The MCH-HB Adjara Study: protocol for a non-randomised hybrid type 1 effectiveness–implementation study of the Maternal and Child Health Handbook in Georgia
6 affiliations
- 1School of International Health, The University of Tokyo Graduate School of Medicine, Faculty of Medicine, Bunkyo-ku, Tokyo, Japan
- 2JICA Project Team for Improving the Quality of Continuum of Care for Mothers and Children through the Introduction of Maternal and Child Health Handbook, Tbilisi, Georgia
- 3Department of Community and Global Health, The University of Tokyo Graduate School of Medicine, Faculty of Medicine, Bunkyo-ku, Tokyo, Japan
- 4Ministry of Internally Displaced Persons from the Occupied Territories Labour Health and Social Affairs of Georgia, Tbilisi, Georgia
- 5National Center for Disease Control and Public Health, Tbilisi, Georgia
- 6Japan International Cooperation Agency, Tokyo, Japan
Abstract
Introduction: Home-based maternal and child health records, such as the Maternal and Child Health Handbook (MCH-HB), may strengthen the continuum of care (CoC) from pregnancy through early childhood by improving continuity of care, communication between women and healthcare providers, and women’s engagement in maternal and child healthcare. However, evidence regarding their effects on CoC and quality-adjusted service coverage remains limited, particularly under routine implementation conditions and in upper-middle-income settings. In collaboration with the Japan International Cooperation Agency, the Government of Georgia has recently introduced the MCH-HB in the Autonomous Republic of Adjara as a pilot programme to inform potential national scale-up. This protocol describes the MCH-HB Adjara Study, a hybrid effectiveness–implementation study evaluating the introduction of the MCH-HB within routine maternal and child healthcare services in Georgia.
Methods and analysis: The MCH-HB Adjara Study is a non-randomised type 1 hybrid effectiveness–implementation study consisting of a maternal survey and a healthcare provider survey. The maternal survey consists of two analytical components: (1) a quasi-experimental controlled comparison using a difference-in-differences design between mothers in Batumi (intervention site) and those in Kutaisi (comparison site) and (2) supplementary pre–post analyses conducted within the broader pilot region, including Batumi, Kobuleti and Khulo. The target sample is approximately 400 women in each of the four main comparison groups (Batumi-pre, Batumi-post, Kutaisi-pre and Kutaisi-post). Structured interviews are conducted shortly before discharge following childbirth and again at 3 months postpartum. The healthcare provider survey is a cross-sectional survey conducted in health facilities implementing the MCH-HB to assess implementation processes, perceived usefulness and challenges related to the routine use of the handbook. The primary effectiveness outcome is uptake of at least eight antenatal care (ANC) visits. Secondary outcomes include uptake of recommended postnatal care (PNC) for mothers and infants, a composite CoC indicator combining ANC and PNC uptake, quality-adjusted coverage indicators, breastfeeding practices, maternal knowledge, and indicators of communication and experience of care. The primary effectiveness analysis will use a difference-in-differences approach with multivariable regression models. Implementation outcomes will be assessed using selected domains of the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework, including reach, adoption, implementation fidelity and maintenance, drawing on data from both mothers and healthcare providers.
Ethics and dissemination: Ethical approval for this study was obtained from the Research Ethics Committee of the Faculty of Medicine, The University of Tokyo, Japan (Approval Number 2025021NI) and the Medical Ethics Committee for the Evaluation of Biomedical Research of the National Center for Disease Control and Public Health, Georgia (Protocol Number 2025-031). Findings from the MCH-HB Adjara Study will be disseminated through peer-reviewed publications, conference presentations and reports to relevant policy stakeholders and health authorities in Georgia.
Trial registration number: UMIN000061527.
Related
- Food supplementation and behavioural counselling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K’ASLEM hybrid type 1 effectiveness-implementation randomised controlled trial
- Improving the detection, assessment, management and prevention of delirium in palliative care units (the DAMPen-Delirium II study): protocol for an implementation-to-target Type III hybrid effectiveness-implementation cluster randomised-controlled trial, economic evaluation and process evaluation of the Creating Learning Environments for Compassionate Care-Palliative (CLECC-Pal) implementation strategy.
