Selvavinayagam T S

Protocol for a cervical screening implementation trial comparing two approaches for delivering HPV self-collection in low-resource settings in India: a type 3 hybrid cluster randomised controlled trial (SHE-CAN)

Background Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India. Methods A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities. HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability. Analysis The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes. Ethics and dissemination Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences. Trial registration number The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

Readiness to transition to HPV self-collection from VIA screening: a mixed methods health systems assessment from Tamil Nadu, India

As a frontrunner in introducing cervical screening in India, the state of Tamil Nadu urgently needs to consider how to improve screening rates and switch to Human Papillomavirus (HPV) detection tests. We used a mixed methods design to assess the readiness of the state health system for delivering the current cervical screening program, as well as for future HPV self-collection. Following a desk review, we surveyed 14 government health facilities in three districts of Tamil Nadu and calculated overall and domain-specific (service utilization, service availability, general service, cervical screening) readiness scores as percentages. We conducted four interviews and five focus group discussions with 37 participants [managers, primary care nurses, community health workers (CHWs)] to clarify findings and obtain suggestions regarding the introduction of HPV self-collection in tribal, rural, and urban low-resource settings. Scores for general services and readiness to offer visual inspection with acetic acid (VIA) and follow-up were more than 70% in the surveyed facilities. Despite the availability of trained nurses, infrastructure and resources, utilisation was primarily limited to symptomatic women attending health facilities due to poor acceptability of screening that would require facility visits. Most participants felt that self-collection could reduce women's fear and embarrassment and could be delivered through CHWs in the community or by nurses at facilities. However, motivation for screening may remain low as most asymptomatic women do not perceive a need for screening, and/or fear implications of a positive test. Tertiary laboratories appear ready for HPV testing, given availability of high-throughput PCR equipment, computerised laboratory information management systems, and a planned hub and spoke model of improving access to laboratory tests. Despite relatively good infrastructure and staffing for VIA screening in public healthcare facilities, service utilisation was primarily by symptomatic women, contributing to low screening rates. HPV self-collection was highly acceptable to administrative and field staff. Widespread educational approaches to motivate asymptomatic women to screen using self-collection, with decentralised sample collection and treatment, could potentially improve cervical screening rates. Not applicable.