Abstract
BACKGROUND: Human papillomavirus (HPV) is the primary cause of cervical cancer, which is preventable through screening and early treatment. The Papanicolaou (Pap) test and visual inspection with acetic acid (VIA), which are traditionally performed in clinical settings, have been used effectively to screen for cervical cancer and precancerous changes and reduce cervical cancer mortality in high-income countries for many decades. However, these screening methods are not easily accessible to women living in low- and middle-income countries, especially women living in rural areas. OBJECTIVE: The project will use HPV self-sampling, which will be supported by a sexual health literacy intervention, to increase rural women's participation in cervical cancer screening. The objectives are to determine the effectiveness of this program in (1) increasing sexual health literacy, (2) reducing the gendered stigma of HPV and cervical cancer, and (3) promoting cervical cancer screening by using HPV self-sampling. METHODS: The pilot study will use a community-based, family-centered, mixed methods design. We will recruit 120 women aged 30 to 69 years who are underscreened or were never screened for cervical cancer, along with 120 supportive male relatives or friends from 3 low-income rural/tribal villages in Maharashtra, India. Participants will attend gender-specific sexual health education sessions, followed by a movie matinee. Data will be collected through an interviewer-administered questionnaire before and after sexual health education sessions. The questionnaire will include items on social demographics, medical histories, attitudes, sexual health stigma, cervical cancer knowledge, and screening practices. Women will self-select whether to use HPV self-sampling. Those who do not may undergo a Pap test or VIA. Participants' views regarding barriers and facilitators and their suggestions for improving access and uptake will also be elicited. This protocol was approved by the research ethics boards of Toronto Metropolitan University (formerly known as Ryerson University; reference number: REB 2020-104) and Tata Memorial Center (reference number: OIEC/3786/2021 /00003). RESULTS: The Preventing Cervical Cancer in India Through Self-Sampling study was funded in January 2020 for 15 months. Due to the COVID-19 pandemic, the project was extended by 1 year. The study outcome measures will include changes in knowledge and attitudes about cervical cancer screening, the proportion of participants who self-select into each cohort, the proportion of positive test results in each cohort, and the proportion of participants with confirmed cervical cancer. Women's experiences regarding barriers and facilitators of screening uptake will be captured. CONCLUSIONS: Our multifaceted work could lead to reduced cervical cancer mortality and morbidity and increased community capacity in sexual health promotion and cervical cancer prevention. The insights and lessons learned from our project can be used to inform the adaptation and scale-up of HPV self-sampling among women across India and in other countries; promote collective commitment to family-centered wellness; and support women to make healthful, personalized cervical screening decisions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/35093.