Profiling the real-world management status of high-risk human papillomavirus infection: a protocol to establish a prospective cohort of high-risk human papillomavirus-infected women in Lueyang County, China

Abstract

Introduction: Persistent infection with high-risk human papillomavirus (hrHPV) is the main cause of cervical cancer. Thus, the effective treatment against HPV represents an opportunity to reduce the incidence of cervical cancer. Although various treatments are effective in treating HPV infection, they still provide limited benefit in reducing the rate of cervical cancer due to the lack of implementation of a standardised protocol in many low/middle-income areas. This proposed cohort study aims to describe the status quo of treatment, attributions of the treatment decision-making process and potential factors influencing treatment decisions.

Methods and analysis: This is a mixed-method, 5-year prospective longitudinal study in Lueyang County, China, one of the areas with the highest cervical cancer incidence rates and lowest mean income in China. We will enrol women with hrHPV infection (at least one HPV type in the 13 high-risk subtypes) diagnosed via a county-wide HPV infection and cervical cancer screening programme. The study procedures describe the treatment patterns and explore the potential influencing factors in treatment decision-making through questionnaires, laboratory examinations and in-depth interviews. All participants will be evaluated at baseline and at 6, 12, 24, 36, 48 and 60 months. The primary outcome is the treatment pattern, the type and duration of which will be described later. The secondary outcomes include guideline compliance and changes in the HPV infection status. The HPV impact profile, intimate relationship satisfaction, and costs within different management groups are also described and compared.

Ethics and dissemination: This study was reviewed, and all of the relevant approvals were obtained from the Ethics Committee of the Maternity Service Centre of Lueyang Maternal and Child Health Care Hospital (2021-001). The findings from this study will be disseminated through peer-reviewed publications, conference presentations and academic workshops.

Trial registration number: ChiCTR2100053757.

Keywords: EPIDEMIOLOGY; Infection control; Public health.

Figure 1

Workflow for the recruitment procedure. HR-HPV, high-risk human papillomavirus.

Figure 2

The specific examination procedures. ^ahrHPV, high-risk human papilloma virus; ^bTCT, Thin-prep liquid-based cytology test; ^c≥ASC-US, atypical squamous cells of undetermined significance or above; ^dNILM, negative for intraepithelial lesions or malignancy; ^eLSIL, low‐grade squamous intraepithelial lesion; ^fHSIL, high‐grade squamous intraepithelial lesion.