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.: PACTR202204635504887 Date of Approval: 25/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Examining the effects of maternal mental health on child health outcomes (early childhood development, nutrition and poverty-related diseases)
Official scientific title Examining the effects of maternal mental health on child health outcomes (early childhood development, nutrition and poverty-related diseases)
Brief summary describing the background and objectives of the trial The study addressed the critical gaps in maternal mental health research in Africa. By systematically reviewing existing research in Africa and conducting field studies in Kenya, we aimed to understand the epidemiology, determinants, effects and accessibility of care related maternal mental health. We analysed a longitudinal data from a cohort of low-income rural families, focusing on the relationship between maternal mental health problems (depressive symptoms) and early childhood development, nutrition and common poverty-related childhood illnesses. The specific objectives include: 1. to examine the epidemiology of maternal mental health in Africa. 2. to investigate the effect of maternal mental health on child health (poverty-related childhood diseases or infections), early childhood development and nutrition outcomes (malnutrition). 3. to identify modifiable determinants in the path from maternal mental health to poor child health, development and nutrition outcomes. 4. to investigate the trajectory of maternal mental health and associated risk factors.
Type of trial Observational
Acronym (If the trial has an acronym then please provide) iPUSH RCT EDCTP
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Neonatal Diseases,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 18/10/2019
Actual trial start date 18/10/2019
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 31/12/2023
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 240
Recruitment status Completed
Publication URL https://pubmed.ncbi.nlm.nih.gov/34526072/
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
Single Group Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
Single Group Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group iPUSH NA One year. The intervention was excluded from the final analyses due to an insufficient sample size for the perinatal depression outcome across the study period. Consequently, the analysis employed a cross-sectional study design, which has been rigorously justified and included in the final submitted/approved report. This shift was necessary to ensure the robustness of the findings. However, this has not significant changed overall study objectives, participant characteristics, etc. For a comprehensive overview of the study's objectives and results, please refer to the respective sections of the final report, where detailed insights are provided. 120
Control Group No iPUSH NA One year Control group is subjected to the standard services provided by the providers in the designated health facility. 120 Uncontrolled
Experimental Group iPUSH NA One year. The intervention was excluded from the final analyses due to an insufficient sample size for the perinatal depression outcome across the study period. Consequently, the analysis employed a cross-sectional study design, which has been rigorously justified and included in the final submitted/approved report. This shift was necessary to ensure the robustness of the findings. However, this has not significant changed overall study objectives, participant characteristics, etc. For a comprehensive overview of the study's objectives and results, please refer to the respective sections of the final report, where detailed insights are provided. 120
Control Group No iPUSH NA One year Control group is subjected to the standard services provided by the providers in the designated health facility. 120 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A cohort of low-income rural/semi-urban village households with either pregnant women or women of reproductive age group with under 4 child(-ren). Rural/semi-urban village households without pregnant women or women of reproductive age group with under 4 child(-ren) either. Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 4 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 08/11/2021 Amref Health Africa ESRC
Ethics Committee Address
Street address City Postal code Country
Wilson Airport Nairobi 30125, 00 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child health, developmental and nutritional outcomes. Baseline, midline and endline for child health and nutrtion, and endline for child development.
Secondary Outcome Maternal mental health Baseline, midline and endline, and at additional two points.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KWHISERO TOWN NB - STREET ADDRESS IS NOT APPLICABLE/AVAILABLE FOR THIS CENTER. KWHISERO NA Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 2509 AA The Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor APHRC APHRC Campus, Manga Close, Off Kirawa Road Nairobi Kenya Research Centre
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amanuel Abajobir aabajobir@aphrc.org +254721141014 APHRC Campus, Manga Close, Off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi Kenya Associate Research Scientist at APHRC
Role Name Email Phone Street address
Scientific Enquiries Estelle Sidze esidze@aphrc.org +254204001000 APHRC Campus, Kitisuru
City Postal code Country Position/Affiliation
Nairobi Kiribati Research Scientistsupervisor
Role Name Email Phone Street address
Public Enquiries APHRC APHRC info@aphrc.org +254204001000 APHRC Campus, Kitisuru
City Postal code Country Position/Affiliation
Nairobi Kenya Host organisation
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD was kept in The Host Organisation’s safe data repository, after being automatically encrypted by the Secure Sockets Layer (SSL) and doubly-encrypted. IDP was anonymised, and will be available upon request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol It is available in anonymous manner (since March 2024). It will be accessible to any researchers and/or reviewer who might perform some new data analysis and/or review the data once decided by the principal investigator and other research team members, and following health, ethical authorities and funder’s legislation/guidelines (e.g., national data sharing policy and EU legislation).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No available yet but will be provided upon availability. 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 17/07/2024 Edited based on the updated protocol. The impact of maternal perinatal depression on child health outcomes and the role of Innovative Partnership for Universal and Sustainable Healthcare (i-PUSH) intervention Examining the impact of maternal mental health on child health outcomes and the role of Innovative Partnership for Universal and Sustainable Healthcare (i-PUSH) intervention: a cluster randomised controlled trial study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 24/10/2024 The scope of the final dataset and related analyses/report prompted this edit. Examining the impact of maternal mental health on child health outcomes and the role of Innovative Partnership for Universal and Sustainable Healthcare (i-PUSH) intervention: a cluster randomised controlled trial study Examining the effects of maternal mental health on child health outcomes (early childhood development, nutrition and poverty-related diseases)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 17/07/2024 Edited based on the updated protocol. Examining the impact of maternal perinatal depression on child health outcomes and the role of Innovative Partnership for Universal and Sustainable Healthcare (i-PUSH) intervention: a cluster randomised controlled trial study Secondary title: Examining the effect of COVID-19 on maternal mental health: the roles of pregnancy and i-PUSH intervention Examining the impact of maternal mental health on child health outcomes and the role of Innovative Partnership for Universal and Sustainable Healthcare (i-PUSH) intervention: a cluster randomised controlled trial study Secondary title: Examining the effect of COVID-19 on maternal mental health
