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.: PACTR202405854213937 Date of Approval: 24/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of collective community action on the uptake of animal vaccination services, antimicrobial usage, and farmers’ wellbeing in Ghana
Official scientific title Effects of collective community action on the uptake of animal vaccination services, antimicrobial usage, and farmers’ wellbeing in Ghana
Brief summary describing the background and objectives of the trial Infectious animal diseases represent a major constraint to the productivity of livestock in many developing countries. Poor control of infectious animal diseases causes significant livelihood losses to farmers and threatens their food security. To minimize the impact of the diseases, farmers frequently use antimicrobials without professional veterinary advice, potentially yielding medicine residues in livestock products in the food chain, as well as resistant pathogens. Recent studies in Ghana identified Contagious Bovine Pleuropneumonia (CBPP) and Pestes-des-petits ruminants (PPR) as the two infectious diseases most negatively affecting farmers’ wellbeing. Although effective CBPP and PPR vaccines are approved and available in Ghana, acceptability, affordability, accessibility, and availability of vaccination, limit their uptake. As a result, less than 20% of farmers currently vaccinate their herds on a regular basis. During group discussions conducted as part of my previous studies, farmers proposed that formation of localized farmer networks could mitigate most of their challenges. The main idea of these networks is to facilitate information exchange on the value of animal vaccines, enhance scheduling, and share the vaccination costs among farmers living in the same locality, thereby improving access and uptake of animal vaccines. We now wish to test formally this hypothesis. Through a cluster-randomized controlled trial, we aim to determine the potential effects of localized farmer networks on animal vaccination uptake, antimicrobials use in livestock production, disease-induced mortality in livestock, and wellbeing of livestock dependent populations. The findings of this study will inform strategies to tackle the impact of infectious livestock diseases on food security, public health and farmers’ wellbeing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CCAVI
Disease(s) or condition(s) being studied Infectious livestock diseases - Contagious Bovine Pleuropneumonia and Pestes-des-petits ruminants
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/05/2024
Actual trial start date
Anticipated date of last follow up 30/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 460
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
Parallel: different groups receive different interventions at same time 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 Collective Community Action for Vaccination Initiative 12 months The intervention package will entail the training from each intervention community of at least two persons - depending on community size - on vaccine effectiveness, profitability and safety, personal and community level benefits of vaccination, scheduling for vaccination of the priority diseases with veterinary personnel, and herd vulnerability to CBPP and PPR infections. The training module will also include guidance on how to organize and run a farmer cooperative group, to empower trainees. The intervention package will be delivered at baseline, and reinforced at the midpoint follow-up period (6 months). Each trained individual will receive a register to keep records of local network members, meeting days and meeting minutes. The trained individuals will then create their respective local network of farmers within the intervention communities, and schedule vaccination visits with veterinary personnel. The veterinary personnel will also be provided with registers to record all vaccination requests received from all farmers, and the number of requests honored (in both study arms), as well as any adverse events following vaccination. A radio sensitization program will be held to inform all livestock farmers in both study arms about the vaccines availability. The program will be broadcast live on local radio stations in each study district, and the recordings repeated over two weeks prior to intervention implementation to sensitize the communities. The broadcasts will be done in the local languages by veterinary personnel in the study districts, with support from the research team. In one of the study districts, we will evaluate the effect of the provision of an add-on intervention to half of the intervention communities. This add-on intervention entails three discount vouchers worth 25%, 50% and 75% of the cost of vaccinating eligible animals in a farmers’ herd. The farmers in selected communities will ballot for the vouchers during the first local network meeting. 230
Control Group Collective Community Action for Vaccination Initiative 12 months In the control communities, the existing standard of care remains, whereby farmers schedule vaccination visits with veterinary personnel on their own or individually. To ensure that control communities are aware of the availability and effectiveness of the vaccines, the radio sensitization program will be held to inform all livestock farmers in both study arms about the vaccines availability. The program will be broadcast live on local radio stations in each study district, and the recordings repeated over two weeks prior to intervention implementation to sensitize the communities. The broadcasts will be done in the local languages by veterinary personnel in the study districts, with support from the research team. 230 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Household owns at least 3 Tropical Livestock Units (TLUs) of eligible ruminants that are at least 3 months old. The farmer is a permanent resident in area with no intention of emigration during the study period Caretaker farmers who do not own the minimum TLUs of the livestock in the herds kept 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 120 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 04/04/2024 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Castle Rd, Adabraka Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Level of uptake for vaccines against CBPP for cattle owners, and PPR for sheep and goat owners Is assessed at 6 months, and at 12 months after the delivery of training at baseline
Secondary Outcome Frequency and quantity of antimicrobials used by farmers per month Is assessed at 6 months, and at 12 months after the delivery of training at baseline
Secondary Outcome Proportion of livestock herd dying due to disease Is assessed at 12 months after the delivery of training at baseline
Secondary Outcome Farmers’ wellbeing on the physical, psychological, social, and environment domains Is assessed at 6 months, and at 12 months after the delivery of training at baseline
Secondary Outcome Acceptability and feasibility to scale of CCAVI to the key stakeholders including farmers and veterinary service providers Is assessed at 6 months, and at 12 months after the delivery of training at baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mion District 14 villages - 7 intervention and 7 control Sang Ghana
Pru East district 14 villages - 7 intervention and 7 control villages Yeji Ghana
Kwahu Afram Plains South District 18 villages - 9 intervention and 9 control villages Tease Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Science for Africa Foundation 3 Riverside Drive Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre Suisse de Recherches Scientifiques Rte de Dabou Abidjan Cote Divoire Research Institution
COLLABORATORS
Name Street address City Postal code Country
Guenther Fink Kreuzstrasse 2 Allschwil 4123 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francis Sena Nuvey fsnuvey@gmail.com +233504991496 Daytona Street, Adenta
City Postal code Country Position/Affiliation
Accra Ghana Scientist
Role Name Email Phone Street address
Scientific Enquiries Bassirou Bonfoh bassirou.bonfoh@csrs.ci +2250103488960 Rt de Dabou
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Director
Role Name Email Phone Street address
Public Enquiries Francis Sena Nuvey fsnuvey@gmail.com +233504991496 Daytona Street, Adenta
City Postal code Country Position/Affiliation
Accra Ghana Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices). The study protocol will be submitted for publication in an open access peer reviewed journal. The study data will be published alongside the results in the journal article. Analytic Code,Informed Consent Form,Study Protocol Immediately alongside the study results Data will be accessed by anyone subject to the compliance with journal copyright conditions
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