[show abstract][hide abstract] ABSTRACT: Since 2010, World Health Organization (WHO) guidelines discourage using stavudine in first-line regimens due to frequent and severe side effects. This study describes the implementation of this recommendation and trends in usage of antiretroviral therapy combinations in a cohort of HIV-positive patients in rural Tanzania.
We analyzed longitudinal, prospectively collected clinical data of HIV-1 infected adults initiating antiretroviral therapy within the Kilombero Ulanga Antiretroviral Cohort (KIULARCO) in Ifakara, Tanzania from 2007-2011.
This analysis included data of 3008 patients. Median age was 38 (interquartile range [IQR] 31-45) years, 1962 (65.2%) of all subjects were female, and median CD4+ cell count at enrollment was 168 cells/mm3 (IQR 81-273). The percentage of prescriptions containing stavudine in initial regimens fell from a maximum of 75.3% in 2008 to 10.7% in 2011. TDF/FTC/EFV became available in 2009 and was used in 41.9% of patients initiating cART in 2011. An overall on-treatment analysis revealed that d4T/3TC/NVP and AZT/3TC/EFV were the most prescribed combinations in each year, including 2011 (674 [36.5%] and 641 [34.7%] patients, respectively). Of those receiving stavudine in 2011, 659 (89.1%) initiated it before 2011.
Initial cART with stavudine declined to low levels according to recommendations but the overall use of stavudine remained substantial, as individuals already on cART containing stavudine were not changed to alternative drugs. Our findings highlight the critical need to exchange stavudine in treatment regimens of patients who initiated therapy in earlier years.
[show abstract][hide abstract] ABSTRACT: The genetic diversity of Plasmodium falciparum allows the molecular discrimination of otherwise microscopically identical parasites and the identification of individual clones in multiple infections. The study reported here investigated the P. falciparum multiplicity of infection (MOI) and genetic diversity among school-aged children in the Man region, western Cote d'Ivoire.
Blood samples from 292 children aged seven to 15 years were collected in four nearby villages located at altitudes ranging from 340 to 883 m above sea level. Giemsa-stained thick and thin blood films were prepared and examined under a microscope for P. falciparum prevalence and parasitaemia. MOI and genetic diversity of the parasite populations were investigated using msp2 typing by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).
Plasmodium falciparum prevalence and parasitaemia were both found to be significantly lower in the highest altitude village. Genotyping of the isolates revealed 25 potentially new msp2 alleles. MOI varied significantly across villages but did not correlate with altitude nor children's age, and only to a limited extent with parasitaemia. An analysis of molecular variance (AMOVA) indicated that a small, but close to statistical significance (p = 0.07), fraction of variance occurs specifically between villages of low and high altitudes.
Higher altitude was associated with lower prevalence of P. falciparum but not with reduced MOI, suggesting that, in this setting, MOI is not a good proxy for transmission. The evidence for partially parted parasite populations suggests the existence of local geographical barriers that should be taken into account when deploying anti-malarial interventions.
[show abstract][hide abstract] ABSTRACT: Access to sufficient quantities of safe drinking water is a human right. Moreover, access to clean water is of public health relevance, particularly in semi-arid and Sahelian cities due to the risks of water contamination and transmission of water-borne diseases. We conducted a study in Nouakchott, the capital of Mauritania, to deepen the understanding of diarrhoeal incidence in space and time. We used an integrated geographical approach, combining socio-environmental, microbiological and epidemiological data from various sources, including spatially explicit surveys, laboratory analysis of water samples and reported diarrhoeal episodes. A geospatial technique was applied to determine the environmental and microbiological risk factors that govern diarrhoeal transmission. Statistical and cartographic analyses revealed concentration of unimproved sources of drinking water in the most densely populated areas of the city, coupled with a daily water allocation below the recommended standard of 20 l per person. Bacteriological analysis indicated that 93% of the non-piped water sources supplied at water points were contaminated with 10-80 coliform bacteria per 100 ml. Diarrhoea was the second most important disease reported at health centres, accounting for 12.8% of health care service consultations on average. Diarrhoeal episodes were concentrated in municipalities with the largest number of contaminated water sources. Environmental factors (e.g. lack of improved water sources) and bacteriological aspects (e.g. water contamination with coliform bacteria) are the main drivers explaining the spatio-temporal distribution of diarrhoea. We conclude that integrating environmental, microbiological and epidemiological variables with statistical regression models facilitates risk profiling of diarrhoeal diseases. Modes of water supply and water contamination were the main drivers of diarrhoea in this semi-arid urban context of Nouakchott, and hence require a strategy to improve water quality at the various levels of the supply chain.
