Implementation and Scale Up of a Single-visit, Screen-and-treat Approach With Thermal Ablation for Sustainable Cervical Cancer Prevention Services in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 565
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
The mainstay of cervical cancer (CC) prevention in low- and middle-income counties (LMIC) has been the single-visit approach with screen-and-treat (SVA-SAT) method, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. It is a low-cost screening approach and minimizes loss to follow-up compared to traditional cytology. In Kenya, there is extremely low fidelity of SVA-SAT. Thermal ablation (TA) is an effective alternative to cryotherapy for ablation of precancerous lesions, and has been recommended by the World Health Organization (WHO) since 2019. Preliminary data from an investigative team member demonstrated safety, effectiveness, and acceptability to women when delivered by nurses in Zambia and Kenya. The portable device can be charged with electricity, batteries or solar panels, which is ideal for low-resource settings. Successful implementation and scale-up of TA within the SVA-SAT approach could optimize CC prevention.
This is a five-year prospective, stepped-wedge, cluster randomized trial to implement SVA-SAT+TA in 10 reproductive health (RH) clinics in central Kenya. The study uses mixed-methods evaluation based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework to assess the intervention's impact.
In collaboration with multi-level (clinic, county, national) stakeholders this project will develop a sustainable D&I strategy and leverage trial implementation to include costing and budget impact analysis. The objective is to develop and evaluate a locally contextualized dissemination and implementation (D&I) strategy for SVA-SAT with TA (SVA-SAT+TA) to inform national scale-up. The hypothesis is that TA will enhance the feasibility, adoption, and sustainability of CC prevention services via SVA-SAT, compared to the standard of care with cryotherapy.
Design:
Prospective, stepped-wedge, cluster randomized trial to implement SVA-SAT+TA in ten reproductive health (RH) clinics in central Kenya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Any individual who declines to participate or have their data collected for purpose of research
结局指标
主要结局
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
时间窗: 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
HPV Clearance post treatment with TA
时间窗: 6 months after treatment
The number of screen positive women treated with TA that clear HPV infection post treatment
Sustained use of TA to treat pre cancer lesions of the cervix in RH clinics in Kenya
时间窗: 4 years
The treatment completion rates of women with pre-cancer lesions of the cervix after withdrawal of active implementation support by project personnel
Index of barriers to introduction of SAT_SVA+TA
时间窗: 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
时间窗: 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
Impact of the SVA-SAT+TA on effective uptake of treatment of pre-cancer lesions of the cervix
时间窗: 4 years
Measure treatment completion rate compared to pre-intervention for women who screen positive for pre-cancer lesions of the cervix
次要结局
- Cost impact of SVA-SAT_TA(4 years)
研究者
Nelly Mugo
Research Associate Professor: Global Health
University of Washington