In Bolivia, where prevalence of selleck chemical infection is higher than in Egypt or Vietnam, a more inclusive strategy offering treatment to entire population sectors without individual diagnosis might be appropriate in order to reduce costs and logistics related to the implementation of screening exercises. This approach would mirror the one currently recommended for schistosomiasis and soil-transmitted helminthiasis in areas of moderate and high risk [1]; the procurement of larger quantities of medicines needed for its implementation has been made possible via the donation of triclabendazole (Egaten) by Novartis Pharma AG through the WHO. Consequently, in 2008, following suggestions by a panel of experts convened by the WHO [24], the Ministerio de Salud y Deportes of Bolivia decided to opt for large-scale distribution of triclabendazole in endemic areas without individual diagnosis.
Before this approach was widely implemented, a pilot study was conducted to test the safety and efficacy of such intervention. Safety assessments consisted of monitoring and recording any AEs occurring after treatment, and efficacy was assessed by monitoring prevalence and intensity of infection and by calculating cure and egg reduction rates. Safety, in particular, was considered as a key component of the protocol as AEs are known to limit the feasibility of preventive chemotherapy interventions for helminth infections, as their occurrence confines treatment to a clinical setting where proper management of cases is ensured by health personnel.
AEs also have the potential to jeopardize compliance to the intervention as effects of treatment can be perceived as a greater health risk than the disease itself [25]. Methods Ethics The study protocol was approved by the Comisi��n de Etica de la Investigaci��n (CEI) of the National Bioethics Committee of Bolivia on September 10, 2007. A written informed consent form explaining the purpose and the modalities of the study was developed, translated into Aymara and obtained from the parents/guardians of each participating child. The initiative was agreed by the civil (sub-alcalde, head of the health post, director of the educational unit), and traditional (jilakatas and malkus) authorities of the community where the study was implemented. Study setting The study was conducted in Huacullani, a community in the Bolivian northern Altiplano, where prevalence of F.
hepatica infection among school-aged children ranged between 31.2% and 38.2% in the 1990s [9]. Huacullani (16��26��0��S, 68��44��0��W) is located at an altitude of 3,850 metres, approximately 500 meters from the shores of Lake Titicaca, in the municipality of Tihuanaku (province of Ingavi, department of La Paz). At the time of the survey, Batimastat the population of Huacullani was 2,472.