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 24/10/2024 The scope of the final dataset and related analyses/report prompted this edit. Examining the impact of maternal mental health on child health outcomes and the role of Innovative Partnership for Universal and Sustainable Healthcare (i-PUSH) intervention: a cluster randomised controlled trial study Secondary title: Examining the effect of COVID-19 on maternal mental health Examining the effects of maternal mental health on child health outcomes (early childhood development, nutrition and poverty-related diseases)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 23/09/2021 To address reviewers comments. The burden of maternal perinatal depression in low- and middle-income countries (LMICs) and its consequences on child health and development are emerging public health problems. Although the pathways connecting maternal perinatal depression and poor childhood outcomes are likely to be complex and varied, perinatal depression during this critical period is more likely associated with poor health, developmental and nutritional outcomes in children. However, data on maternal mental healthcare, including perinatal depression, is meager, with limited evidence on feasible detection and treatment strategies, lack of specialist services, lack of guidelines for pregnant and breastfeeding mothers, and stigmatising attitudes among primary healthcare workers and the community. This study aims to investigate the effect of maternal perinatal depression on child health, developmental and nutritional outcomes and whether an innovative partnership for sustainable and healthcare (i-PUSH) intervention using digital technology (mhealth) modifies perinatal depression and its effect on child health, development and nutrition. It also examines the effect of COVID-19 on maternal overall mental health and whether this effect varies by i-PUSH intervention. In addition, it explores the trajectory of maternal mental health over time and characterizes the trajectory by baseline socioeconomic and health status as well as adverse financial or health-related shocks. This is a nested study on the main RCT study to evaluate the impact of i-PUSH on maternal on maternal and child health care utilisation, health outcomes and financial protection, registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571 : AEARCTR-0006089 ; date: 29 August 2019) and The American Economic Association's registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020). The burden of maternal perinatal depression in low- and middle-income countries and its consequences on child health and development are emerging public health problems. Perinatal depression during this critical period is more likely associated with poor health, developmental and nutritional outcomes in children. However, data on maternal mental healthcare, including perinatal depression, is meager, with limited evidence on feasible detection and treatment strategies, lack of specialist services, lack of guidelines for pregnant and breastfeeding mothers, and stigmatising attitudes among primary healthcare workers and the community. This study aims to investigate the effect of maternal perinatal depression on child health, developmental and nutritional outcomes and whether an innovative partnership for sustainable and healthcare intervention using digital technology (mhealth) modifies perinatal depression and its effect on child health, development and nutrition. It also examines the effect of COVID-19 on maternal overall mental health and whether this effect varies by i-PUSH intervention. In addition, it explores the trajectory of maternal mental health over time and characterizes the trajectory by baseline socioeconomic and health status as well as adverse financial or health-related shocks. This is a nested study on the main RCT study to evaluate the impact of i-PUSH on maternal on maternal and child health care utilisation, health outcomes and financial protection, registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571 : AEARCTR-0006089 ; date: 29 August 2019) and The American Economic Association's registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020). This study uses data collected as part of the main RCT and does not provide other intervention to any group. Hence, additional data collection points are just supplementary to the already collected data as part of the main study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 23/09/2021 To address reviewers comments. The burden of maternal perinatal depression in low- and middle-income countries and its consequences on child health and development are emerging public health problems. Perinatal depression during this critical period is more likely associated with poor health, developmental and nutritional outcomes in children. However, data on maternal mental healthcare, including perinatal depression, is meager, with limited evidence on feasible detection and treatment strategies, lack of specialist services, lack of guidelines for pregnant and breastfeeding mothers, and stigmatising attitudes among primary healthcare workers and the community. This study aims to investigate the effect of maternal perinatal depression on child health, developmental and nutritional outcomes and whether an innovative partnership for sustainable and healthcare intervention using digital technology (mhealth) modifies perinatal depression and its effect on child health, development and nutrition. It also examines the effect of COVID-19 on maternal overall mental health and whether this effect varies by i-PUSH intervention. In addition, it explores the trajectory of maternal mental health over time and characterizes the trajectory by baseline socioeconomic and health status as well as adverse financial or health-related shocks. This is a nested study on the main RCT study to evaluate the impact of i-PUSH on maternal on maternal and child health care utilisation, health outcomes and financial protection, registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571 : AEARCTR-0006089 ; date: 29 August 2019) and The American Economic Association's registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020). This study uses data collected as part of the main RCT and does not provide other intervention to any group. Hence, additional data collection points are just supplementary to the already collected data as part of the main study The burden of maternal perinatal depression in low- and middle-income countries and its consequences on child health and development are emerging public health problems. Perinatal depression during this critical period is more likely associated with poor health, developmental and nutritional outcomes in children. However, data on maternal mental healthcare, including perinatal depression, is meager, with limited evidence on feasible detection and treatment strategies, lack of specialist services, lack of guidelines for pregnant and breastfeeding mothers, and stigmatising attitudes among primary healthcare workers