Human Papillomavirus Vaccine Integrated Service Implementation Study in Ethiopia (HPV-VISION)

Background Cervical cancer is the second most common cancer in Ethiopia. Vaccinating very young adolescent girls is the most effective long-term strategy to reduce its risk. Ethiopia introduced the human papillomavirus (HPV) vaccine in 2018, initially targeting 14-year-old girls through school-based campaigns and updated its guidelines in 2021 to target girls aged 9-14 years. Despite vaccinating around eight million girls since the launch of the program, very young adolescent (VYA) girls, particularly those in rural, out-of-school, and hard-to-reach areas, remain underserved, prompting new strategies to more effectively address this age group. Integrating HPV vaccinations into existing adolescent health services offers a strategic opportunity to enhance vaccine accessibility and coverage by utilizing established healthcare platform. This approach can address both logistical challenges and health disparities, ultimately improving adolescent health outcomes and contributing to the prevention of HPV-related diseases. To address this, implementation research is needed to evaluate the effectiveness of this approach. If successful, it could be scaled and adapted to similar contexts, contributing to the global effort to reduce cervical cancer incidence and mortality.

Objectives We propose a type 3 hybrid effectiveness implementation research study to evaluate the effectiveness, feasibility, fidelity, acceptability, and scalability of integrating HPV vaccination into a very young adolescent services package to increase HPV vaccine coverage among girls aged 9-14 years in rural Ethiopia.

A secondary objective of the research is to assess the feasibility, acceptability and potential for scalability of integrated HPV vaccination with VYA services with Ethiopia's existing 'Smart Start' platform.

Methods The study will be conducted in four intervention and four comparison woredas in Oromia, Sidama, and Somali regions of Ethiopia. It will use a hybrid effectiveness implementation research design, comprising two main phases from July 2024 to December 2025. Phase 1, the rapid formative and design phase, will include key informant interviews (KIIs), a desk review of the literature and existing data sources and retrospective service statistics data, and co-design workshops in which a design prototype ('Model 0') will be refined and finalized as the initial implementation model ('Model 1'). Phase 2 will include a quasi-experimental effectiveness component comparing HPV vaccine delivery to girls aged 9-14 in intervention and comparison areas, along with implementation research activities to assess adoption, reach, implementation, activity-based costing, and readiness for integration and scale-up. In additional, phase 2 will include gender formative phase, in which a formal gender analysis will be conducted using data from KIIs, quantitative exit interviews (EIs) with girls and caregivers, qualitative in-depth interviews (IDIs) and focus group discussions (FGDs) with girls, caregivers, and health workers. At the end of phase 2, 'pause-and-reflect' gender co-design workshops will be conducted to refine 'Model 1' based on the results from the formal gender analysis. The resulting 'Model 2' intervention model will explicitly incorporate a gender-lens, with the objective of engaging very young girls (aged 9-14 years), their caregivers, health workers, and communities to reduce gender barriers faced by very young girls to improve self-efficacy and increase access to and uptake of HPV vaccination and other integrated VYA interventions.

A mixed methods design, incorporating both quantitative and qualitative research methods, will be used. A total of approximately 40 KIIs will be conducted in each of the three phases, with 10 KIIs in each intervention woreda and at the national level conducted in each phase. A total of approximately 60 in-depth interviews (IDIs) will be conducted with parents/guardians, girls, and health workers in each implementation phase (phases 2 and 3), with ~15 IDIs in each intervention woreda. Approximately 8 focus group discussions (FGD) with eligible girls and their parents/guardians will be conducted in phases 2 and 3 each, with approximately 1 FGD with girls and 1 FGD with parents/guardians per intervention woreda per implementation phase. The EIs will be conducted with approximately 400 VYA girls and 400 parents/guardians in each of phases 2 and 3 in intervention areas. In addition, anonymized routine monitoring data, including aggregated service delivery data collected by program monitoring systems as well as through the Ethiopian Ministry of Health DHIS2 (an open-source health information management system) platform and other existing data sources, will be extracted and analyzed from both comparison and intervention woredas. Of the primary data collection proposed in this study, only program monitoring data will be collected in comparison woredas. Phase 3 activities are dependent on the confirmation of anticipated additional co-funding.