Condition category
Not Applicable
Date applied
05/12/2019
Date assigned
11/12/2019
Last edited
10/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Current plain English summary as of 10/11/2020:

Background and study aims
Mortality rates in children under-five years are unacceptably high, and pneumonia is the leading cause of such deaths, with 880,000 deaths in 2016. Half of these global deaths occurred in just five countries, one of which is Nigeria. The under-5 mortality in Jigawa state (North-West Nigeria) is 192 per 1000 live births, and it is estimated that there are 14,988 cases of paediatric pneumonia in Jigawa annually. From November 2018 to June 2019 we conducted a situational analysis of paediatric pneumonia in Jigawa, to inform the design of an intervention programme aiming to reduce paediatric mortality in these settings. We found protective and preventive factors, such as vaccine coverage and clean cooking fuel use, were low. Additionally, knowledge, care-seeking and health system factors were poor. Therefore, a whole systems approach, from prevent and protect to diagnose and treat, is needed for sustainable reductions in child mortality.

Since March 2020, Nigeria reported cases of COVID-19 and instituted various control measures to try and mitigate the local epidemic. We therefore delayed the start of the trial from January 2020 to January 2021. In Kiyawa local government authority area (LGA), Jigawa State, Save the Children Nigeria implemented a radio-based participatory information campaign about COVID-19 and child health from June-December 2020. In addition, healthcare providers have been trained in infection prevention and control, and the use of pulse oximetry. This study aims to reduce the number of under-five deaths, with a specific focus on pneumonia morbidity and mortality, in Kiyawa LGA, Jigawa State.

Who can participate?
The study will include the whole population of Kiyawa LGA, excluding those in the catchment area of Kiyawa Primary Health Centre. In particular, the intervention will target caregivers of children under-five years and healthcare providers.

What does the study involve?
The intervention is a whole systems approach to building capacity, focussed on child health and paediatric pneumonia.
The trial will run from January 2021 – December 2022. The intervention will delivered and evaluated as a cluster randomised controlled trial, with 32 primary health facility catchment areas as the unit of randomisation. All primary healthcare facilities of Kiyawa LGA (and their surrounding villages) will be included in the trial, excluding Kiyawa PHC – as this facility is planned to be upgraded to a secondary referral facility during the period of the trial.
The intervention consists of two elements:
1. Community women’s and men’s groups
2. An adapted community-score card process which links men's and women's groups with health facility committees
All facilities in Kiyawa LGA will be supported with Integrated management of childhood illnesses (IMCI), infection prevention and control training and mentorship, and personal protective equipment. In addition, the secondary government health facilities will be supported with medical oxygen, to ensure this is always available for children who are referred throughout the whole project period. The intervention is delivered by Save the Children Nigeria, independent from the evaluation.
The main outcome is the reduction in under-five (children aged 7 days to 59 months) mortality between intervention and control clusters. A baseline (Jan 2021) and endline (June 2022) cross-sectional compound survey, will measure secondary outcomes of care-seeking behaviours, knowledge, and pneumonia prevalence. The main outcome will be measured through a prospective cohort evaluation amongst a randomly selected cohort of compounds, with vital event reporting every 4 months. The evaluation will include a random selection of 4,160 compounds, covering all villages in Kiyawa LGA. A concurrent process and economic evaluation will be conducted.