and the community. This study aims to investigate the effect of maternal perinatal depression on child health, developmental and nutritional outcomes and whether an innovative partnership for sustainable and healthcare intervention using digital technology (mhealth) modifies perinatal depression and its effect on child health, development and nutrition. It also examines the effect of COVID-19 on maternal overall mental health and whether this effect varies by i-PUSH intervention. In addition, it explores the trajectory of maternal mental health over time and characterizes the trajectory by baseline socioeconomic and health status as well as adverse financial or health-related shocks. This is a nested study on the main RCT study to evaluate the impact of i-PUSH on maternal on maternal and child health care utilisation, health outcomes and financial protection, registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571; date: 29 August 2019) and The American Economic Association's registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020). This study uses data collected as part of the main RCT and does not provide other intervention to any group. Additional data collection points are supplementary to the already collected data as part of the main study to address the nested study.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 17/07/2024 Minor edition as per the close-out report. The burden of maternal perinatal depression in low- and middle-income countries and its consequences on child health and development are emerging public health problems. Perinatal depression during this critical period is more likely associated with poor health, developmental and nutritional outcomes in children. However, data on maternal mental healthcare, including perinatal depression, is meager, with limited evidence on feasible detection and treatment strategies, lack of specialist services, lack of guidelines for pregnant and breastfeeding mothers, and stigmatising attitudes among primary healthcare workers and the community. This study aims to investigate the effect of maternal perinatal depression on child health, developmental and nutritional outcomes and whether an innovative partnership for sustainable and healthcare intervention using digital technology (mhealth) modifies perinatal depression and its effect on child health, development and nutrition. It also examines the effect of COVID-19 on maternal overall mental health and whether this effect varies by i-PUSH intervention. In addition, it explores the trajectory of maternal mental health over time and characterizes the trajectory by baseline socioeconomic and health status as well as adverse financial or health-related shocks. This is a nested study on the main RCT study to evaluate the impact of i-PUSH on maternal on maternal and child health care utilisation, health outcomes and financial protection, registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571; date: 29 August 2019) and The American Economic Association's registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020). This study uses data collected as part of the main RCT and does not provide other intervention to any group. Additional data collection points are supplementary to the already collected data as part of the main study to address the nested study. The burden of maternal mental health in low- and middle-income countries and its consequences on child health and development are emerging public health problems. Poor maternal mental health during this critical period is more likely associated with poor health, developmental and nutritional outcomes in children. However, data on maternal mental healthcare, including perinatal depression, is meager, with limited evidence on feasible detection and treatment strategies, lack of specialist services, lack of guidelines for pregnant and breastfeeding mothers, and stigmatising attitudes among primary healthcare workers and the community. This study aims to investigate the effect of maternal mental health on child health, developmental and nutritional outcomes and whether an innovative partnership for sustainable and healthcare intervention using digital technology (mhealth) modifies perinatal depression and its effect on child health, development and nutrition. In addition, it explores the trajectory of maternal mental health over time and characterizes the trajectory by baseline socioeconomic and health status as well as adverse financial or health-related shocks. This is a nested study on the main RCT study to evaluate the impact of i-PUSH on maternal on maternal and child health care utilisation, health outcomes and financial protection, registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571; date: 29 August 2019) and The American Economic Association's registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020). This study uses data collected as part of the main RCT and does not provide other intervention to any group. Additional data collection points are supplementary to the already collected data as part of the main study to address the nested study.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 24/10/2024 The scope of the final dataset and related analyses/report prompted this edit. The burden of maternal mental health in low- and middle-income countries and its consequences on child health and development are emerging public health problems. Poor maternal mental health during this critical period is more likely associated with poor health, developmental and nutritional outcomes in children. However, data on maternal mental healthcare, including perinatal depression, is meager, with limited evidence on feasible detection and treatment strategies, lack of specialist services, lack of guidelines for pregnant and breastfeeding mothers, and stigmatising attitudes among primary healthcare workers and the community. This study aims to investigate the effect of maternal mental health on child health, developmental and nutritional outcomes and whether an innovative partnership for sustainable and healthcare intervention using digital technology (mhealth) modifies perinatal depression and its effect on child health, development and nutrition. In addition, it explores the trajectory of maternal mental health over time and characterizes the trajectory by baseline socioeconomic and health status as well as adverse financial or health-related shocks. This is a nested study on the main RCT study to evaluate the impact of i-PUSH on maternal on maternal and child health care utilisation, health outcomes and financial protection, registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571; date: 29 August 2019) and The American Economic Association's registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020). This study uses data collected as part of the main RCT and does not provide other intervention to any group. Additional data collection points are supplementary to the already collected data as part of the main study to address the nested study. The study addressed the critical gaps in maternal mental health research in Africa. By systematically reviewing existing research in Africa and conducting field studies in Kenya, we aimed to understand the epidemiology, determinants, effects and accessibility of care related maternal mental health. We analysed a longitudinal data from a cohort of low-income rural families, focusing on the relationship between maternal mental health problems (depressive symptoms) and early childhood development, nutrition and common poverty-related childhood illnesses. The specific objectives include: 1. to examine the epidemiology of maternal mental health in Africa. 2. to investigate the effect of maternal mental health on child health (poverty-related childhood diseases or infections), early childhood development and nutrition outcomes (malnutrition). 3. to identify modifiable determinants in the path from maternal mental health to poor child health, development and nutrition outcomes. 4. to investigate the trajectory of maternal mental health and associated risk factors.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 24/10/2024 The scope of the final dataset and related analyses/report prompted this edit. RCT Observational