Geospatial health 11/2013; 8(1):53-63. · 1.65 Impact Factor
[show abstract][hide abstract] ABSTRACT: Progress towards reaching Millennium Development Goals four (child health) and five (maternal health) is lagging behind, particularly in sub-Saharan Africa, despite increasing efforts to scale up high impact interventions. Increasing the proportion of birth attended by a skilled attendant is a main indicator of progress, but not much is known about the quality of childbirth care delivered by these skilled attendants. With a view to reducing maternal mortality through health systems improvement we describe the care routinely offered in childbirth offered at dispensaries, health centres and hospitals in five districts in rural Southern Tanzania. We use data from a health facility census assessing 159 facilities in five districts in early 2009. A structural and operational assessment was undertaken based on staff reports using a modular questionnaire assessing staffing, work load, equipment and supplies as well as interventions routinely implemented during childbirth.
Health centres and dispensaries attended a median of eight and four deliveries every month respectively. Dispensaries had a median of 2.5 (IQR 2--3) health workers including auxiliary staff instead of the recommended four clinical officer and certified nurses. Only 28% of first-line facilities (dispensaries and health centres) reported offering active management in the third stage of labour (AMTSL). Essential childbirth care comprising eight interventions including AMTSL, infection prevention, partograph use including foetal monitoring and newborn care including early breastfeeding, thermal care at birth and prevention of ophthalmia neonatorum was offered by 5% of dispensaries, 38% of health centres and 50% of hospitals consistently. No first-line facility had provided all signal functions for emergency obstetric complications in the previous six months.
Essential interventions for childbirth care are not routinely implemented in first-line facilities or hospitals. Dispensaries have both low staffing and low caseload which constraints the ability to provide high-quality childbirth care. Improvements in quality of care are essential so that women delivering in facility receive "skilled attendance" and adequate care for common obstetric complications such as post-partum haemorrhage.
[show abstract][hide abstract] ABSTRACT: Dans le Sahel, entre la Mauritanie et la Somalie incluant le Nord Kenya, environ 20 à 30 millions de personnes vivent en transhumance. Le rythme de leur migration suit l'évolution saisonnière du climat et la disponibilité des ressources, telle que l'eau, le pâturage et le sel. Malgré une exposition élevée à certaines maladies comme les zoonoses et les problèmes conditionnés liés au climat, les pasteurs mobiles sont parmi les populations quasiment exclues du système de santé, car la mise à disposition des services sociaux adaptés à un mode de vie mobile est difficile. Suivant l'objectif de recherche d'un meilleur accès aux soins des pasteurs mobiles, l'Institut Tropical et de Santé Publique Suisse, en partenariat avec plusieurs institutions dans la région, est actif au Sahel depuis 15 ans, aussi bien dans le domaine de la recherche, que celui des actions de développement. Basées sur une approche orientée vers les besoins des pasteurs mobiles pour leur développement, des recherches interdisciplinaires ont contribué à mieux comprendre la situation et les problèmes des éleveurs. En relation de la proximité entre l'homme et son bétail, une approche unissant la santé humaine et animale s'est avérée bonne et la valeur ajoutée d'une meilleure collaboration entre médecine humaine, animale et l'environnement a été démontrée. Ces approches utiles devraient être poursuivies et consolidées dans les recherches et le développement des actions futurs.
