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

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...

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Autores principales: Kabue, Mark, Gauvreau, Cindy L., Daceney, Nemdia, Bertram, Margaret Mary, Shissler, Tracey, Reis, Veronica, Dodo, Mathurin, Garces, Ana, Llave, Cecilia, Dao, Blami, Mohan, Diwakar, Huang, Lisa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10644460/
https://www.ncbi.nlm.nih.gov/pubmed/37957689
http://dx.doi.org/10.1186/s12978-023-01696-8
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author Kabue, Mark
Gauvreau, Cindy L.
Daceney, Nemdia
Bertram, Margaret Mary
Shissler, Tracey
Reis, Veronica
Dodo, Mathurin
Garces, Ana
Llave, Cecilia
Dao, Blami
Mohan, Diwakar
Huang, Lisa
author_facet Kabue, Mark
Gauvreau, Cindy L.
Daceney, Nemdia
Bertram, Margaret Mary
Shissler, Tracey
Reis, Veronica
Dodo, Mathurin
Garces, Ana
Llave, Cecilia
Dao, Blami
Mohan, Diwakar
Huang, Lisa
author_sort Kabue, Mark
collection PubMed
description 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.
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spelling pubmed-106444602023-11-13 Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol Kabue, Mark Gauvreau, Cindy L. Daceney, Nemdia Bertram, Margaret Mary Shissler, Tracey Reis, Veronica Dodo, Mathurin Garces, Ana Llave, Cecilia Dao, Blami Mohan, Diwakar Huang, Lisa Reprod Health Research 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. BioMed Central 2023-11-13 /pmc/articles/PMC10644460/ /pubmed/37957689 http://dx.doi.org/10.1186/s12978-023-01696-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Kabue, Mark
Gauvreau, Cindy L.
Daceney, Nemdia
Bertram, Margaret Mary
Shissler, Tracey
Reis, Veronica
Dodo, Mathurin
Garces, Ana
Llave, Cecilia
Dao, Blami
Mohan, Diwakar
Huang, Lisa
Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol
title Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol
title_full Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol
title_fullStr Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol
title_full_unstemmed Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol
title_short Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol
title_sort understanding integrated hpv testing and treatment of pre-cancerous cervical cancer in burkina faso, cote d’ivoire, guatemala and philippines: study protocol
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10644460/
https://www.ncbi.nlm.nih.gov/pubmed/37957689
http://dx.doi.org/10.1186/s12978-023-01696-8
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