Cervical Cancer Screening Strategies in Women Living With HIV and HIV Uninfected Women in Cameroon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 873
- 试验地点
- 1
- 主要终点
- Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+
研究概览
简要总结
Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world. Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy, 2-3 generations of at-risk HIV[+] and HIV[-] women are already highly exposed to human papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine. Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is expensive and requires a complex clinical and lab infrastructure that does not generally exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily implemented, and effective cervical cancer screening methods are greatly needed in Sub-Saharan Africa, especially for HIV[+] women. This cervical cancer screening study of 1,200 women (800 HIV[+] and 400 HIV[-] women), aged 25-59 years, living in Cameroon, utilized our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women. All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of sensitivity, specificity, and positive and negative predictive value. The goal of this study was to establish the foundation and capacity for future studies designed to reduce the burden of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other countries with high HIV burdens on the best strategies for cervical cancer screening in their HIV[+] and HIV[-] women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
The US pathologist was masked to the original cytologic interpretation but unmasked to being hrHPV positive to reduce influence of how the slides were read.
入排标准
- 年龄范围
- 25 Years 至 56 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women living in Limbe town and neighborhood
- •Confirmed to be HIV[+] or HIV[-]
- •Have never undergone cervical cancer screening, with no history of ICC
- •Willing and able to competently understand and provide written, informed paper-based consent
- •Women who are having a menstrual period will be deferred for 2 weeks from participating in the study
排除标准
- •Pregnant women
- •Women with signs of abnormalities
- •Non-menstrual bleeding suggestive of ICC
- •Without a cervix because they have undergone hysterectomy
- •Based on the judgment of the clinicians not sufficiently healthy to participate in a research study
结局指标
主要结局
Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+
时间窗: 0 days
To compare the clinical performance of VIA, detection of the most carcinogenic hrHPV genotypes HPV16, 18, or/and 45, and biomarkers Ki-67, p16INK4a, and TOP2A mRNA, HPV viral load, and LBC as triage strategies for hrHPV-positive women for detection of CIN2+ and CIN3+.
Age-Specific Prevalence of Screen Positives in Limbé
时间窗: 0 days
To measure the age-group specific prevalence of hrHPV DNA, LBC, and VIA positivity, and CIN2+ and CIN3+ in HIV\[+\] and HIV\[-\] women living in Limbé, Cameroon.
Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+
时间窗: 0 days
To evaluate and compare the clinical performance of high-risk human papillomavirus (hrHPV) DNA testing using provider-collected specimens (Provider/hrHPV) and self-collected specimens (Self/hrHPV), visual inspection after acetic acid (VIA), and liquid-based cytology (LBC) for detection of cervical intraepithelial neoplasia (CIN) grade 2 or more severe diagnoses (CIN2+) and grade 3 or more severe diagnoses (CIN3+) in HIV\[+\] and HIV\[-\] women.
次要结局
- Qualitative interviews to assess acceptability and feasibility of self-collection from women(0 days)
研究者
Adebola Adedimeji
Research Associate Professor
Albert Einstein College of Medicine