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.: PACTR202107762759962 Date of Approval: 19/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the effectiveness of the Kidogo model in empowering women and strengthening their capacities to engage in paid labor opportunities through provision of quality childcare: An exploratory study in Nakuru County
Official scientific title Evaluating the effectiveness of the Kidogo model in empowering women and strengthening their capacities to engage in paid labor opportunities through provision of quality childcare: An exploratory study in Nakuru County
Brief summary describing the background and objectives of the trial Abstract Background: Worldwide, there is a wide gap between what women can contribute to the economy and what they actually contribute. One of the main barriers to women’s engagement in the labor market and productivity at work is the fact that they have to take care of their families in addition to meeting the demands of their employment. Building on the findings from an earlier study done by the APHRC, we would like to identify a scalable childcare model for enhancing the economic outcomes of women living in low-income communities in Kenya. Such models will assist women in balancing childcare and economic productivity through reducing the time that they spend on childcare and using that time in the labor market and other economic activities. Kidogo runs an innovative “Hub & Spoke” model for low-income communities based on a two-fold approach: first, establishing best-practice early childhood development (ECD) “hubs” with a holistic curriculum. Secondly, Kidogo works to improve the quality of local babycare centers, referred to as “spokes” through its micro-franchising program with “mamapreneurs”. Objectives: The purpose of the project is to evaluate the effectiveness of the Kidogo model in empowering women through provision of quality childcare. The overall objective of the proposed study is to evaluate whether provision of quality childcare opportunities for working women through the Kidogo model is feasible and acceptable, and whether it contributes to improvements in their incomes and productivity at work. Study design: The study will employ a quasi-experimental design with two study arms, that is, intervention and comparison groups. We will use a mixed methods approach that combines quantitative, qualitative data collection methods and records review. The intervention group will be purposively selected and a matched comparison will be recruited based on population size and background characteristics.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Baseline
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 12/07/2021
Actual trial start date
Anticipated date of last follow up 03/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 340
Actual target sample size (number of participants)
Recruitment status 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 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 Will comprise women using quality childcare services in the Kidogo hub and spokes 18 months Kidogo will establish one community “hub” center, one employer-supported childcare center and 20-40 spokes. The partnership with spokes will begin with identification, mapping and recruitment of mamapreneurs. Through the social franchising approach, Kidogo will provide training, mentorship, new skills and tools that will help the mamapreneurs improve the quality and profitability of their childcare micro-businesses, as well as grow their businesses. Specifically, Kidogo will take mamapreneurs through a nine-month program that offers monthly workshops on an ECD or business-related theme. This will be followed by a bi-weekly, two-hour on-site coaching/mentoring visit by a Franchising Officer. In recognition of the limitations of in-person interactions occasioned by the COVID-19 pandemic, Kidogo will include a smartphone in its Starter Kit. The smartphone is an essential engagement and business management tool as it will enable the mamapreneurs to participate virtually in training, receive updates and have meetings with the franchising team. The internet cost will be borne by Kidogo. The phones will also enable the team to follow-up on the business operations of the mamapreneurs in real time. 170
Control Group will comprise women using childcare services in other centers that are not supported by Kidogo 24 months Will comprise women using childcare services in other centers that are not supported by Kidogo 170 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All primary caregivers of children aged between six and 36 months will be eligible for inclusion in the study. Families will be selected on the basis of their vulnerability status (for example, teenage mothers, poor health and nutrition indicators, HIV exposure, and poverty levels). They will be long-term residents (more than one year) of the study area. Any short-term residents (less than one year) will be excluded from the study. Caregivers with children above three years will also be excluded from the study. Also excluded will be women (or men) incapable of giving consent (e.g. those with mental illness). Adult: 19 Year-44 Year 19 Year(s) 44 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 28/06/2021 AMREF Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 30125-00100-Nairobi Nairobi 30125 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Women labour outcomes 3
Secondary Outcome Cost and cost-effectiveness of the Kidogo Program Quaterly for 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
African Population and Health Research Center APHRC Campus, Kitisuru,Nairobi, Kenya Nairobi 10787 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
IDRC Canada K1G 3H9 Ontario 8500 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African Population and Health Research Centre APHRC Campus, Kitisuru,Nairobi, Kenya Nairobi 10787 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patricia Wekulo pwekulo@aphrc.org +254204001000 APHRC Campus, Kitisuru,Nairobi, Kenya
City Postal code Country Position/Affiliation
Nairobi 10787 Kenya Associate Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Kenneth Okelo kokelo@aphrc.org +254204001000 APHRC Campus, Kitisuru,Nairobi, Kenya
City Postal code Country Position/Affiliation
Nairobi 10787 Kenya African Population and Health Research Center
Role Name Email Phone Street address
Public Enquiries Pauline Ochieng pochieng@aphrc.org +254204001000 APHRC Campus, Kitisuru,Nairobi, Kenya
City Postal code Country Position/Affiliation
Nairobi 10787 Kenya African Population and Health Research Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Analyzed summary of recruited participants Informed Consent Form,Study Protocol 24 months Controlled, through email
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