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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Gavi |
| Funder | GAVI Alliance |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre three-province quasi-experimental interventional study |
| Secondary study design | Cluster randomised trial |
| Study type | Participant 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(s) |
Measured at the end of the study: |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication, Other |
| 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? |
|---|---|---|---|---|---|
| Results article | 24/01/2025 | 28/01/2025 | Yes | No | |
| Funder report results | 01/11/2023 | 17/06/2024 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 21/10/2021 | 29/10/2021 | No | No |
Additional files
- 40584 PROTOCOL_21Oct2021.pdf
- Protocol file
- ISRCTN65876428_Mapping4Health_DRC_ComprehensiveResearchReport_Final.pdf
- Funder report results
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.
