Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Feasibility of delivering the intervention
研究概览
简要总结
Human Papillomavirus (HPV) is the most common sexually transmitted infection globally, and is causally linked to cervical, anogenital, and oropharyngeal cancers. HPV-associated cancers have a disproportionate impact in low-resource settings and nowhere is this evident than in South Africa, which has a uniquely vulnerable population due to the convergence of the largest HIV epidemic globally, with HPV rates of up to 85% in young women under the age of 25. For the clinical trial phase of this study, we intend to evaluate preliminary effects of a communications strategy and key criteria to advance to a full scale hybrid type 2 trial. Our systems-focused approach leverages established partnerships with area schools serving diverse populations who are not always effectively served by traditional healthcare channels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study will include children enrolled in Grade 5 in participating schools (ages 9-12 years old) in Gauteng province, South Africa, who have no prior history of HPV immunization. We have selected fifth graders for our target population to follow the current Provincial Guidelines. This is in line with National Cervical Guidelines aimed at reaching young people prior to their sexual debut.
- •We will also be recruiting parents/caregivers of these children, given their role in decision-making. All parents/caregivers will be at least 18 years old. We will also be including adults who are at least 18 years of age, who are employed at participating schools as teachers or school administrators, and others who are engaged in the planning or implementation of the school-based HPV vaccine program (e.g., representatives from the Department of Health, nurses). We have no upper age limit for this population.
排除标准
- •Children below the age of 9 years old will not be included in the study.
结局指标
主要结局
Feasibility of delivering the intervention
时间窗: Six Months
Feasibility will be assessed using the Feasibility of Intervention Measure.
Uptake of HPV vaccine
时间窗: within Six Months
Successful uptake of 1 dose of HPV vaccine
Feasibility of delivering the intervention
时间窗: Six Months
Feasibility will be assessed using the Feasibility of Intervention Measure.
次要结局
- Preliminary Effectiveness of the HPV intervention(Six Months)
研究者
Ingrid Theresa Katz, M.D.
Associate Professor
Brigham and Women's Hospital