The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Percentage of women treated with high grade lesions in both arms
研究概览
简要总结
The main objectives of CESTA are (1) to compare the efficacy of two cervical cancer screening algorithms: HPV test followed by visual inspection with acetic acid (VIA) and treatment (HPV + VIA + treat) and HPV test followed by immediate treatment (HPV + treat). The study will be conducted to address its objectives in women living with HIV (from now on called HIV positive women); and 2) To evaluate the performance of other techniques for primary screening and as triage for HPV positives WLHIV.
1,500 women living with HIV WLHIV will be recruited from HIV care clinics, also called antiretrovirals (ARV) clinics in South Africa. After giving informed consent, women will be screened with HPV testing and those that have a HPV positive test will be randomized at a 4:1 ratio into HPV + VIA + treat (Arm 1) and HPV + treat (Arm 2). Women in Arm 1 will receive VIA and only positive for VIA will be treated. In Arm 2, all HPV positive women will be treated. Women that are eligible for ablative treatment will be randomized into treatment with TA or cryotherapy in both arms. Others will be referred to colposcopy. After VIA in Arm 1 or before treatment in Arm 2, the nurses will collect 2-4 biopsies on all HPV positive women. The biopsies will be used as gold standard for disease detection. Treated women will be called by telephone after 1 week and 1 month to assess side-effects and satisfaction with the procedures. Cervical samples from women will be tested with HPV DNA test and HPV mRNA test to evaluate different screening tests for WLHIV. All women with a positive HPV test (treated or not) will be called back after 1 year for a follow-up visit. At this visit, women will be screened with HPV testing and VIA and 2-4 colposcopy-directed biopsies will be taken from all HPV positive women. Women with remaining/recurrent CIN2+ disease will receive appropriate management.
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
- Double (Participant, Care Provider)
盲法说明
Care providers and participants are masked to the intervention ahead of the intervention. However, the strategy delivery is not blinded.
入排标准
- 年龄范围
- 25 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing to disclose HIV status
- •HIV negative women aged 30-54 years; HIV positive women aged 25-54 years
- •Mentally competent to give informed consent
- •Physically able to have a pelvic exam
排除标准
- •Women reporting no previous sexual activity
- •History of cervical cancer
- •Treatment for cervical precancer in the last six months
- •Hysterectomy
- •Pregnancy
- •Serious pre-existing medical conditions (e.g. history of bleeding disorders, serious physical or mental disease)
研究组 & 干预措施
Arm 1
In this arm, HPV-positive women will undergo a Visual Inspection with Acetic Acid (VIA) triage test followed by biopsies. Treatment by thermal ablation (or cryotherapy in South Africa) will be applied to VIA positive women eligible for ablative treatment. Non eligible women will be referred to colposcopy.
干预措施: HPV DNA Test (Diagnostic Test)
Arm 1
In this arm, HPV-positive women will undergo a Visual Inspection with Acetic Acid (VIA) triage test followed by biopsies. Treatment by thermal ablation (or cryotherapy in South Africa) will be applied to VIA positive women eligible for ablative treatment. Non eligible women will be referred to colposcopy.
干预措施: VIA triage test (Diagnostic Test)
Arm 2
In this arm, HPV positive women will get biopsies and receive an ablative treatment by thermal ablation (or cryotherapy in South Africa) if they are eligible to ablative treatment. Non eligible women will be referred to colposcopy
干预措施: HPV DNA Test (Diagnostic Test)
Arm 2
In this arm, HPV positive women will get biopsies and receive an ablative treatment by thermal ablation (or cryotherapy in South Africa) if they are eligible to ablative treatment. Non eligible women will be referred to colposcopy
干预措施: Treatment by ablative treatment (Procedure)
Arm 2
In this arm, HPV positive women will get biopsies and receive an ablative treatment by thermal ablation (or cryotherapy in South Africa) if they are eligible to ablative treatment. Non eligible women will be referred to colposcopy
干预措施: Colposcopy (Procedure)
Arm 1
In this arm, HPV-positive women will undergo a Visual Inspection with Acetic Acid (VIA) triage test followed by biopsies. Treatment by thermal ablation (or cryotherapy in South Africa) will be applied to VIA positive women eligible for ablative treatment. Non eligible women will be referred to colposcopy.
干预措施: Treatment by ablative treatment (Procedure)
Arm 1
In this arm, HPV-positive women will undergo a Visual Inspection with Acetic Acid (VIA) triage test followed by biopsies. Treatment by thermal ablation (or cryotherapy in South Africa) will be applied to VIA positive women eligible for ablative treatment. Non eligible women will be referred to colposcopy.
干预措施: Colposcopy (Procedure)
结局指标
主要结局
Percentage of women treated with high grade lesions in both arms
时间窗: up top 1 month
Percentage of women treated with low grade lesions in both arms
时间窗: up to 1 month
次要结局
- Persistence of HPV infection and lesions at one year(up to 14 months)