What are the potential benefits and risks to participation?
We are conscious that the nature of the group intervention could increase participants’ risks of transmitting COVID-19 if there is on-going community transmission. We will therefore conduct a local risk assessment prior to commencing the trial, which deems the risk of infection to be low.
The risk assessment will be based on reported local and national numbers of cases, numbers of deaths (ascertained by speaking with community and religious leaders and healthcare workers), and in accordance with local government advice. We will also engage with traditional leaders, local government and communities prior to starting to ensure there is community consent to proceed. In addition, stop and start rules will be used (based on the same criteria as above), and the COVID-19 situation will be reviewed on a monthly basis to minimise risks to both participants and project staff. Decisions to stop or re-start will be approved by both the Project Management Board (PMB) and Trial Steering Committee (TSC).
Further, all facilitators and study staff will be provided with face masks, hand sanitizer and training on physical distancing procedures and healthcare facilities will be supported with PPE. We will monitor the use and access to PPE as part of the process evaluation, and therefore the project may benefit communities and healthcare providers by improving infection prevention and control practices. Aside from possible COVID-19 risks, we do not anticipate any other serious negative impacts to participants taking part in this research, and the intervention package could provide benefits to individuals and wider communities. If there are concerns regarding the benefits of the intervention, the TSC will have the power to terminate the study.
The main ethical concern is the study team’s responsibility to act if a severely sick child is identified during the compound survey. The data collector conducting these assessments will be clinically trained, and will follow World Health Organisation guidelines to classify children who
have any signs and symptoms of pneumonia. If a child meets the referral criteria (i.e. has a general danger sign or is hypoxic) they will recommend the child is referred to secondary care, and support the family to find transportation.
Interviews and surveys will all take between 15 and 90 minutes, which will impose a time-burden on participants. To mitigate this as much as possible, data collection will be conducted in locations that are convenient to the participants, or by phone, but ensuring these locations offer privacy to maintain confidentiality. In addition, participants will be reimbursed for any transport cost to attend, and given a small token of appreciation (e.g. soap or face masks). Participants will be informed of the use of their data during informed consent, and will be reminded that they do not have to participate.

Where is the study run from?
University College Hospital, Ibadan (Nigeria)

When is the study starting and how long is it expected to run for?
The trial will run from January 2021 to October 2022. Two cross-sectional surveys will be conducted (01/21-03/21, 07/22-09/22), with prospective vital sign registration in between. The intervention will be delivered over 18 months, from 01/2021 - 06/2022. October - December
2022 will be used for write-up and dissemination of the results.

Who is funding the study?
This study is funded by Save the Children UK

Who is the main contact?
1. Dr Carina King
carina.king@ki.se; c.king@ucl.ac.uk
2. Dr Tim Colbourn
t.colbourn@ucl.ac.uk
3. Prof. A. G. Falade
afalade33@hotmail.com


_____

Previous plain English summary:

Background and study aims
Mortality rates in children under-five years are unacceptably high, and pneumonia is the leading cause of such deaths, with 880,000 deaths in 2016. Half of these global deaths occurred in just five countries, one of which is Nigeria. The under-5 mortality in Jigawa state (North-West Nigeria) is 192 per 1000 live births, and it is estimated that there are 14,988 cases of paediatric pneumonia in Jigawa annually. From November 2018 to June 2019 researchers conducted a situational analysis of paediatric pneumonia in Jigawa, in order to inform the design of an intervention programme with the aim of reducing paediatric mortality in these settings. They found that protective and preventive factors, such as vaccine coverage and clean cooking fuel, were low. Additionally, knowledge, care-seeking and health system factors were poor. Therefore, a whole systems approach, from prevent and protect to diagnose and treat, is needed for sustainable reductions in child mortality. This study aims to reduce the number of under-five deaths, with a specific focus on pneumonia morbidity and mortality, in Kiyawa local government authority, Jigawa State.

Who can participate?
The study will include the whole population of Kiyawa LGA. In particular, the intervention will target caregivers of children under-five years and healthcare providers.

What does the study involve?
An intervention will be delivered to half of Kiyawa LGA for two years, and then scaled-up to the remaining areas if the intervention is found to not be harmful. Primary health facility population catchment areas are randomly allocated to receive either the intervention or control.
The intervention is a whole systems approach to building capacity. The intervention consists of three elements:
1. Community women’s and men’s groups
2. An adapted community-score card process which links men's and women's groups with health facility committees
3. Integrated management of childhood illnesses (IMCI) training and mentorship for primary healthcare providers.
In addition, one secondary government health facility is supported to ensure that medical oxygen is always available for children who are referred. The intervention is delivered by Save the Children Nigeria, independent from the evaluation.
The main outcome is the reduction in under-five mortality between intervention and control clusters after two years of intervention delivery. This is measured through three cross-sectional household surveys conducted at the start of the trial, in the middle and at the end. The household surveys are done in a random sub-set of 3900 households in each survey, covering all villages in Kiyawa LGA. A concurrent process and economic evaluation are also conducted.

