Magister Public Health - MPH / Background: Globally, neonatal mortality (i.e. deaths occurring during the first month of life) accounts for 44% of the 11 million infants that die every year (Lawn, Cousens Zupan, 2005). Early detection of illness and referral of mothers and infants during the peri-natal period to higher levels of care can lead to substantial reductions in maternal and child mortality in developing countries. Establishing effective referral systems from the community to health facilities can be achieved through greater utilization of community health workers and improved health seeking behaviour. Study design: The Good Start Saving Newborn Lives study being conducted in Umlazi, KwaZulu-Natal, is a community randomized trial to assess the effect of an integrated home visit package delivered to mothers during pregnancy and post delivery on uptake of PMTCT interventions and appropriate newborn care practices. The home visit package is delivered by community health workers in fifteen intervention clusters. Control clusters receive routine health facility antenatal and postpartum care. For any identified danger signs during a home visit, community health workers write a referral and if necessary refer infants to a local clinic or hospital. The aim of this study was to assess the effectiveness of this referral system by describing community health worker referral completion rates as well as health-care seeking practices and perceptions of mothers. A cross- sectional survey was undertaken using a structured questionnaire with all mothers who had been referred to a clinic or hospital by a community health worker since the start of the Good Start Saving Newborn Lives Trial. Data collection: Informed consent was obtained from willing participants. Interviews were conducted by a trained research assistant in the mothers home or at the study offices. Road to Health Cards were reviewed to confirm referral completion. Data was collected by means of a cell phone (mobile researcher software) and the database was later transferred to Epi-info and STATA IC 11 for analysis. Descriptive analysis was conducted so as to establish associations between explanatory factors and referral completion and to describe referral processes experienced by caregivers. Significant associations between categorical variables were assessed using chi square tests and continuous variables using analysis of variance. Results: A total of 2423 women were enrolled in the SNL study and 148 had received a referral for a sick infant by a CHW by June 2010. The majority (95%) of infants were referred only once during the time of enrolment, the highest number of which occurred within the first 4 weeks of life (62%) with 22% of these being between birth and 2 weeks of age. Almost all mothers (95%) completed the referral by taking their child to a health facility. Difficulty in breathing and rash accounted for the highest number of referrals (26% and 19% respectively). None of the six mothers who did not complete referral recognised any danger signs in their infants. In only 16% of cases did a health worker give written feedback on the outcome of the referral to the referring CHW. Conclusion: This study found high compliance with referrals for sick infants by community health workers in Umlazi. This supports the current primary health care re-engineering process being undertaken by the South African National Department of Health (SANDOH) which will involve the establishment of family health worker teams including community health workers. A key function of these workers will be to conduct antenatal and postnatal visits to women in their homes and to identify and refer ill children. Failure of mothers to identify danger signs in the infant was associated with non-completion of referral. This highlights the need for thorough counseling of mothers during the antenatal and early postnatal period on neonatal danger signs which can be reinforced by community health workers. Most of the referrals in this study were neonates which strengthens the need for home visit packages delivered by community health workers during the antenatal and post-natal period as currently planned by the South African National Department of Health.Recommendations: This study supports the current plans of the Department of Health for greater involvement of CHWs in Primary Health Care. Attention should be given to improving communication between health facilities and CHWs to ensure continuity of care and greater realization of a team approach to PHC. / South Africa

Grâce aux combinaison d’antirétroviraux (ART), le taux de transmission mère-enfant (TME) du Virus de l’Immunodéficience Humaine VIH est maintenant réduit à moins de 1%. Des progrès restent néanmoins à faire, en particuliers chez les femmes débutant tardivement leurs consultations prénatales. Mais l’évaluation de nouvelles stratégies ART pour la prévention de la TME (PTME) devient de plus en plus complexe à cause des exigences statistiques liées au fait que les transmissions sont rares. Dés lors, il devient crucial de modéliser l’efficacité des ART sur la charge virale (CV) et la transmission. Dans cette thèse, nous modélisons les mécanismes et le moment de la TME du VIH en utilisant des modèles mixtes. Les données proviennent de 4 études de prévention périnatales du VIH en Thaïlande (PHPT-1, PHPT-2, PHPT-5 1st phase et PHPT-5 2nd phase), une base de données historiques de qualité, collectées de 1996 à 2015, où différentes prophylaxies ART ont été prescrites à plus de 4000 femmes enceintes pendant des durées variables: Zidovudine (ZDV) seule; ZDV + une dose unique de nevirapine périnatale (sdNVP); ZDV+lopinavir/ritonavir (LPV/r) ou ZDV+LPV/r+lamivudine (3TC). Les modèles développés apportent un éclairage sur les mécanismes et le moment de la PTME ainsi que sur le rôle respectif de différents ART sur la réduction de la CV et sur leur contribution à la prophylaxie pre/post exposition. Partant de ces connaissances, une approche bayésienne est appliquée à une étude de cas (essai de supériorité dans le contexte d’un événement rare comme la TME du VIH) afin d’améliorer la puissance statistique tout en limitant la taille de l’échantillon, et comparée à une approche fréquentiste. / Nowadays, with the use of highly efficacious antiretroviral (ART) combination, the rate of mother-to-child transmission (MTCT) of Human Immunodeficiency Virus (HIV) is reduced to less than 1%. However, there are still some gaps to be filled, especially in women who initiate antenatal prophylaxis late. The evaluation of new ART strategies or drug combinations for the prevention of MTCT (PMTCT) of HIV becomes more difficult in view of the statistical requirements in case of rare outcomes. Therefore modeling the impact of ART on maternal viral load (VL) and transmission rate is increasingly important. In this thesis, the mechanisms and timing of MTCT of HIV were investigated using mixed model approaches. Data were derived from four perinatal HIV prevention studies in Thailand (PHPT-1, PHPT-2, PHPT-5 1st phase and PHPT-5 2nd phase), a unique set of quality historical data, consistently collected from 1996 to 2015, in which different ART prophylaxis regimens were provided to more than 4000 HIV-infected pregnant women for varying durations: Zidovudine (ZDV) alone; ZDV plus perinatal single dose nevirapine; ZDV+lopinavir/ritonavir (LPV/r) or ZDV+LPV/r+lamivudine. The developed models provide insights on the mechanisms and timing of PMTCT as well as on the respective role of different ARTs on the maternal VL reduction and in turn on their contribution to pre/post-exposure prophylaxis in MTCT of HIV. With this prior knowledge, a Bayesian design is applied to a case study, a trial aimed at evaluating treatment superiority in the context of rare outcomes such as MTCT of HIV, to improve the statistical power –while limiting sample size— and compared to a frequentist design.

