A Pilot Study on HPV and Cervical Cancer Screening in Mumbai
试验速览
- 阶段
- 不适用
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.
研究概览
简要总结
The Study goals are to test feasibility and acceptability of point of care HPV testing with 227 women already accessing an existing cancer screening program in Mumbai, India. Describe HPV infection types in women screened. Compare if the quality of HPV clinician-collected and self-collected samples are equally efficient to detect HPV and cervical cancer precursor lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the clinician-collected sample
详细描述
In this pilot study, Investigators will assess the feasibility and acceptability of point of care HPV testing in an existing SVA program. There is no control group since neither the efficacy nor effectiveness is to be tested. In the pilot study the screen positive women will be referred to the Tata Memorial Hospital for further diagnostic work-up to restrict the programme logistics. While in the main study, Colposcopy and Cryotherapy will be conducted at the community level. The evaluation framework will be based on a robust D&I model called REAIM.
i.TMH staff will hold health camps to mobilize women to attend. Providers already trained in the TMH outreach program will identify women eligible for screening. After obtaining the consent, the medical social worker will collect baseline data and record the results of the GeneXpert HPV testing on self sample and health care provider collected sample.
Data Collection:
ii. Quantitative data: Data will be collected in-person by the Medical Social worker. De-identified data will be uploaded to Own Cloud, a file-sharing program in the University of Arizona, College of Nursing.
ii. Qualitative data: There will be a discussion on cultural appropriateness and possible adjustments to the procedures based on the healthcare providers' experiences with a small subset of the 227 women already screened. Between one to two focus groups will be conducted by the study investigators with assistance from local staff with a subset of women, separately to qualitatively assess acceptability of HPV testing using GeneXpert.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 30 to 55 years (the age when screening for HPV and cervical cancer is recommended) who participate in the TMH cancer screening outreach program.
排除标准
- •Women with a known diagnosis of cancer, any other terminal diagnosis, or who are pregnant
研究组 & 干预措施
Cluster of 3000 women
Cluster will be selected from an existing cervical, breast, and oral cancer screening program in Mumbai, India and its surrounding semi-urban and rural areas.
干预措施: Cluster of 3000 women (Other)
结局指标
主要结局
The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.
时间窗: 3 months
This will be predominantly for counts and percentages for categorical variables (e.g., number of women screened, number of women with incomplete self-collected specimens). In addition to the numbers of participants, the notes from the providers' debriefing regarding culturally appropriateness of HPV testing will be considered.
次要结局
- The focus group data will be analyzed using constant comparative data analysis to identify thematic components and sub-themes.(3 months)
- Documentation of six different genotypes/ genotype families of HPV from cervical tissue samples, which will inform the development of HPV vaccinations specific to the strains of HPV in India.(3 months)
- The HPV GeneXpert by health care provider and HPV HC2 samples by health care provider will be compared to study the agreement rates.(3 months)
- Overall agreement between clinician-collected versus self-collected samples will be compared using pairwise t tests(3 months)
- Probe for perceptions about self-collection of vaginal samples to describe acceptability of this process.(3 months)
- Fit a predictive model of HPV infection(s).(3 months)
研究者
Gauravi Ashish Mishra
Professor and Physician
Tata Memorial Hospital