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.: PACTR202102477794401 Date of Approval: 25/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessing the effectiveness of using the Community Directed Intervention (CDI) approach to improve community ownership of Mass Drug Administration (MDA) for Neglected Tropical Diseases (NTDs) in Malawi
Official scientific title Assessing the effectiveness of using the Community Directed Intervention (CDI) approach to improve community ownership of Mass Drug Administration (MDA) for Neglected Tropical Diseases (NTDs) in Malawi
Brief summary describing the background and objectives of the trial This project intends to assess the effectiveness of using the CDI approach as a vehicle for delivery of MDA campaigns against targeted NTDs namely, schistosomiasis and STH in three selected southern Malawi districts of Mangochi, Zomba and Chiradzulu. In this project, it is hypothesized that the combination of 1) publicly prioritized NTD-MDA efforts, 2) successful CDI programme and 3) well-organized community direction will provide synergy and increased popularity, empowerment, efficiency, coverage, health impact and sustainability for NTD-MDA interventions in the project communities as compared to control communities. The primary research question is: Can the CDI approach be effectively used to deliver MDA to control NTDs at community level in rural Malawi districts? The main objective of the study is to assess the effectiveness of using the CDI approach to improve community ownership of MDA for selected NTDs in rural Malawi districts. The following are the specific objectives for the study: a) To describe the processes of using the CDI approach to deliver MDA campaigns for selected NTDs in rural Malawi districts. b) To assess the effectiveness of using the CDI approach for delivery of MDA for selected NTDs in rural Malawi districts. c) To identify the critical factors that facilitate or hinder the use of the CDI approach for delivery of MDA for selected NTDs in rural Malawi districts. d) To identify the enabling elements of sustainability of using the CDI approach for delivery of MDA for selected NTDs in rural Malawi districts.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SCHIMDA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Schistosomiasis and soil-transmitted helminths
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2020
Actual trial start date 10/01/2020
Anticipated date of last follow up 08/03/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 48676
Actual target sample size (number of participants) 50000
Recruitment status Closed to recruitment,follow-up continuing
Publication URL Not applicable
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Status quo arm of the study intervention - implementing MDA campaigns at community level using the standard of care of using community based health workers once in year 2020 MDA campaign to last for one week (7 day) in one year During the MDA, only communities in the control arm of the study will implement MDA campaigns at community level using the community based health workers. In addition to MDA intervention, health education and promotion for behavioural change, advocacy for improvement of hygiene and safe water supply will be carried out on the ongoing basis by the responsible community based health workers (HSAs) in communities 25000 Dose Comparison
Experimental Group CDI arm of study Implementing MDA campaigns at community level using the CDI approach of using community based volunteers known as Community-directed distributors. Only one campaign in the year 2020 Campaign will last one week (7 days) once in year 2020 During the second MDA, only communities in the intervention arm of the study will implement MDA campaigns at community level using the CDI approach. In addition to MDA intervention, health education and promotion for behavioural change, advocacy for improvement of hygiene and safe water supply will be carried out on the ongoing basis by the responsible community based volunteers in communities 25000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children aged above 5 years as well as the at risk adults residing in the study communities. The study population includes minors (aged under 18 years) because they constitute the high risk for schistosomiasis and STH due to frequent water exposure, heavy infection intensity and morbidity All children aged below 5 years, the clinically sick, pregnant women and the elderly 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),Preschool Child: 2 Year-5 Year 5 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 10/01/2020 National Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 30377 Lilongwe 3 Lilongwe 0000 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Enhanced capacity for implementation of the CDI strategy within community and health care delivery system in the involved districts. 31 May 2021
Primary Outcome Increased number of health care workers actively involved and supporting in implementation of MDA using the CDI strategy at district, health centre and community levels 31 May 2021
Secondary Outcome Number of community based CDI implementers actively engaged in delivery of MDA using the CDI strategy in the involved districts 31 May 2021
Secondary Outcome Increased number of targeted population accessing health services through the CDI strategy in the involved districts 31 May 2021
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mangochi district PO Box 42 Mangochi Mangochi Malawi
Zomba district PO Box 18 Zomba Zomba Malawi
Chiradzulu district PO Box 27 Chiradzulu Chiradzulu Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
DFID 330 W. Ponce de Leon Ave Decatur 30030 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NTD Support Centre 330 W. Ponce de Leon Ave Decatur 30030 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Mr Peter Furu Oster Farimagsgade Copenhagen 1013 Denmark
Dr Janelisa Musaya P/Bag 360 Blantyre Malawi
Dr Sekeleghe Kayuni 22 Lower Scalter Road Blantyre Malawi
Dr Kondwani Mamba PO Box 42 Mangochi Malawi
Mr Lazarus Juziwelo PO Box 65 Lilongwe Malawi
Mr Peter Makaula PO Box 345 Mangochi Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Furu furu@sund.ku.dk +4535326786 Oster Farimagsgade 5
City Postal code Country Position/Affiliation
Copenhagen 1013 Denmark Associate Professor University of Copenhagen
Role Name Email Phone Street address
Public Enquiries Peter Makaula petmakau@yahoo.co.uk +265594540 PO Box 345
City Postal code Country Position/Affiliation
Mangochi Malawi Co Principal Investigator Research for Health Environment and Development
Role Name Email Phone Street address
Scientific Enquiries Peter Furu furu@sund.ku.dk +4535326786 Oster Farimagsgade 5
City Postal code Country Position/Affiliation
Copenhagen 1013 Denmark Associate Professor University of Copenhagen
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol One year from 1 July 2021 up to 30 June 2022 The datasets used and/or analyzed during the current study are openly available from the corresponding author on reasonable request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not applicable 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