Tropical Medicine & International Health 07/2013; · 2.94 Impact Factor
[show abstract][hide abstract] ABSTRACT: In the Sahel, between Mauritania and Somalia including Northern Kenya, about 20-30 million people live as mobile pastoralists. The rhythm of their migration follows the seasons and the availability of resources such as water, pasture and salt. Despite their high exposure to zoonoses and problems caused by extreme climatic conditions, mobile pastoralists are virtually excluded from health services because the provision of social services adapted to their way of life is challenging. In cooperation with various partners in the region, the Swiss Tropical and Public Health Institute has been active in research and development in the Sahel for 15 years. Based on the perceived needs of mobile pastoralists and the necessities of development, interdisciplinary research has considerably contributed to better understanding of their situation and their problems. Close contact between humans and livestock necessitates close cooperation between human and animal health specialists. Such useful approaches should be continued and extended.
Tropical Medicine & International Health 07/2013; · 2.94 Impact Factor
[show abstract][hide abstract] ABSTRACT: ABSTRACT The development of resistance mutations in drug-targeted HIV-1 genes compromises the success of antiretroviral therapy (ART) programmes. Genotyping of these mutations enables adjusted therapeutic decisions both at the individual and population level. We investigated over time the prevalence of HIV-1 primary drug resistance mutations in treatment naive patients and described the HIV-1 subtype distribution in a cohort in rural Tanzania at the beginning of the ART rollout in 2005-2007 and later in 2009. Viral RNA was analyzed in 387 baseline plasma samples from treatment naïve patients over a period of five years. The reverse transcriptase (RT) and protease genes were reversely transcribed, PCR amplified, and directly sequenced to identify HIV-1 subtypes and single nucleotide polymorphisms associated with drug resistance (DR-SNPs). The prevalence of major DR-SNPs in 2005-2007 in the RT gene was determined: K103N (5.0%), Y181C (2.5%), M184V (2.5%), G190A (1.7%) and M41L, K65KR, K70KR and L74LV (0.8%). In samples from 2009 only K103N (3.3%), M184V and T215FY (0.8%) were detected. Initial frequencies of subtypes C, A, D and recombinants were 43%, 32%, 18% and 7%, respectively. Later similar frequencies were found except for the recombinants which were found twice as much (15%), highlighting the subtype diversity and a relatively stable subtype frequency in the area. DR-SNPs were found at initiation of the cohort despite very low previous ART use in the area. Statistically frequencies of major mutations did not change significantly over the studied five-year interval. These mutations could reflect primary resistances and may indicate a possible risk for treatment failure.
AIDS research and human retroviruses 06/2013; · 2.18 Impact Factor
[show abstract][hide abstract] ABSTRACT: We studied coverage and timeliness of vaccination and risk factors for low and delayed vaccine uptake in children aged <2 years in rural Tanzania.
We used data from a cluster survey conducted in 2004, which included 1403 children. Risk factors were analysed by log-binomial regression adjusted for the clustering. The analysis was restricted to BCG, first and third dose of Diphtheria-Tetanus-Pertussis vaccines (DTP-1 and DTP-3) and first dose of measles-containing vaccine (MCV-1).
Coverage for BCG, DTP-1, DTP-3 and MCV-1 was 94%, 96%, 90% and 86%, respectively. Delayed vaccination (>1 month after the recommended age) occurred in 398/1205 (33%) children for BCG, 404/1189 (34%) for DTP-1, 683/990 (69%) for DTP-3 and 296/643 (46%) for MCV-1. Coverage was lower for all vaccines except DTP-1 in children living ≥5 km from a healthcare facility. Delayed uptake was associated with poverty. Low and delayed MCV-1 vaccination was associated with low maternal education. Delayed BCG vaccination was associated with ethnicity and rainy season.
