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CompletedNCT03874689TEPIMUpdated Nov 30, 2023

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

An observational study in Neurocysticercosis and Taeniosis, sponsored by Technical University of Munich. Completed at 1 site in Zambia. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Technical University of Munich · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,921
Ages
10 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Neurocysticercosis
  • Taeniosis

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Keywords

  • Neurocysticercosis
03

In context

Neurocysticercosis

21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.

Browse Neurocysticercosis studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 320 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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) (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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,921 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Prevalence of T. solium cysticercosis

    Prevalence of human T. solium cysticercosis

    Time frame: Assessment through blood sampling at baseline

  2. Prevalence of neurocysticercosis

    Prevalence of human neurocysticercosis among people with positive serology for T. solium cysticercosis

    Time frame: Assessment at CT scanning at baseline

  3. Prevalence of taeniosis

    Prevalence of human T. solium taeniosis

    Time frame: Assessment through stool sampling at baseline

Secondary outcomes

  1. Prevalence of intestinal helminth infection

    Prevalence of intestinal helminth infection

    Time frame: Assessment through stool sampling at baseline

07

Study locations

1 site
  • University of Zambia
    Lusaka, 32379, Zambia
08

References and documents

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. eCollection 2023 Nov. PubMed 37983246 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03874689
Responsible party
Sponsor
First posted
Mar 14, 2019
Start date
Jun 1, 2019
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Nov 30, 2023

Study contacts

Chummy S. Sikasunge, PhD
principal investigator · University of Zambia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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