Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Patient Indication of Willingness to Accept the Vaccine Based on Survey
研究概览
简要总结
Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 26 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital
- •Exclusion criteria
- •Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid use, preeclampsia, non-English speaking
排除标准
- 未提供
研究组 & 干预措施
Gardasil9
干预措施: Gardasil9 (Drug)
结局指标
主要结局
Patient Indication of Willingness to Accept the Vaccine Based on Survey
时间窗: 1 day (at the time of initial recruitment /survey)
This was established using a survey to indicate willingness to receive vaccine.
次要结局
- Serum Titers of Vaccine-specific HPV Types(baseline and 7 months)
- Uptake of the Vaccine Doses(at 6 months)
研究者
Haller Smith
Professor
University of Alabama at Birmingham
