ASPIRE Pilot: Determining Optimal Cervical Cancer Screening in a Low-resource Setting: A Randomized Controlled Trial Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid (VIA) Screening in Kampala, Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy
研究概览
简要总结
Cervical cancer remains a public health burden, particularly in developing countries such as sub-saharan Africa where the infrastructure for organized screening programs does not exist. As a result, other screening modalities (visual inspection with acetic acid) are the standard of care in such regions. It is now known, persistent infection with an oncogenic Human papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing HPV testing is a potential, safe and effective alternative to cytology testing (The Pap smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs. VIA in a cohort of women from Kisenyi, Uganda.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 30-65yrs
- •Living or working in community of Kisenyi, Uganda
- •Access to mobile telephone
- •Fluent in Luganda, Somali or English
- •Competent to provide informed consent
排除标准
- •Known to be pregnant at study entry (self-reported)
- •Complete hysterectomy
- •Prior diagnosis or treatment of cervical dysplasia or cervical cancer
研究组 & 干预措施
HPV Self-collection
Subjects will self-collect a cervical-vaginal sample. One time use.
干预措施: HPV self-colleciton (Procedure)
VIA arm
Standard of care in Uganda is visual inspection with acetic acid (VIA). Women randomized to this arm will undergo the following: Cervix examined by clinician using speculum and light source. Cervix then sprayed with 3-5% acetic acid, and then lesions described one minute after application of acetic acid. VIA negative no acetowhite lesions detected; positive is when dense aceto-white lesions are seen touching squamocolumnar junction
干预措施: visual inspection with acetic acid (VIA) (Procedure)
VIA arm
Standard of care in Uganda is visual inspection with acetic acid (VIA). Women randomized to this arm will undergo the following: Cervix examined by clinician using speculum and light source. Cervix then sprayed with 3-5% acetic acid, and then lesions described one minute after application of acetic acid. VIA negative no acetowhite lesions detected; positive is when dense aceto-white lesions are seen touching squamocolumnar junction
干预措施: 3-5% acetic acid (Drug)
结局指标
主要结局
Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy
时间窗: At the 12 month follow-up visit
Presence of low grade (CIN1) or moderate to high grade lesions (CIN2 or greater) will be compared between the two groups using chi-square testing at month 12.
次要结局
- Prevalence rates of high-risk HPV in the self-collection arm.(One year)
- Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda(One Year)
- Evaluation of adverse events or complications documented at time of sample collection, 4-6 weeks after cryotherapy and at 12 and 36 months by study questionnaire(36 months)
- Assess screen positive rates by nurse-midwife exam in VIA arm(One year)
研究者
Gina Ogilvie
Dr. Gina Ogilvie
University of British Columbia