Acceptability and Validity of Self Sampling for High Risk HPV Detection Among Women in Maharashtra
试验速览
- 阶段
- 不适用
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Agreement rate between health care personnel collected samples and self collected samples in these two groups.
研究概览
简要总结
The study goals are,
- To determine the test characteristics (sensitivity, specificity, positive predictive value, negative predictive value, false positivity rates, false negativity rates) of health personnel collected and self collected HPV samples for Hybrid capture explained by two different methods (pamphlets/ health education programme).
- To evaluate the agreement between self collected HPV samples and health personnel collected HPV samples for Hybrid capture with two different methods of education (pamphlets/ health education programme).
- To study the attitudes, acceptability and barriers of self-collection of specimens for HPV DNA testing in three sub groups of population in Maharashtra with two different methods of education (pamphlets/ health education programme).
- To determine the predictors of self-sampling preference.
- To determine the Knowledge, Attitudes and Practices (KAP) regarding cervical cancer and HPV infection among these women in pre-intervention and post-intervention period.
详细描述
The three communities, urban slum area in Mumbai, urban non slum area in Mumbai and rural area in Raigad/ Thane district will be selected. The eligible women will be contacted by door to door visit and the purpose of the campaign will be explained to them. Informed consent will be obtained from those who are willing to participate in the study.
Step 1: They will be interviewed to collect the baseline Knowledge, Attitude and Practices (KAP) regarding cervical cancer, screening and HPV. The information will be recorded on a structured questionnaire.
Step 2: Half of the women in each group will be invited to specially organized camps in their neighborhood for Health Education and distribution of self samplers while the other half will be provided an information pamphlet on the risk factors, methods of early detection, prevention, signs and symptoms of cervical cancer and how to use the self samplers at home. Similar personal interviews, collection of used/unused self sampler and collection of HPV samples by health worker will be followed for both groups of women.
Intervention one: (Health Education Group) Detailed health education programme explaining them the risk factors, methods of early detection, prevention, signs and symptoms of cervical cancer will be conducted. They will be explained the importance of getting screened for cervical cancer and will be encouraged to undergo screening at any nearby screening centre. They will be given information regarding HPV self samplers and will be taught the method of its use and storage in detail. Any queries with this regard will be answered.
Intervention two: (Both Groups) HPV self samplers will be distributed free of cost to the women and the social workers will instruct them to return it to the clinic or will collect the samplers from their houses, either on the same day or the following day as per the convenience of the woman. For HPV self collection the participating women will be asked to collect the sample specimen as per instructions provided during the health education session/ pamphlets and store it at room temperature till the time of collection by the social worker. The willingness to use self sampler or refusal to use the HPV self sampler will be captured. Also, the reasons for their refusal shall be captured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Sexually active women in the age group of 30-55 years in the selected areas.
排除标准
- •Pregnant women
- •Women having frank cervical cancer
- •Women who have undergone total hysterectomy
结局指标
主要结局
Agreement rate between health care personnel collected samples and self collected samples in these two groups.
时间窗: 18 months
Results obtained out of the health care personnel collected samples Vs self collected samples and correspondingly results of the test among women taught to use self samplers with the aid of pamphlets as compared to a well conducted health education programme will be evaluated using kappa statistics.
次要结局
- Test characteristics of HPV self sample and health care worker collected sample by HPV HC 2.(18 months)
- Acceptability and barriers for self-collection of specimens for HPV DNA testing in an urban population.(18 months)
研究者
Gauravi Ashish Mishra
Physician&Professor
Tata Memorial Hospital