What are the potential benefits and risks to participation?
The researchers do not anticipate any serious negative impacts to participants, and the intervention package could provide benefits to individuals and wider communities. The researchers have planned an interim analysis after one year of intervention implementation, to check for harm and futility. If there are concerns regarding the benefits of the intervention, the trial steering committees will have the power to terminate the study. The researchers plan to scale-up the intervention after two years, following an end line analysis and approval from the steering committee. They will proceed to scale-up if the study shows benefit or no effect.
The main ethical concern is the study team’s responsibility to act if a severely sick child is identified during the household survey. The data collector conducting these assessments will be clinically trained, and will follow World Health Organisation guidelines to classify children who have any signs and symptoms of pneumonia. If a child meets the referral criteria (i.e. has a general danger sign or is hypoxic) they will recommend the child is referred to secondary care, and support the family to find transportation.
Interviews and surveys will all take between 15 and 90 minutes, which will impose a time-burden on participants. To mitigate this as much as possible, data collection will be conducted in locations that are convenient to the participants, but ensuring these locations offer privacy to maintain confidentiality. In addition, participants will be reimbursed for any transport cost to attend, and given a small token of appreciation (e.g. soap). Participants will be informed of the use of their data during informed consent, and will be reminded that they do not have to participate.

Where is the study run from?
University College Hospital, Ibadan (Nigeria)

When is the study starting and how long is it expected to run for?
The trial will run from January 2020 to December 2021. From January 2022 to October 2022 the intervention package will be scaled-up to control clusters. October 2022 to December 2022 will be used for write-up and dissemination of the results.

Who is funding the study?
This study is funded by a GSK-Save the Children Partnership

Who is the main contact?
1. Dr Carina King
carina.king@ki.se; c.king@ucl.ac.uk
2. Dr Tim Colbourn
t.colbourn@ucl.ac.uk
3. Prof. A. G. Falade
afalade33@hotmail.com

Trial website

https://www.ucl.ac.uk/igh

Contact information

Type

Scientific

Primary contact

Dr Carina King

ORCID ID

http://orcid.org/0000-0002-6885-6716

Contact details

Widerströmska huset
Tomtebodavägen 18
Solna
Stockholm
171 65
Sweden
+44 (0)7780862657
carina.king@ki.se

Type

Scientific

Additional contact

Dr Tim Colbourn

ORCID ID

http://orcid.org/0000-0002-6917-6552

Contact details

Institute for Global Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)207 905 2839
t.colbourn@ucl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

INtegrated and Sustainable childhood Pneumonia and Infectious disease Reduction In NiGeria – the INSPIRING Project, Jigawa

Acronym

INSPIRING Project

Study hypothesis

The implementation of a whole systems approach to build capacity and empowerment for improved childhood health, with a focus on paediatric pneumonia, in Kiyawa LGA, Jigawa State, Nigeria, will reduce deaths in children aged 0-59 months.

Ethics approval

1. Approved 27/09/2019, University College London Research Ethics Committee (Office of the Vice Provost Research, 2 Taviton Street, University College London, London, WC1H 0BT, UK; +44 (0)20 7679 8717; ethics@ucl.ac.uk), ref: 3433/004 (An amendment was submitted and approved on 14/08/2020)
2. Approval 26/11/2019, Jigawa State Ministry of Health (Block B-Q2/23, New Secretariat Complex, Dutse, Jigawa State, Nigeria; no telephone number provided; smoh_jigawa@yahoo.com), ref: JPHCDA/ADM/GEN/073/V.I. (An amendment was submitted and approved on 20/07/2020)
3. Approved 10/01/2020, University of Ibadan/University College Hospital Ibadan research ethics committee (College of Medicine, University of Ibadan, Ibadan, Oyo State, Nigeria; Tel: +234 (0)8033264593; Email: cfalade@comui.edu.ng), ref: UI/EC/19/0551