Despite reasonably high vaccination coverage, we observed substantial vaccination delays, particularly for DTP-3 and MCV-1. We found specific factors associated with low and/or delayed vaccine uptake. These findings can help to improve strategies to reach children who remain inadequately protected.
International Health 06/2013; 5(2):139-47. · 1.01 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: The four common soil-transmitted helminth species-Ascaris lumbricoides, Trichuris trichiura, and the two hookworm species Ancylostoma duodenale and Necator americanus-are endemic in South America, but their distribution, infection prevalence, and regional burden are poorly understood. We aimed to estimate the risk and number of people infected with A lumbricoides, T trichiura, and hookworm across South America. METHODS: We did a systematic review of reports on the prevalence of soil-transmitted helminth infection in South America published up to May 14, 2012. We extracted and georeferenced relevant survey data and did a meta-analysis of the data to assess the geographical distribution of the infection risk with Bayesian geostatistical models. We used advanced Bayesian variable selection to identify environmental determinants that govern the distribution of soil-transmitted helminth infections. FINDINGS: We screened 4085 scientific papers and identified 174 articles containing relevant survey prevalence data. We georeferenced 6948 survey locations and entered the data into the open-access Global Neglected Tropical Diseases database. Survey data were sparse for the south of the continent and for the western coast, and we identified no relevant information for Uruguay and little data for smaller countries such as Suriname, Guyana, French Guiana, and Ecuador. Population-adjusted prevalence of infection with A lumbricoides was 15·6%, with T trichiura was 12·5%, and with hookworm was 11·9% from 2005 onwards. Risks of contracting soil-transmitted helminth infection have substantially reduced since 2005 (odds ratio 0·47 [95% Bayesian credible interval 0·46-0·47] for A lumbricoides, 0·54 [0·54-0·55] for T trichiura, and 0·58 [0·58-0·59] for hookworm infection). INTERPRETATION: Our findings offer important baseline support for spatial targeting of soil-transmitted helminthiasis control, and suggest that more information about the prevalence of soil-transmitted helminth infection is needed, especially in countries in which we estimate prevalence of infection to be high but for which current data are scarce. FUNDING: UBS Optimus Foundation and Brazilian Swiss Joint Research Programme (BSJRP 011008).
The Lancet Infectious Diseases 04/2013; · 19.97 Impact Factor
[show abstract][hide abstract] ABSTRACT: The World Health Organization has promoted health impact assessment (HIA) for over 20 years. At the 2012 United Nations Conference on Sustainable Development (Rio+20), HIA was discussed as a critical method for linking health to "green economy" and "institutional framework" strategies for sustainable development. In countries having a high human development index (HDI), HIA has been added to the overall assessment suite that typically includes potential environmental and social impacts, but it is rarely required as part of the environmental and social impact assessment for large development projects. When they are performed, project-driven HIAs are governed by a combination of project proponent and multilateral lender performance standards rather than host country requirements. Not surprisingly, in low-HDI countries HIA is missing from the programme and policy arena in the absence of an external project driver. Major drivers of global change (e.g. population growth and urbanization, growing pressure on natural resources and climate change) inordinately affect low- and medium-HDI countries; however, in such countries HIA is conspicuously absent. If the cloak of HIA invisibility is to be removed, it must be shown that HIA is useful and beneficial and, hence, an essential component of the 21st century's sustainable development agenda. We analyse where and how HIA can become fully integrated into the impact assessment suite and argue that the impact of HIA must not remain obscure.
