Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services: a protocol for a stepped-wedge cluster randomized trial in Kenya

Implementation Science

Study Protocol

Leeya F. Pinder¹  Harriet Fridah²  Michelle B. Shin²  Sarah Gimbel³  Colin Baynes⁴  Katherine K. Thomas⁴  Ruanne V. Barnabas⁵  Jesse Heitner⁵  Lynda Myra Oluoch⁶  Mary Bernadette Kerubo⁶  Nelly Rwamba Mugo⁷  Kenneth Ngure⁸ 

[1] College of Medicine, University of Cincinnati, Cincinnati, OH, USA;Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, Seattle, WA, USA;Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, Seattle, WA, USA;Department of Global Health, University of Washington, Seattle, USA;Department of Global Health, University of Washington, Seattle, USA;Division of Infectious Diseases, Massachusetts General Hospital, Harvard Medical School, Boston, USA;Kenya Medical Research Institute, Nairobi, Kenya;Kenya Medical Research Institute, Nairobi, Kenya;Department of Global Health, University of Washington, Seattle, USA;School of Public Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya;

关键词: Human papilloma virus;    Cervical cancer;    Thermal ablation;    Single visit;    Screen-and-treat approach;    Kenya;    RE-AIM;    CFIR;    ORIC;    Implementation science;   

DOI  :  10.1186/s13012-023-01282-3

 received in 2023-03-10, accepted in 2023-06-09,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAn important cervical cancer prevention strategy in low- and middle-income countries (LMICs) has been single-visit screen-and-treat (SV-SAT) approach, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. While SV-SAT with VIA and cryotherapy have established efficacy, its population level coverage and impact on reducing cervical cancer burden remains low. In Kenya, the estimated cervical cancer screening uptake among women aged 30–49 is 16% and up to 70% of screen-positive women do not receive treatment. Thermal ablation for treatment of precancerous lesions of the cervix is recommended by the World Health Organization and has the potential to overcome logistical challenges associated with cryotherapy and facilitate implementation of SV-SAT approach and increase treatment rates of screen-positive women. In this 5-year prospective, stepped-wedge randomized trial, we plan to implement and evaluate the SV-SAT approach using VIA and thermal ablation in ten reproductive health clinics in central Kenya.MethodsThe study aims to develop and evaluate implementation strategies to inform the national scale-up of SV-SAT approach with VIA and thermal ablation through three aims: (1) develop locally tailored implementation strategies using multi-level participatory method with key stakeholders (patient, provider, system-level), (2) implement SV-SAT approach with VIA and thermal ablation and evaluate clinical and implementation outcomes, and (3) assess the budget impact of SV-SAT approach with VIA and thermal ablation compared to single-visit, screen-and-treat method using cryotherapy.DiscussionOur findings will inform national scale-up of the SV-SAT approach with VIA and thermal ablation. We anticipate that this intervention, along with tailored implementation strategies will enhance the adoption and sustainability of cervical cancer screening and treatment compared to the standard of care using cryotherapy.Trial registrationNCT05472311.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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