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临床试验/NCT06683664
NCT06683664尚未招募不适用

Human Papillomavirus Vaccine Integrated Service Implementation Research in Cameroon

Population Services International0 个研究点目标入组 40 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
HPV vaccine delivery

研究概览

简要总结

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 and boys in the North and Far North Regions of Cameroon. The main questions this study aims to answer are:

  • Can a package of community-based interventions increase delivery of routine HPV vaccination to boys and girls aged 9-13 in Cameroon's North and Far North Regions?
  • What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to deliver routine HPV vaccination in Cameroon?

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 9 months 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. The study will be conducted in two phases, with the first phase focused on gathering formative data through interviews with key informants. This data will be used to inform the design of the intervention, which will be implemented and evaluated in phase 2. Only phase 1 of this study protocol has been currently approved.

In phase 1, key informant interview participants will be asked to participate in a an interview to discuss HPV vaccination services and their perspectives on how to integrate HPV vaccination within existing community-based and health facility structures and programs. Key informants will include government officials, health program implementers, representatives from non-government organizations working on HPV vaccine delivery, and healthcare providers, as well as community leaders including school and religious leaders.

详细描述

Introduction Cervical cancer is a leading cause of cancer among women in Cameroon. Vaccinating very young adolescent girls and boys is the most effective long-term strategy to reduce its risk. Despite the introduction of the human papillomavirus (HPV) vaccine in Cameroon in 2020, the vaccination program has faced substantial challenges, including widespread vaccine hesitancy and low awareness of the vaccine. As a result, an initial approach focusing on school-based vaccination was shifted to routine, health facility-based distribution. Integrating HPV vaccinations into existing health platforms that reach very young adolescents and their caregivers presents an opportunity to improve the effectiveness, acceptability, and feasibility of routine, community-based HPV vaccination in Cameroon. Implementation research is needed to evaluate the effectiveness of such integrated service delivery approaches, contributing to more effective HPV vaccine programs in Cameroon and other, similar settings.

Objectives The aim of this research project is to evaluate the effectiveness, feasibility, acceptability, and potential for scalability of integrating HPV vaccination into an existing supply- and demand-side sexual and reproductive health and rights (SRHR) intervention to increase HPV vaccine coverage among girls and boys aged 9-13 years in the North and far North regions of Cameroon. The intervention will aim to deliver HPV vaccination through integration with demand- and supply-side program interventions in addition to an existing program implemented by Population Services International-Cameroon (PSI-C) and Association Camerounaise pour le Marketing Social (ACMS): Programme d'Accès aux Services de Santé de la Reproduction (PASSR).

Specific objectives

  1. To describe the barriers and facilitators affecting the implementation of HPV vaccination services for VYA girls (aged 9-13) in the North and Far North Regions of Cameroon, and to assess how these impact access and uptake of HPV vaccination.
  2. To evaluate the effectiveness of integrating HPV vaccination interventions into existing supply- and demand-side SRHR programs on uptake of HPV vaccination.
  3. To evaluate the effectiveness of integrating HPV vaccination interventions into existing supply- and demand-side SRHR programs on uptake of other VYA health service utilization.
  4. To assess acceptability, feasibility, cost, equity, and potential for maintenance and scale of HPV vaccination for adolescent girls integrated into an SRHR intervention.
  5. To provide evidence for policy integration of HPV vaccine in the adolescent sexual and reproductive health package at the MOH

Methods The study will be conducted in 4 intervention PASSR health districts (HDs) and 4 'standard of care' comparison HDs in the North and Far North regions of Cameroon. It will use a hybrid model of effectiveness and implementation research, with research conducted from approval until December 2025 (with the potential for ongoing data analysis, manuscript preparation, and dissemination through conferences and publications after this end date). Phase 1, the rapid formative and design phase, research activities will include interviews with key informants and secondary analysis of service statistics and program monitoring data. Key informant interview data will contribute to the development of the implementation model, which will also be informed by programmatic co-design workshops. The second phase (implementation) will include a quasi-experimental effectiveness study comparing HPV vaccine administration to girls and boys aged 9-13 years in the intervention and comparison areas, as well as implementation research activities to assess uptake, reach, implementation, activity-based costing and readiness for integration and scale-up. In addition, phase 2 will include analyses of acceptability, feasibility, and satisfaction, using data from key informant interviews; and quantitative exit interviews, focus group discussions, and qualitative in-depth interviews with girls, boys, and caregivers and health professionals. A mixed methodology, integrating quantitative and qualitative research methods, will be used.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Key informant identified by study and implementation teams (purposive sampling by key informant type)

排除标准

  • Does not provide written informed consent

结局指标

主要结局

HPV vaccine delivery

时间窗: The primary outcome measure is an aggregated, facility-level outcome which will be assessed at the facility-month level using aggregated routine service statistics data over a period of up to 36 months

Number of HPV vaccinations provided to adolescents aged 9-13 years old per facility per month

次要结局

未报告次要终点

研究者

发起方
Population Services International
申办方类型
Other
责任方
Sponsor

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