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.: PACTR202312684981844 Date of Registration: 13/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Empowering Informal Food Vendors in LMICs: Enhancing Business Skills, Practices, and Food Safety through Training and Mentoring
Official scientific title Empowering Informal Food Vendors in LMICs: Enhancing Business Skills, Practices, and Food Safety through Training and Mentoring
Brief summary describing the background and objectives of the trial The informal markets in urban and per-urban areas of low- and middle-income countries are a crucial source of food for the built-up populations. These informal markets are a major source of employment for the urban poor, and a significant proportion of these informal vendors are women who encounter additional problems such as low wages, unsafe environments, a lack of security, and increased household responsibilities. Together with partners International Potato Centre (CIP) and International Rice Research Institute (IRRI), the International Livestock Research Institute (ILRI) has developed a program/strategy known as Vendor Business School (VBS) to empower small food vendors and equip them with the essential knowledge, skills, and resources to overcome their daily business challenges and improve their food safety practices. The program encompasses training and mentoring of the vendors on entrepreneurship, business planning, budgeting, marketing, risk management, rapid technology changes, financial linkages, and food safety. The objective of this study is to comprehensively evaluate the effectiveness of training and mentoring in VBS aimed at enhancing business improvement skills, business practices, and food safety among informal food vendors (specifically women) operating in LMICs. The study seeks to assess the extent to which such trainings contribute to the vendors' business growth, adherence to food safety standards, and overall economic well-being, thereby informing policy and programmatic decisions to support this vital sector.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Food safety, women empowerment, and business performance
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 08/01/2024
Actual trial start date
Anticipated date of last follow up 30/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program 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 Vendor business school Six months (Training and coaching) The VBS sessions consist of a scheme of training and mentoring for the milk vendors operating in the informal sector. The components of each are explained below: Training: The participants in the treatment arm will be given training on basic entrepreneurial skills, financial literacy, digital literacy, financial linkages, and linkages to small and medium enterprises. They will be sensitized about achieving a healthy work-life balance and time management. Mentorship/coaching: Individual mentorship (this method will be employed when dealing with a single entrepreneur (woman milk vendor)). Fortnightly or monthly visits will be done over a period of 6 months. An individual mentorship guide will guide the discussions and the focus of the visits. Group mentorship (one mentor attached to several mentees). The session is a combination of peer and senior mentoring. This session will be done once every 2–3 months. Experienced mentors will lead the sessions and offer participants advice, support, and useful tools to help them advance their knowledge and skills in their respective fields. Additionally, the group mentoring sessions will provide a platform for networking and collaboration among participants, fostering a sense of community and shared learning. * Inspirational talks: successful women entrepreneurs will be invited to meet with the trainees on a quarterly basis. This will be a voluntary event where the entrepreneurs will share their experiences and answer any questions the trainees may have. 125
Control Group Vendor business school 2-3 weeks The control group will receive no alternative intervention during the trial. After the endline, the participants in the control arm will receive 2-3 individual coaching sessions and will get copy of the training materials used in the VBS training sessions. 125 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Women vendors who work at least five days per week in the informal dairy industry (selling unpackaged milk, not formally processed milk) and intend to stay in the business for at least the next 12 months. 2. Run a milk bar (exclusively selling dairy products and eggs), a shop or kiosk (licensed to sell other products), or be a street vendor (selling in a specified location along the street rather than in a permanent building structure). 1. The vendor cannot run a milk dispenser or be a mobile vendor (selling from a cart or bicycle). 2. Vendors operating out of farm gates. Adult: 18 Year(s)-44 Year(s) 19 Year(s) 80 Year(s) Female
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
No 23/11/2023 Institutional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
International Livestock Research Institute, Old Naivasha road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Business net profit Before and after intervention in both groups
Primary Outcome Food safety: Proportion of vendors adopting at least one new good milk safety practice Before and after intervention in both groups
Secondary Outcome Turnover rate (volume of milk sold/month) Before and after intervention in both the groups
Secondary Outcome - Business revenue (amount earned/month) Before and after intervention in both groups
Secondary Outcome Cost structure (expenses) Before and after intervention in both groups
Secondary Outcome Women empowerment: access to financial services; entrepreneurial psychology (aggregated score), self-efficacy (aggregated score), autonomy in income (decision-making) Before and after intervention in both groups
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
International Livestock Research Institute ILRI ILRI, Old Naivasha Road, near Uthiru Nairobi 00101 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
CGIAR trust fund CGIAR System Organization 1000, Avenue Agropolis Montpellier F-34394 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Livestock Research Institute ILRI, Old Naivasha Road, near Uthiru Nairobi 00100 Kenya Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
International Potato Center CIP Avenida La Molina 1895, La Molina Apartado Lima 1558 Peru
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Silvia Alonso s.alonso@cgiar.org 983983245 International Livestock Research Institute
City Postal code Country Position/Affiliation
Addis Ababa 5689 Ethiopia Principal scientist
Role Name Email Phone Street address
Public Enquiries Hung Nguyen h.nguyen@cgiar.org 204223036 International Livestock Research Institute
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Coleader Animal and Human Health Program
Role Name Email Phone Street address
Scientific Enquiries Garima Sharma G.Sharma@cgiar.org 786039646 International Livestock Research Institute
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Post Doctoral researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlies the results will be reported in this trial, after anonymization Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years From publishing journal website and request from principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
NA 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