Preventing Cervical Cancer through HPV self-sampling

Not yet recruiting

• Conditions: 120 women, who are under or never screened (UNS) for cervical cancer and 120 male partners (supportive partners)

• Registration Number: CTRI/2021/11/038129
• Lead Sponsor: Fund for Innovation and Transformation ICN Global Affairs Canada

Brief Summary

Cervical cancer is the 2nd leading cause of cancer death in Indian women. Screening for Human Papilloma Virus (HPV), which causes cervical cancer, is effective for early diagnosis and prevention of the disease. Cervical cancer screening rates in low- and middle-income countries (LMIC) are very low (19%) as compared to High-income countries (69%). In India, limited screening resources, low knowledge and stigma around cervical cancers are the recognized barriers for screening among women. HPV self-sampling allows women to self-sample in the privacy of their home and at a time that is convenient for them.  It has proven to be effective in engaging under/never screened (UNS) women in cervical cancer screening, which results in early detection, reduced mortality and morbidity, and improved overall quality of life for a woman.

The overall goal of our proposed pilot study is to improve the sexual health of women in rural India by reducing avoidable health disparities associated with HPV and cervical cancer. The intended target shall be 120 under/never screened rural Indian women and 120 male partners in Palghar district of Maharashtra**.**

The objective of the study is development of innovative art based sexual health education materials (Videos, story telling, Graphic novels, family centred activities) to engage women and their male partners for two main objectives under the study-

(1) to increase awareness and knowledge of sexual health education including HPV and cervical cancer among women and men in the families. (Primary cervical cancer prevention)

(2) to increase cervical cancer screening uptake by enabling women to self-sample using an HPV kit in their homes. (Secondary cervical cancer prevention)

The anticipated outcome of the study are

1.There will be an increase in sexual health literacy (knowledge) and reduction in sexual heath stigma (attitudes) related to cervical cancer and increase uptake of screening after participating in the study.

**2.** There will be a higher uptake of HPV self-sampling compared to traditional method of screening (Pap-test/ VIA test) among under and never screened women.

 Contribution of the study for National health priority

Study shall contribute to primary and secondary awareness for cervical cancer which is the common cancer among Indian women. The study would lead to increased awareness and knowledge of sexual health, HPV and cervical cancer among women and men in their families and communities (primary prevention) and increased cervical cancer screening uptake practice of HPV self-sampling among women who have been unscreened or never screened for cervical cancer (secondary prevention).The study has a capacity building component for ASHA workers/ Community health volunteers and graduate nursing students by appointing them as a part of study team and training them with the goal of transferrable skills that will in long run contribute to increase awareness towards cervical cancer.This shall also contribute to increased local capacity in promoting cervical cancer screening and follow-up. The engagement of men as a secondary target population from the community in this study will ensure their direct support to the women in undertaking the test and further referrals, if necessary. This shall indirectly contribute to positive parenting, which will also in turn lead to improved wellbeing among girls and possibly support boys to grow up with less gender biases.

The study shall highly contribute to WHO’s global effort to eliminate cervical cancer worldwide.The Project Advisory Committee formed under the study shall critically review the sexual health material developed under the project so that the communication materials are culturally and linguistically appropriate. These materials can be utilized during and after the project’s conclusion by other Indian States to promote awareness about cervical cancer screening and sexual health literacy. This intervention has a high likelihood of success and will provide new concept to scale up implementation of cervical cancer screening in rural India, if proven successful.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-10-11
• Study Start: 2022-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Female Participants’ eligibility criteria include: 1.Under or Never screened (UNS) women (i.e. self-report of >4 years since last Pap test/VIA test, including no history of Pap test or VIA test in past).
• 2.Sexually active women aged 30-69 years.
• 3.No history of hysterectomy or past history of precancerous or cancerous lesions.
• 4.Willing to share contact information with the study team.
• Eligibility criteria for men Participants include: Male family members (husbands, fathers, brothers, sons, cousins, friends) identified and referred by UNS women participants shall be above age of 18 years.
• The service providers eligibility criteria for focus group discussion include: Shall be from the villages identified for implementation of the study and having a fair knowledge of cervical cancer screening.

Exclusion Criteria

• Pregnant women 2.
• Women with past history of cervical cancer 3.
• Women who have undergone hysterectomy 4.
• Individuals not willing to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Acceptability / Preference outcome for HPV Self sampling kits.	15 months
3.Quantifying educational outcomes for knowledge and attitude about cervical cancer risk factors and screening( overall and by gender) in the community	15 months
1. Quantify the screening outcomes and referrals for diagnostic test	15 months

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Gauravi Mishra

Principal investigator

02224177000

gauravi2005@yahoo.co.in