Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thermal Ablation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treat with thermal ablation
- description
- Women who screen positive for pre-cancer lesions of the cervix will be offered treatment with thermal ablation and the process of implementation evaluated using implementation science RE-AIM framework
- interventionNames
- Other: Thermal Ablation
Primary outcomes (6)
- measure
- Index of barriers to introduction of SAT_SVA+TA
- timeFrame
- 3 months
- description
- Using a participatory approach through engagement of key stakeholders (women seeking cervical cancer prevention services, frontline health care workers, managers and policy makers) describe factors that deter successful introduction and scalability of SAT-SVA+TA intervention
- measure
- Index of facilitators to introduction of SAT_SVA+TA
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDAdhiambo HF, Thomas K, Coe MM, Oluoch L, Ihaji V, Kerubo MB, Kinyua A, Njoroge S, Ngure K, Shin M, Odeny TA, Weiner B, Mugo N, Gimbel S. Applying FRAME-IS to characterize provider-led adaptations to a cervical cancer prevention intervention in Kenya. Implement Sci Commun. 2026 Feb 24;7(1):61. doi: 10.1186/s43058-026-00883-5. PMID 41731591
- DERIVEDAdhiambo HF, Thomas K, Coe MM, Oluoch L, Ihaji V, Kerubo MB, Kinyua A, Njoroge S, Ngure K, Shin M, Odeny TA, Weiner B, Mugo N, Gimbel S. Applying FRAME-IS to Characterize Provider-led Adaptations to a Cervical Cancer Prevention Intervention in Kenya. Res Sq [Preprint]. 2025 Jul 15:rs.3.rs-6933921. doi: 10.21203/rs.3.rs-6933921/v1. PMID 40709265
- DERIVEDShin MB, Oluoch LM, Barnabas RV, Baynes C, Fridah H, Heitner J, Kerubo MB, Ngure K, Pinder LF, Thomas KK, Mugo NR, Gimbel S. 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. Implement Sci. 2023 Jun 26;18(1):26. doi: 10.1186/s13012-023-01282-3. PMID 37365575