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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101751275357 Date of Registration: 29/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title “Slash and clear” for onchocerciasis control and epilepsy prevention in Cameroon
Official scientific title “Slash and clear” vector control for onchocerciasis elimination and epilepsy prevention: a community-based trial in Cameroonian villages
Brief summary describing the background and objectives of the trial Onchocerciasis is a parasitic disease caused by Onchocerca volvulus and transmitted to humans via blackfly bites. Besides the usual skin and eye symptoms reported in persons with onchocerciasis, it is becoming obvious that the parasite also causes epileptic disorders. Despite years of annual mass treatment with ivermectin, onchocerciasis transmission persists in Cameroon especially in villages with loiasis co-endemicity. Moreover, with the preventive measures instituted to limit COVID-19 transmission, the usual door-to-door distribution of ivermectin for onchocerciasis control may be implausible until the pandemic has been fully contained. Alternative elimination strategies are urgently needed to curtail onchocerciasis transmission and reduce its disease burden without violating the health safety guidelines in place. The effectiveness of the “slash and clear” (S&C) method in reducing blackfly biting rates has been demonstrated in onchocerciasis foci in Uganda. However, little is known regarding the effects of S&C on parasitological and serological markers of onchocerciasis transmission. This project seeks to follow-up on the transmission of onchocerciasis when annual S&C is implemented in Cameroonian villages, and the consequences on new cases of epilepsy after two consecutive years of intervention. Study villages with similar onchocerciasis endemicity levels at baseline will be randomised to annual S&C and no S&C. Outcome parameters such as Ov16 seroprevalence in children < 10 years, O. volvulus microfilarial load in the general population, and entomological measures (blackfly biting rates, blackfly infectivity rates) will be investigated prospectively to monitor onchocerciasis transmission patterns, while the number of new epilepsy cases during the study period will indicate S&C impact on epilepsy incidence.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SCONE
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Onchocerciasis
Purpose of the trial Prevention
Anticipated trial start date 01/05/2021
Actual trial start date 12/07/2021
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date 31/10/2024
Anticipated target sample size (number of participants) 1448
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://bmjopen.bmj.com/content/11/9/e050341
Secondary Ids Issuing authority/Trial register
IRB202103 Institutional Review Board of the Cameroon Baptist Convention Health Board
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Slash and Clear to destroy blackfly breeding sites Once a year 2 years The "Slash and Clear" (S&C) technique consists of clearing the vegetation at blackfly breeding sites: Trained volunteers will be deployed to the blackfly breeding sites, where they will cut the trailing vegetation from the water and throw it on the river banks to dry, thereby killing the adherent blackfly larvae. Volunteers will be trained to measure blackfly biting rates (via Human landing catches) at baseline and prospectively throughout the study period. Of note, S&C will be done between the months of April-May of the second and third study years because April marks the transition from the dry to the rainy season in Cameroon, which is the recommended period for the intervention. All eligible residents will be treated with ivermectin (by the Ministry of Public Health, annually) as standard care for onchocerciasis prevention. 724
Control Group No Slash and clear in the control villages NA 2 years No slash and clear intervention will be performed in control villages. However the residents will benefit from annual ivermectin mass treatment (done by the government) as standard care for onchocerciasis prevention, same as ivermectin treatment will be given annually to the intervention villages as well. 724 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ages 3-6 years for Ov16 seroprevalence studies, and aged >5 years for skin snip studies Villages within 5 Km of blackfly breeding sites, with recent data confirming ongoing onchocerciasis transmission Villages that are not directly close to the blackfly breeding sites (second line villages) even if they are located within 5 Km. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 3 Year(s) 50 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 19/01/2021 Institutional Review Board of the Cameroon Baptist Convention Health Board
Ethics Committee Address
Street address City Postal code Country
Baptist Center, Nkwen - Bamenda Bamenda PO Box 1 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blackfly biting rates Measured prospectively, but comparisons done annually: Month 1, 12, 24, 36
Primary Outcome Ov16 seroprevalence in children Annually: Month 1, 12, 24, 36
Secondary Outcome Microfilarial loads Annually: Month 1, 12, 24, 36
Secondary Outcome Epilepsy incidence Month 3, Month 36
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
In the villages given that it is a Community based trial. Recruitment supervised by Brain Research Africa Initiative Brain Research Africa Initiative, Nsimeyong II Yaounde 25625 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership EDCTP Anna van Saksenlaan 51 The Hague 2593 HW Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Brain Research Africa Initiative BRAIN Cameroon Nsimeyong II Yaounde 25625 Cameroon Non-profit research institution
COLLABORATORS
Name Street address City Postal code Country
Prof Alfred K Njamnshi Nsimeyong II Yaounde 25625 Cameroon
Dr Leonard Ngarka Nsimeyong II Yaounde 25625 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Nelson Siewe Fodjo jsieweking@gmail.com 00237677932608 Nsimeyong II
City Postal code Country Position/Affiliation
Yaounde 25625 Cameroon Research Officer at Brain Research Africa Initiative
Role Name Email Phone Street address
Public Enquiries Leonard Ngarka lngarka@yahoo.com 00237675005575 Nsimeyong II
City Postal code Country Position/Affiliation
Yaounde 25625 Cameroon Administrator at Brain Research Africa Initiative
Role Name Email Phone Street address
Scientific Enquiries Alfred K. Njamnshi alfred.njamnshi@brainafrica.org 00237677619964 Nsimeyong II
City Postal code Country Position/Affiliation
Yaounde 25625 Cameroon Executive Director at Brain Research Africa Initiative
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results will be available on the website of the Sponsor institution: www.brainafrica.org Informed Consent Form,Study Protocol IPD and additional documents will be available for 3 years after the end of the project. Access to the results will be open. However, access to datasets will be controlled. All requests for data will be addressed to the Principal Investigator, and upon reasonable request (as assessed by a committee composed of the principal investigator, the executive director of the sponsor institution, and others as needed), datasets for which all personal information have been codified will be shared. Secondary analysis of the collected data will be permitted, particularly for mathematical modeling of onchocerciasis transmission.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.brainafrica.org 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