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Under-five mortality, with a specific focus on the prevention of pneumonia morbidity and mortality in children under-five

Intervention

Current interventions as of 10/11/2020:

The intervention is a whole systems approach to building capacity, focussed on child health and paediatric pneumonia.
The intervention will delivered and evaluated as a cluster randomised controlled trial, with primary health facility catchment areas as the unit of randomisation. All primary healthcare facilities of Kiyawa LGA (and their surrounding villages) will be included in the trial, excluding
Kiyawa PHC – as this facility is planned to be upgraded to a secondary referral facility during the period of the trial and the cluster is peri-urban, different from the others.
The intervention consists of two elements:
1. Community women’s and men’s groups
2. An adapted community-score card process which links men's and women's groups with health facility committees
All facilities in Kiyawa LGA will be supported with Integrated management of childhood illnesses (IMCI), infection prevention and control training and mentorship and supported with personal protective equipment. In addition, the secondary government health facility will be supported to ensure that medical oxygen is always available for children who are referred throughout the whole project period. The intervention will be delivered by Save the Children Nigeria, independent from the evaluation.

_____

Previous interventions:

Cluster randomized controlled trial, that will run from January 2020 to December 2021, with a subsequent scale-up to control clusters from January 2022 to October 2022

Clusters will be populations living within 39 primary health centre catchment areas, with a 1:1 allocation into intervention and control. Clusters will be assigned using a random number sequence, and due to the nature of the intervention, participants will not be blinded to their allocation.

The intervention is a whole systems approach to capacity building and empowerment, consisting of three elements:
1. Community women’s and men’s groups
2. An adapted community-score card process which links men's and women's groups with health facility committees
3. Integrated management of childhood illnesses (IMCI) training and mentorship for primary healthcare providers.

In addition, one secondary government health facility, outside of the study area, will be supported to ensure that medical oxygen is always available for children who are referred there as part of improved case management. The intervention will be delivered by Save the Children Nigeria, independently of the evaluation team.

The main outcome will be the reduction in under-five mortality, between intervention and control clusters after two years of intervention delivery. This will be measured through three cross-sectional household surveys, conducted at the start of the trial, in the middle and at the end. The household surveys will be done in a random sub-set of 3900 households in each survey, covering all villages in Kiyawa LGA. A concurrent process and economic evaluation will also be conducted.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Current primary outcome measure as of 10/11/2020:

Under-five mortality compared between intervention and control clusters. This will be calculated as the number of children aged 7 days to 59 months reported to have died over a 12-month period who resided in sampled compounds (numerator), divided by the total number of children aged 7 days to 59 months who reside in sampled compounds (denominator). We will exclude deaths in the first week of life due to inaccuracies in reporting of early neonatal deaths, and we do not expect the intervention to impact on perinatal causes of death. These data will be
collected from self-reporting by women aged 15-49 years old during the vital events surveillance (prospective cohort evaluation), in a random sample of compounds from all villages within study clusters. Compounds will be selected using stratified random sampling within the health facility catchment areas. Primary outcome data will be collected from January 2021 to October 2022.

_____

Previous primary outcome measure:

Under-five mortality after two years of intervention implementation. This will be calculated as the number of children aged 0-59 months reported to have died in the previous 12 months who resided in sampled households (numerator), divided by the total number of children age 0-59 months who reside in sampled households (denominator). These data will be collected from women aged 15-49 years old during household surveys, in a random sample of households from all villages within study clusters. Households will be selected using stratified random sampling. Data will be collected at three timepoints, a baseline survey (January-March 2020), midline survey (January-March 2021) and endline survey (January-March 2022).

