Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in Botswana
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval
研究概览
简要总结
Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary HPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and HPV genotype restriction for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for HPV self-sampling in our setting. We will evaluate optimal screening intervals in women living with HIV (WLHIV) in an HPV-based cervical cancer screening program and compare triage strategies for positive HPV results at WHO recommended screening intervals for WLHIV. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cis-gender female or transgender male (must have a cervix)
- •≥25 years of age
- •Competent to understand study procedures and give informed consent.
排除标准
- •Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy)
- •Previous hysterectomy
- •Previous diagnosis of cervical cancer
研究组 & 干预措施
Baseline screening cohort
This group undergoes HPV testing using self-collected swabs. Triage evaluation occurs in all women who test HPV positive which includes visual inspection with acetic acid and colposcopy. The WLHIV in the cohort who test HPV positive at baseline but who have concurrent benign histopathology results will be invited back for re-screening at a 2-year interval, and undergo similar HPV testing and triage procedures. The WLHIV in the cohort who test HPV negative at baseline will be invited back for re-screening at a 3-year interval and undergo similar HPV testing and triage procedures.
干预措施: 8-type HPV genotype restriction (Diagnostic Test)
结局指标
主要结局
Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval
时间窗: 5 years
Determine the incidence of HPV infection in WLHIV at the pre-specified follow-up interval
时间窗: 5 years
Determine the clearance of HPV infection in WLHIV at the pre-specified follow-up interval
时间窗: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
时间窗: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
时间窗: 5 years
Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.
时间窗: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
时间窗: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
时间窗: 5 years
Compare the sensitivity, specificity, PPV and NPV of triage of primary human papillomavirus testing with 8-type HPV genotype restriction to visual inspection with acetic acid and colposcopy
时间窗: 3 years
次要结局
- Understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study.(6 years)
- Evaluate the performance of a novel HPV assay as a stand-alone screening tool in our high-prevalence HIV population(3 years)
- Evaluate the impact of patient characteristics and and risk factors on the risk for cervical disease(5 years)
- Evaluate the impact of patient demographic and clinical factors, such as number of sexual partners, smoking, HIV status and related HIV immune markers, on risk of cervical dysplasia(5 years)
- Evaluate the impact of patient characteristics and and risk factors on the incidence of cervical dysplasia(5 years)
研究者
Rebecca Luckett
Obstetrician Gynecologist
Beth Israel Deaconess Medical Center