow-up duration of 1.08 [0.69; 2.07] months until ART initiation or last visit. ART initiation rates at M1 varied substantially (36.9% in the group CD4>350 without WHO stage 3/4 or pregnancy, and 55.2-71.8% in the three groups with CD4≤350) but less at M6 (from 85.3% in the first group to 96.1-98.3% in the three other groups). Factors associated with lower ART initiation at M1 were a higher CD4 count and attending clinics with both high patient load and higher cluster HIV prevalence. After M1, having a regular partner was the only factor associated with higher likelihood of ART initiation. These findings suggest good ART uptake within a UTT setting, even among individuals with high CD4 count. However, inadequate staffing and healthcare professional practices could result in prioritizing ART initiation in patients with the lowest CD4 counts.
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http://dx.doi.org/10.1080/09540121.2016.1164808DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5096681PMC
July 2017

"It is better to die": experiences of traditional health practitioners within the HIV treatment as prevention trial communities in rural South Africa (ANRS 12249 TasP trial).

AIDS Care 2016 ;28 Suppl 3:24-32

a Africa Centre for Population Health , University of KwaZulu-Natal , Mtubatuba , South Africa.

The ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomized trial in rural South Africa uses a "test and treat" approach. Home-based testing services and antiretroviral treatment initiation satellite clinics were implemented in every cluster as part of the trial. A social science research agenda was nested within TasP with the aim of understanding the social, economic and contextual factors that affect individuals, households, communities and health systems with respect to TasP. Considering the rural nature of the trial setting, we sought to understand community perceptions and experiences of the TasP Trial interventions as seen through the eyes of traditional health practitioners (THPs). A qualitative study design was adopted using four repeat focus group discussions conducted with nine THPs, combined with community walks and photo-voice techniques, over a period of 18 months. A descriptive, interpretive and explanatory approach to analysis was adopted. Findings indicate that THPs engaged with the home-based testing services and HIV clinics established for TasP. Specifically, home-based testing services were perceived as relatively successful in increasing access to HIV testing. A major gap observed by THPs was linkage to HIV clinics. Most of their clients, and some of the THPs themselves, found it difficult to use HIV clinics due to fear of labelling, stigma and discrimination, and the ensuing personal implications of unsolicited disclosure. On the one hand, a growing number of patients diagnosed with HIV have found sanctuary with THPs as alternatives to clinics. On the other hand, THPs in turn have been struggling to channel patients suspected of HIV into clinics through referrals. Therefore, acceptability of the TasP test and treat approach by THPs is a major boost to the intervention, but further success can be achieved through strengthened ties with communities to combat stigma and effectively link patients into HIV care, including partnerships with THPs themselves.
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http://dx.doi.org/10.1080/09540121.2016.1181296DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5096678PMC
July 2017

Community perceptions of repeat HIV-testing: experiences of the ANRS 12249 Treatment as Prevention trial in rural South Africa.

AIDS Care 2016 ;28 Suppl 3:14-23

c Africa Centre for Population Health , University of KwaZulu-Natal , Durban , South Africa.

In the context of the ANRS 12249 Treatment as Prevention (TasP) trial, we investigated perceptions of regular and repeat HIV-testing in rural KwaZulu-Natal (South Africa), an area of very high HIV prevalence and incidence. We conducted two qualitative studies, before (2010) and during the early implementation stages of the trial (2013-2014), to appreciate the evolution in community perceptions of repeat HIV-testing over this period of rapid changes in HIV-testing and treatment approaches. Repeated focus group discussions were organized with young adults, older adults and mixed groups. Repeat and regular HIV-testing was overall well perceived before, and well received during, trial implementation. Yet community members were not able to articulate reasons why people might want to test regularly or repeatedly, apart from individual sexual risk-taking. Repeat home-based HIV-testing was considered as feasible and convenient, and described as more acceptable than clinic-based HIV-testing, mostly because of privacy and confidentiality. However, socially regulated discourses around appropriate sexual behaviour and perceptions of stigma and prejudice regarding HIV and sexual risk-taking were consistently reported. This study suggests several avenues to improve HIV-testing acceptability, including implementing diverse and personalised approaches to HIV-testing and care, and providing opportunities for antiretroviral therapy initiation and care at home.
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July 2017

Access to HIV care in the context of universal test and treat: challenges within the ANRS 12249 TasP cluster-randomized trial in rural South Africa.