- Remotely delivered support to promote physical activity behaviour change for women aged 50 years and over: study protocol for the Active Women over 50 hybrid type I effectiveness-implementation randomised controlled trial
- Bump2Baby & Me+ (B2B&Me+): Protocol for a multi-country, European hybrid type 3 implementation-effectiveness study to reduce the incidence of gestational diabetes mellitus and improve maternal and child health
- Effectiveness of an Artificial Intelligence Health Education Accurately Linking System (AI-HEALS) for the intervention of chronic kidney disease: a randomised controlled trial protocol
BibTeX
@article{nanishi2026mchhb,
title = {{The MCH-HB Adjara Study: protocol for a non-randomised hybrid type 1 effectiveness–implementation study of the Maternal and Child Health Handbook in Georgia}},
author = {Keiko Nanishi and Aya Hasegawa and Akira Shibanuma and Vera Baziari and Nino Lomia and Shorena Gozalishvili and Keiko Osaki},
journal = {BMJ Open},
year = {2026},
month = nov,
doi = {10.1136/bmjopen-2026-122875},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122875},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - The MCH-HB Adjara Study: protocol for a non-randomised hybrid type 1 effectiveness–implementation study of the Maternal and Child Health Handbook in Georgia
AU - Keiko Nanishi
AU - Aya Hasegawa
AU - Akira Shibanuma
AU - Vera Baziari
AU - Nino Lomia
AU - Shorena Gozalishvili
AU - Keiko Osaki
PY - 2026
DA - 2026/11/02
JO - BMJ Open
DO - 10.1136/bmjopen-2026-122875
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122875
AB - Introduction: Home-based maternal and child health records, such as the Maternal and Child Health Handbook (MCH-HB), may strengthen the continuum of care (CoC) from pregnancy through early childhood by improving continuity of care, communication between women and healthcare providers, and women’s engagement in maternal and child healthcare. However, evidence regarding their effects on CoC and quality-adjusted service coverage remains limited, particularly under routine implementation conditions and in upper-middle-income settings. In collaboration with the Japan International Cooperation Agency, the Government of Georgia has recently introduced the MCH-HB in the Autonomous Republic of Adjara as a pilot programme to inform potential national scale-up. This protocol describes the MCH-HB Adjara Study, a hybrid effectiveness–implementation study evaluating the introduction of the MCH-HB within routine maternal and child healthcare services in Georgia. Methods and analysis: The MCH-HB Adjara Study is a non-randomised type 1 hybrid effectiveness–implementation study consisting of a maternal survey and a healthcare provider survey. The maternal survey consists of two analytical components: (1) a quasi-experimental controlled comparison using a difference-in-differences design between mothers in Batumi (intervention site) and those in Kutaisi (comparison site) and (2) supplementary pre–post analyses conducted within the broader pilot region, including Batumi, Kobuleti and Khulo. The target sample is approximately 400 women in each of the four main comparison groups (Batumi-pre, Batumi-post, Kutaisi-pre and Kutaisi-post). Structured interviews are conducted shortly before discharge following childbirth and again at 3 months postpartum. The healthcare provider survey is a cross-sectional survey conducted in health facilities implementing the MCH-HB to assess implementation processes, perceived usefulness and challenges related to the routine use of the handbook. The primary effectiveness outcome is uptake of at least eight antenatal care (ANC) visits. Secondary outcomes include uptake of recommended postnatal care (PNC) for mothers and infants, a composite CoC indicator combining ANC and PNC uptake, quality-adjusted coverage indicators, breastfeeding practices, maternal knowledge, and indicators of communication and experience of care. The primary effectiveness analysis will use a difference-in-differences approach with multivariable regression models. Implementation outcomes will be assessed using selected domains of the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework, including reach, adoption, implementation fidelity and maintenance, drawing on data from both mothers and healthcare providers. Ethics and dissemination: Ethical approval for this study was obtained from the Research Ethics Committee of the Faculty of Medicine, The University of Tokyo, Japan (Approval Number 2025021NI) and the Medical Ethics Committee for the Evaluation of Biomedical Research of the National Center for Disease Control and Public Health, Georgia (Protocol Number 2025-031). Findings from the MCH-HB Adjara Study will be disseminated through peer-reviewed publications, conference presentations and reports to relevant policy stakeholders and health authorities in Georgia. Trial registration number: UMIN000061527.
SN - 2044-6055
SN - 2044-6055
ER -