NCT05472311Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 565 (estimated)
- First submitted
- 10 Jun 2022
- Start date
- 17 May 2022
- Primary completion date
- 26 Apr 2026
- Lead sponsor
- University of Washington
- Diseases
- Cervical cancer
- NCT number
- NCT05472311
What you commit to
- Study type: Interventional
- Planned participants: 565
- From 17 May 2022 to the primary completion date, 26 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -Any individual who declines to participate or have their data collected for purpose of research
Who the study is looking for
- Policy makers
- Health facility managers
- Health care providers at participating reproductive health clinics
- Women seeking cervical cancer screening services
- Women who screen positive for pre-cancer lesion of the cervix
- Consent to study participation
- Age 25-60 years
- Women seeking cervical cancer screening services at participating RH clinics
- Health care providers providing cervical cancer prevention services at participating RH clinics
Age in the registry: 21 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Phrd-Ccr-Kemri Coordinator of this site? Confirm its status | Thika | Kenya | Recruiting |
Related publications
- Applying FRAME-IS to characterize provider-led adaptations to a cervical cancer prevention intervention in Kenya.Implement Sci Commun · 2026 · PMID 41731591
This page is information, not medical advice. Discuss any trial with your doctor.