Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol

Abstract

Background

Many low- and-middle-income countries are disproportionately burdened by cervical cancer, resulting in high morbidity and mortality. HPV-DNA testing coupled with treatment with thermal ablation is a recommended screening and precancer treatment strategy, but not enough is known about how this can be effectively implemented in the context of integrated services. The (Scale Up Cervical Cancer Elimination by Secondary prevention Strategy, (SUCCESS) project is conducting a study to understand this approach, integrated into existing women’s health services in Burkina Faso, Cote d’Ivoire, Guatemala, and the Philippines (2020–2024).

Methods

A hybrid effectiveness-implementation type III mixed-methods observational study design is used to assess feasibility, acceptability, and costs of integrated service delivery in 10 sites per country, selected considering urban/rural location, facility level, onsite/offsite laboratories, and health services type. In each country, a sample size of 2227 women aged 25–49 years will be enrolled with about 20% being women living with HIV. The primary outcome is proportion of HPV positive women completing precancer treatment, if eligible, within three months of screening. Data collection and analysis includes; facility and client exit surveys, key informant and client interviews, registries and project records extractions, and costing data analysis. Analysis includes descriptive statistics, context description, thematic analysis, and document analysis. Quantitative analyses will be stratified by participant’s HIV status.

Discussion

Recruitment of study participants started in April 2022 (Burkina Faso and Côte d’Ivoire) and August 2022 (Guatemala and the Philippines). Enrolment targets for women screened, client exit, in-depth and key informant interviews conducted were reached in Burkina Faso and Cote d’Ivoire in November 2022. Guatemala and Philippines are expected to complete enrolment by June 2023. Follow-up of study Participants 12-months post-treatment is ongoing and is expected to be completed for all countries by August 2024. In LMICs, integrating cervical cancer secondary prevention services into other health services will likely require specific rather than incidental recruitment of women for screening. Reconfiguration of laboratory infrastructure and planning for sample management must be made well in advance to meet induced demand for screening.

Trail Registration ClinicalTrials.Gov ID: NCT05133661 (24/11/2021).

Supplementary Information

The online version contains supplementary material available at 10.1186/s12978-023-01696-8.

Abstract

Low- and middle-income countries bear a disproportionate burden of cervical cancer deaths and suffering from a disease that is preventable and treatable. Unitaid is funding and working collaboratively with the governments of Burkina Faso, Côte d'Ivoire, Guatemala, and the Philippines to implement Scale Up Cervical Cancer Elimination with Secondary prevention Strategy (SUCCESS) project. Significant advancements on cervical cancer management have been made in last four decades. However, the optimal approaches to translating available evidence into actionable screening and treatment implementation strategies in the context of mass-screening programmes is uncertain. SUCCESS project aims to generate evidence on how to deliver cervical cancer services in a way that promotes human papilloma virus (HPV) screening using newer diagnostic and treatment technologies available. This mixed methods study aims to contribute to the evidence on how HPV testing and treatment can be done in manner that is acceptable and feasible in the context of integrated service delivery. Quantitative and qualitative data will be collected over a period of 24 months (2022–2024) across the four countries. In each country, 2227 women aged 25–49 years will be enrolled and screened for HPV, with 20% of them being women living with HIV. In this study, HPV positive will be retested 12-months after initial screening and/or treatment. The findings of the study will add to the body of literature especially from low- and middle-income countries how to implement promising strategies for scaling up cervical cancer screening and treatment coverage.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12978-023-01696-8.