Bulletin of the World Health Organisation 04/2013; 91(4):298-305. · 5.25 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: A high-resolution surveillance-response system has been developed within a geographic information system (GIS) to support malaria elimination in the Pacific. This paper examines the application of a GIS-based spatial decision support system (SDSS) to automatically locate and map the distribution of confirmed malaria cases, rapidly classify active transmission foci, and guide targeted responses in elimination zones. METHODS: Customized SDSS-based surveillance-response systems were developed in the three elimination provinces of Isabel and Temotu, Solomon Islands and Tafea, Vanuatu. Confirmed malaria cases were reported to provincial malaria offices upon diagnosis and updated into the respective SDSS as part of routine operations throughout 2011. Cases were automatically mapped by household within the SDSS using existing geographical reconnaissance (GR) data. GIS queries were integrated into the SDSS-framework to automatically classify and map transmission foci based on the spatiotemporal distribution of cases, highlight current areas of interest (AOI) regions to conduct foci-specific targeted response, and extract supporting household and population data. GIS simulations were run to detect AOIs triggered throughout 2011 in each elimination province and conduct a sensitivity analysis to calculate the proportion of positive cases, households and population highlighted in AOI regions of a varying geographic radius. RESULTS: A total of 183 confirmed cases were reported and mapped using the SDSS throughout 2011 and used to describe transmission within a target population of 90,354. Automatic AOI regions were also generated within each provincial SDSS identifying geographic areas to conduct response. 82.5% of confirmed cases were automatically geo-referenced and mapped at the household level, with 100% of remaining cases geo-referenced at a village level. Data from the AOI analysis indicated different stages of progress in each province, highlighting operational implications with regards to strategies for implementing surveillance-response in consideration of the spatiotemporal nature of cases as well as logistical and financial constraints of the respective programmes. CONCLUSIONS: Geospatial systems developed to guide Pacific Island malaria elimination demonstrate the application of a high resolution SDSS-based approach to support key elements of surveillance-response including understanding epidemiological variation within target areas, implementing appropriate foci-specific targeted response, and consideration of logistical constraints and costs.
[show abstract][hide abstract] ABSTRACT: Guidelines on prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV) are inconsistently implemented in low-income countries. Strategies are needed to improve the uptake of these guidelines to prevent avoidable new HIV infections of infants. In 2010 the World Health Organisation presented its new PMTCT guidelines, offering two options for short courses of antiretroviral prophylaxis: Option A and Option B. Option A consists of antenatal prophylaxis with zidovudine followed by intrapartum and postpartum prophylaxis with single-dose nevirapine and zidovudine plus lamivudine. Option B recommends triple antiretroviral prophylaxis until after finishing breastfeeding. Tanzania has adopted Option A, and it is currently implementing it. A new option termed Option B+ has emerged recently, which recommends providing lifelong antiretroviral treatment to all HIV-positive pregnant women. In this article, we discuss the likely impact of this last PMTCT strategy in rural Africa with an example of an observational
cross-sectional analysis in a rural referral hospital in Tanzania aiming to assess the uptake of PMTCT
recommendations. Gaps were identified at all steps of the PMTCT pathway. Effective uptake of PMTCT guidelines has been shown to be extremely challenging in this setting. The continuously changing recommendations on PMTCT stress the need for a much simpler and effective approach. We argue
in favour of implementing Option B+ in Tanzania. Financial challenges need to be faced, but Option B+ would help to overcome many barriers that prevent guidelines to be implemented in order to increase coverage and ultimately achieve the goal of ‘virtual elimination’ of mother-to-child transmission in sub-Saharan Africa.