Introdução: Com o surgimento da epidemia da AIDS na década de 80, vários têm sido os desafios enfrentados pela sociedade, devido à rápida disseminação, em escala global. A epidemia acomete cerca de 34 milhões nos diversos continentes, e segundo a UNAIDS (2012), a maior parcela está em países em desenvolvimento. O continente africano, com mais de 800 milhões de habitantes, em 54 países, é o que mais tem sofrido os impactos da doença, apresentando a maior parcela de infectados pelo vírus HIV no mundo, com cerca de 23,5 milhões de infectados registrados. Assim como globalmente, a preocupação que tem suscitado debates é a crescente feminização dessa epidemia em Guiné-Bissau, aumentando as taxas de transmissão vertical do vírus HIV, que, segundo as últimas projeções do país (PEN III, 2012), o risco estimado foi de 8,9 por cento. O advento do antirretroviral (Zidovudina), em 1994, a partir da publicação do protocolo 076 da ACTG veio mudar o cenário da transmissão vertical. Em Guiné-Bissau, a chegada dos antirretrovirais, em 2006, constituiu uma nova fase na luta contra a disseminação do vírus, em particular, no âmbito da transmissão vertical, proporcionando melhor qualidade de vida e chances de uma criança nascer sem AIDS. A ONG Céu e Terras atua no país desde 2001, e, em julho de 2007, adotou o protocolo recomendado pela OMS: tríplice terapia e amamentação exclusiva, visando à redução da transmissão vertical. Objetivo - Analisar a atuação da ONG Associação Céu e Terras quanto à prevenção da transmissão vertical do vírus HIV no contexto da Guiné-Bissau, a partir da introdução do novo protocolo da tríplice terapia antirretroviral e amamentação exclusiva. Método - É um estudo descritivo de dados secundários de mães e de seus filhos, mães estas inscritas no programa da instituição (ONG) Associação Céu e Terras em Bissau, República da Guiné-Bissau, no período de julho de 2007 a junho de 2011. População estudada: 430 mulheres soropositivas e 417 crianças nascidas vivas dessas mães que participaram do programa de prevenção da transmissão vertical na ONG. Para analisar a ocorrência de transmissão vertical nessa população, foram considerados os fatores sociais, culturais, a aderência à terapia, o tipo de aleitamento praticado e via de parto. Para isso, foi usado o programa SPSS 18.0. Resultado - Entre 430 grávidas, houve 7 casos de óbito materno e 417 crianças nasceram vivas, e destas, 347 foram testadas no final do seguimento: 328 resultaram HIV negativas e 19 resultaram HIV positivas, ou seja, ocorreu a transmissão vertical. Das crianças que nasceram vivas, 11 delas morreram antes de completar 18 meses e 13 foram a óbito depois de 18 meses de vida. É importante relatar que ocorreram 13 casos de óbito fetal, excluídos do estudo, por não ter sido feito teste para diagnóstico de HIV/AIDS. Conclusões - No período estudado, a taxa de transmissão vertical foi de 4,6 por cento, Valor esse bem abaixo da estimada pelo governo do país. A análise feita para o período de estudo mostrou uma diminuição da transmissão vertical, sugerindo uma ligeira tendência de queda durante os semestres estudados, mas sem diferença significante entre eles. Observou-se, também, falha na adesão à terapia antirretroviral, sendo essa a principal causa da ocorrência na transmissão vertical; por outro lado, a via de parto e amamentação praticada são fortes aliados nessa ocorrência, sem esquecer-se das questões culturais e sociais, fortemente presentes na sociedade guineense e que influenciam na não efetivação do programa em reduzir a taxa de transmissão vertical e da disseminação do vírus HIV no país / Introduction: With the emergence of the AIDS epidemic in the decade of the eighties. Around the world, there are several challenges faced by society due to its rapid dissemination in global scale. The epidemic affects approximately 34 million people around the world, according to UNAIDS, the largest portion is observed in third world. The African continent with over 800 million inhabitants, which contains 54 countries, is what most has suffered the impact of the disease presenting the largest portion of HIV patients in the world, with about 23.5 million infected registered. As globally, the concern that has sparked debates is the increasing feminization of the virus in Guinea - Bissau, the country which consequently increased rates of vertical transmission of HIV, which according to recent projections, the risk is estimated at 8.9 percent (PEN III,2012). The advent of antiretroviral (zidovudine) in 1994, from the publication of 076 protocol of the ACTG come to change the scenario of vertical transmission. In Guinea-Bissau, the arrival of antiretrovirals in 2006, marked a new phase in the fight against the spread of the vírus particularly in the context of vertical transmission, providing more life quality and chances of a child born without AIDS. The NGO Associação Céu e Terras acts in the country since 2001, and in 2007 adopted the protocol recommended by WHO with triple therapy and exclusive breastfeeding, in order to reduce vertical transmission in the country. Objective - Analyze the performance of the NGO Associação Céu e Terras as the prevention of vertical HIV transmission in the context of Guinea-Bissau. Examine the proposal from the introduction of the new protocol of triple antiretroviral therapy, exclusive breastfeeding, 2007 2011. Method - It is a descriptive study of secondary data from mothers and their children whose women enrolled in the period July 2007 to June 2011 the institution (NGO) Associação Céu e Terras in Bissau, Republic of Guinea-Bissau program. The population studied was composed of 430 HIV-positive women and 417 children born of those mothers who participated in the program to prevent vertical transmission in NGOs. To analyze the occurrence of vertical transmission in this population were analyzed mainly the social, cultural, the adherence to therapy, the type of breastfeeding practiced and route of delivery. For data analysis, we used the SPSS 18.0 program. Result - among 430 pregnant there were 7 cases of maternal deaths and 417 children were born alive, among these, 347 children were tested at final follow up, 328 resulted HIV negative and 19 HIV positive, meaning, the transmission vertical occurred. Of the live births, 11 of them died before reaching 18 months and 13 have died after 18 months of life. It is important to report that 13 cases of fetal death. Conclusions - Among this population during that period, the rate of vertical transmission was 4.6 percent. Amount which well below the estimated by the government. The analysis made for the study period showed a decrease in vertical transmission, have suggested a slight decreasing trend during the semesters studied, but no difference between them. It was also observed failure in adherence to antiretroviral therapy being the main cause of this occurrence in the transmission, on the other hand, the mode of delivery and breastfeeding practiced are strong allies in this occurrence, without forgetting the cultural and social issues strongly present in Guinean society that influence the effectiveness of the program in not further reduce the rate of vertical transmission and spread of HIV in the country

Introdução: Com o surgimento da epidemia da AIDS na década de 80, vários têm sido os desafios enfrentados pela sociedade, devido à rápida disseminação, em escala global. A epidemia acomete cerca de 34 milhões nos diversos continentes, e segundo a UNAIDS (2012), a maior parcela está em países em desenvolvimento. O continente africano, com mais de 800 milhões de habitantes, em 54 países, é o que mais tem sofrido os impactos da doença, apresentando a maior parcela de infectados pelo vírus HIV no mundo, com cerca de 23,5 milhões de infectados registrados. Assim como globalmente, a preocupação que tem suscitado debates é a crescente feminização dessa epidemia em Guiné-Bissau, aumentando as taxas de transmissão vertical do vírus HIV, que, segundo as últimas projeções do país (PEN III, 2012), o risco estimado foi de 8,9 por cento. O advento do antirretroviral (Zidovudina), em 1994, a partir da publicação do protocolo 076 da ACTG veio mudar o cenário da transmissão vertical. Em Guiné-Bissau, a chegada dos antirretrovirais, em 2006, constituiu uma nova fase na luta contra a disseminação do vírus, em particular, no âmbito da transmissão vertical, proporcionando melhor qualidade de vida e chances de uma criança nascer sem AIDS. A ONG Céu e Terras atua no país desde 2001, e, em julho de 2007, adotou o protocolo recomendado pela OMS: tríplice terapia e amamentação exclusiva, visando à redução da transmissão vertical. Objetivo - Analisar a atuação da ONG Associação Céu e Terras quanto à prevenção da transmissão vertical do vírus HIV no contexto da Guiné-Bissau, a partir da introdução do novo protocolo da tríplice terapia antirretroviral e amamentação exclusiva. Método - É um estudo descritivo de dados secundários de mães e de seus filhos, mães estas inscritas no programa da instituição (ONG) Associação Céu e Terras em Bissau, República da Guiné-Bissau, no período de julho de 2007 a junho de 2011. População estudada: 430 mulheres soropositivas e 417 crianças nascidas vivas dessas mães que participaram do programa de prevenção da transmissão vertical na ONG. Para analisar a ocorrência de transmissão vertical nessa população, foram considerados os fatores sociais, culturais, a aderência à terapia, o tipo de aleitamento praticado e via de parto. Para isso, foi usado o programa SPSS 18.0. Resultado - Entre 430 grávidas, houve 7 casos de óbito materno e 417 crianças nasceram vivas, e destas, 347 foram testadas no final do seguimento: 328 resultaram HIV negativas e 19 resultaram HIV positivas, ou seja, ocorreu a transmissão vertical. Das crianças que nasceram vivas, 11 delas morreram antes de completar 18 meses e 13 foram a óbito depois de 18 meses de vida. É importante relatar que ocorreram 13 casos de óbito fetal, excluídos do estudo, por não ter sido feito teste para diagnóstico de HIV/AIDS. Conclusões - No período estudado, a taxa de transmissão vertical foi de 4,6 por cento, Valor esse bem abaixo da estimada pelo governo do país. A análise feita para o período de estudo mostrou uma diminuição da transmissão vertical, sugerindo uma ligeira tendência de queda durante os semestres estudados, mas sem diferença significante entre eles. Observou-se, também, falha na adesão à terapia antirretroviral, sendo essa a principal causa da ocorrência na transmissão vertical; por outro lado, a via de parto e amamentação praticada são fortes aliados nessa ocorrência, sem esquecer-se das questões culturais e sociais, fortemente presentes na sociedade guineense e que influenciam na não efetivação do programa em reduzir a taxa de transmissão vertical e da disseminação do vírus HIV no país / Introduction: With the emergence of the AIDS epidemic in the decade of the eighties. Around the world, there are several challenges faced by society due to its rapid dissemination in global scale. The epidemic affects approximately 34 million people around the world, according to UNAIDS, the largest portion is observed in third world. The African continent with over 800 million inhabitants, which contains 54 countries, is what most has suffered the impact of the disease presenting the largest portion of HIV patients in the world, with about 23.5 million infected registered. As globally, the concern that has sparked debates is the increasing feminization of the virus in Guinea - Bissau, the country which consequently increased rates of vertical transmission of HIV, which according to recent projections, the risk is estimated at 8.9 percent (PEN III,2012). The advent of antiretroviral (zidovudine) in 1994, from the publication of 076 protocol of the ACTG come to change the scenario of vertical transmission. In Guinea-Bissau, the arrival of antiretrovirals in 2006, marked a new phase in the fight against the spread of the vírus particularly in the context of vertical transmission, providing more life