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 26/05/2022 Updated as per fieldwork implementation timeline. 09 Aug 2020 18 Oct 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 26/05/2022 Updated as per fieldwork implementation timeline. 09 Aug 2020 18 Oct 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 26/05/2022 Updated as per fieldwork implementation timeline. 08 Aug 2021 31 Dec 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 26/05/2022 Updated as per fieldwork implementation timeline. 08 Aug 2021 31 Dec 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 24/10/2024 The study is completed and final reports have been submitted/approved. Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 24/10/2024 Intervention was not included in the analyses the justification of which was incorporated in the report and approved. Therefore, the analyses were considered in a "Single Group" or cross-sectional study design context. Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Single Group
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 17/07/2024 Minor edition as per the close-out report. Mental and Behavioural Disorders, Neonatal Diseases, Nutritional, Metabolic, Endocrine, Pregnancy and Childbirth Mental and Behavioural Disorders, Neonatal Diseases, Pregnancy and Childbirth, Paediatrics
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 23/09/2021 To address reviewer's comment. Experimental Group, iPUSH, NA, One year., i-PUSH is a comprehensive intervention that primarily aims to improve the utilisation of Reproductive and Maternal and Child Health (RMNCH) services among WRA and their young children in Kakamega County, by increasing knowledge about health and (financial) access to RMNCH services as well as improving the quality of RMNCH care services. In the original i-PUSH programme, households receive the first year of health insurance premium for free, and they are stimulated and supported to save for a 50% co-payment in the second year and a 100% premium payment thereafter. The free provision in year one is expected to show the benefits of insurance to the selected households. The 50% co-payment and the support for savings in the second year is expected to install a habit of savings [1]. This evaluation study will focus on the first two of these three spheres of interest: knowledge and (financial) access; the third sphere of interest–quality upgrades at the health facilities, cannot be evaluated with our study design because all i-PUSH clinics in our study area were already upgraded at baseline. Through the i-PUSH programme, women receive the National Health Insurance Fund (NHIF) SupaCover at subsidised premiums on their mobile phone, using the PAF’s so-called “health wallet”. The “health wallet” runs on the digital platform M-TIBA, which registers health care utilisation at participating clinics, connecting patients, providers and clinics on one platform. Women from control villages do not receive the i-PUSH intervention, although they are entitled to get health care services as per the national Ministry of Health protocol. Moreovere, our evaluation study will focus on the first of these two spheres of interest. Working with CHVs, i-PUSH will increase the knowledge on both RMNCH and on insurance/health financing among women and men in the target communities. To this end, CHVs receive additional training through the specially developed LEAP training tool developed and carri, 1, Experimental Group, iPUSH, NA, One year., i-PUSH is a comprehensive intervention that primarily aims to improve the utilisation of Reproductive and Maternal and Child Health (RMNCH) services among WRA and their young children in Kakamega County, by increasing knowledge about health and (financial) access to RMNCH services as well as improving the quality of RMNCH care services. In the original i-PUSH programme, households receive the first year of health insurance premium for free, and they are stimulated and supported to save for a 50% co-payment in the second year and a 100% premium payment thereafter. The free provision in year one is expected to show the benefits of insurance to the selected households. The 50% co-payment and the support for savings in the second year is expected to install a habit of savings [1]. This evaluation study will focus on the first two of these three spheres of interest: knowledge and (financial) access; the third sphere of interest–quality upgrades at the health facilities, cannot be evaluated with our study design because all i-PUSH clinics in our study area were already upgraded at baseline. Through the i-PUSH programme, women receive the National Health Insurance Fund (NHIF) SupaCover at subsidised premiums on their mobile phone, using the PAF’s so-called “health wallet”. The “health wallet” runs on the digital platform M-TIBA, which registers health care utilisation at participating clinics, connecting patients, providers and clinics on one platform. Women from control villages do not receive the i-PUSH intervention, although they are entitled to get health care services as per the national Ministry of Health protocol. Moreover, our evaluation study will focus on the first of these two spheres of interest. Working with CHVs, i-PUSH will increase the knowledge on both RMNCH and on insurance/health financing among women and men in the target communities. To this end, CHVs receive additional training through the specially developed LEAP training tool., 120,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 24/10/2024 Insufficient sample size for perinatal depression (see above). Experimental Group, iPUSH, NA, One year., i-PUSH is a comprehensive intervention that primarily aims to improve the utilisation of Reproductive and Maternal and Child Health (RMNCH) services among WRA and their young children in Kakamega County, by increasing knowledge about health and (financial) access to RMNCH services as well as improving the quality of RMNCH care services. In the original i-PUSH programme, households receive the first year of health insurance premium for free, and they are stimulated and supported to save for a 50% co-payment in the second year and a 100% premium payment thereafter. The free provision in year one is expected to show the benefits of insurance to the selected households. The 50% co-payment and the support for savings in the second year is expected to install a habit of savings [1]. This evaluation study will focus on the first two of these three spheres of interest: knowledge and (financial) access; the third sphere of interest–quality upgrades at the health facilities, cannot be evaluated with our study design because all i-PUSH clinics in our study area were already upgraded at baseline. Through the i-PUSH programme, women receive the National Health Insurance Fund (NHIF) SupaCover at subsidised premiums on their mobile phone, using the PAF’s so-called “health wallet”. The “health wallet” runs on the digital platform M-TIBA, which registers health care utilisation at participating clinics, connecting patients, providers and clinics on one platform. Women from control villages