ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cysticercosis

Taeniosis

Condition category

Condition code

Public Health

Health promotion/education

Infection

Other infectious diseases

Neurological

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Ten to twelve months after intervention randomisation.

Secondary outcome [1]

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]

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?

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]

Tanzania, United Republic Of

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Danish International Development Agency (DANIDA), which is under the Ministry of Foreign Affairs

Address [1]

Asiatisk Plads, DK-1448 Copenhagen K

Country [1]

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]

Individual

Name [1]

Ayub A. Kassuku

Address [1]

Sokoine University of Agriculture, Department of Veterinary Microbiology and Parasitology, P. O. Box 3019, Morogoro

Country [1]

Tanzania, United Republic Of

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute for Medical Research (NIMR)

Ethics committee address [1]

2448, Ocean Road, P. O. Box 9653, Dar es Salaam

Ethics committee country [1]

Tanzania, United Republic Of

Date submitted for ethics approval [1]

Approval date [1]

02/10/2001

Ethics approval number [1]

NIM/HQ/R.8a/Vol IX/88

Summary

Brief summary

The primary purpose of this randomised controlled field intervention trial was to determine the effectiveness of health education in reducing porcine cysticercosis, with an overall objective of reducing human taeniosis and cysticercosis caused by the zoonotic tapeworm, Taenia solium, which is transmitted primarily between human and pigs.  The tapeworm causes serious neurological syndromes (commonly epilepsy) in human.  It was hypothesized that educating smallholder pig farmers on the causes, impact, and ways to control Taenia solium infections, would reduce the incidence rate of porcine cysticercosis and improve people's knowledge and practices related to the transmission of the parasite.

Trial website

Trial related presentations / publications

1. Ngowi HA, Carabin H, Kassuku AA, Mlozi MRS, Mlangwa JED, et al. (2008) A health-education intervention trial to reduce porcine cysticercosis in Mbulu District, Tanzania.  Prev Vet Med 85: 52–67.

2. Ngowi HA, Mlangwa JED, Carabin H, Mlozi MRS, Kassuku AA, et al. (2007) Financial efficiency of health and pig management education intervention in controlling porcine cysticercosis in Mbulu District, northern Tanzania.  Available: http://www.cipav.org.co/lrrd/lrrd19/5/ngow19062.htm.  Accessed 30 May 2007. 

3. Ngowi HA, Tolma EL, Kassuku AA, Mlozi MRS, Mlangwa JED, et al. (2007) Using the “PRECEDE” model to plan a health promotion strategy for control of Taenia solium infections in northern Tanzania. Int J Health Promot Educ 45: 41-48.

4. Ngowi HA, Mlangwa JED, Mlozi MRS, Tolma EL, Kassuku AA, et al. (2009). Implementation and evaluation of a health-promotion strategy for control of Taenia solium infections in northern Tanzania.  Int J Health Promot Educ 47: 24-34.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

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

Phone

+255232604542

Fax

hngowi@suanet.ac.tz

Contact person for scientific queries

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

Phone

+255232604542

Fax

hngowi@suanet.ac.tz

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

Source	Title	Year of Publication	DOI
Dimensions AI	Spatial Clustering of Porcine Cysticercosis in Mbulu District, Northern Tanzania	2010	https://doi.org/10.1371/journal.pntd.0000652

N.B. These documents automatically identified may not have been verified by the study sponsor.

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