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

NCT05472311 | Recruiting

• 2 other identifiers: STUDY00014200R01CA258590-01
• Study Type: interventional
• Target: 565
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

invasive cervical cancer; cervical intra-epithelial lesion (CIN); human papillomavirus; single visit screen- and - treat (SVA-SAT); thermal ablation; implementation science

Outcome Measures

Primary Outcomes (6)

• Index of barriers to introduction of SAT_SVA+TA

  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

  3 months

• Index of facilitators to introduction of SAT_SVA+TA

  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 make it suitable for successful introduction and scalability of SAT-SVA+TA intervention

  3 months

• Deliver and Using the RE-AIM Framework Evaluate the Implementation of Thermal Number of providers trained who continue to provide treatment for pre-cancer lesions of the cervix using thermal ablation with a single visit approach

  The number of providers trained who continue to provide treatment for pre-cancer lesions of the cervix using thermal ablation with a single visit approach during the periods before, during and after introduction of TA to RH clinics

  4 years

• Impact of the SVA-SAT+TA on effective uptake of treatment of pre-cancer lesions of the cervix

  Measure treatment completion rate compared to pre-intervention for women who screen positive for pre-cancer lesions of the cervix

  4 years

• Sustained use of TA to treat pre cancer lesions of the cervix in RH clinics in Kenya

  The treatment completion rates of women with pre-cancer lesions of the cervix after withdrawal of active implementation support by project personnel

  4 years

• HPV Clearance post treatment with TA

  The number of screen positive women treated with TA that clear HPV infection post treatment

  6 months after treatment

Secondary Outcomes (1)

• Cost impact of SVA-SAT_TA

  4 years

Study Arms (1)

Treat with thermal ablation

OTHER

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

Other: Thermal Ablation

Interventions

Thermal Ablation OTHER

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.

Also known as: TA

Treat with thermal ablation

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any individual who declines to participate or have their data collected for purpose of research

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Phrd-Ccr-Kemri

Thika, Kiambu County, Kenya

RECRUITING

Related Publications (2)

• Adhiambo 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 DERIVED

• Shin 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 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nelly Mugo, MPH, MMed

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynda Oluoch, MBChB, MPH

CONTACT

206-520-3866; lynda@pipsthika.org

Jason Caucutt

CONTACT

206-353-8069; jcaucutt@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor: Global Health

Model Details: Using implementation science methods to evaluate the implementation of thermal ablation for treatment of pre-cancer lesions of the cervix in reproductive health clinics

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: July 25, 2022
• Study Start: May 17, 2022
• Primary Completion: April 26, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)