Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia (TEPIM)

Establishment and Application of a Taenia Solium Experimental Pig Infection Model and Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Eastern and Southern Provinces of Zambia

This study aims to determine the prevalence of taeniosis and (neuro)cysticercosis in two districts in the southern (Gwembe) and eastern province (Chipata) of Zambia.

Study Overview

• Status: Completed
• Conditions: Neurocysticercosis; Taeniosis

Detailed Description

The true prevalence of Neurocyticercosis in Zambia is not well known. Only one study which was a pilot study done in Katete district of eastern province demonstrated the prevalence of NCC among people with epilepsy. There is need to provide an accurate estimate of the prevalence of NCC among people with cysticercosis in Zambia as well as understand the clinical manifestations of the disease in humans. Data on the full range of clinical characteristics of NCC is essential to accurately estimate the burden of the disease in the community.

The epidemiology work package within the human health sector will create awareness of the size of the problem by delivering scientifically generated prevalence data on TSCT and NCC in various population groups (adults, children, and those living with epilepsy) in two provinces of Zambia. This will form an essential prerequisite for the development of public health policy guidelines for the control/elimination of TSCT/NCC in the country.

Further, environmental factors that could play a role in the transmission and maintenance of T. solium eggs will be studied. This will provide essential data in understanding the epidemiology of the parasite in endemic regions.

• Study Type: Observational
• Enrollment (Actual): 2921

Contacts and Locations

• Study Contact: Name: Chummy S. Sikasunge, PhD; Phone Number: 672 +260 979 878; Email: cssikasunge@unza.zm
• Study Contact Backup: Name: Andrea S. Winkler, MD PhD; Phone Number: 9210 +49 89 4140; Email: andrea.winkler@tum.de

Study Locations

• Zambia
  • Lusaka, Zambia, 32379
    • University of Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Study participants will be sampled from villages of two districts in Sambia (Gwembe and Chipata). Villages of these districts will be selected at random and all people from these villages will be invited to take part in the study. No selection apart from the exclusion criteria will take place.

Description

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
• Willing and able to provide informed consent (signature or thumbprint 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 10 years or older

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.
• Unwilling or unable to provide written (signature or thumbprint 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 less than 10 years.
• Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of T. solium cysticercosis	Prevalence of human T. solium cysticercosis	Assessment through blood sampling at baseline
Prevalence of neurocysticercosis	Prevalence of human neurocysticercosis among people with positive serology for T. solium cysticercosis	Assessment at CT scanning at baseline
Prevalence of taeniosis	Prevalence of human T. solium taeniosis	Assessment through stool sampling at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of intestinal helminth infection	Prevalence of intestinal helminth infection	Assessment through stool sampling at baseline

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Chummy S. Sikasunge, PhD, University of Zambia

Publications and helpful links

General Publications

• Zulu G, Sikasunge CS, Welte TM, Simuunza MC, Stelzle D, Schmidt V, Hachangu A, Mutale W, Masuku M, Chembensofu M, da Costa CP, Mwape KE, Winkler AS, Phiri IK. Epidemiology of intestinal helminthiasis with an emphasis on taeniasis in Chipata district of the Eastern province of Zambia. PLoS Negl Trop Dis. 2023 Nov 20;17(11):e0011561. doi: 10.1371/journal.pntd.0011561. Online ahead of print.

Helpful Links

• Epidemiology of intestinal helminthiasis with an emphasis on taeniasis in Chipata district of the Eastern province of Zambia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Neurocysticercosis
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Cysticercosis; Taeniasis; Neurocysticercosis
• Other Study ID Numbers: TEPIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No