Assessing the use of Mapping for Health (M4H) data for immunisation programme implementation and associated impact on coverage, equity, and cost-effectiveness in the Democratic Republic of Congo
| ISRCTN | ISRCTN65876428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65876428 |
- Submission date
- 25/10/2021
- Registration date
- 03/11/2021
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There are many children who do not receive immunizations because they live in hard to reach locations that are often not included on maps. The use of maps can help to identify children who are often missed to make sure that they are included in immunization program plans. This study will measure the acceptance and use of maps as part of the planning and implementation of the immunization program in Democratic Republic of Congo (DRC) to see if they can help increase the number of children who are vaccinated, especially those who are the hardest to reach.
The goal of this study is to evaluate the impact of the Mapping for Health programme, which produces and provides geospatial data with the aim of improving immunisation coverage and equity, especially in the identification of previously missed settlements.
Who can participate?
Essential Programme for Immunisation administrators, supervisors, and vaccinators and associated individuals engaged in the generation and/or use of M4H geospatial data for immunisation microplanning, macroplanning, and service delivery.
What does the study involve?
EPI managers, supervisors, and vaccinators will be invited to be interviewed for the study. Those who agree to will be interviewed for 30-45 minutes about their experiences with the use of maps within the program planning and implementation.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Kinshasa School of Public Health (Democratic Republic of Congo)
When is the study starting and how long is it expected to run for?
January 2020 to December 2023
Who is funding the study?
Gavi, the Vaccine Alliance (Switzerland)
Who is the main contact?
Dr. Patricia Mechael, patty@healthenabled.org
Contact information
Public
4101 Albemarle St NW
Apt 521
Washington
20016
United States of America
 ORCID ID |
0000-0002-1034-0549 |
|---|---|
| Phone | +1 9732228252 |
| patty@healthenabled.org |
Study information
| Study design | Single-centre three-province quasi-experimental interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Large-scale effectiveness study of the effective use of Mapping for Health Data on immunisation coverage and equity in the Democratic Republic of Congo |
| Study objectives | The effective use of M4H geospatial data can increase immunisation coverage and equity through the identification of missed settlements (and zero dose children) and optimization of vaccination strategies and supply distribution as well as a gender-specific interventions in a sub-set of Health Zones and Health Areas in Kasai and Kinshasa. Study aim 1: Conduct a process evaluation to understand the program and implementation context, and identify the mechanisms through which geospatial data use influences immunisation coverage Study aim 2: Conduct a quasi-experimental design study in three provinces (two intervention- one with gender activities, one without gender activities, and one control) to determine the associated effects of the acceptance and use of M4H data by Health Zones and Health Areas on immunisation coverage and equity (especially zero-dose children). Study aim 3: Determine the incremental cost-effectiveness of geospatial data use as compared to the status quo |
| Ethics approval(s) | Approved 27/07/2021, Kinshasa School of Public Health Internal Review Board (BP 11850 Kinshasa, DRC; +243 817 493194; espsec_unikin@yahoo.fr), ref: none provided |
| Health condition(s) or problem(s) studied | Routine immunisation |
| Intervention | There is a control province and two intervention provinces, where sites will be stratified and then randomly selected for inclusion in the intervention strength study based on immunisation coverage and equity at baseline, urban/rural, and connectivity status. Intervention: Immunisation microplans with geospatial data, updated immunisation targets based on geospatial modeled population estimates, and population mobility data. Control: Standard practice or status quo in the control province - immunisation microplans without geospatial data and immunisation targets based on census data. The overall structure of the research study includes three provinces - one province selected for inclusion to assess M4H geospatial data interventions with gender-specific activities in a subset of Health Zones and Health Areas, namely Kasai; another M4H province selected to assess effects of M4H geospatial data interventions without gender, namely Lomami; and a control site to compare both M4H sites, namely Kasai Central. In addition, the protocol includes prioritization and segmentation of primary research participants, Essential Programme for Immunisation (EPI) staff and affiliates, for the intervention strength survey and qualitative in-depth interviews (where possible engaging with equal numbers of male and female EPI managers, supervisors, and vaccinators) as well as in the secondary analyses of immunisation coverage and equity surveys (gender-disaggregated analyses of birth cohorts). Each study arm will be segmented into the following categories (urban, rural, per-urban, conflict, and high/low/moderate connectivity) and a random selection of Health Areas will be chosen for inclusion in the intervention strength survey and qualitative in-depth interviews. Complementary qualitative data collection will be conducted in the form of direct observation and in-depth interviews at the National, Province, and Health Zone levels. Additional rapid ethnographic field work will be conducted to assess the gender -specific interventions. |
| Intervention type | Mixed |
| Primary outcome measure | Measured at the end of the study: 1. Acceptance of M4H geospatial data in micro planning and macro planning- measured as the percent of Provinces and Health Zones EPI Managers who state that they intend to use M4H geospatial data in EPI programme planning and implementation 2. Use of M4H geospatial data in micro planning and macro-planning - measured as the percent of Health Zone EPI Managers who include the M4H geospatial data in their micro plans 3. Use of M4H data in immunisation programme delivery - measured as the percent of Health Area EPI supervisors and vaccinators who use the M4H geospatial data to manage the implementation of the routine immunisation programme/ all eligible Health Area EPI supervisors and vaccinators 4. Effects of M4H data on immunisation programme outcomes - measured as change in immunisation coverage and equity through secondary analyses of immunisation survey data from baseline to end-line (pre/ post-intervention) in Health Areas as correlated to the percentages of acceptance and use of M4H geospatial data 5. Cost-effectiveness of M4H data on immunisation programme outcomes - measured in Lives Saved using the Lives Saved Tool and Disability-Adjusted Life-years alongside change in immunisation coverage and equity through secondary analyses of immunisation survey data from baseline to end-line (pre/ post-intervention) in Health Areas as correlated to the percentages of acceptance and use of M4H geospatial data |
| Secondary outcome measures | Gender-associated affects in the creation, acceptance, and use of M4H geospatial data- measured through a Rapid Ethnographic Study of the gender intervention and through gender-related questions and disaggregation of respondents by gender as correlated to the percentages of acceptance and use of M4H geospatial data at the end of the study |
| Overall study start date | 01/01/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | ~500 |
| Total final enrolment | 111 |
| Key inclusion criteria | Essential Programme for Immunisation administrators, supervisors, and vaccinators and associated individuals engaged in the generation and/or use of M4H geospatial data for immunisation microplanning, macroplanning, and service delivery. |
| Key exclusion criteria | Those who do not provide consent to participate in the study. |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Congo, Democratic Republic
Study participating centre
Kinshasa
-
Congo, Democratic Republic
Sponsor information
Charity
Global Health Campus
Chemin du Pommier 40
Le Grand-Saconnex
1218
Switzerland
| Phone | +41 22 909 6500 |
|---|---|
| info@gavi.org | |
| Website | http://www.gavi.org/ |
"ROR" |
https://ror.org/0141yg674 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Gavi, Gavi The Vaccine Alliance
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication, Other |
| Publication and dissemination plan | The aim will be to create one comprehensive report with all research findings and submit a summary paper to a peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 21/10/2021 | 29/10/2021 | No | No | |
| Funder report results | 01/11/2023 | 17/06/2024 | No | No | |
| Results article | 24/01/2025 | 28/01/2025 | Yes | No |
Additional files
Editorial Notes
28/01/2025: Publication reference added.
17/06/2024: Funder report and total final enrolment added.
06/11/2023: The study public contact confirmed that the record was up to date.
29/10/2021: Trial's existence confirmed by Kinshasa School of Public Health Internal Review Board.
