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

NCT02612896 | Completed

• 1 other identifier: CYSTISTOP_2.2_07012016
• Study Type: interventional
• Target: 2,900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Taenia Solium Infection

Keywords

Taenia solium; control; elimination; One Health

Outcome Measures

Primary Outcomes (1)

• Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure

  serological measurement of porcine cysticercosis (in pigs), antigen ELISA result: ratio

  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

Secondary Outcomes (3)

• Change in human cysticercosis active infection (serum: )

  in both study arms: day 0, Year 5.

• Change in human cysticercosis, exposure to infection (serum)

  in both study arms: day 0, year 5

• Change in human taeniasis (stool)

  in both study arms: day 0, year 5; elimination study arm: Year 1, Year 2, year 2.5, year 3, year 3.5,year 4, year 4.5 and year 5

Study Arms (2)

Elimination arm

EXPERIMENTAL

Both human and porcine interventions at four-monthly intervals in the first two study years, for a total of six iterations (only human interventions will be detailed here): Human: Mass drug administration, praziquantel 10mg/kg, according to the list of WHO recommended anthelmintic drugs for use in preventive chemotherapy for taeniasis. And Health Education

Drug: Mass drug administration, praziquantel 10mg/kg; Behavioral: Health education

Control intervention arm

EXPERIMENTAL

Human: yearly health education, for a total of five iterations. The intervention on the pig host will not be detailed here)

Behavioral: Health education

Interventions

Mass drug administration, praziquantel 10mg/kg DRUG

see previous, in elimination study arm only

Also known as: praziquantel

Elimination arm

Health education BEHAVIORAL

in all study arms, using village meetings, posters, pamphlets.

Also known as: education

Control intervention arm; Elimination arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University of Zambia: collaborator
• Ministry of Health, Zambia: collaborator
• Université Catholique de Louvain: collaborator
• University Ghent: collaborator

Study Sites (1)

Nyembe and Mtandaza Rural Health Centre

Katete, Eastern Province, Zambia

Location

MeSH Terms

Conditions

Taeniasis

Interventions

Mass Drug Administration; Praziquantel; Educational Status

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Disease Eradication; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Socioeconomic Factors; Population Characteristics

Study Officials

• Pierre Dorny, PhD

  Institute of Tropical Medicine, Belgium

  STUDY CHAIR

• Emmanuel Bottieau, PhD, MD

  Institute of Tropical Medicine, Belgium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 24, 2015
• Study Start: March 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

ZA (1)