Trypanocide resistance and opportunities in the era of the COVID-19 pandemic in East Africa

ISRCTN	ISRCTN54255798
DOI	https://doi.org/10.1186/ISRCTN54255798
Secondary identifying numbers	AC22065

Submission date: 10/04/2022
Registration date: 23/05/2022
Last edited: 19/01/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Liberalization of the pharmaceutical industry in several developing countries has increased farmers' access to trypanocides (veterinary drugs) without seeking prescriptions from veterinarians, enabling farmers to rely on indigenous knowledge thus raising major global health challenges. Treatments and dosages are influenced by the farmers' personal knowledge, consultations with friends and learning through trial and error while using trypanocides. A great disregard for professional consultations has led to resistance to trypanocides, especially diminazene aceturate and isometamidium chloride which are massively abused.
Individual farmers’ sentiments don’t necessarily influence the adoption of pharmacovigilance (drug safety) approaches to minimize the threat of trypanocide resistance. Perceived production costs, community superstitious beliefs, miscommunication, and adverse side effects are major barriers faced in rural communities of Africa. Common practices are increased farmer supervised vector control methods, bush burning and acaricide use, practices which raise major public health concerns of drug toxicity and environmental pollution. These practices have also been associated with enormous farm economic losses, making livestock production very unproductive. The continued lack of routine strategic national trypanocide monitoring infrastructure in several developing countries has led to the emergency of resistant trypanosomes in healthy communities. Fake trypanocides smuggled into the country and unlicensed unprofessional animal attendants continue to create further confusion in rural communities on how to effectively address trypanocide resistance.
Trypanosomiasis is a zoonotic infection involving wildlife, humans, and livestock with interlocking socioeconomic drivers, necessitating the adoption of a One Health paradigm to address challenges at the community interface. The development of trypanocide resistance implies that the World Health Organization (WHO) 2030 target is threatened should different stakeholders fail to work together. Competing interests from other neglected zoonotic diseases (NZD) in Africa implies there is a competition for capital, demonstrating a need to revise the global health strategy in developing countries. The WHO and World Trade Organization have expressed an interest in supporting studies on trypanocides, although this initiative has been slowed down by the current pandemic. Controlling NZD helps developing countries establish strong inter-multidisciplinary teams which will help them address regional epidemics and the next pandemic better.

Who can participate?
Adults who are engaged in livestock production or COVID control (veterinarians, farmers and veterinary drugshop sellers in Mbarara district, ministerial officials, local government policymakers and key academic research contacts)

What does the study involve?
This will be a questionnaire survey conducted amongst people who interact with livestock species in East Africa.

What are the possible benefits and risks of participating?
None

Where is the study run from?
University of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
April 2022 to December 2022

Who is funding the study?
1. National Institute for Health Research (UK)
2. Royal Society of Tropical Medicine and Hygiene (UK)
3. Commonwealth Scholarship Commission (UK)

Who is the main contact?
Prof. Sue Welburn
sue.welburn@ed.ac.uk

Contact information

Dr Keneth Iceland Kasozi
Principal Investigator

1 George Square
Infection Medicine, Deanery of Biomedical Sciences
College of Medicine and Veterinary Medicine
University of Edinburgh
Edinburgh
EH8 9JZ
United Kingdom

ORCID ID	0000-0002-5763-7964
Phone	+44 (0)7495572560
Email	keneth.kasozi@ed.ac.uk