quality and chances of a child born without AIDS. The NGO Associação Céu e Terras acts in the country since 2001, and in 2007 adopted the protocol recommended by WHO with triple therapy and exclusive breastfeeding, in order to reduce vertical transmission in the country. Objective - Analyze the performance of the NGO Associação Céu e Terras as the prevention of vertical HIV transmission in the context of Guinea-Bissau. Examine the proposal from the introduction of the new protocol of triple antiretroviral therapy, exclusive breastfeeding, 2007 2011. Method - It is a descriptive study of secondary data from mothers and their children whose women enrolled in the period July 2007 to June 2011 the institution (NGO) Associação Céu e Terras in Bissau, Republic of Guinea-Bissau program. The population studied was composed of 430 HIV-positive women and 417 children born of those mothers who participated in the program to prevent vertical transmission in NGOs. To analyze the occurrence of vertical transmission in this population were analyzed mainly the social, cultural, the adherence to therapy, the type of breastfeeding practiced and route of delivery. For data analysis, we used the SPSS 18.0 program. Result - among 430 pregnant there were 7 cases of maternal deaths and 417 children were born alive, among these, 347 children were tested at final follow up, 328 resulted HIV negative and 19 HIV positive, meaning, the transmission vertical occurred. Of the live births, 11 of them died before reaching 18 months and 13 have died after 18 months of life. It is important to report that 13 cases of fetal death. Conclusions - Among this population during that period, the rate of vertical transmission was 4.6 percent. Amount which well below the estimated by the government. The analysis made for the study period showed a decrease in vertical transmission, have suggested a slight decreasing trend during the semesters studied, but no difference between them. It was also observed failure in adherence to antiretroviral therapy being the main cause of this occurrence in the transmission, on the other hand, the mode of delivery and breastfeeding practiced are strong allies in this occurrence, without forgetting the cultural and social issues strongly present in Guinean society that influence the effectiveness of the program in not further reduce the rate of vertical transmission and spread of HIV in the country

This study aimed to identify factors affecting women’s utilisation of the prevention of mother-to-child transmission (PMTCT) of HIV, evaluate the quality of PMTCT services, describe health outcomes of mothers and infants and to identify factors that influence mother-to-child transmission (MTCT) of HIV. Structured interviews were conducted with 384 women who had utilised PMTCT services. Information was also obtained from the health records of these women and of their infants. Better educated women, who had male partners and were self-employed were more likely to use PMTCT services. Being unmarried, poor and feeling stigmatised made it difficult for women to use these services. Respondents were satisfied with PMTCT services except that clinics sometimes had no medications. The health care workers followed the Ethiopian guidelines during HIV testing and counseling but not when prescribing treatment. Although the respondents’ CD4 cell counts improved, their clinical conditions did not improve. The MTCT rate was significantly higher if infants did not receive ARVs, had APGAR scores below seven, weighed less than 2.5kg at birth, were born prematurely, and if their mothers had nipple fissures. PMTCT services could be improved if more women used these services, health care workers followed the national guidelines when prescribing ARVs, clinics had adequate supplies of medicines, all infants received ARVs, and mothers’ nipple fissures could be prevented. Antenatal care should help to avoid premature births of infants weighing less than 2.5kg and having APGAR scores below 7. Future research should compare formula feeding versus breastfeeding of infants with HIV-positive mothers / Health Studies / D. Litt. et Phil. (Health Studies)

This study aimed to identify factors affecting women’s utilisation of the prevention of mother-to-child transmission (PMTCT) of HIV, evaluate the quality of PMTCT services, describe health outcomes of mothers and infants and to identify factors that influence mother-to-child transmission (MTCT) of HIV. Structured interviews were conducted with 384 women who had utilised PMTCT services. Information was also obtained from the health records of these women and of their infants. Better educated women, who had male partners and were self-employed were more likely to use PMTCT services. Being unmarried, poor and feeling stigmatised made it difficult for women to use these services. Respondents were satisfied with PMTCT services except that clinics sometimes had no medications. The health care workers followed the Ethiopian guidelines during HIV testing and counseling but not when prescribing treatment. Although the respondents’ CD4 cell counts improved, their clinical conditions did not improve. The MTCT rate was significantly higher if infants did not receive ARVs, had APGAR scores below seven, weighed less than 2.5kg at birth, were born prematurely, and if their mothers had nipple fissures. PMTCT services could be improved if more women used these services, health care workers followed the national guidelines when prescribing ARVs, clinics had adequate supplies of medicines, all infants received ARVs, and mothers’ nipple fissures could be prevented. Antenatal care should help to avoid premature births of infants weighing less than 2.5kg and having APGAR scores below 7. Future research should compare formula feeding versus breastfeeding of infants with HIV-positive mothers / Health Studies / D. Litt. et Phil. (Health Studies)

