| Protocol No: | ECCT/25/02/02 | Date of Protocol: | 20-09-2024 |
| Study Title: | Generating local data on HPV vaccination impact and training needs at the level of vaccine implementers – A feasibility study |
| Study Objectives: | 1) To demonstrate feasibility to measure vaccine induced long-term immune response (vaccination status) and infection prevalence using first-void urine sample in Gavi pilot vaccinated cohort
2) Investigate training challenges among HCWs on HPV vaccination
3) Assess gaps in HCWs’ training
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| Laymans Summary: |
This study aims to understand how well HPV vaccination programs are working and to identify areas where healthcare workers may need more training in Kenya, Uganda, and Senegal. This protocol will specifically cover activities in Kenya. The primary goal is to gather information on the effectiveness of HPV vaccines and assess the training of healthcare workers who administer them.
To measure the vaccine's impact, the study will collect urine samples from both vaccinated and unvaccinated girls and women in the three countries. These samples will be tested to see how well the vaccine is helping the body build long-term protection and to track HPV infection rates 126 among the participants.
The study will also explore training challenges faced by healthcare workers involved in giving the HPV vaccine. Through surveys and interviews, researchers will identify gaps in knowledge and training to understand what improvements are needed.
The findings are expected to provide important local data on vaccine coverage, HPV infection rates, and immune responses. Additionally, the study will offer suggestions on how to improve healthcare worker training for more effective HPV vaccination programs. The research will follow ethical standards to protect participant privacy, and everyone will have the option to withdraw at any time. Ultimately, this work aims to strengthen HPV vaccination efforts and improve training for those who deliver the vaccines.
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| Abstract of Study: |
Background: Local data availability on HPV disease burden, prevalence, vaccination coverage and impact of vaccination has been challenging in Africa due to the absence or lack of cancer registers, vaccination registers, population databases and electronic health information systems. Therefore, generating local data and promoting capacity building at local institutes is critical to sustaining HPV vaccination programs. Furthermore, among programmatic challenges, the initial training of healthcare professionals (HCWs) prior to the introduction is deemed insufficient. National stakeholders in Africa have emphasized the need for refresher training and capacity building of the healthcare workforce for sustained implementation.
Study Objectives: Therefore, using a multi-pronged approach, our study will 1) generate local data on vaccination coverage, HPV infection prevalence and HPV vaccination impact using first-void urine (FVU) in Kenya, Senegal and Uganda, 2) investigate training challenges among HCWs at the national and district level, 3) assess gaps in HCWs' training in Kenya and Uganda.
Study Methodology: This study adopts a multiple-methods approach addressing the above stated objectives. To address the objective of measuring HPV infection prevalence and impact using first void urine, we will use an observational cross-sectional study design to collect samples in Kenya including HPV vaccinated females as part of Gavi demonstration project, and adolescent females vaccinated under national immunization program and control groups for respective study groups. To address the objectives of investigating training challenges among HCWs at the national and district level, we will adopt a mixed-method study design to conduct survey and in-depth interviews with healthcare workers at the health facility. Identical studies will be conducted in Senegal and Uganda.
Expected Outcome/Results: This study aims to evaluate the long-term immune response induced by the HPV vaccine and assess infection prevalence using a non-invasive first-void urine sampling device. By measuring vaccine impact in targeted settings, the study will generate local data on vaccine effectiveness and impact. Additionally, it will explore the feasibility of implementing similar studies at the host institute to facilitate knowledge transfer and skill development in conducting such sampling methods. Furthermore, the study will identify key challenges in training healthcare workers, essential for the successful implementation of HPV vaccination programs. It will also propose sustainable training approaches and methods for assessing healthcare workers' knowledge to ensure program effectiveness and sustainability.
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