Barrières à l'initiation des traitements antirétroviraux : le cas d'une zone rurale de la région du KwaZulu Natal en Afrique du Sud.

Antiretroviral treatments (ART) have been available in sub-Saharan Africa for more than ten years.Their use was initially targeted with the strict aim to control severe morbidity in individuals with an advancedHIV disease. International guidelines for initiating ART have subsequently evolved as clinical andepidemiological studies highlighted the therapeutic and preventive benefits of early ART initiation. Randomizedtrials are currently underway in several southern African countries to measure the benefits of the universal“Test and Treat” approach on HIV incidence in a community. However, ART coverage is still far from optimal insub-Saharan Africa, especially in South Africa where 6.3 millions of individuals are living with HIV. We thusaimed to better understand what are the barriers to ART initiation by focusing on a rural area heavily affectedby HIV in the province of KwaZulu-Natal, South Africa. We first briefly described the journey HIV-infectedindividuals embark on, from entry into a large HIV treatment and care programme to ART initiation. Then wemeasured the temporal evolutions of ART initiation rates according to the changes of clinical guidelines. Wefinally identified some barriers to ART initiation linking data from the HIV care programme with those from ademographic surveillance system. The results of this thesis will help to better understand the issues relative toaccess to ART that might arise with the universal “Test and Treat” approach, especially in South Africa.Les traitements antirétroviraux (TARV) sont proposés à large échelle en Afrique sub-Sahariennedepuis plus de dix ans, au départ destinés à contrôler la morbidité sévère des personnes à un stade avancé del’infection à VIH. Les recommandations pour initier les TARV ont ensuite évolué à mesure que les étudescliniques et épidémiologiques mettaient en évidence les bénéfices thérapeutiques et préventifs d’une initiationprécoce des TARV. Des essais randomisés sont actuellement en cours en Afrique australe pour vérifier lesbénéfices d’une approche universelle de dépistage et de traitement à des stades précoces de l’infection à VIH(approche « Test and Treat ») sur l’incidence du VIH en communauté. Cependant, la couverture antirétroviraleest encore loin d’être optimale au sud du Sahara, notamment en Afrique du Sud où 6,3 millions de personnesvivent avec le VIH. L’objectif de cette thèse est de comprendre quelles sont les barrières à l’initiation des TARVen nous intéressant à une zone rurale fortement touchée par le VIH au sein de la province sud-africaine duKwaZulu-Natal. Après avoir brièvement décrit le suivi des patients de l’entrée dans un large programme desoins VIH jusqu’à l’initiation des TARV, nous avons mesuré l’évolution des taux d’initiation des TARV suite àl’expansion des critères d’éligibilité dans ce programme. Nous avons ensuite identifié certaines barrières àl’initiation des TARV en croisant les données du programme de soins VIH à celles recueillies au sein d’unesurveillance démographique. Les résultats de cette thèse permettent de mieux appréhender les questionsrelatives à l’accès aux TARV qui pourraient se poser avec une approche « Test and Treat »

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

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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Test but not treat: community members’ experiences with barriers and facilitators to universal antiretroviral therapy uptake in rural 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

A community-based healthcare package combining testing and prevention tools, including pre-exposure prophylaxis (PrEP), immediate HIV treatment, management of hepatitis B virus, and sexual and reproductive health (SRH), targeting female sex workers (FSWs) in Cote d'Ivoire: the ANRS 12381 PRINCESSE project

BACKGROUND: Pre-exposure prophylaxis (PrEP) is recommended by the WHO for HIV prevention among female sex workers (FSWs). A study conducted in 2016-2017 in Côte d'Ivoire showed that if PrEP is acceptable, FSWs also have many uncovered sexual health needs. Based on this evidence, the ANRS 12381 PRINCESSE project was developed in collaboration with a community-based organization. The main objective is to develop, document, and analyze a comprehensive sexual and reproductive healthcare package among FSWs in Côte d'Ivoire. METHODS: PRINCESSE is an open, single-arm interventional cohort of 500 FSWs in San Pedro (Côte d'Ivoire) and its surroundings. Recruitment started on November 26th, 2019 and is ongoing; the cohort is planned to last at least 30 months. The healthcare package (including HIV, hepatitis B, and sexually transmitted infection management, pregnancy screening, and contraception) is available both at mobile clinics organized for a quarterly follow-up (10 intervention sites, each site being visited every two weeks) and at a fixed clinic. Four waves of data collection were implemented: (i) clinical and safety data; (ii) socio-behavioral questionnaires; (iii) biological data; and (iv) in-depth interviews with female participants. Four additional waves of data collection are scheduled outside the cohort itself: (i) the medical and activity records of Aprosam for the PRINCESSE participants; (ii) the medical records of HIV+ FSW patients not participating in the PRINCESSE cohort, and routinely examined by Aprosam; (iii) in-depth interviews with key informants in the FSW community; and (iv) in-depth interviews with PRINCESSE follow-up actors. DISCUSSION: The PRINCESSE project is one of the first interventions offering HIV oral PrEP as part of a more global sexual healthcare package targeting both HIV- and HIV+ women. Second, STIs and viral hepatitis B care were offered to all participants, regardless of their willingness to use PrEP. Another innovation is the implementation of mobile clinics for chronic/quarterly care. In terms of research, PRINCESSE is a comprehensive, interdisciplinary project combining clinical, biological, epidemiological, and social specific objectives and outcomes to document the operational challenges of a multidisease program in real-life conditions. TRIAL REGISTRATION: The PRINCESSE project was registered on the Clinicaltrial.gov website ( NCT03985085 ) on June 13, 2019