Dans cette thèse, nous décrivons les résultats d’un projet de recherche visant à mesurer et évaluer la qualité des soins obstétricaux des hôpitaux de référence au Mali et au Sénégal. Dans ces pays, la mortalité maternelle hospitalière est élevée et est liée en partie à la pratique médicale inadéquate. Cette recherche a été réalisée dans le cadre de l’étude QUARITE, un essai randomisé en grappe évaluant l’efficacité du programme GESTA International visant à réduire la mortalité maternelle hospitalière. GESTA a été mis en œuvre entre 2008 et 2010 et consistait en la formation des professionnels de santé et en la revue des cas de décès maternels. En parallèle de QUARITE, les programmes de prévention de la transmission du VIH de la mère à l’enfant (PTME) ont été mis à l’échelle à travers les pays. Ces derniers ayant également la capacité d’augmenter la qualité des soins obstétricaux, nous avons donc évalué les effets des deux programmes (GESTA et PTME) sur la qualité des soins. Dans un premier temps, à l’aide d’une recension des écrits nous avons évalué la capacité d’un audit clinique basé sur des critères à mesurer la qualité des soins obstétricaux. Cet audit vérifiait si l’offre des soins avait respecté les critères cliniques définissant la meilleure prise en charge selon l’évidence scientifique et l’avis des experts. Nous avons démontré que cet outil est largement utilisé dans les pays à faibles et moyens revenus, malgré le peu d’évidence sur sa validité (article 1). Dans un deuxième temps, nous avons développé un audit clinique basé sur des critères qui s’applique au contexte ouest-africain et qui a été approuvé par des experts-obstétriciens nationaux et internationaux. À partir des dossiers obstétricaux, les actes médicaux posés pendant le travail et l’accouchement ont été évalués à l‘aide de cet instrument. La qualité des soins a été estimée sous forme de pourcentage de critères atteints. Appliqué dans différents contextes et par différents auditeurs, nous avons démontré que notre instrument est fiable et valide (article 3). Néanmoins, l’expérience de l’audit nous a amenés à nous questionner sur le mauvais remplissage des dossiers médicaux et ses conséquences sur la qualité des soins (article 2). Dans un troisième temps, l’outil a été appliqué à large échelle pour évaluer les effets de l’intervention GESTA (article 4). Nous avons mené une révision de plus de 800 dossiers obstétricaux dans 32 hôpitaux de référence (16 bénéficiaires de l’intervention et 16 non-bénéficiaires). Grâce à cet audit clinique, nous avons démontré que le programme GESTA contribue à l’amélioration de la qualité des soins, spécifiquement l’examen clinique lors de l’admission et le suivi après l’accouchement. Dernièrement, nous avons utilisé cet instrument afin d’évaluer les effets des programmes de PTME sur la qualité des soins obstétricaux (article 5). Notre travail a documenté que seulement certaines composantes du programme de PTME améliorent la qualité des soins telles que la formation des professionnels et les services complémentaires en nutrition. En conclusion, cette recherche a identifié plusieurs pistes d’intervention pour améliorer la qualité des soins obstétricaux en Afrique de l’Ouest. / In this thesis, we describe the results of a research project that aimed to measure and evaluate quality of care in referral hospitals in Mali and Senegal. In these countries, hospital maternal mortality is high and linked, in part, to inadequate medical practice. This research was conducted as part of the QUARITE cluster randomized trial that assessed whether the program, ALARM International, could reduce facility maternal mortality. ALARM was implemented from 2008 to 2010 and consisted of the training of local health professionals and the use of maternal death reviews. At the same time as QUARITE was ongoing, programs for the prevention of maternal to child transmission of HIV (PMTCT) were scaled- up; these can also improve obstetrical quality of care. Thus, we evaluated the effects of both programs (ALARM and PMTCT) on quality of care. We began with a systematic review of the literature to evaluate the capacity of a criterion-based clinical audit to measure the quality of obstetrical care (article 1). This type of audit verifies if the care provided meets criteria indicative of best clinical practices, according to the literature and expert opinion. Our review demonstrates that this tool has been used in a variety of low- and middle-income settings, but the way it has previously been employed leaves doubts as to its validity (article 1). We thus developed a criterion based clinical audit specific to the West African context and approved by national and international expert obstetricians. Using patient medical records, with this instrument we evaluated obstetrical care provided during labour and delivery. Quality of care was calculated based on the percentage of care criteria met. Applied to different sites and by different auditors, our instrument demonstrated concordant results and provided a valid image of the quality of obstetrical care provided at hospitals in the region (article 3). Nonetheless, the audit experience raised concerns about the implications of poor medical recordkeeping and archiving on quality of care (article 2). We used the criterion-based clinical audit to review over 800 medical records at 32 QUARITE hospitals (16 intervention and 16 control hospitals) in order to evaluate the effects of the ALARM intervention. We demonstrated that the ALARM program contributes to better obstetrical quality of care, especially during the first clinical examination and postpartum monitoring of women treated at intervention hospitals (article 4). Finally, we used this instrument to evaluate the effects of PMTCT programs on obstetrical quality of care (article 5). Our work demonstrated that certain components of a PMTCT program, specifically training of healthcare professionals and supplementary nutritional services, are associated with better obstetrical care. In all, this research identified several mechanisms that can be targeted by quality improvement interventions in West Africa.

