Implementing High-Risk Human Papillomavirus Self-Sampling for Cervical Cancer Screening in Ghana: A Study (CarciSCAN) Protocol.

The World Health Organization (WHO) aims to eliminate cervical cancer by 2030 through a global strategy, centred on high-risk Human papillomavirus (hrHPV)-based screening and treatment. Implementing these strategies in low-resource settings remains challenging, due to barriers associated with limited healthcare infrastructure and patient awareness. Self-sampling for hrHPV has shown higher acceptability and similar diagnostic accuracy compared to clinician-taken samples. This study proposes a protocol to evaluate the clinical efficacy of a cervical cancer screening program utilising hrHPV self-sampling in Ghana. 1000 non-pregnant women aged 30-65 years will be invited to self-collect hrHPV samples. Those testing hrHPV positive will undergo visual inspection with acetic acid. Those diagnosed with high-grade squamous intraepithelial lesions will be offered ablation. In any case where there is a suspicion of invasion, or equivocal diagnosis, biopsies will be taken. Follow-up for women who are test positive for hrHPV and/or undergo treatment, will involve hrHPV self-sampling after 6 months. HrHPV-negative women will rescreen after 3 years. Biopsies will be taken where immediate treatment is not suitable, and women with confirmed or suspected invasive cervical carcinoma will be referred for surgical and/or oncological care. The primary outcome will be the proportion of women successfully screened, defined as the proportion of women with a valid HPV test result out of those invited to attend cervical screening. Secondary outcomes include screening uptake, disease detection rate, hrHPV genotype prevalence, treatment acceptance rate, successful treatment response, missed disease during treatment, number lost to follow-up, and disease recurrence. In low-resource settings, hrHPV self-sampling offers an accessible method to increase screening uptake. This study will inform strategies for broader implementation of cervical cancer screening and contribute to achieving the WHO's goal of elimination by 2030. Ethical approval for this study was obtained from the Kintampo Health Research Centre Institutional Ethics Committee (IEC), Bono East, Ghana, West Africa, on 24 May 2024 (IEC IRB Registration No. 0004854; Study ID: KHRCIEC/2024-03).