Swiss medical weekly: official journal of the Swiss Society of Infectious Diseases, the Swiss Society of Internal Medicine, the Swiss Society of Pneumology 03/2013; Swiss Med Wkly. · 1.82 Impact Factor
[show abstract][hide abstract] ABSTRACT: The study explored the childbirth-related hygiene and newborn care practices in home-deliveries in Southern Tanzania and barriers to and facilitators of behaviour change. Eleven home-birth narratives and six focus group discussions were conducted with recently-delivering women; two focus group discussions were conducted with birth attendants. The use of clean cloth for delivery was reported as common in the birth narratives; however, respondents did not link its use to newborn's health. Handwashing and wearing of gloves by birth attendants varied and were not discussed in terms of being important for newborn's health, with few women giving reasons for this behaviour. The lack of handwashing and wearing of gloves was most commonly linked to the lack of water, gloves, and awareness. A common practice was the insertion of any family member's hands into the vagina of delivering woman to check labour progress before calling the birth attendant. The use of a new razor blade to cut the cord was near-universal; however, the cord was usually tied with a used thread due to the lack of knowledge and the low availability of clean thread. Applying something to the cord was near-universal and was considered essential for newborn's health. Three hygiene practices were identified as needing improvement: family members inserting a hand into the vagina of delivering woman before calling the birth attendant, the use of unclean thread, and putting substances on the cord. Little is known about families conducting internal checks of women in labour, and more research is needed before this behaviour is targeted in interventions. The use of clean thread as cord-tie appears acceptable and can be addressed, using the same channels and methods that were used for successfully encouraging the use of new razor blade.
Journal of Health Population and Nutrition 03/2013; 31(1):110-7. · 1.12 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: The poor maintenance of equipment and inadequate supplies of drugs and other items contribute to the low quality of maternity services often found in rural settings in low- and middle-income countries, and raise the risk of adverse maternal outcomes through delaying care provision. We aim to describe staff experiences of providing maternal care in rural health facilities in Southern Tanzania, focusing on issues related to equipment, drugs and supplies. METHODS: Focus group discussions and in-depth interviews were conducted with different staff cadres from all facility levels in order to explore experiences and views of providing maternity care in the context of poorly maintained equipment, and insufficient drugs and other supplies. A facility survey quantified the availability of relevant items. RESULTS: The facility survey, which found many missing or broken items and frequent stock outs, corroborated staff reports of providing care in the context of missing or broken care items. Staff reported increased workloads, reduced morale, difficulties in providing optimal maternity care, and carrying out procedures that carried potential health risks to themselves as a result. CONCLUSIONS: Inadequately stocked and equipped facilities compromise the health system's ability to reduce maternal and neonatal mortality and morbidity by affecting staff personally and professionally, which hinders the provision of timely and appropriate interventions. Improving stock control and maintaining equipment could benefit mothers and babies, not only through removing restrictions to the availability of care, but also through improving staff working conditions.
BMC Health Services Research 02/2013; 13(1):61. · 1.77 Impact Factor
[show abstract][hide abstract] ABSTRACT: The anthelminthic drug tribendimidine has been approved by Chinese authorities for human use in 2004, and a first comprehensive review was published in Acta Tropica in 2005. Here, we summarise further advances made through additional clinical trials and laboratory investigations. Two phase IV trials have been conducted in the People's Republic of China, the first one enrolling 1,292 adolescents and adults aged 15-70 years and the second one conducted with 899 children aged 4-14 years who were infected with one or multiple species of soil-transmitted helminths. Oral tribendimidine (single 400mg enteric-coated tablet given to adolescents/adults and 200mg to children) showed high cure rates against Ascaris lumbricoides (90.1-95.0%) and moderate-to-high cure rates against hookworm (82.0-88.4%). Another trial done in school-aged children using a rigorous diagnostic approach found a cure rate against hookworm of 76.5%. A single oral dose of tribendimidine showed only low cure rates against Trichuris trichiura (23.9-36.8%) confirming previous results. Tribendimidine administered to children infected with Enterobius vermicularis (two doses of 200mg each on consecutive days) resulted in a high cure rate (97.1%). Importantly, a series of randomised, exploratory trials revealed that tribendimidine shows interesting activity against the liver flukes Opisthorchis viverrini and Clonorchis sinensis, the tapeworm Taenia spp. and the threadworm Strongyloides stercoralis with respective cure rates of 70.0%, 40.0%, 53.3% and 36.4%. Pharmacokinetic studies in healthy Chinese volunteers indicated that after oral administration of tribendimidine, no parent drug was detected in plasma, but its primary metabolite, p-(1-dimethylamino ethylimino) aniline (aminoamidine, deacylated amidantel) (dADT), was found in plasma. dADT is then further metabolized to acetylated dADT (AdADT). dADT exhibits activity against several species of hookworm and C. sinensis in experimental studies, similar to that of tribendimidine. First studies elucidating the mechanism of action suggested that tribendimidine is an L-type nicotinic acetylcholine receptor agonist. Additional experimental studies revealed that the anti-parasite spectrum of tribendimidine is very broad. Indeed, to date, activity has been documented against 20 different nematode, trematode and cestode species. Taken together, tribendimidine warrants further scientific inquiry, including more comprehensive toxicity appraisals mechanism of action studies and clinical investigation as it holds promise as a broad spectrum anthelminthics.
