Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Antibody Response to HPV Vaccine for HPV 6,11,16,18.
研究概览
简要总结
The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.
详细描述
FSWs are at higher risk of HPV infection and presumably cervical cancer, and the recently available vaccine has been shown to protect against persistent infection from these types. If this study gives evidence showing the vaccine is acceptable in preventing cervical HPV infection by types 16 and 18 in this population, then the burden of cervical cancer and cancer precursors could be drastically decreased through widespread vaccination of this target group. Vaccination at the point of entry of brothel based sex work may become a requirement to lower the burden of cervical cancer among FSWs and also among all other sex partners of clients of FSWs. A modified schedule may prove beneficial for FSWs in Peru to complete the vaccine regimen.
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
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the age of 18 and 26 years
- •Registered female sex worker living in Lima
- •Healthy with no known immune deficiency
- •Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months
- •Willing to provide informed consent
排除标准
- •Currently pregnant or planning to get pregnant in the next six months
- •Known immune deficiency disorder
- •Current receipt of immunosuppressive drugs
- •Allergy to yeast or known contraindication to HPV vaccine
- •Women who have had their cervix removed
- •Previous HPV vaccination
- •Current fever over 100 degrees Fahrenheit
结局指标
主要结局
Antibody Response to HPV Vaccine for HPV 6,11,16,18.
时间窗: Month 7
We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.
Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.
时间窗: 6 months
Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.
次要结局
- Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers(Month 0)
- Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers(Baseline)
研究者
Neal Halsey
Professor of International Health
Johns Hopkins Bloomberg School of Public Health