Methodology

The Nepal Vaccine Delivery study is a collaboration between Emory University, the Center for Molecular Dynamics—Nepal, the Georgia Institute of Technology, the Gates Foundation, and Gates Ventures, as part of the Exemplars in Global Health program.

Exemplar country selection

Filtering criteria were used to identify low-income countries that increased immunization coverage from 2006 to 2016. From these candidates, countries with diverse locations, cultures, and health system attributes were selected for deeper examination.

Project frameworks

In this mixed-methods research, several existing frameworks informed data collection and interpretation.

Conceptual framework for vaccine delivery

An existing framework describing the determinants of success in immunization systems¹ was adapted to incorporate contextual factors such as governance, financing and health care system attributes. This framework informed analysis of delivery system components.

Frameworks for systems change

Three frameworks informed our research around systems change:

• To elucidate the implementation of specific interventions, we established a simple “Why-How-What” framework. In this framework, we defined Why as the process of problem identification, How as the mechanisms for change, and What as the solutions that were implemented. This framework was applied to the adaption of external policies, and to the development and delivery of internal innovations.
• The Consolidated Framework for Implementation Research (CFIR) serves as a guide to understand the contextual factors that influenced the success or failure of implementation of a specific intervention. These include the outer context, the inner (organizational) context, the characteristics of the intervention, the implementation approach, and the individual actors responsible for implementation. ²
• The Context and Implementation of Complex Interventions (CICI) framework aims to advance the understanding of how and why interventions work.³ The CICI framework informed analysis of context and setting for system change.

Desk review

The study team undertook an extensive review of available information and published data on the state of immunization in Nepal from 2000 to the present. This included coverage data from surveys, World Health Organization (WHO) and United Nations Children’s Fund (UNICEF) estimates of national immunization coverage, and the Institute for Health Metrics and Evaluation (IHME), as well as historic and current health policies, economic conditions, the political context, and other factors that may have impacted the immunization program. The desk review informed the interview guides used in the in-depth research visit, data analysis, and synthesis.

Primary research

Primary research was conducted in two stages. An initial scoping was conducted in March 2019. In this stage, key informant interviews (KIIs) were conducted to understand the evolution of immunization programming and the factors thought to contribute to Nepal’s performance in immunization. Altogether, nine KIIs were conducted with high-level Ministry of Health and Population (MoHP) representatives and professionals involved in country-level immunization programming. These included WHO and UNICEF staff as well as National Immunization Technical Advisory Group (NITAG) and National Health Research Council members.

The scoping and desk review informed the second stage of primary research: in-depth KIIs and focus group discussions (FGDs) conducted from August to November 2019.

The in-depth research was conducted at national, provincial, district, health facility, and community levels. The selection of study provinces and districts aimed for diversity in geography and coverage in the table below. Study districts included the national and provincial capitals.

Table. Comparison of study districts as of 2018.

Interview guides were informed by the CFIR domains and adjusted to the local context. All interview guides were piloted before use and adjusted iteratively throughout data collection. KIIs and FGDs were conducted in Nepali in-person by trained facilitators.

KIIs were conducted at the national, provincial, district, and health facility levels to (1) identify the strategies behind current immunization programs to inform the current context; (2) identify previous immunization activities occurring during changes in DTP1 and DTP3 coverage from 2000 to 2018; and (3) identify key internal and external actors, stakeholders, and partnerships in the immunization program both past and present.

At the national level, an initial list of KIIs was developed with the help of MoHP officials. We then used snowball sampling to identify other potential informants. KIIs were conducted with past and present senior managers and directors at the MoHP involved in immunization activities, and with staff of the Ministry of Finance and partner organizations involved in the immunization program. Partner organizations included the WHO, UNICEF, Nepal Health Research Council, Tribhuvan University-Institute of Medicine, Rotary Polio Plus Committee, NITAG, and Nepal Pediatric Society.

At the provincial level, KIIs were conducted with provincial health officers, cold chain officers, and immunization officers.

At the district level, KIIs were conducted with the district health officers. Health facilities were selected in collaboration with the local government and then KIIs were conducted with the health post in-charge, vaccinators, and community leaders (including ward officers, village committee members, and women’s health management committees).

FGDs were conducted at the community level with female community health volunteers (FCHVs) and caregivers. The goals of the FGDs were to (1) understand the service provided by the health system, including past and present vaccine interventions; (2) identify the roles and responsibilities of FCHVs in the health and immunization sector; and (3) understand the previous and current factors behind vaccination coverage in their respective communities.

These discussions were organized with the support of district health directors. FGDs had a maximum of eight participants in each discussion and were held in private health facility rooms. Mothers, fathers, grandparents, and FCHVs were separated for FGDs.

FGD participants were selected in advance. FCHVs had to be active and work within the ward; preference was given to FCHVs who had worked in the community for over five years. Mothers had to be below the age of 45 and have a child who was 1 to 17 years old; preference was given to women in mothers’ health groups. Fathers had to be below the age of 55 and have a child who was 1 to 17 years old. Grandmothers had to be older than the age of 55 and have a grandchild who was 1 to 17 years old.

Qualitative data analysis

We conducted a thematic analysis of KII and FGD transcripts to identify the key drivers of success in immunization programs relative to deductive and inductive themes, applying constructs from the Why-How-What, CFIR, and CICI frameworks. We considered context and participant roles while uncovering key points, and triangulated data with historical documents and literature review. Emerging themes were identified and grouped with predetermined research questions and objectives, while also accounting for unexpected themes.

Ethical approval

The research protocol was reviewed and approved by the National Health Research Council in Nepal. This study was also approved as exempt human research by the Institutional Review Board committee of Emory University, Atlanta, Georgia, USA (IRB00111474). This project qualified for exemption from the requirements of federal regulations under 45 CFR 46.104(d)(2). Participation in the KIIs and FGDs were voluntary. Consent forms were read verbatim to participants in their preferred language by a trained interviewer. Participants provided written informed consent in the presence of a witness.