Dans cette thèse, nous décrivons les résultats d’un projet de recherche visant à mesurer et évaluer la qualité des soins obstétricaux des hôpitaux de référence au Mali et au Sénégal. Dans ces pays, la mortalité maternelle hospitalière est élevée et est liée en partie à la pratique médicale inadéquate. Cette recherche a été réalisée dans le cadre de l’étude QUARITE, un essai randomisé en grappe évaluant l’efficacité du programme GESTA International visant à réduire la mortalité maternelle hospitalière. GESTA a été mis en œuvre entre 2008 et 2010 et consistait en la formation des professionnels de santé et en la revue des cas de décès maternels. En parallèle de QUARITE, les programmes de prévention de la transmission du VIH de la mère à l’enfant (PTME) ont été mis à l’échelle à travers les pays. Ces derniers ayant également la capacité d’augmenter la qualité des soins obstétricaux, nous avons donc évalué les effets des deux programmes (GESTA et PTME) sur la qualité des soins. Dans un premier temps, à l’aide d’une recension des écrits nous avons évalué la capacité d’un audit clinique basé sur des critères à mesurer la qualité des soins obstétricaux. Cet audit vérifiait si l’offre des soins avait respecté les critères cliniques définissant la meilleure prise en charge selon l’évidence scientifique et l’avis des experts. Nous avons démontré que cet outil est largement utilisé dans les pays à faibles et moyens revenus, malgré le peu d’évidence sur sa validité (article 1). Dans un deuxième temps, nous avons développé un audit clinique basé sur des critères qui s’applique au contexte ouest-africain et qui a été approuvé par des experts-obstétriciens nationaux et internationaux. À partir des dossiers obstétricaux, les actes médicaux posés pendant le travail et l’accouchement ont été évalués à l‘aide de cet instrument. La qualité des soins a été estimée sous forme de pourcentage de critères atteints. Appliqué dans différents contextes et par différents auditeurs, nous avons démontré que notre instrument est fiable et valide (article 3). Néanmoins, l’expérience de l’audit nous a amenés à nous questionner sur le mauvais remplissage des dossiers médicaux et ses conséquences sur la qualité des soins (article 2). Dans un troisième temps, l’outil a été appliqué à large échelle pour évaluer les effets de l’intervention GESTA (article 4). Nous avons mené une révision de plus de 800 dossiers obstétricaux dans 32 hôpitaux de référence (16 bénéficiaires de l’intervention et 16 non-bénéficiaires). Grâce à cet audit clinique, nous avons démontré que le programme GESTA contribue à l’amélioration de la qualité des soins, spécifiquement l’examen clinique lors de l’admission et le suivi après l’accouchement. Dernièrement, nous avons utilisé cet instrument afin d’évaluer les effets des programmes de PTME sur la qualité des soins obstétricaux (article 5). Notre travail a documenté que seulement certaines composantes du programme de PTME améliorent la qualité des soins telles que la formation des professionnels et les services complémentaires en nutrition. En conclusion, cette recherche a identifié plusieurs pistes d’intervention pour améliorer la qualité des soins obstétricaux en Afrique de l’Ouest. / In this thesis, we describe the results of a research project that aimed to measure and evaluate quality of care in referral hospitals in Mali and Senegal. In these countries, hospital maternal mortality is high and linked, in part, to inadequate medical practice. This research was conducted as part of the QUARITE cluster randomized trial that assessed whether the program, ALARM International, could reduce facility maternal mortality. ALARM was implemented from 2008 to 2010 and consisted of the training of local health professionals and the use of maternal death reviews. At the same time as QUARITE was ongoing, programs for the prevention of maternal to child transmission of HIV (PMTCT) were scaled- up; these can also improve obstetrical quality of care. Thus, we evaluated the effects of both programs (ALARM and PMTCT) on quality of care. We began with a systematic review of the literature to evaluate the capacity of a criterion-based clinical audit to measure the quality of obstetrical care (article 1). This type of audit verifies if the care provided meets criteria indicative of best clinical practices, according to the literature and expert opinion. Our review demonstrates that this tool has been used in a variety of low- and middle-income settings, but the way it has previously been employed leaves doubts as to its validity (article 1). We thus developed a criterion based clinical audit specific to the West African context and approved by national and international expert obstetricians. Using patient medical records, with this instrument we evaluated obstetrical care provided during labour and delivery. Quality of care was calculated based on the percentage of care criteria met. Applied to different sites and by different auditors, our instrument demonstrated concordant results and provided a valid image of the quality of obstetrical care provided at hospitals in the region (article 3). Nonetheless, the audit experience raised concerns about the implications of poor medical recordkeeping and archiving on quality of care (article 2). We used the criterion-based clinical audit to review over 800 medical records at 32 QUARITE hospitals (16 intervention and 16 control hospitals) in order to evaluate the effects of the ALARM intervention. We demonstrated that the ALARM program contributes to better obstetrical quality of care, especially during the first clinical examination and postpartum monitoring of women treated at intervention hospitals (article 4). Finally, we used this instrument to evaluate the effects of PMTCT programs on obstetrical quality of care (article 5). Our work demonstrated that certain components of a PMTCT program, specifically training of healthcare professionals and supplementary nutritional services, are associated with better obstetrical care. In all, this research identified several mechanisms that can be targeted by quality improvement interventions in West Africa.