J Int AIDS Soc 2016 1;19(1):20913. Epub 2016 Jun 1.

INSERM, UMR_S 1136, Pierre Louis Institute of Epidemiology and Public Health, Team of research in Social Epidemiology, F-75013, Paris, France.

Introduction: We aimed to quantify and identify associated factors of linkage to HIV care following home-based HIV counselling and testing (HBHCT) in the ongoing ANRS 12249 treatment-as-prevention (TasP) cluster-randomized trial in rural KwaZulu-Natal, South Africa.

Methods: Individuals ≥16 years were offered HBHCT; those who were identified HIV positive were referred to cluster-based TasP clinics and offered antiretroviral treatment (ART) immediately (five clusters) or according to national guidelines (five clusters). HIV care was also available in the local Department of Health (DoH) clinics. Linkage to HIV care was defined as TasP or DoH clinic attendance within three months of referral among adults not in HIV care at referral. Associated factors were identified using multivariable logistic regression adjusted for trial arm.

Results: Overall, 1323 HIV-positive adults (72.9% women) not in HIV care at referral were included, of whom 36.9% (n=488) linked to care <3 months of referral (similar by sex). In adjusted analyses (n=1222), individuals who had never been in HIV care before referral were significantly less likely to link to care than those who had previously been in care (<33% vs. >42%, p<0.001). Linkage to care was lower in students (adjusted odds-ratio [aOR]=0.47; 95% confidence interval [CI] 0.24-0.92) than in employed adults, in adults who completed secondary school (aOR=0.68; CI 0.49-0.96) or at least some secondary school (aOR=0.59; CI 0.41-0.84) versus ≤ primary school, in those who lived at 1 to 2 km (aOR=0.58; CI 0.44-0.78) or 2-5 km from the nearest TasP clinic (aOR=0.57; CI 0.41-0.77) versus <1 km, and in those who were referred to clinic after ≥2 contacts (aOR=0.75; CI 0.58-0.97) versus those referred at the first contact. Linkage to care was higher in adults who reported knowing an HIV-positive family member (aOR=1.45; CI 1.12-1.86) versus not, and in those who said that they would take ART as soon as possible if they were diagnosed HIV positive (aOR=2.16; CI 1.13-4.10) versus not.

Conclusions: Fewer than 40% of HIV-positive adults not in care at referral were linked to HIV care within three months of HBHCT in the TasP trial. Achieving universal test and treat coverage will require innovative interventions to support linkage to HIV care.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4891946PMC
http://dx.doi.org/10.7448/IAS.19.1.20913DOI Listing
July 2017

Strengthening universal HIV 'test-and-treat' approaches with social science research.

AIDS 2016 Mar;30(6):969-70

aDepartment of Obstetrics, Gynaecology and Reproductive Sciences and Division of Prevention Science, University of California, San Francisco, California, USA bDepartment of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK cDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa dAmsterdam Institute for Social Science Research, Department of Anthropology, University of Amsterdam, Amsterdam, The Netherlands eZambart, University of Zambia, Ridgeway Campus, Lusaka, Zambia fPopulation Studies and Training Center, Brown University, Providence, Rhode Island, USA gDepartment of Anthropology, University of Amsterdam, Amsterdam, The Netherlands hThe Children's Institute, School of Child and Adolescent Health, University of Cape Town, Cape Town, South Africa iBrigham and Women's Hospital jHarvard School of Public Health, Boston, Massachusetts, USA kINSERM Unité 897, Institut de Santé Publique Epidémiologie Développement, University of Bordeaux, Bordeaux, France lFaculty of Medicine, University of Southampton, Southampton, UK mCEPED (UMR 196 UPD IRD), Institut de Recherche pour le Développement (IRD), Paris, France nUniversity of California at San Francisco, San Francisco, California, USA oUniversity of California, Center for AIDS Prevention Studies, San Francisco, California, USA pZambart, University of Zambia, Ridgeway Campus, Lusaka, Zambia qLeiden University Medical Center, The Netherlands rAfrica Centre for Population Health, University of KwaZulu-Natal, South Africa.