[show abstract][hide abstract] ABSTRACT: BACKGROUND: The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02D vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. METHODS: This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02D or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. RESULTS: From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02D (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02D and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02D and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02D group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072) and 26.7% (95% CI: -33.1 to 59.6, p = 0.307) over 12 and 18 months post vaccination, respectively. In the Intention to Treat population, over the 20-month follow up, vaccine efficacy against multiple episodes of malaria disease was 14.4% (95%CI: -41.9 to 48.4, p = 0.545). CONCLUSIONS: The acceptable safety profile and good tolerability of RTS,S/AS02D in combination with EPI vaccines previously reported from month 0 to 9 was confirmed over a 20 month surveillance period in this infant population. Antibodies against both CS and HBsAg in the RTS,S/AS02D group remained significantly higher compared to control for the study duration. Over 18 months follow up, RTS,S/AS02D prevented approximately a quarter of malaria cases in the study population.Clinical trials: Gov identifier: NCT00289185.
[show abstract][hide abstract] ABSTRACT: Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available.African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need.However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained.
[show abstract][hide abstract] ABSTRACT: Co-infection with hepatitis B virus (HBV) is highly prevalent in people living with HIV in Sub-Saharan Africa. Screening for HBV surface antigen (HBsAg) before initiation of combination antiretroviral therapy (cART) is recommended. However, it is not part of diagnostic routines in HIV programs in many resource-limited countries although patients could benefit from optimized antiretroviral therapy covering both infections. Screening could be facilitated by rapid diagnostic tests for HBsAg. Operating experience with these point of care devices in HIV-positive patients in Sub-Saharan Africa is largely lacking. We determined the prevalence of HBV and Hepatitis C virus (HCV) infection as well as the diagnostic accuracy of the rapid test device Determine HBsAg in an HIV cohort in rural Tanzania.
Prospectively collected blood samples from adult, HIV-1 positive and antiretroviral treatment-naïve patients in the Kilombero and Ulanga antiretroviral cohort (KIULARCO) in rural Tanzania were analyzed at the point of care with Determine HBsAg, a reference HBsAg EIA and an anti-HCV EIA.
Samples of 272 patients were included. Median age was 38 years (interquartile range [IQR] 32-47), 169/272 (63%) subjects were females and median CD4+ count was 250 cells/µL (IQR 97-439). HBsAg was detected in 25/272 (9.2%, 95% confidence interval [CI] 6.2-13.0%) subjects. Of these, 7/25 (28%) were positive for HBeAg. Sensitivity of Determine HBsAg was rated at 96% (95% CI 82.8-99.6%) and specificity at 100% (95% CI, 98.9-100%). Antibodies to HCV (anti-HCV) were found in 10/272 (3.7%, 95% CI 2.0-6.4%) of patients.
This study reports a high prevalence of HBV in HIV-positive patients in a rural Tanzanian setting. The rapid diagnostic test Determine HBsAg is an accurate assay for screening for HBsAg in HIV-1 infected patients at the point of care and may further help to guide cART in Sub-Saharan Africa.
PLoS ONE 01/2013; 8(3):e58468. · 3.73 Impact Factor