Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Compare efficacy of cryotherapy and LEEP
研究概览
简要总结
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.
Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV positive women in South Africa
详细描述
Cervical cancer is the most common cancer in HIV positive women. This is due to immunosuppression and lack of organized and effective screening and treatment programs in Africa. Other screening and treatment modalities need to be evaluated in resource limited countries as there is not capacity in most of these countries to implement a cytology/histology based program. The treatment modality of cryotherapy is easy to train and perform and can be done by a nurse. LEEP requires significant training usually doctors and skills in administering local anaesthetic. This study compares the two modalities of cryotherapy vs LEEP in a randomized controlled study in HIV positive women in South Africa.
A. PRIMARY AIMS (S.A.):
- To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
- To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
- To compare the safety of cryotherapy versus LLETZ in HIV seropositive women.
SECONDARY AIMS:
- To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-65 years of age
- •Not menstruating (if menstruating, the patient can be screened at another date)
- •Able to sign consent
- •Able to follow the study protocol
- •HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1)
- •Participant with histology-proven CIN 2 or 3 disease
排除标准
- •Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management)
- •Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy)
- •Previous hysterectomy with removal of the cervix
- •Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk
- •Cervical dysplastic lesions that are not appropriate for cryotherapy, defined as the following:
- •Lesion is greater than ≥75% cervix
- •Lesion entering into the cervical canal and the complete lesion cannot be visualized
- •Presence of abnormal vasculature
- •Lesion bigger that the cryotherapy probe
结局指标
主要结局
Compare efficacy of cryotherapy and LEEP
时间窗: 1 year
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
次要结局
- The ability to use Human Papillomavirus as the measure of treatment success(1 year)
- To compare the safety of cryotherapy versus LLETZ in HIV seropositive women(1 month, 6 months and 12 months)
- Describe factors associated with successful treatment of CIN 2/3(1 year)
- To determine the cervical disease recurrence rates with cryotherapy and LLETZ.(6 months and 12 months)
研究者
Cynthia S Firnhaber
Associate Professor of Medicine
University of Witwatersrand, South Africa