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http://dx.doi.org/10.1097/QAD.0000000000001008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4794132PMC
March 2016

Change of treatment guidelines and evolution of ART initiation in rural South Africa: data of a large HIV care and treatment programme.

BMC Infect Dis 2015 Oct 26;15:452. Epub 2015 Oct 26.

INSERM, UMR_S 1136, Pierre Louis Institute of Epidemiology and Public Health, Team of research in Social Epidemiology, F-75013, Paris, France.

Background: While WHO recommendations are to treat people earlier and earlier, it will considerably increase the number of HIV infected people eligible for antiretroviral therapy (ART). In South Africa, a country which carries one of the highest HIV burden worldwide, very few studies are available on the impact of the ART guidelines on time to ART initiation in both individuals with low CD4 count and those newly eligible for ART. We thus aimed to describe ART initiation percentages in a large HIV programme in rural KwaZulu-Natal, South Africa, according to the temporal changes of national ART eligibility guidelines from 2007 to 2012.

Methods: Adults who accessed the decentralized Hlabisa HIV treatment programme in 2007-2012 were included. Three periods following the temporal change of ART eligibility guidelines were defined (Period 1: until April 2010; Period 2: April 2010 - July 2011; Period 3: from August 2011). Percentages of ART initiation within three months of programme entry were estimated in men, in women of childbearing age (<40 years old) and in older women, and stratifying by CD4 count. Trend tests and logistic regression models were used to study the effects of change of guidelines on ART initiation percentages.

Results: In individuals with CD4 count ≤200 cells/μL (N = 5709 men, N = 6743 women <40 years old and N = 2017 older women), percentages of ART initiation did not differ over time (p trend = 0.25; 0.28; and 0.14, respectively). In individuals with CD4 count = 201-350 cells/μL (N = 2680 men, N = 6086 women <40 years old and N = 1415 older women), percentages of ART initiation significantly increased over time (p trend <0.01 for the three groups): from 6 % in Period 1 to 20 % in Period 2 to 40 % in Period 3 in women of childbearing age, and from 7 % to 8-10 % to 42 % in men and in older women.

Conclusions: As temporal changes of guidelines, percentages of ART initiation significantly increased in newly ART eligible people and did not decrease in individuals with very low CD4 counts. It will be crucial to continue verifying the evolution of these percentages of ART initiation with future recommendations reaching near-to-universal access to ART, to ensure that individuals most in need of ART receive it.
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http://dx.doi.org/10.1186/s12879-015-1207-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4620741PMC
October 2015

Retention in care prior to antiretroviral treatment eligibility in sub-Saharan Africa: a systematic review of the literature.

BMJ Open 2015 Jun 24;5(6):e006927. Epub 2015 Jun 24.

Department of Social Epidemiology, INSERM, UMR_S 1136, Pierre Louis Institute of Epidemiology and Public Health, Paris, France Department of Social Epidemiology, Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Pierre Louis Institute of Epidemiology and Public Health, Paris, France.

Objective: We aimed at summarising rates and factors associated with retention in HIV care prior to antiretroviral treatment (ART) eligibility in sub-Saharan Africa.

Design: We conducted a systematic literature review (2002-2014). We searched Medline/Pubmed, Scopus and Web of Science, as well as proceedings of conferences. We included all original research studies published in peer-reviewed journals, which used quantitative indicators of retention in care prior to ART eligibility.

Participants: People not yet eligible for ART.

Primary And Secondary Outcomes: Rate of retention in HIV care prior to ART eligibility and associated factors.

Results: 10 papers and 2 abstracts were included. Most studies were conducted in Southern and Eastern Africa between 2004 and 2011 and reported retention rates in pre-ART care up to the second CD4 measurement. Definition of retention in HIV care prior to ART eligibility differed substantially across studies. Retention rates ranged between 23% and 88% based on series ranging from 112 to 10,314 individuals; retention was higher in women, individuals aged >25 years, those with low CD4 count, high body mass index or co-infected with tuberculosis, and in settings with free cotrimoxazole use.

