NCT05472311 Cervical Cancer Elimination -Using Implementation Science to Evaluate Deliver and Cost Introduction of Thermal Ablation
| NCT ID | NCT05472311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 565 participants |
| Start Date | 2022-05-17 |
| Primary Completion | 2026-04-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 565 participants in total. It began in 2022-05-17 with a primary completion date of 2026-04-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: -Any individual who declines to participate or have their data collected for purpose of research
Contact & Investigator
Nelly Mugo, MPH, MMed
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05472311 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05472311 currently recruiting?
Yes, NCT05472311 is actively recruiting participants. Contact the research team at lynda@pipsthika.org for enrollment information.
Where is the NCT05472311 trial being conducted?
This trial is being conducted at Thika, Kenya.
Who is sponsoring the NCT05472311 clinical trial?
NCT05472311 is sponsored by University of Washington. The principal investigator is Nelly Mugo, MPH, MMed at University of Washington. The trial plans to enroll 565 participants.
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