do not receive the i-PUSH intervention, although they are entitled to get health care services as per the national Ministry of Health protocol. Moreover, our evaluation study will focus on the first of these two spheres of interest. Working with CHVs, i-PUSH will increase the knowledge on both RMNCH and on insurance/health financing among women and men in the target communities. To this end, CHVs receive additional training through the specially developed LEAP training tool., 120, Experimental Group, iPUSH, NA, One year., The intervention was excluded from the final analyses due to an insufficient sample size for the perinatal depression outcome across the study period. Consequently, the analysis employed a cross-sectional study design, which has been rigorously justified and included in the final submitted/approved report. This shift was necessary to ensure the robustness of the findings. However, this has not significant changed overall study objectives, participant characteristics, etc. For a comprehensive overview of the study's objectives and results, please refer to the respective sections of the final report, where detailed insights are provided. , 120,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 23/09/2021 To address reviewer's comment. Control Group, No iPUSH, NA, One year, NA, 1, Active-Treatment of Control Group Control Group, No iPUSH, NA, One year, Control group is subjected to the standard services provided by the providers in the designated health facility. , 120, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 24/10/2024 Kindly see the previous change on the intervention. Control Group, No iPUSH, NA, One year, Control group is subjected to the standard services provided by the providers in the designated health facility. , 120, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 25/04/2022 REVERTED FOR REVISION. Villages, NA, NA, NA, Kenya KWHISERO TOWN, NB - CITIES ADDRESSES ARE NOT APPLICABLE/AVAILABLE FOR THIS CENTER, KWHISERO, NA, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 25/04/2022 REVERTED FOR REVISION. KWHISERO TOWN, NB - CITIES ADDRESSES ARE NOT APPLICABLE/AVAILABLE FOR THIS CENTER, KWHISERO, NA, Kenya KWHISERO TOWN, NB - STREET ADDRESS IS NOT APPLICABLE/AVAILABLE FOR THIS CENTER., KWHISERO, NA, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 25/04/2022 There were not listed in previous submission. 24, NA, These villages are found in Kwhisero subcounty Kakamega Kenya, -, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 25/04/2022 These were not included in the previous submission. 24, NA, These villages are found in Kwhisero subcounty Kakamega Kenya, -, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 08/02/2022 Submitting ethics approval as per the request. FALSE, Amref Health Africa ESRC, Wilson Airport, Nairobi, 30125, 00, Kenya, 02 Aug 2021, , +254206994000, info.kenya@amref.org, 16143_13552_4737.pdf FALSE, Amref Health Africa ESRC, Wilson Airport, Nairobi, 30125, 00, Kenya, 02 Aug 2021, , +254206994000, info.kenya@amref.org, 16143_13552_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 08/02/2022 Wrongly attached document. FALSE, Amref Health Africa ESRC, Wilson Airport, Nairobi, 30125, 00, Kenya, 02 Aug 2021, , +254206994000, info.kenya@amref.org, 16143_13552_4737.pdf TRUE, Amref Health Africa ESRC, Wilson Airport, Nairobi, 30125, 00, Kenya, 02 Aug 2021, 08 Nov 2021, +254206994000, info.kenya@amref.org, 16143_13552_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 08/02/2022 Wrongly placed contents. The proposed study supports Sustainable Development Goal (SDG) 3–‘ensure healthy lives and promote wellbeing for all at all ages’. It is particularly important to achieve SGD goals related to maternal and child health (SGDs 3.1 and 3.2) and reducing premature mortality from non-communicable diseases through prevention and treatment and promote mental health and wellbeing (SDG 3.4). Some publications are anticipated to come out of this study within the next one year. The ongoing study is being carried out by abiding on all ethical standards including obtaining informed consent based on detailed orientation on project information and the purpose of the research. As well, all interviews are conducted by maintaining privacy of the participants (i.e., participants have been interviewed separately and in private places to ensure confidentiality) and no identifying information is included in any data or reports; all data are anonymised to protect the identity of respondents. Moreover, field staff and respondents have built a mutual and faithful trust as there has been an ongoing connection between the parties for the longitudinal data collection. Furthermore, respondents are incentivised (namely, minimal cash transfers and provided low-cost mobile phones) both to motivate and increase response rate during COVID-19 pandemic, associated restriction measures and remote data collection. And, under nourished or sick children are advised to seek health care based on the national sick/malnourished children referral guidelines in collaboration with the community health volunteers. Other incidental findings during fieldwork are also recognised and implemented during data collection. For instance, fieldworkers were trained to assess any vulnerability of study participants (e.g., domestic violence or overt mental health problems) and report to relevant and refer community/government agencies or mental health experts to mitigate further vulnerabilities. This maximises benefits of the respondents and ensures that the research activities do not result in any discriminatory practices or unfair treatments to the participants. The incidental findings policy will be included in the information sheets and consent forms.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 08/02/2022 Based on the guidelines. The ongoing study is being carried out by abiding on all ethical standards including obtaining informed consent based on detailed orientation on project information and the purpose of the research. As well, all interviews are conducted by maintaining privacy of the participants (i.e., participants have been interviewed separately and in private places to ensure confidentiality) and no identifying information is included in any data or reports; all data are anonymised to protect the identity of respondents. Moreover, field staff and respondents have built a mutual and faithful trust as there has been an ongoing connection between the parties for the longitudinal data collection. Furthermore, respondents are incentivised (namely, minimal cash transfers and provided low-cost mobile phones) both to motivate and increase response rate during COVID-19 pandemic, associated restriction measures and remote data collection. And, under nourished or sick children are advised to seek health care based on the national sick/malnourished children referral guidelines in collaboration with the community health volunteers. Other incidental findings during fieldwork are also recognised and implemented during data collection. For instance, fieldworkers were trained to assess any vulnerability of study participants (e.g., domestic violence or overt mental health problems) and report to relevant and refer community/government agencies or mental health experts to mitigate further vulnerabilities. This maximises benefits of the respondents and ensures that the research activities do not result in any discriminatory practices or unfair treatments to the participants. The incidental findings policy will be included in the information sheets and consent forms. The anticipated dates towards IDP sharing statement: 1. Date of posting of results summaries: 1 July 2024 2. Date