La transmission prénatale du VIH de la mère à l’enfant est à l’origine de la majorité des infections à VIH/sida chez les nourrissons. En dépit du risque quasi omniprésent de faire naître des enfants infectés et de l’accès encore très limité aux thérapies antirétrovirales, le nombre des femmes séropositives menant leur grossesse à terme est en augmentation constante en Afrique subsaharienne. Motivée par ce constat empirique, l’étude aborde une gamme des questions juridiques et de bioéthique, pour certaines encore inédites, tiraillées entre désir légitime d’enfant (droit à l’enfant) et devoir de la société de mettre les futurs enfants à l’abri d’un handicap congénital prévisible reconnu comme incurable (droit de l’enfant). Fondamentalement, elle interroge le législateur sur la manière de saisir le risque biologique de transmission maternelle du VIH, sans rompre avec l’équilibre éthique nécessaire entre les droits et libertés fondamentaux de la femme ou mère séropositive et l’intérêt supérieur de l’enfant à naître. À partir de l’exemple du droit congolais et suivant la démarche d’information comparative, l’étude s’attache à démontrer systématiquement que face à la forte probabilité de naître avec le VIH, la protection que les droits africains actuels apportent à l’enfant est insuffisante et, à certains égards, incohérente. Pour y remédier, elle préconise un nouveau paradigme de normativité fondé sur la philosophie de la recherche d’une conciliation éthique, qui n’apparaisse pas manifestement disproportionnée, entre l’autonomie de soi de la femme ou mère séropositive sur son corps et la responsabilité de ses choix en matière de santé de la reproduction. Ainsi, grâce à ses nombreuses propositions innovantes de refonte du droit, cette étude est-elle parvenue à contribuer, significativement, à la recherche d’outils théoriques nécessaires à l’émergence de nouveaux droits africains en ordre de bataille pour des générations futures sans sida. / Prenatal HIV transmission from mother to child is responsible for the majority of HIV / AIDS infections in infants. Despite the almost ubiquitous risk of infected children and still very limited access to antiretroviral therapy, the number of HIV-positive women who complete their pregnancies is increasing steadily in sub-Saharan Africa. Motivated by this empirical observation, the study tackles a range of legal and bioethical questions, some of which are still unpublished, torn between legitimate desire for children (right to the child) and society's obligation to protect future children against a predictable congenital disability recognized as incurable (right of the child). Fundamentally, it questions the legislator on how to capture the biological risk of maternal HIV transmission without breaking the necessary ethical balance between the fundamental rights and freedoms of the HIV-positive woman or mother and the best interests of the unborn child. Using the example of Congolese law and following the comparative information approach, the study seeks to systematically demonstrate that, in the face of the high probability of being born with HIV, the protection that the current African rights bring to the child is insufficient and, in some respects, incoherent. To remedy this, she advocates a new paradigm of normativity based on the philosophy of seeking an ethical reconciliation which does not appear to be manifestly disproportionate between the autonomy of the woman or mother who is HIV-positive on her body and the responsibility of its choices in reproductive health. Thus, thanks to its many innovative proposals for the revision of the law, has this study managed to contribute significantly to the search for theoretical tools necessary for the emergence of new African rights in order of battle for future generations without AIDS.

