NCT05472311: TIBA

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

Recruiting now NA Last updated 19 August 2024

What this trial tests

NA trial testing Thermal Ablation in Cervical Cancer in 565 participants. Currently enrolling.

Timeline

17 May 2022

Primary endpoint
26 April 2026

30 November 2026

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	565
Start date	17 May 2022
Primary completion	26 April 2026
Estimated completion	30 November 2026
Sites	1 location across Kenya

Drugs / interventions tested

• Thermal Ablation

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

University of Washington

Who can join

Adults 21 to 60, any sex, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Shin MB, Oluoch LM, Barnabas RV, Baynes C, et al · · 2023 · cited 5× · PMID 37365575 · DOI 10.1186/s13012-023-01282-3
2. An evaluation of barrier-strategy matching for a cervical cancer prevention intervention in Kenya: A convergent mixed methods study
   Adhiambo HF, Mutai SC, Coe M, Ihaji V, et al · · 2026 · DOI 10.21203/rs.3.rs-9622859/v1
3. Applying FRAME-IS to characterize provider-led adaptations to a cervical cancer prevention intervention in Kenya.
   Adhiambo HF, Thomas K, Coe MM, Oluoch L, et al · · 2026 · PMID 41731591 · DOI 10.1186/s43058-026-00883-5
4. Applying FRAME-IS to Characterize Provider-led Adaptations to a Cervical Cancer Prevention Intervention in Kenya
   Adhiambo HF, Thomas K, Coe M, Oluoch L, et al · · 2025 · DOI 10.21203/rs.3.rs-6933921/v1