of the first journal publication of results: 1 July 2023 3. URL hyperlink(s) related to results and publications: upon availability 4. Baseline Characteristics: Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and sex, and study-specific measures: 1 July 2024 5. Participant flow: Information to document the progress and numbers of research participants through each stage of a study in a flow diagram or tabular format: 1 July 2024 6. Adverse events: An unfavourable change in the health of a participant, including abnormal laboratory findings, and all serious adverse events and deaths that happen during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied: depends on the incident 7. Outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision (e.g. a 95% confidence interval) by arm (that is, initial assignment of participants to arms or groups) or comparison group (that is, analysis groups), including the result(s) of scientifically appropriate statistical analyses that were performed on the outcome measure data, if any: 1 July 2014 8. URL link to protocol file(s) with version and date. This will apply when the protocol has wither been published in a journal or on an institutional website: depends on availability of the publication/link 9. Brief summary: A statement from a designated Data Protection Officer that all personal data collection and processing will be carried out according to EU and national legislation will be provided before the start of the study. All of the data that we intend to process is relevant and limited to the research project's purposes (in accordance with th
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 21/04/2022 It was not effected in the previous submission. The anticipated dates towards IDP sharing statement: 1. Date of posting of results summaries: 1 July 2024 2. Date of the first journal publication of results: 1 July 2023 3. URL hyperlink(s) related to results and publications: upon availability 4. Baseline Characteristics: Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and sex, and study-specific measures: 1 July 2024 5. Participant flow: Information to document the progress and numbers of research participants through each stage of a study in a flow diagram or tabular format: 1 July 2024 6. Adverse events: An unfavourable change in the health of a participant, including abnormal laboratory findings, and all serious adverse events and deaths that happen during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied: depends on the incident 7. Outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision (e.g. a 95% confidence interval) by arm (that is, initial assignment of participants to arms or groups) or comparison group (that is, analysis groups), including the result(s) of scientifically appropriate statistical analyses that were performed on the outcome measure data, if any: 1 July 2014 8. URL link to protocol file(s) with version and date. This will apply when the protocol has wither been published in a journal or on an institutional website: depends on availability of the publication/link 9. Brief summary: A statement from a designated Data Protection Officer that all personal data collection and processing will be carried out according to EU and national legislation will be provided before the start of the study. All of the data that we intend to process is relevant and limited to the research project's purposes (in accordance with th The anticipated dates towards IDP sharing statement: 1. Date of posting of results summaries: 1 July 2024 2. Date of the first journal publication of results: 1 July 2023 3. URL hyperlink(s) related to results and publications: This will be updated once available. 4. Baseline Characteristics: Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and sex, and study-specific measures: will be incorporated in relevant publications. 5. Participant flow: Information to document the progress and numbers of research participants through each stage of a study in a flow diagram or tabular format: This will be incorporated in all relevant publications. 6. Adverse events: An unfavourable change in the health of a participant, including abnormal laboratory findings, and all serious adverse events and deaths that happen during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied: action plans in case of such indents have already been in place in the approved protocol. 7. Outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision (e.g. a 95% confidence interval) by arm (that is, initial assignment of participants to arms or groups) or comparison group (that is, analysis groups), including the result(s) of scientifically appropriate statistical analyses that were performed on the outcome measure data, if any: These measures and their details will be incorporated within the respective papers. 8. URL link to protocol file(s) with version and date. This will apply when the protocol has wither been published in a journal or on an institutional website: This will be updated once it is published in APHRC/EDCTP websites. 9. Brief summary: All Personal Data Protection mechanisms are in place.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 22/04/2022 Reverted for edited and resubmission. The anticipated dates towards IDP sharing statement: 1. Date of posting of results summaries: 1 July 2024 2. Date of the first journal publication of results: 1 July 2023 3. URL hyperlink(s) related to results and publications: This will be updated once available. 4. Baseline Characteristics: Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and sex, and study-specific measures: will be incorporated in relevant publications. 5. Participant flow: Information to document the progress and numbers of research participants through each stage of a study in a flow diagram or tabular format: This will be incorporated in all relevant publications. 6. Adverse events: An unfavourable change in the health of a participant, including abnormal laboratory findings, and all serious adverse events and deaths that happen during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied: action plans in case of such indents have already been in place in the approved protocol. 7. Outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision (e.g. a 95% confidence interval) by arm (that is, initial assignment of participants to arms or groups) or comparison group (that is, analysis groups), including the result(s) of scientifically appropriate statistical analyses that were performed on the outcome measure data, if any: These measures and their details will be incorporated within the respective papers. 8. URL link to protocol file(s) with version and date. This will apply when the protocol has wither been published in a journal or on an institutional website: This will be updated once it is published in APHRC/EDCTP websites. 