The Human Papillomavirus (HPV) Transmission Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Proportion of men in the HIM study willing to invite their female partner to participate in partner study, proportion of female partners who: a) contact clinic for enrollment in study b) are eligible to participate in the study c) enroll in study.
研究概览
简要总结
This transmission pilot study is a prospective study to determine feasibility of enrolling female partners into an international transmission study. Companion study to MCC-13930.
详细描述
We planned to enroll 150 female sexual partners, 75 per year for 2 years, of male study participants in the HPV Infection in Men (HIM) Study. The enrollment period is from June 2006 through May 2008 and participants will be followed through May 2010. At all study visits participants will undergo interviews, a physical exam and laboratory analysis for HPV for a total of 5 clinical visits scheduled every 6 months over 2 years of follow-up. In addition, at each study visit, participants will provide blood for HPV antibody analyses. At enrollment, visit 3 and visit 5 a Pap smear test will be done. At the enrollment visit, study participants will complete a questionnaire designed to assess social and behavioral risk factors for the acquisition of HPV. At each subsequent study visit, participants will be asked to provide updated information to assess changes in risk behaviors such as condom use, relations with new partners, and tobacco use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female partners of HIM Study participants
- •report no abnormal Pap smear during the past 6 months;
- •have not had a hysterectomy
- •have never been diagnosed with genital warts;
- •are not pregnant;
- •residents of southern Florida;
- •are not and have not been enrolled in an HPV vaccine trial;
- •willing to comply with scheduled visits every 6 months for 2 years.
排除标准
- •Do not meet the Inclusion Criteria.
结局指标
主要结局
Proportion of men in the HIM study willing to invite their female partner to participate in partner study, proportion of female partners who: a) contact clinic for enrollment in study b) are eligible to participate in the study c) enroll in study.
时间窗: 2 year accrual period
次要结局
- Proportion of female partners who report being monogamous with the HIM partner, proportion of women that are both HPV sero negative and HPV DNA negative at enrollment, proportion of women who comply with study protocol over 2 years of follow up.(2 years per participant)