Conclusions: Retention in HIV care prior to ART eligibility in sub-Saharan Africa has been insufficiently described so far leaving major research gaps, especially regarding long-term retention rates and sociodemographic, economic, clinical and programmatic logistic determinants. The prospective follow-up of newly diagnosed individuals is required to better evaluate attrition prior to ART eligibility among HIV-infected people.
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http://dx.doi.org/10.1136/bmjopen-2014-006927DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4479994PMC
June 2015

Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal.

BMC Public Health 2015 Mar 1;15:209. Epub 2015 Mar 1.

Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa.

Background: The Universal HIV Test and Treat (UTT) strategy represents a challenge for science, but is also a challenge for individuals and societies. Are repeated offers of provider-initiated HIV testing and immediate antiretroviral therapy (ART) socially-acceptable and can these become normalized over time? Can UTT be implemented without potentially adding to individual and community stigma, or threatening individual rights? What are the social, cultural and economic implications of UTT for households and communities? And can UTT be implemented within capacity constraints and other threats to the overall provision of HIV services? The answers to these research questions will be critical for routine implementation of UTT strategies.

Methods/design: A social science research programme is nested within the ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomised trial in rural South Africa. The programme aims to inform understanding of the (i) social, economic and environmental factors affecting uptake of services at each step of the continuum of HIV prevention, treatment and care and (ii) the causal impacts of the TasP intervention package on social and economic factors at the individual, household, community and health system level. We describe a multidisciplinary, multi-level, mixed-method research protocol that includes individual, household, community and clinic surveys, and combines quantitative and qualitative methods.

Discussion: The UTT strategy is changing the overall approach to HIV prevention, treatment and care, and substantial social consequences may be anticipated, such as changes in social representations of HIV transmission, prevention, HIV testing and ART use, as well as changes in individual perceptions and behaviours in terms of uptake and frequency of HIV testing and ART initiation at high CD4. Triangulation of social science studies within the ANRS 12249 TasP trial will provide comprehensive insights into the acceptability and feasibility of the TasP intervention package at individual, community, patient and health system level, to complement the trial's clinical and epidemiological outcomes. It will also increase understanding of the causal impacts of UTT on social and economic outcomes, which will be critical for the long-term sustainability and routine UTT implementation.

Trial Registration: Clinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.
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http://dx.doi.org/10.1186/s12889-015-1344-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4351958PMC
March 2015

Factors Associated with HIV Testing History among Pregnant Women and Their Partners in Georgia: The ANRS 12127 Prenahtest Trial.

AIDS Res Treat 2014 29;2014:356090. Epub 2014 Sep 29.

Centre INSERM U897 "Epidémiologie et Biostatistique", INSERM, 146 rue Léo Saignat, 33076 Bordeaux, France ; Institut de Santé Publique Epidémiologie Développement (ISPED), Université Bordeaux Segalen, 146 rue Léo Saignat, 33076 Bordeaux, France.

Despite the benefits of timely diagnosis of HIV infection and the wide availability of VCT services, the acceptance of HIV testing and counseling still remains a challenge in Georgia. The goal of our study was to assess the history of HIV testing and associated factors among pregnant women. The recruitment of study participants took place during routine antenatal care visits at one of the large Maternity Hospitals in Tbilisi, capital of Georgia. A total of 491 pregnant women were included in the sample. More than a third of women (38.5%) reported that they were tested for HIV before the current pregnancy and almost all of them (91.5%) were tested during previous pregnancies. Bivariate analysis revealed statistically significant association of women's history of HIV testing with age, education level, remunerated activity, history of STI, and multiparity. In multivariate analysis, the only independent predictor of being HIV tested was ever being pregnant. In conclusion, HIV testing history among women at reproductive age was poor in Georgia. Women mostly received HIV testing at prenatal centers. Efforts should be made to promote HIV testing in primary care settings, which would increase its acceptability and overall testing rate in the population.
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http://dx.doi.org/10.1155/2014/356090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4195251PMC
October 2014
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