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.: PACTR202301534749787 Date of Registration: 04/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving Mycetoma Case-Detection through Training of Community Health Workers in Northern Uganda: Stepped Wedged Cluster Randomised Controlled Trial
Official scientific title Improving Mycetoma Case-Detection through Training of Community Health Workers in Northern Uganda: Stepped Wedged Cluster Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Background: Mycetoma is now recognized by the World Health Organization (WHO) as a neglected tropical disease (NTD) and the WHO acknowledges the need for countries to incorporate NTDs care into their routine health care system. However, low detection rates and late presentation of mycetoma to health facilities has been observed. Therefore, this project seeks to empower community-health workers (CHWs) in Uganda to recognize and refer suspects of mycetoma to health facilities to address the burden of mycetoma. Overall aim: To improve mycetoma case detection through training of community health workers in selected districts of Northern Uganda. Specific aim: 1) To assess the baseline knowledge and practices of community-health workers in Northern Uganda on mycetoma 2) To provide basic training to the community-health workers on clinical presentation of mycetoma 3) To evaluate the impact of training of the community-health workers on case-detection and referral of suspected mycetoma cases
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Mycetoma
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/03/2023
Actual trial start date
Anticipated date of last follow up 21/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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
Experimental Group Education Training of community health workers N/A Training will be done for a duration of 3 days. The selected CHWs will undertake a 3-day training on all aspects of mycetoma. A curriculum will be developed using existing training materials on Mycetoma and related Fungal Neglected Tropical Disease by the Leading International Fungal Education (LIFE) (https://life-worldwide.org/life-education-slide-sets-video-presentations-and-reading-materials). The training will be delivered by two trained clinical mycologists/clinicians. We will use a combination of PowerPoint presentations, tutorials, pictorials, and group discussions. 100
Control Group Control N/A 3 months The control group will not undergo any intervention until the point of crossing-over. They will undergo the continuous training offer by the partnership between the Northern Uganda Medical Mission (NUMEM) and Ministry of Health of Uganda. 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All CHWs who were trained by NUMEM and Uganda Ministry of Health. All CHWs who are above 18 years of age. CHWs who stay outside of the selected districts will be excluded. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 15/12/2022 Mulago Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Upper Mulago Hill Road Kampala 7051 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reach; the number of CHWs who are willing to participate in this study. Effectiveness; the impact of our intervention on the outcomes; knowledge, practices and mycetoma case detection. Adoption; number of CHWs willing to initiate the program. Implementation; proportion of the intervention conducted, consistency of implementing the intervention by the CHWs, time and cost of training. Maintenance; extent to which program becomes routine practice in the selected districts 3, 6 and 9 months.
Secondary Outcome Level of knowlegde and practices about Mycetoma among CHWs. At baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gulu University Pece-Laroo Division Gulu 166 Uganda
Pader Pader Pader Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Royal Society of Tropical Medicine and Hygiene Northumberland House, 303-306 High Holborn London WC1V 7JZ United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gulu University Laroo division Gulu City 166 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Richard Kwizera Upper Mulago Hill Road Kampala Uganda
Andrew Weil Semulimi Upper Mulago Hill Road Kampala Uganda
Felix Bongomin Laroo division Gulu City Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Winnie Kibone kibonewinnie@gmail.com +256755104733 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Medical Doctor
Role Name Email Phone Street address
Scientific Enquiries Felix Bongomin drbongomin@gmail.com +256784523395 Laroo Division
City Postal code Country Position/Affiliation
Gulu Uganda Lecturer
Role Name Email Phone Street address
Public Enquiries Winnie Kibone kibonewinnie@gmail.com +256755104733 Upper Mulago hill
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Medical doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant data that underline the results reported in this trial after deidentification. (texts, figures, tables and appendices) Statistical Analysis Plan,Study Protocol Immediately after publication. No end date Researchers who provide methodologically sound proposals.
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