9. Brief summary: All Personal Data Protection mechanisms are in place. The Host Organisation has a robust data usage and storage guidelines. This includes detailed information on the procedures for data collection, storage, protection, retention, destruction. Data processing and protection will comply with national and EU legislation, as well as WHO guidelines.A statement from a designated Data Protection Officer that all personal data collection and processing will be carried out according to EU and national legislation will be provided before the start of the study. All of the data that we intend to process is relevant and limited to the research project's purposes (in accordance with the ‘data minimisation‘ principle). A description of the security measures and anonymisation/pseudonymisation techniques that will be implemented to prevent unauthorised access to personal data or the equipment used for processing must be submitted as a deliverable. These involves uploading data from tablets onto a safe server and verification for quality. The software used will ensure that data contents are encrypted (transformed into cipher text) using a public encryption key soon after an interview is completed, and from that point forward, the data will no longer be readable without decryption. As data is transmitted using an internet network, it will be automatically encrypted by the Secure Sockets Layer (SSL), in a sense, it will be doubly-encrypted. After submission/transfer to the server/cloud, data will remain encrypted until a private encryption key is used to decrypt and download it. Access to the cloud server will be restricted, and only authorized staff will be able to login and download data. Fine-grained access control method will be applied to the data collection software. Data will be anonymized, and details that can be used to identify participants will be concealed in write-ups and data portals.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 25/04/2022 Reverted for revision. The Host Organisation has a robust data usage and storage guidelines. This includes detailed information on the procedures for data collection, storage, protection, retention, destruction. Data processing and protection will comply with national and EU legislation, as well as WHO guidelines.A statement from a designated Data Protection Officer that all personal data collection and processing will be carried out according to EU and national legislation will be provided before the start of the study. All of the data that we intend to process is relevant and limited to the research project's purposes (in accordance with the ‘data minimisation‘ principle). A description of the security measures and anonymisation/pseudonymisation techniques that will be implemented to prevent unauthorised access to personal data or the equipment used for processing must be submitted as a deliverable. These involves uploading data from tablets onto a safe server and verification for quality. The software used will ensure that data contents are encrypted (transformed into cipher text) using a public encryption key soon after an interview is completed, and from that point forward, the data will no longer be readable without decryption. As data is transmitted using an internet network, it will be automatically encrypted by the Secure Sockets Layer (SSL), in a sense, it will be doubly-encrypted. After submission/transfer to the server/cloud, data will remain encrypted until a private encryption key is used to decrypt and download it. Access to the cloud server will be restricted, and only authorized staff will be able to login and download data. Fine-grained access control method will be applied to the data collection software. Data will be anonymized, and details that can be used to identify participants will be concealed in write-ups and data portals. IPD will be kept in The Host Organisation’s safe data repository, after being automatically encrypted by the Secure Sockets Layer (SSL) and doubly-encrypted. IDP will be anonymised, and will be available upon request.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 17/07/2024 Updated based on close-out report. IPD will be kept in The Host Organisation’s safe data repository, after being automatically encrypted by the Secure Sockets Layer (SSL) and doubly-encrypted. IDP will be anonymised, and will be available upon request. IPD was kept in The Host Organisation’s safe data repository, after being automatically encrypted by the Secure Sockets Layer (SSL) and doubly-encrypted. IDP was anonymised, and will be available upon request.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/02/2022 Change in the overall GANTT chart. 33 months. 2.5 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/02/2022 Wrongly placed content. 2.5 years. 3 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/02/2022 Based on the guideline. 3 years. 1 year.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 21/04/2022 It was not up to date in the previous submission. 1 year. 1-2 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 25/04/2022 Reverted for revision. 1-2 years. It will be available in anonymous manner in 2 years time (by June 2024).
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 17/07/2024 Updated based on close-out report. It will be available in anonymous manner in 2 years time (by June 2024). It is available in anonymous manner (since March 2024).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 08/02/2022 Inclusion of these items as per the request. Controlled. In each household in the original main study, all economically active adults including the target women have been invited to participate in the weekly diaries data collection. Respondents reported their financial flows for each week, including income, expenditures, gifts/remittances provided and received, loans provided and taken out and savings deposited and withdrawn. Each week, respondents were asked about any health events in their household and health events were recorded for each household member separately. If a health event occurred, follow-up questions were asked about the type of health event, care-seeking, consultations and health care expenditures. The data include the occurrence of minor and major illnesses, symptoms, health care utilisation and foregone care, provider type, health expenditures and services or treatments received. The data will be analysed using Stata version 14 software. A first set of analysis will consist of descriptive statistics. Descriptive data will be summarized and compared using measures of central tendency and dispersion (mean (SD), range and median). This will allow us to detect similarities and/or differences between subjects’ characteristics across the different groups. In other words, we will compare some baseline measurements between the control group and intervention group using the t-test adjusted for clustering at the community unit for continuous variables, and cluster-adjusted chi-square for binary variables. We will first check whether the outcomes and covariates in the control group and treatment group are comparable at baseline. The second set of analysis will consist of assessing the causal effect of the i-PUSH intervention via an analysis of covariance (ANCOVA) based on intention-to-treat analysis (all respondents who are randomized are included in the statistical analysis and analysed according to the group they were initially/originally assigned). Based on our research questions, we will explore econometric