Study information

Study design	Observational cross sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Community
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Trypanocide resistance and COVID
Study acronym	TrypCOV
Study objectives	Poor pharmacovigilance practices are responsible for the increasing trypanocide resistance in developing countries in an era of the pandemic
Ethics approval(s)	1. Approved 10/06/2022, Edinburgh Medical School Research Ethics Committee (EMREC, Welcome Trust Centre for Cell Biology, Michael Swann Building, King's Buildings, Mayfield Road, Edinburgh, EH9 3BF, UK; Tel: not provided; emrec@ed.ac.uk), ref: 22-EMREC-022 2. Approved 14/07/2022, School of Veterinary Medicine and Animal Resources Institutional Animal Care and Use Committee (SVAR IACUC, Makerere University, College of Veterinary Medicine, Animal Resources and Biosecurity, PO Box 7062, Kampala, Uganda; Tel: not provided; svariacuc.irb@gmail.com), ref: SVAR-IACUC/114/2022
Health condition(s) or problem(s) studied	Antimicrobial resistance
Intervention	This will be done in the Mbarara district of southwestern Uganda. Study areas in Mbarara are Kashari, Rwampara and Biharwe subcounty. This will be done strategically leaving out the city center which has all the veterinary drug pharmacies. In each subcounty, after reading the participant information form (Appendix I and II) and filing in the data consent form (Appendix III), 384 farmers will be chosen and a questionnaire will be administered by the Chief Investigator (Appendix IV-V). In a follow-up survey, a qualitative case study methodology with an inductive thematic approach will be applied in Uganda and Tanzania to help categorize the institutional current level of preparedness to handle the COVID-19 pandemic as previously described (Elton et al., 2021). The study will explore barriers and facilitators to more resilient and sustainable policy, explore policy networks and identify opportunities to strengthen national One Health coordination mechanisms (A. L. Okello et al., 2014). To assess how and where to apply the One Health in the pandemic control strategies, key informant interviews from the Ministry of Health, Ministry of Agriculture Animal Industry and Fisheries (MAAIF), Ministry of Gender, National Environmental Management Authority (NEMA), Uganda Wildlife Authority (UWA) and Ministry of Justice will be conducted in Uganda and Tanzania.
Intervention type	Other
Primary outcome measure	Knowledge of, attitudes towards and practices leading to trypanocide resistance assessed using a questionnaire at a single timepoint
Secondary outcome measures	Government policy regarding trypanocide resistance assessed using interviews with policy makers at a single timepoint
Overall study start date	10/04/2022
Completion date	20/12/2022

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	384
Total final enrolment	570
Key inclusion criteria	1. Willing and able to provide written informed consent 2. Study 1: veterinarians, farmers and veterinary drugshop sellers in Mbarara district 3. Study 2: ministerial officials, local government policymakers and key academic research contacts
Key exclusion criteria	Study I: 1. Unwilling or unable to provide written informed consent 2. Conflict of interest i.e., drug company officials and politicians Study II: 1. Unwillingness to provide consent 2. Failure to establish contact with participants due to unreliable appointments 3. Persons in influential political positions who could offer a biased opinion (e.g., opposition politicians and persons in the community)
Date of first enrolment	20/07/2022
Date of final enrolment	20/12/2022

Locations

Countries of recruitment

Tanzania
Uganda

Study participating centre

University of Edinburgh

Old College
South Bridge
Edinburgh
EH8 9YL
United Kingdom

Sponsor information

University of Edinburgh
University/education

ACCORD
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH1 64TJ
Scotland
United Kingdom

Phone	+44 (0)131 242 9100
Email	ellie.mcmaster@ed.ac.uk
Website	https://www.ed.ac.uk/medicine-vet-medicine/institutes-centres-facilities-networks/institutes-and-centres/queens-medical-research
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Government

Royal Society of Tropical Medicine and Hygiene
Private sector organisation / Associations and societies (private and public)

Alternative name(s): RSTMH
Location: United Kingdom

Commonwealth Scholarship Commission
Government organisation / Other non-profit organizations

Alternative name(s): Commonwealth Scholarship Commission UK, Commonwealth Scholarship Commission, United Kingdom, CSC
Location: United Kingdom

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	20/03/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		13/12/2023	18/12/2023	Yes	No
Dataset			19/01/2024	No	No

Editorial Notes

19/01/2024: A link to a dataset was added.
24/01/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2022 to 20/12/2022.
2. The overall trial end date was changed from 30/11/2022 to 20/12/2022.
3. The intention to publish date was changed from 23/12/2022 to 20/03/2023.
4. Total final enrolment added.
31/08/2022: Ethics approval details added.
17/06/2022: The following changes have been made:
1. The funder has been changed from the National Institute for Medical Research (Tanzania) to the National Institute for Health Research (UK).
2. The recruitment start date has been changed from 15/06/2022 to 20/07/2022.
26/04/2022: Trial's existence confirmed by the University of Edinburgh.