RecruitingNot ApplicableNCT05472311

Cervical Cancer Elimination -Using Implementation Science to Evaluate Deliver and Cost Introduction of Thermal Ablation

Implementation and Scale Up of a Single-visit, Screen-and-treat Approach With Thermal Ablation for Sustainable Cervical Cancer Prevention Services in Kenya


Sponsor

University of Washington

Enrollment

565 participants

Start Date

May 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Global elimination of cervical cancer is a feasible goal; however, the countries with the greatest disease burden also have the greatest healthcare system challenges. Cervical cancer (CC) is almost entirely preventable, yet, it remains the 2nd most common cause of cancer and is the most common cause of cancer deaths among women in the majority of Low-Middle-Income-Countries (LMIC) including Kenya. Effective low-cost interventions for early detection of pre-cancer lesions have been available but there remains very low coverage with about 16% eligible women screened in Kenya. Cryotherapy has been introduced as a low-cost intervention for treatment of pre-cancer lesions, however, challenges with equipment shortage, costs, supply chain difficulties of refrigerant gas and equipment failure health facilities has been cited as a reason for the low treatment rates of screen positive women. In Kenya only about 30% of women screening positive access treatment for the pre-cancer lesions. This project will introduce thermal ablation (TA), which is proven to be safe and as effective as cryotherapy for treatment of pre-cancer lesions of the cervix. TA uses electricity, batteries or solar to charge, takes a shorter time to use, is a small easily portable equipment. The primary aim of the study is to deliver, evaluate and cost implementation of the 'Single Visit Screen and Treat with Thermal Ablation' (SVA-SAT+TA) intervention for treatment of women who screen positive for pre-cancer lesions of the cervix in reproductive health clinics in Kenya, using implementation science framework to inform National scale-up. To achieve national and global goals to eliminate cervical cancer, there is an urgent need to adapt, implement, and scale-up effective technologies in Kenya. The proposed research project will develop a contextually appropriate implementation and dissemination model to guide effective scale-up of the single visit screen and treat approach with use of thermal ablation to health facilities to bridge access to cervical cancer prevention services for women in Kenya and similar low resource settings.


Eligibility

Min Age: 21 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the rollout of thermal ablation — a less invasive treatment that uses heat to destroy pre-cancerous cells on the cervix — as a way to expand cervical cancer prevention services in under-resourced health settings. **You may be eligible if...** - You are a woman aged 25–60 years seeking cervical cancer screening at a participating clinic - You have tested positive for a pre-cancerous lesion on your cervix - You are a healthcare provider or health system manager involved in cervical cancer prevention at a participating facility **You may NOT be eligible if...** - You decline to participate or have your data used for research purposes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThermal Ablation

Thermal ablation is based on local heating (around 100 degrees centigrade), applied for 20 to 60 seconds to destroy abnormal tissue by burning and inducing necrosis of pre-cancer and surrounding tissue. It has been used in by gynecological surgery for over 50 years, proven safe and easy to use by middle level health care providers in primary care settings.


Locations(1)

Phrd-Ccr-Kemri

Thika, Kiambu County, Kenya

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NCT05472311


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