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

Intervention / Treatment

• Other: Thermal Ablation

Primary Outcome Measures

• Index of barriers to introduction of SAT_SVA+TA (3 months)
  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
• Index of facilitators to introduction of SAT_SVA+TA (3 months)
  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
• 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 (4 years)
  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
• Impact of the SVA-SAT+TA on effective uptake of treatment of pre-cancer lesions of the cervix (4 years)
  Measure treatment completion rate compared to pre-intervention for women who screen positive for pre-cancer lesions of the cervix
• Sustained use of TA to treat pre cancer lesions of the cervix in RH clinics in Kenya (4 years)
  The treatment completion rates of women with pre-cancer lesions of the cervix after withdrawal of active implementation support by project personnel
• HPV Clearance post treatment with TA (6 months after treatment)
  The number of screen positive women treated with TA that clear HPV infection post treatment

Countries

Kenya

Locations and Investigators

• Phrd-Ccr-Kemri, Thika, Kenya (Recruiting)
  • Lynda Oluoch, MD
  • Catherine Kiptiness

Study Officials

• Nelly Mugo, MPH, MMed (Principal Investigator) — University of Washington