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临床试验/CTRI/2025/02/079915
CTRI/2025/02/079915尚未招募不适用

Prevalence of Human Papilloma Virus [HPV] Infection & Acceptability, Feasibility of HPV Self-Sampling as an Alternative Primary Cervical Cancer Screening in Under-Screened, Hard to reach Tribal Women population in Maharashtra: A Cross-Sectional Study.

Dr Sharmila Pimple1 个研究点 分布在 1 个国家目标入组 4,941 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
4,941
试验地点
1
主要终点
Percentage of eligible women aware of cervical cancer screening programs.

研究概览

简要总结

Cervical cancer is a significant health issue for women in India, particularly those in remote tribal areas who face barriers like cultural, social, low literacy, poverty, and limited access to healthcare. This study aims to introduce HPV self-sampling as an easier way for these women to screen for cervical cancer.

HPV (Human Papillomavirus) can cause cervical cancer. Unlike traditional Pap tests that require a clinic visit, HPV self-sampling allows women to collect their own samples at home or at local health camps. This method is more accessible and comfortable for women in remote areas.

The study will be conducted over two years in the tribal regions of Raigad District, Maharashtra. Eligible women aged 25-60 will be educated by community health workers on cervical cancer and will be trained on using the self-sampling kits. They will then collect and return their samples for testing.

Women who test positive for HPV will receive further evaluation, while those who test negative will be advised to screen again after five years. The study aims to demonstrate that HPV self-sampling is a feasible and acceptable method for cervical cancer screening. It also aims to enumerate all the socio-cultural barriers and challenges faced by tribal women for getting themselves tested for cervical cancer screening. By increasing screening rates, the study hopes to enable earlier detection and better health outcomes for tribal women, leading to improved cancer prevention strategies in India.

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Women between the age group of 25-60 years, Non-pregnant With an intact uterus and, No past history of cervical neoplasia.

排除标准

  • Unmarried Have had a total hysterectomy Have a history of cervical cancer.

结局指标

主要结局

Percentage of eligible women aware of cervical cancer screening programs.

时间窗: 24 months.

Percentage of eligible women screened using hrHPV self-sampling.

时间窗: 24 months.

Percentage of hrHPV-positive women adhering to follow-up recommendations

时间窗: 24 months.

Percentage of women receiving appropriate treatment following cervical cancer screening.

时间窗: 24 months.

Operational Feasibility:

时间窗: 24 months.

Coverage of self-sample HPV/DNA screening among the target population.

时间窗: 24 months.

Number and percentage of invalid test results.

时间窗: 24 months.

Compliance rates of screen-positive cases undergoing reference diagnostic procedures:

时间窗: 24 months.

Conventional cytology.

时间窗: 24 months.

Colposcopy-guided biopsy or Endocervical Curettage (ECC).

时间窗: 24 months.

Technical Feasibility:

时间窗: 24 months.

Duration from sample collection to laboratory transport.

时间窗: 24 months.

Duration from sample collection to report delivery.

时间窗: 24 months.

次要结局

  • To identify the sociocultural barriers, preferences, and facilitators influencing the adoption of HPV self-sampling among under-screened tribal women in Maharashtra.(To evaluate the acceptability of HPV self-sampling as a screening method in the tribal population.)

研究者

发起方
Dr Sharmila Pimple
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sharmila Pimple

Tata Memorial Hospital

研究点 (1)

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