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

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 9 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)

Barriers to antiretroviral treatment initiation : the case of a rural area in the KwaZulu-Natal region, South Africa

Les traitements antirétroviraux (TARV) sont proposés à large échelle en Afrique sub-Sahariennedepuis plus de dix ans, au départ destinés à contrôler la morbidité sévère des personnes à un stade avancé del’infection à VIH. Les recommandations pour initier les TARV ont ensuite évolué à mesure que les étudescliniques et épidémiologiques mettaient en évidence les bénéfices thérapeutiques et préventifs d’une initiationprécoce des TARV. Des essais randomisés sont actuellement en cours en Afrique australe pour vérifier lesbénéfices d’une approche universelle de dépistage et de traitement à des stades précoces de l’infection à VIH(approche « Test and Treat ») sur l’incidence du VIH en communauté. Cependant, la couverture antirétroviraleest encore loin d’être optimale au sud du Sahara, notamment en Afrique du Sud où 6,3 millions de personnesvivent avec le VIH. L’objectif de cette thèse est de comprendre quelles sont les barrières à l’initiation des TARVen nous intéressant à une zone rurale fortement touchée par le VIH au sein de la province sud-africaine duKwaZulu-Natal. Après avoir brièvement décrit le suivi des patients de l’entrée dans un large programme desoins VIH jusqu’à l’initiation des TARV, nous avons mesuré l’évolution des taux d’initiation des TARV suite àl’expansion des critères d’éligibilité dans ce programme. Nous avons ensuite identifié certaines barrières àl’initiation des TARV en croisant les données du programme de soins VIH à celles recueillies au sein d’unesurveillance démographique. Les résultats de cette thèse permettent de mieux appréhender les questionsrelatives à l’accès aux TARV qui pourraient se poser avec une approche « Test and Treat ».Antiretroviral treatments (ART) have been available in sub-Saharan Africa for more than ten years.Their use was initially targeted with the strict aim to control severe morbidity in individuals with an advancedHIV disease. International guidelines for initiating ART have subsequently evolved as clinical andepidemiological studies highlighted the therapeutic and preventive benefits of early ART initiation. Randomizedtrials are currently underway in several southern African countries to measure the benefits of the universal“Test and Treat” approach on HIV incidence in a community. However, ART coverage is still far from optimal insub-Saharan Africa, especially in South Africa where 6.3 millions of individuals are living with HIV. We thusaimed to better understand what are the barriers to ART initiation by focusing on a rural area heavily affectedby HIV in the province of KwaZulu-Natal, South Africa. We first briefly described the journey HIV-infectedindividuals embark on, from entry into a large HIV treatment and care programme to ART initiation. Then wemeasured the temporal evolutions of ART initiation rates according to the changes of clinical guidelines. Wefinally identified some barriers to ART initiation linking data from the HIV care programme with those from ademographic surveillance system. The results of this thesis will help to better understand the issues relative toaccess to ART that might arise with the universal “Test and Treat” approach, especially in South Africa

Barriers to antiretroviral treatment initiation : the case of a rural area in the KwaZulu-Natal region, South Africa

