Cancer incidence in Tamil Nadu has been reported as 77138, with a crude incidence rate (CIR) of 96.1 per 100000 population in 2018. For cervical cancer, there were 7,130 cases, resulting in a CIR of 17.7 per 100000. Notably, our study area, Viluppuram district, which has a predominantly rural population, exhibits a higher burden of cervical cancer, with an incidence rate of 24.6 per 100,000 women. Limited access to cancer care in rural areas leads to delayed diagnoses and lower survival rates. The Access Cancer Care India (ACCI) project aims to enhance early detection and treatment through evidence-based interventions tailored to the local healthcare system. A pre-intervention assessment was conducted in four blocks (Mailam, Vanur, Vikravandi, and Kanai) of the Viluppuram district and identified key barriers to cancer screening. Surveys, focus group discussions, and in-depth interviews helped in the joint development of evidence-based strategies with the key stakeholders.

The current cervical cancer screening method, visual inspection using acetic acid (VIA), has shown a low participation rate (26%) in the general population survey conducted during the pre-intervention phase. To improve screening uptake, an evidence-based HPV self-sampling for cervical cancer screening will be piloted. A single-arm intervention trial is planned in randomly selected villages within the Mailam block of Viluppuram district, Tamil Nadu. Designated health workers (project staff) will enumerate eligible women aged 30 to 59 years through a household survey. The health workers will sensitize them about HPV self-sampling through interpersonal or group communication. They will provide individual counseling and guidance using pictorial charts and posters on self-collecting cervical samples. Women who consent to participate will be offered HPV self-sampling at their homes. After collecting the sample, they can return it to the health worker, who will transport it to the point-of-care testing laboratory. Women who prefer provider-assisted samples will be referred to the nearest health facility, where the NCD nurse will collect cervical samples for HPV testing.

According to published literature, the cervical HPV prevalence rate among adult women is 12 to 14%. For a 95% confidence interval and 80% power, the sample size is estimated to be 2000 women. HPV testing will be conducted at a point-of-care testing laboratory using the Truenat HPV-HR OCTA kit, which detects eight high-risk HPV types: 16, 18, 31, 33, 35, 45, 52, and 58. This chip-based device utilizes Taqman RT-PCR (Real-Time Reverse Transcription Polymerase Chain Reaction) technology. The feasibility of implementing this platform in public health facilities will be assessed, focusing on its accessibility, cost-effectiveness, and potential for scaling up. The equipment will be located in a healthcare facility in the Mailam block for HPV testing. Health workers will collect and transport samples, receive test results, and communicate them to participants. To address issues of privacy, confidentiality, and stigma, appropriate measures will be taken when disclosing information to women who test positive for HPV. Health workers will meet with each participant individually to communicate test outcomes. For women with HPV infections, they will provide counseling and explain the significance of the results, the need for further testing, and the importance of regular follow-up care.

All screened individuals will receive their test reports, regardless of the results, to maintain a record and prevent selective stigmatization. Results will be presented as “HPV – Present” or “HPV – Absent” instead of “Positive” or “Negative” to mitigate emotional distress or stigma associated with the terminology. Information about HPV will be clearly communicated to participants through information sheets and interactions with health workers. These workers will be trained to handle sensitive information with empathy and professionalism.  Women diagnosed with HPV infection will be referred to a tertiary care center for further evaluation by a gynecologist and will be navigated through the cancer care pathway. The participation rate in cervical cancer screening through self-collection will be estimated. This study will employ a mixed-methods approach guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and will be monitored for fidelity. A process evaluation will document implementation challenges and adaptations.

This intervention aims to enhance the early detection of cervical precancer and cancer through HPV self-sampling, thereby improving cancer survival rates and the quality of life for patients in rural Tamil Nadu. By evaluating its effectiveness and identifying best practices, the findings will support the scaling up of the intervention across the state.