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 08/02/2022 Wrongly placed contents. In each household in the original main study, all economically active adults including the target women have been invited to participate in the weekly diaries data collection. Respondents reported their financial flows for each week, including income, expenditures, gifts/remittances provided and received, loans provided and taken out and savings deposited and withdrawn. Each week, respondents were asked about any health events in their household and health events were recorded for each household member separately. If a health event occurred, follow-up questions were asked about the type of health event, care-seeking, consultations and health care expenditures. The data include the occurrence of minor and major illnesses, symptoms, health care utilisation and foregone care, provider type, health expenditures and services or treatments received. The data will be analysed using Stata version 14 software. A first set of analysis will consist of descriptive statistics. Descriptive data will be summarized and compared using measures of central tendency and dispersion (mean (SD), range and median). This will allow us to detect similarities and/or differences between subjects’ characteristics across the different groups. In other words, we will compare some baseline measurements between the control group and intervention group using the t-test adjusted for clustering at the community unit for continuous variables, and cluster-adjusted chi-square for binary variables. We will first check whether the outcomes and covariates in the control group and treatment group are comparable at baseline. The second set of analysis will consist of assessing the causal effect of the i-PUSH intervention via an analysis of covariance (ANCOVA) based on intention-to-treat analysis (all respondents who are randomized are included in the statistical analysis and analysed according to the group they were initially/originally assigned). Based on our research questions, we will explore econometric All questionnaires and instruments used for data collection, including Informed Consent Form, will be translated into local languages (Luhya and Swahili). Informed consent will be obtained from all participants. Adolescent mothers less than 18 years will be required to sign documents of informed assent and their parent(s)/guardian(s) to sign a document of informed consent. We will obtain signed or thumb-printed informed consent, for those mothers not able to write, from each study participant. Interviewers will be responsible for obtaining informed consent. They will read the Informed Consent Form to the potential participant, explain anything she or he does not understand, and answer individual’s questions. Once a participant gives their consent, she or he will be given a copy of the Informed Consent Form and the other copy will be kept in the study records. Paper copies of data collection of Informed Consent Form will be stored in a locked file cabinet at the Host Organisation. Copies of Informed Consent Form and Information Sheets will be provided to EDCTP before start of the study. All economically active adults including the target women have been invited to participate in the weekly diaries data collection.A statement from a designated Data Protection Officer that all personal data collection and processing will be carried out according to EU and national legislation will be provided before the start of the study. All of the data that we intend to process is relevant and limited to the research project's purposes (in accordance with the ‘data minimisation‘ principle).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 08/02/2022 Based on the guideline. All questionnaires and instruments used for data collection, including Informed Consent Form, will be translated into local languages (Luhya and Swahili). Informed consent will be obtained from all participants. Adolescent mothers less than 18 years will be required to sign documents of informed assent and their parent(s)/guardian(s) to sign a document of informed consent. We will obtain signed or thumb-printed informed consent, for those mothers not able to write, from each study participant. Interviewers will be responsible for obtaining informed consent. They will read the Informed Consent Form to the potential participant, explain anything she or he does not understand, and answer individual’s questions. Once a participant gives their consent, she or he will be given a copy of the Informed Consent Form and the other copy will be kept in the study records. Paper copies of data collection of Informed Consent Form will be stored in a locked file cabinet at the Host Organisation. Copies of Informed Consent Form and Information Sheets will be provided to EDCTP before start of the study. All economically active adults including the target women have been invited to participate in the weekly diaries data collection.A statement from a designated Data Protection Officer that all personal data collection and processing will be carried out according to EU and national legislation will be provided before the start of the study. All of the data that we intend to process is relevant and limited to the research project's purposes (in accordance with the ‘data minimisation‘ principle). The Host Organisation has a robust data usage and storage guidelines and practice (see Data management and sharing section in Application Form/Annex 1). These guidelines will be modified and incorporated as a working document for data management plan as per requirements of the EDCTP CDF Fellowships. A data management plan will be submitted by month 5 and before start of the study activities. This will include detailed information on the procedures for data collection, storage, protection, retention, destruction. Data processing and protection will comply with national and EU legislation.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 22/04/2022 Edited. The Host Organisation has a robust data usage and storage guidelines and practice (see Data management and sharing section in Application Form/Annex 1). These guidelines will be modified and incorporated as a working document for data management plan as per requirements of the EDCTP CDF Fellowships. A data management plan will be submitted by month 5 and before start of the study activities. This will include detailed information on the procedures for data collection, storage, protection, retention, destruction. Data processing and protection will comply with national and EU legislation. The Host Organisation has a robust data usage and storage guidelines and practice. These guidelines will be modified and incorporated as a working document for data management plan as per requirements of the EDCTP CDF Fellowships. A data management plan will be submitted by month 5 and before start of the study activities. This will include detailed information on the procedures for data collection, storage, protection, retention, destruction. Data processing and protection will comply with national and EU legislation.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 25/04/2022 Reverted for revision. The Host Organisation has a robust data usage and storage guidelines and practice. These guidelines will be modified and incorporated as a working document for data management plan as per requirements of the EDCTP CDF Fellowships. A data management plan will be submitted by month 5 and before start of the study activities. This will include detailed information on the procedures for data collection, storage, protection, retention, destruction. Data processing and protection will comply with national and EU legislation. It will be accessible to any researchers and/or reviewer who might perform some new data analysis and/or review the data once decided by the principal investigator and other research team members, and following health, ethical authorities and funder’s legislation/guidelines (e.g., national data sharing policy and EU legislation).
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 08/02/2022 Not available. No available yet.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 21/04/2022 It was not up to date in the previous submission. No available yet. No available yet but will be provided upon availability.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 08/02/2022 Wrongly selected items. Statistical Analysis Plan Statistical Analysis Plan, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 08/02/2022 Based on the guidelines. Statistical Analysis Plan, Informed Consent Form Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code