Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000190202
Ethics application status
Approved
Date submitted
7/03/2009
Date registered
17/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of public health education on Taenia solium transmission
Scientific title
Evaluation of pig farmers' health education intervention against monitoring alone on the incidence rate of cysticercosis in sentinel pigs in Mbulu district, Tanzania
Secondary ID [1] 823 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cysticercosis 4433 0
Taeniosis 4434 0
Condition category
Condition code
Public Health 4700 4700 0 0
Health promotion/education
Infection 4701 4701 0 0
Other infectious diseases
Neurological 4702 4702 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health education intervention. A health educational package was developed with community participation. The intervention package consisted of a training manual, a video programme, two posters, a leaflet and booklet. In the first stage, local livestock/agricultural extension agents and health workers were updated on Taenia solium cysticercosis and taeniosis by the principal investigator, and practised on how to educate smallholder pig farners on the problem. This training lasted for two days, approximately two hours each day. In the second stage, a trained extension agent addressed smallholder pig farmers on Taenia solium using the training manual and posters in a special seminar. Thereafter, seminar participants watched a 14-minute video on Taenia solium. The video was produced locally and acted by the local people. Finally, each participant was given a booklet and a leaflet to take home. Pig farmers' training was a one-day intervention that lasted for approximately two hours. The health education package informed smallholder pig farmers on the mode of transmission, impact, prevention and control of Taenia solium, a zoonotic parasite that was highly prevalent in Mbulu district, northern Tanzania. Pig farmers' education was administered at village level. Assessment of specific knowledge, practices and incidence of porcine cysticercosis was done before the intervention and one to two times after the intervention for a median of 4 months (range: 2-9 months).
Intervention code [1] 4178 0
Behaviour
Intervention code [2] 4179 0
Lifestyle
Intervention code [3] 4180 0
Prevention
Comparator / control treatment
Monitoring alone. The smallholder pig farmers in the control villages were not given any health education. However, monitoring of specific knowledge, practices and incidence rate of porcine cysticercosis was done parallel to that in the intervention group, and compared with the baseline levels. Like for the intervention group, assessment of knowledge, practices and incidence of porcine cysticercosis was done before the intervention and one to two times after the intervention for a median of 4 months (range: 2-9 months).
Control group
Active

Outcomes
Primary outcome [1] 5570 0
Incidence rate of porcine cysticercosis in sentinel pigs (as an indirect measure of the risk of human cysticercosis). The incidence rate of porcine cysticercosis was determined using lingual examination and antigen enzyme-linked immunosorbent assay methods. The rates were later adjusted for the baseline prevalence of porcine cysticercosis.
Timepoint [1] 5570 0
Ten to twelve months after intervention randomisation.
Secondary outcome [1] 9381 0
Knowledge and practices related to Taenia solium transmission. Knowledge on the transmission of T. solium infections was assessed using face-to-face structured questionnaire interviews of household leaders or their representatives. Practices related to T. solium were assessed using structured questionnaire interviews and direct observations.
Timepoint [1] 9381 0
At baseline and 10-12 months after intervention randomisation.

Eligibility
Key inclusion criteria
(1) Pig-keeping villages not extensively studied for cysticercosis, and independent from other villages;
(2) A random sample of smallholder pig-keepng households in each study village;
(3) Willingness of the household head to participate in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Villages not keeping pigs;
(2) Villages overly studied for porcine cysticercosis previously, including the pilot study village;
(3) School children.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Intervention randomisation was done at village level. Following identification of eligible villages based on the predetermined eligibility criteria, the 42 selected villages were numbered serially. These numbers were then used in the intervention randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using a random number table from a statistic book. The factor used to stratify the intervention allocation was the baseline village-level prevalence of porcine cysticercosis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
836
Accrual to date
Final
Recruitment outside Australia
Country [1] 1656 0
Tanzania, United Republic Of
State/province [1] 1656 0

Funding & Sponsors
Funding source category [1] 4626 0
Charities/Societies/Foundations
Name [1] 4626 0
Danish International Development Agency (DANIDA), which is under the Ministry of Foreign Affairs
Country [1] 4626 0
Denmark
Primary sponsor type
Individual
Name
Helena A. Ngowi
Address
Sokoine University of Agriculture, Department of Veterinary Medicine and Public Health, P. O. Box 3021, Morogoro
Country
Tanzania, United Republic Of
Secondary sponsor category [1] 4170 0
Individual
Name [1] 4170 0
Ayub A. Kassuku
Address [1] 4170 0
Sokoine University of Agriculture, Department of Veterinary Microbiology and Parasitology, P. O. Box 3019, Morogoro
Country [1] 4170 0
Tanzania, United Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6664 0
National Institute for Medical Research (NIMR)
Ethics committee address [1] 6664 0
Ethics committee country [1] 6664 0
Tanzania, United Republic Of
Date submitted for ethics approval [1] 6664 0
Approval date [1] 6664 0
02/10/2001
Ethics approval number [1] 6664 0
NIM/HQ/R.8a/Vol IX/88

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29362 0
Address 29362 0
Country 29362 0
Phone 29362 0
Fax 29362 0
Email 29362 0
Contact person for public queries
Name 12609 0
Helena A. Ngowi
Address 12609 0
Sokoine University of Agriculture, Department of Veterinary Medicine and Public Health, P. O. Box 3021, Morogoro
Country 12609 0
Tanzania, United Republic Of
Phone 12609 0
+255232604542
Fax 12609 0
Email 12609 0
[email protected]
Contact person for scientific queries
Name 3537 0
Helena A. Ngowi
Address 3537 0
Sokoine University of Agriculture, Department of Veterinary Medicine and Public Health, P. O. Box 3021, Morogoro
Country 3537 0
Tanzania, United Republic Of
Phone 3537 0
+255232604542
Fax 3537 0
Email 3537 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISpatial Clustering of Porcine Cysticercosis in Mbulu District, Northern Tanzania2010https://doi.org/10.1371/journal.pntd.0000652
N.B. These documents automatically identified may not have been verified by the study sponsor.