Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201811769142678 Date of Approval: 30/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of a locally developed health education package in the control of Taenia solium infections in humans and pigs in Tanzania
Official scientific title Development and evaluation of a locally adapted health education package for control of Taenia solium taeniasis and cysticercosis in Tanzania
Brief summary describing the background and objectives of the trial Besides human and animal health community education plays a major role on the way to control/elimination of Taenia solium taeniosis and cysticercosis (TSTC). In addition, sustainable disease control in resource-poor countries requires low-cost interventions. Therefore, a low-cost health education package to control TSTC will be developed, evaluated and implemented using the method of knowledge translation and targeting opinion leaders such as teachers, livestock/health extension agents and village headmen. The intervention will be incorporated into routine educational systems and political forums to enhance sustainability. Effectiveness of the intervention will be measured through a village-level randomised controlled trial. It is expected that after the project, health education for TSTC will become a routine activity in the communities and will improve knowledge, attitudes and practices regarding TSTC as well as reduce the risk of contracting TSTC in the area. Specific objectives of the study are (1) Development and adaptation of a low-cost, ready-to-use health education intervention package targeting village opinion leaders for the prevention and control of TSTC in Kongwa and Songwe districts, Tanzania, (2) Determination of the effectiveness of the community-adapted health education intervention package on the community’s knowledge, attitudes and practices (KAPs) and risk of porcine and human cysticercosis in Kongwa and Songwe districts, Tanzania, and (3) Development of evidence-based policy guidelines for locally adapted prevention and control of TSTC in Iringa Rural district, southern Tanzania.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Musculoskeletal Diseases,Nervous System Diseases,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2019
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 1462
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NIMRHQR.8aVol.IX2802 National Institute for Medical Research
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education One-time package 3 months A health education package consisting of training of various key stakeholders such as veterinary professionals, health personnel, policy makers and school children will be administered in villages allocated to the intervention group using various information communication channels. 731
Control Group Monitoring alone Twice Within 1 month during each of the two monitoring times. The control group persons will be serologically tested for Taenia solium cysticercosis and assessed for related knowledge, attitudes and practices at baseline and 12 months after the intervention group persons have been educated. Similarly, a statistical sample of pigs living in the control villages will be serologically tested for Taenia solium cysticercosis at baseline and 12 months after the intervention villagers have been educated. The group sizes indicated in this application are for the human study. 731 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Residing in the study districts (Kongwa and Songwe), Tanzania Aged 6-65 years Willing to participate Residing outside the study districts (Kongwa and Songwe), Tanzania Aged below 6 or above 65 years Unwilling to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 6 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/06/2018 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 00255 United Republic of Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/07/2017 Research Innovation and Publication Committee
Ethics Committee Address
Street address City Postal code Country
Sokoine University of Agriculture Morogoro 00255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cumulative incidence of Taenia solium cysticercosis seroconversion in humans compared between the intervention and control groups. 12 months post-intervention.
Secondary Outcome Change in knowledge, attitudes and practices related to Taenia solium. 12 months post-intervention.
Secondary Outcome Change in the prevalence of cysticercosis in pigs 12 months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kongwa district Kongwa Kongwa United Republic of Tanzania
Songwe district Songwe Songwe United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
German Federal Ministry of Education and Research BMBF Germany Berlin Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Helena A. Ngowi Sokoine University of Agriculture, P. O. Box 3021 Morogoro United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
Bernard Ngowi National Institute for Medical Research Dar es Salaam United Republic of Tanzania
Sayoki Mfinanga National Institute for Medical Research Dar es Salaam United Republic of Tanzania
Ernatus Mkupasi Sokoine University of Agriculture Morogoro United Republic of Tanzania
George Makingi Sokoine University of Agriculture Morogoro United Republic of Tanzania
Christina Wilson Sokoine University of Agriculture Morogoro United Republic of Tanzania
Andrea Winkler Technical University of Munich Munich Germany
Veronika Schmidt Technical University of Munich Munich Germany
Clarissa Prazeres da Costa Technical University of Munich Munich Germany
Emilia Noormahomed Eduardo Mondlane University Maputo Mozambique
Chummy Sikasunge University of Zambia Lusaka Zambia
Helene Carabin University of Oklahoma Health Sciences Center Oklahoma United States of America
Chacha Nyangi Sokoine University of Agriculture Morogoro United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Helena Ngowi helenangowi@gmail.com +255754374839 Sokoine University of Agriculture, P. O. Box 3021
City Postal code Country Position/Affiliation
Morogoro United Republic of Tanzania Associate Professor at Sokoine University of Agriculture
Role Name Email Phone Street address
Public Enquiries Ernatus Mkupasi emkupasi@yahoo.com +255763929 Sokoine University of Agriculture, P. O. Box 3021
City Postal code Country Position/Affiliation
Morogoro United Republic of Tanzania Lecturer
Role Name Email Phone Street address
Scientific Enquiries George Makingi makingi19@yahoo.co.uk +255713588069 Sokoine University of Agriculture, P. O. Box 3021
City Postal code Country Position/Affiliation
Morogoro United Republic of Tanzania PhD student Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information