Secondary outcome measures

Current secondary outcome measures as of 10/11/2020:
1. Suspected-pneumonia under-five mortality rate, assigned using InterVA-4
2. Caregiver knowledge of pneumonia symptoms
3. Clinical pneumonia point prevalence, defined according to the World Health Organisation’s
Integrated Management of Childhood Illnesses guidelines
4. Care-seeking behaviours for pneumonia
5. Vaccination coverage
6. Protective/prevention measures for pneumonia including exclusive breastfeeding, handwashing with soap, no indoor smoke from cooking.
These data will be collected from women aged 15-49 years old during compound surveys and from clinical screening of children under-five by a study nurse, in a random sample of compounds from all villages within study clusters. Compounds will be selected using stratified random sampling within the health facility catchment areas. The trial will run from January 2021 to October 2022. Two cross-sectional surveys will be conducted (01/21-03/21 baseline survey, 07/22-09/22 – endline survey), and prospective recording of vital events will be done every four months in between the baseline and endline survey.

_____

Previous secondary outcome measures:

1. Suspected-pneumonia under-five mortality rate
2. Caregiver knowledge of pneumonia symptoms
3. Clinical pneumonia point prevalence
4. Care-seeking behaviours for pneumonia
5. Vaccination coverage

These data will be collected from women aged 15-49 years old during household surveys and from clinical screening of children under-five by a study nurse, in a random sample of households from all villages within study clusters. Households will be selected using stratified random sampling. Data will be collected at three timepoints, a baseline survey (January-March 2020), midline survey (January-March 2021) and endline survey (January-March 2022).

Overall trial start date

01/11/2019

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Resident in Kiyawa local government area, Jigawa State, Nigeria
2. A child aged 0-59 months is resident in the household

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

4,160 compounds, with a minimum target of 6,225 resident children aged 0-59 months.

Participant exclusion criteria

1. Caregivers aged <15 years or >49 years
2. Temporary residents in the study clusters
3. Individuals who decline to participate in the survey
4. Individuals who lack the capacity to consent to participate in the study

Recruitment start date

06/01/2020

Recruitment end date

31/10/2022

Locations

Countries of recruitment

Nigeria

Trial participating centre

University College Hospital Ibadan
University College Hospital Department of Paediatrics Queen Elizabeth II Road
Ibadan
-
Nigeria

Sponsor information

Organisation

Institute for Global Health, University College London

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2352
ighadmin@ucl.ac.uk

Sponsor type

University/education

Website

https://www.ucl.ac.uk/igh

Funders

Funder type

Charity

Funder name

Save the Children UK - GSK Partnership

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Local dissemination meetings will be held with the Jigawa Ministry of Health and communities in December 2022. Planned publication of study protocol, process evaluation and trial results papers, including cost-effectiveness, in peer-reviewed journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon email request from Dr Carina King (carina.king@ki.se), Dr Tim Colbourn (t.colbourn@ucl.ac.uk) or Prof. Adegoke Falade (afalade33@hotmail.com). Fully anonymised data will be shared for the purposes of scientific research, subject to review by the co-investigators and approval from research ethics committees. Consent for sharing of anonymised data for research purposes is included in the informed consent process.

Intention to publish date

15/12/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/11/2020: The following changes were made to the trial record: 1. The ethics approval was added. 2. The interventions were changed. 3. The primary outcome measure was changed. 4. The secondary outcome measures were changed. 5. The trial website was added. 6. The target number of participants was changed from 3,900 households, with a minimum target of 5,760 resident children aged 0-59 months, at the baseline, midline and endline surveys to 4,160 compounds, with a minimum target of 6,225 resident children aged 0-59 months. 7. The plain English summary was updated to reflect these changes. 28/05/2020: Due to current public health guidance, recruitment for this study has been paused as of 20/03/2020. 18/02/2020: The ethics approval (3) was added. 09/12/2019: Trial's existence confirmed by University College London Research Ethics Committee.