Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Prevalence of cervical neoplasia in HIV positive women
研究概览
简要总结
The prevalence of cervical neoplasia in Cambodia is not known. There are no screening programs in place. The investigators plan on introducing a screening program based on WHO criteria and utilizing visualization with acetic acid. Patients who are positive will be offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).
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
- 30 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female, age 30-49, able to give informed consent
排除标准
- •pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid
结局指标
主要结局
Prevalence of cervical neoplasia in HIV positive women
时间窗: up to 12 months
500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid
Prevalence of cervical neoplasia in HIV negative women
时间窗: up to 12 months
500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid
次要结局
- Treatment of HIV positive women who screen as positive(up to 12 months)
- Treatment of HIV negative women who screen as positive(up to 12 months)