Publication: A Multicentre Randomized Controlled Trial of the Efficacy and Safety of Single-Dose Praziquantel at 40 mg/kg vs. 60 mg/kg for Treating Intestinal Schistosomiasis in the Philippines, Mauritania, Tanzania and Brazil
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Published
2011
ISSN
1935-2735 (Electronic)
1935-2727 (Linking)
Date
2012-03-30
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Abstract
BACKGROUND: Praziquantel at 40 mg/kg in a single dose is the WHO recommended treatment for all forms of schistosomiasis, but 60 mg/kg is also deployed nationally. METHODOLOGY/PRINCIPAL FINDINGS: Four trial sites in the Philippines, Mauritania, Tanzania and Brazil enrolled 856 patients using a common protocol, who were randomised to receive praziquantel 40 mg/kg (n = 428) or 60 mg/kg (n = 428). While the sites differed for transmission and infection intensities (highest in Tanzania and lowest in Mauritania), no bias or heterogeneity across sites was detected for the main efficacy outcomes. The primary efficacy analysis was the comparison of cure rates on Day 21 in the intent-to-treat population for the pooled data using a logistic model to calculate Odd Ratios allowing for baseline characteristics and study site. Both doses were highly effective: the Day 21 cure rates were 91.7% (86.6%-98% at individual sites) with 40 mg/kg and 92.8% (88%-97%) with 60 mg/kg. Secondary parameters were eggs reduction rates (ERR), change in intensity of infection and reinfection rates at 6 and 12 months. On Day 21 the pooled estimate of the ERR was 91% in both arms. The Hazard Ratio for reinfections was only significant in Brazil, and in favour of 60 mg/kg on the pooled estimate (40 mg/kg: 34.3%, 60 mg/kg: 23.9%, HR = 0.78, 95% CI = [0.63;0.96]). Analysis of safety could not distinguish between disease- and drug-related events. 666 patients (78%) reported 1327 adverse events (AE) 4 h post-dosing. The risk of having at least one AE was higher in the 60 than in the 40 mg/kg group (83% vs. 73%, p<0.001). At 24 h post-dosing, 456 patients (54%) had 918 AEs with no difference between arms. The most frequent AE was abdominal pain at both 4 h and 24 h (40% and 24%). CONCLUSION: A higher dose of 60 mg/kg of praziquantel offers no significant efficacy advantage over standard 40 mg/kg for treating intestinal schistosomiasis caused by either S. mansoni or S. japonicum. The results of this study support WHO recommendation and should be used to inform policy decisions in the countries.
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Publication Pre-Referral Rectal Artesunate to Prevent Death and Disability in Severe Malaria : A Placebo-Controlled Trial(2009-02-14)BACKGROUND: Most malaria deaths occur in rural areas. Rapid progression from illness to death can be interrupted by prompt, effective medication. Antimalarial treatment cannot rescue terminally ill patients but could be effective if given earlier. If patients who cannot be treated orally are several hours from facilities for injections, rectal artesunate can be given before referral and acts rapidly on parasites. We investigated whether this intervention reduced mortality and permanent disability. METHODS: In Bangladesh, Ghana, and Tanzania, patients with suspected severe malaria who could not be treated orally were allocated randomly to a single artesunate (n=8954) or placebo (n=8872) suppository by taking the next numbered box, then referred to clinics at which injections could be given. 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We emphasize the need to adopt both a group-based and a place-based approach, as opposed to the dominant high-risk group approach, for understanding the epidemiology of HIV as well as for developing HIV intervention activities.Publication Sexual Behavior Change Intentions and Actions in the Context of a Randomized Trial of a Conditional Cash Transfer for HIV Prevention in Tanzania(2012-03-01)Information, education, communication and interventions based on behavioral-change communication have had success in increasing the awareness of HIV. But these strategies alone have been less successful in changing risky sexual behavior. This paper addresses this issue by exploring the link between action and the intention to change behaviors. In Africa, uncertainty in the lives of those at risk for HIV may affect how intentions are formed. Characterize this uncertainty by understanding the reasons for discrepancies between intentions and actions may help improve the design of HIV-prevention interventions. Based on an incentives-based HIV prevention trial in Tanzania, the longitudinal dataset in this paper allows the exploration of intended strategies for changing sexual behaviors and their results. The authors find that gender, intervention groups and new positive diagnoses of sexually transmitted infections can significantly predict the link between intent and action. The paper examines potential mediators of these relationships.Publication The Contribution of Traditional Herbal Medicine Practitioners to Kenyan Health Care Delivery : Results from Community Health-seeking Behavior Vignettes and a Traditional Herbal Medicine Practitioner Survey(World Bank, Washington, DC, 2011-09)This study examines the role that Traditional Herbal Medicine Practitioners (THMPs) play in Kenya in the context of its human resources for health crisis. Two surveys were carried out to obtain evidence. The first documented the choices and perceptions of households in 36 communities on seeking medical assistance for eight common illnesses. The second survey asked 258 THMPs in five provinces to identify their knowledge sources, training, common illnesses treated, forms of payment, challenges, and concerns. Community-derived data show that households make reasonable decisions when faced with difficult circumstances: they prefer hospitals when these are affordable and seek care at clinics and health centers when hospitals are too far away. There is significant self-care and use of pharmacies, although THMPs are preferred for worms and lower respiratory problems. In general, THMPs provide an important though diminishing role in the provision of health care; they are not sought out in situations when inadequate care is dangerous, specifically infant diarrhoea and potential TB. Whilst Human Resources for Health (HRH) policies are urgently required to strengthen the conventional health workforce and increase their accessibility for the poor, policies should not ignore the findings from this study: many of the rural poor currently receive services from a traditional health workforce not linked to, or regulated by, the national government. This paper argues that formal recognition of their role by the government and by the conventional medical associations, and a targeted strategy to strengthen and build on the positive qualities evident in many traditional medicine practices may be beneficial to safeguarding the well-being of the poor.
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