Les traitements antirétroviraux (TARV) sont proposés à large échelle en Afrique sub-Sahariennedepuis plus de dix ans, au départ destinés à contrôler la morbidité sévère des personnes à un stade avancé del’infection à VIH. Les recommandations pour initier les TARV ont ensuite évolué à mesure que les étudescliniques et épidémiologiques mettaient en évidence les bénéfices thérapeutiques et préventifs d’une initiationprécoce des TARV. Des essais randomisés sont actuellement en cours en Afrique australe pour vérifier lesbénéfices d’une approche universelle de dépistage et de traitement à des stades précoces de l’infection à VIH(approche « Test and Treat ») sur l’incidence du VIH en communauté. Cependant, la couverture antirétroviraleest encore loin d’être optimale au sud du Sahara, notamment en Afrique du Sud où 6,3 millions de personnesvivent avec le VIH. L’objectif de cette thèse est de comprendre quelles sont les barrières à l’initiation des TARVen nous intéressant à une zone rurale fortement touchée par le VIH au sein de la province sud-africaine duKwaZulu-Natal. Après avoir brièvement décrit le suivi des patients de l’entrée dans un large programme desoins VIH jusqu’à l’initiation des TARV, nous avons mesuré l’évolution des taux d’initiation des TARV suite àl’expansion des critères d’éligibilité dans ce programme. Nous avons ensuite identifié certaines barrières àl’initiation des TARV en croisant les données du programme de soins VIH à celles recueillies au sein d’unesurveillance démographique. Les résultats de cette thèse permettent de mieux appréhender les questionsrelatives à l’accès aux TARV qui pourraient se poser avec une approche « Test and Treat ».Antiretroviral treatments (ART) have been available in sub-Saharan Africa for more than ten years.Their use was initially targeted with the strict aim to control severe morbidity in individuals with an advancedHIV disease. International guidelines for initiating ART have subsequently evolved as clinical andepidemiological studies highlighted the therapeutic and preventive benefits of early ART initiation. Randomizedtrials are currently underway in several southern African countries to measure the benefits of the universal“Test and Treat” approach on HIV incidence in a community. However, ART coverage is still far from optimal insub-Saharan Africa, especially in South Africa where 6.3 millions of individuals are living with HIV. We thusaimed to better understand what are the barriers to ART initiation by focusing on a rural area heavily affectedby HIV in the province of KwaZulu-Natal, South Africa. We first briefly described the journey HIV-infectedindividuals embark on, from entry into a large HIV treatment and care programme to ART initiation. Then wemeasured the temporal evolutions of ART initiation rates according to the changes of clinical guidelines. Wefinally identified some barriers to ART initiation linking data from the HIV care programme with those from ademographic surveillance system. The results of this thesis will help to better understand the issues relative toaccess to ART that might arise with the universal “Test and Treat” approach, especially in South Africa

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

Abstract 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)

« La saleté n’a qu’à descendre » : rapport au corps et expériences vécues par les travailleuses du sexe en Côte d’Ivoire (projets ANRS 12361 PrEP-CI et ANRS 12381 PRINCESSE)

Objectifs Analyser le rapport au corps de travailleuses du sexe (TS) enquêtées en Côte d’Ivoire dans la région de San Pedro. Leurs représentations d’un corps situé à la frontière des sphères intime et professionnelle peut éclairer leurs perceptions et l’acceptabilité des services de santé qui leur sont proposés. Matériels et Méthodes Des entretiens qualitatifs ont été réalisés, au sein de l’étude transversale PrEP-CI et du projet PRINCESSE qui a suivi (cohorte interventionnelle mono-bras avec offre élargie en santé sexuelle et reproductive, dont PrEP), en 3 vagues (2016, 2019, 2021) auprès de 100 TS, complétés par des observations de terrain sur sites. Résultats La notion de circulation des fluides et son importance dans le maintien d’un "équilibre" émergent des entretiens. Certaines TS expriment la crainte que les interventions de santé, et en particulier les prises de sang, puissent affaiblir le corps, induire de la "fatigue", notamment si cela n’est pas contrebalancé par l’ingestion de substances énergétiques, comme des boissons sucrées. Le nombre élevé de tubes de prélèvements sanguins et l’absence de collation (jusque mi 2021) sont mentionnés comme des freins à l’engagement dans les soins. La notion de circulation renvoie également à l’expulsion de la "saleté", comme sont souvent définis le sperme ou les règles. Lors d’une rupture de préservatif, il n’est pas rare que les TS se "purgent" en nettoyant leur corps par l’ingestion de cola ou des lavements, ce qu’elles perçoivent comme plus efficace que la prise de comprimés (traitement IST ou post-exposition VIH, pilule du lendemain), qui reste exceptionnelle. Les TS sont souvent réticentes à utiliser les injections ou les implants contraceptifs, car les règles risquent de "rester" plutôt que de "descendre" et d’être évacuées. À l’inverse, il s’agit parfois de bloquer la circulation des fluides. Les TS interrogées se "préservent" en utilisant des préservatifs avec leurs clients. Les rapports tarifés sans préservatif relèvent de l’exception, avec des clients réguliers ou à des tarifs bien plus élevés. Sa non-utilisation avec leur partenaire régulier permet de différencier relation personnelle et professionnelle. Par ailleurs, la circulation des menstrues peut être temporairement suspendue, par du coton ou de la glace, le temps du travail. La PrEP, médicament que l’on prend sans être malade, apparaît pour certaines comme "fatigante" et "inutile", avec le risque de causer un déséquilibre dans un corps bien portant, bien qu’elle empêche la maladie de "rentrer dans le corps". Conclusion Ces analyses, qui seront complétées début 2022 avec une enquête spécifique, montrent que les TS ont une approche de leur santé et du soin de soi qui n’est pas forcément celle pensée par l’équipe du projet. Le rapport au corps des TS éclaire les réticences qu’elles peuvent exprimer quant aux différentes offres de santé, pas toujours perçues comme adaptées, et explique en partie les freins à l’entrée et au maintien dans les soins, confirmés par les données quantitatives