L'intégration du traitement et de la prévention des maladies chroniques non transmissibles (MNT) au sein des soins de santé primaires représente le principal défi à venir pour la santé publique et les systèmes de santé dans les pays à faible et moyen revenu comme l’Afrique du Sud. Il constitue le principal objectif de cette thèse. L’expérience de l'intégration de la prévention de la transmission du VIH de la mère à l'enfant (PTME) dans les soins de santé primaires (SSP) peut apporter des leçons importantes pour l'intégration de la prévention du diabète chez les femmes souffrant de diabète gestationnel récent (DSG) dans les SSP. Il a été estimé que le DSG touche plus de 9,1 % des grossesses en 2018 en Afrique du Sud. Le DSG augmente le risque de développer ultérieurement du diabète de type 2 (DT2). Le DSG multiplie par plus de 7 le risque de développer un DT2 ainsi que les risques de troubles métaboliques pour les bébés des femmes qui en sont atteintes. Cette thèse explore comment appliquer les leçons tirées de l’intégration de la PTME pour intégrer le dépistage du DSG et les initiatives de prévention du DT2 dans les soins de santé primaires de routine en Afrique du Sud. Le cadre conceptuel adapté pour cette thèse permet ainsi de comprendre les aspects de l’intégration au niveau du patient et du système de santé, englobant les contextes, les mécanismes et la mise en œuvre de l’intégration d’interventions préventives dans les services existants. L'étude s'inscrit dans le cadre du projet IINDIAGO, « Intervention intégrée du système de santé visant à réduire les risques de diabète de type 2 chez les femmes défavorisées après un diabète gestationnel en Afrique du Sud ». La thèse présente d’abord une revue narrative de l’impact de la PTME sur les services et les systèmes de soins de santé en Afrique subsaharienne (Article 1). Les résultats de cette revue montrent que la PTME a eu l’impact positif et négatif sur d’autres services de soins de santé et que son intégration dans les systèmes de santé est de plus en plus privilégiée. L’article 2 est une étude qualitative analysant l’histoire et l’expérience locales de l’intégration de la PTME dans les SSP de routine en Afrique du Sud de différents points de vue. Bien qu’elle ait constaté un fort soutien en faveur de l’intégration parmi tous les répondants, cette étude a fait état de multiples obstacles à la pleine intégration de la PTME dans les SSP, le post-partum en particulier. Les articles 3 et 4 ont utilisé les méthodes mixtes et révélé que l’intégration des services dans les SSP de routine, à base communautaire, pour dépister universellement le DSG et pour prévenir ou retarder le DT2 après le DSG, était perçue comme faisable, acceptable et nécessaire de toute urgence en Afrique du Sud. L’article 6 (dont le protocole est l’article 5) présentait une revue systématique et une méta-analyse sur la prise en charge intégrée du DSG et du DT2 dans le contexte de la multimorbidité en Afrique. Les 13 études incluses dans cette étude ont montré que la gestion intégrée du DSG et du DT2 dans le cadre de la multimorbidité était mise en œuvre avec succès, mais qu’elle nécessitait une formation et une supervision adéquates des infirmières, et la fourniture d’équipements et de médicaments additionnels au sein des systèmes de santé nationaux en Afrique. Les conclusions de cette thèse suggèrent que, bien qu’elle n’ait pas toujours été retenue, en raison de défis structurels et opérationnels, l’intégration complète plutôt que partielle des services de santé est considérée comme souhaitable et réalisable par les femmes, les travailleurs de la santé, les gestionnaires et les experts. L’intégration complète pourrait être idéale pour dépister, diagnostiquer et soigner les maladies chroniques, y compris le DSG et le DT2, au sein des SSP de routine et selon l’approche de la PTME dont les leçons d’intégration n’ont pas été adaptées à ce prochain défi de santé publique. / Integrating chronic, non-communicable diseases (NCDs) and their prevention into primary health care is the next major challenge for public health and health systems in low and middle-income countries like South Africa and is the primary focus of this thesis. The experience of integration of Prevention of Mother-to-Child Transmission (PMTCT) of HIV into primary health care (PHC) may have important lessons for integrating prevention of diabetes among women with recent gestational diabetes (GDM) into PHC. GDM was estimated to affect more than 9.1% of pregnancies in 2018 in South Africa. GDM increases the risk of developing subsequent type 2 diabetes (T2DM) more than 7-fold as well as increasing the risks of metabolic disorders for the babies of women who had GDM. This thesis conducted a systematised narrative synthesis, a systematic review and a convergent mixed methods study using primarily qualitative methods in South Africa (focus on Cape Town, Western Cape) to explore how to apply lessons from PMTCT integration in order to integrate GDM screening and T2DM prevention initiatives into routine PHC in South Africa. The adapted conceptual framework for this thesis enables to understand both patient-level and health system-level aspects of integration and encompassing the contexts, mechanisms and implementation for integrating preventive interventions in the existing services. The study was nested in the IINDIAGO project, “Integrated health system intervention aimed at reducing type 2 diabetes risks in disadvantaged women after gestational diabetes in South Africa”. The thesis first presents a narrative review of the impact of PMTCT on health care services and systems in sub-Saharan Africa (Paper 1). This review findings show that PMTCT has had positive and negative impacts on other health care services and that its integration into health systems is increasingly favored. Paper 2 qualitatively documented the local history and experience of PMTCT integration into routine PHC in South Africa from different perspectives. Though it found strong support for integration among all respondents (N=20), this study reported multiple barriers for the full integration of PMTCT into PHC, especially in postpartum. Papers 3 and 4 used mixed methods and highlighted that integrating services within routine, community-based PHC to universally screen GDM and to prevent or delay of T2DM after GDM, was perceived as feasible, acceptable and urgently needed in South Africa – but that it is not currently occurring at a satisfactory level, despite international and national guidelines. The fifth article is a published protocol for Paper 6, a systematic review and meta-analysis on the integrated management of GDM and T2DM in the context of multimorbidity in Africa. This was a study in which all 13 included studies showed that integrated management of GDM and T2DM within multimorbidity was successfully implemented but it required adequate training and supervision of nurses, provision of additional equipment and drugs to the existing resources within national health systems in Africa. This thesis concludes that although not always opted for, due to structural and operational challenges, the full instead of partial integration of health services to screen, diagnose and care for chronic diseases including GDM and T2DM into routine PHC, following the PMTCT approach, was seen as both desirable and feasible by women, health workers, managers, and experts. However, the lessons learned through the history of PMTCT and its integration have not been adapted to this next public health challenge.