About this trial
The goal of this implementation research study is to understand whether a package of community-based interventions can increase access to and uptake of the human papillomavirus (HPV) vaccine among very young adolescent girls in rural Ethiopia. The main questions this study aims to answer are:
* Can a package of community-based interventions increase delivery of routine HPV vaccination to girls aged 9-14 in rural Ethiopia? * Is an intervention model that incorporates strategies that address gender norms and gender-specific barriers more effective at increasing delivery of routine HPV vaccination than a model that does not explicitly address gender? * What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to delivery routine HPV vaccination in rural Ethiopia?
To evaluate the effectiveness of the intervention, researchers will compare HPV vaccination within regions where the new intervention model is being implemented (intervention areas) to regions where the new routine HPV vaccination delivery model is not being implemented (comparison areas) for approximately 1 year before the new intervention model is implemented and for approximately 1 year after the start of implementation to compare changes over time and between intervention and comparison areas.
The study will evaluate the effect of the intervention on HPV vaccination delivery using routine health facility data.
To understand acceptability, feasibility, implementation, and potential for scale, the study will enroll participants including health officials and providers, adolescents girls receiving HPV vaccination and other services in intervention areas, and their parents/caregivers.
These participants may be asked to participate in one or more of the following:
* Completing a short questionnaire after receiving health services, including HPV vaccination, and their knowledge and attitudes towards HPV vaccination and experiences of care * Participating in an interview or a focus group discussion to discuss HPV vaccination services and the role of the intervention in delivering care
Eligibility criteria
Qualifiers
None
Disqualifiers
Girl: aged 9-14 years, female
Caregiver: Parent/legal guardian of eligible 9-14-year-old girl (above); 18 years of age or older
Girl: Does not provide informed assent, including to audio-recording, Parent/legal guardian does not provide consent
Caregiver: Does not provide informed consent, including to audio-recording
Trial design
Treatments tested in this trial
- Integrated health service delivery for very young adolescent girls
Treatment groups
Locations
Sponsors and collaborators
Population Services International
Lead sponsor
Addis Ababa University
Collaborator
Ministry of Health, Ethiopia
Collaborator