Clinical trial

Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?

Name
CYSTISTOP_2.2_07012016
Description
Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with significant economic and public health impacts, occurring primarily in developing countries. Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host develops the metacestode larval stage (porcine cysticercosis). However, people can also act as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC) when the central nervous system is involved. The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan Africa (SSA) have focussed on single control options. It is becoming clear that these stand-alone options have the potential to reduce the occurrence of the parasite, however either long term or more integrated efforts seem to be required to reach an elimination status. The objective of the current study is to evaluate the cost-effectiveness/acceptability of elimination (to be achieved on a short term via integrated measures), and control (single measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in SSA. This intervention study will entail an elimination study arm in which multiple control options are combined (integrated) aiming at the final human host (Mass drug administration (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a second study arm a single control option will be carried out (pig treatment). In both study arms (health) education will be implemented. At baseline and in the final sampling year, prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig sampling will be conducted in the elimination study arm, as well as two-yearly (biennial) sampling of the pig intermediate host in the control study arm. Additionally, (open ended) questionnaires and focus group discussions will be administered/held to obtain data on the cost of pig keeping, T. solium, the interventions and the perception/acceptability of the proposed control measures to the local communities.
Trial arms
Trial start
2016-03-01
Estimated PCD
2021-10-01
Trial end
2022-02-01
Status
Completed
Treatment
Mass drug administration, praziquantel 10mg/kg
see previous, in elimination study arm only
Arms:
Elimination arm
Other names:
praziquantel
Health education
in all study arms, using village meetings, posters, pamphlets.
Arms:
Control intervention arm, Elimination arm
Other names:
education
Size
2900
Primary endpoint
Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure
Elimination arm: day 0, Year 1, Year 2, Year 2.5, Year 3, Year 3.5, Year 4, Year 4.5, Year 5. Control intervention arm: day 0, Year 2, Year 4,Year 5
Eligibility criteria
Inclusion Criteria: * Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm) * Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent). * Living in, attending school in, or regularly visiting the bore holes present in, the study communities * Aged five years of age or older * People without epilepsy Exclusion Criteria: * Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm) * Unwilling or unable to provide written (signature or thumb print with impartial witness) informed consent (or assent for minors) * Living outside of, and not regularly visiting, or attending school in, the study communities * Children aged four years or younger * People with epilepsy (identified cases by the Rural Health Centre, questions included in the registration procedure) * Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 2900, 'type': 'ACTUAL'}}
Updated at
2023-03-01

1 organization

1 product

1 indication

Indication
Taeniasis