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

NCT05472311RecruitingNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University of Washington

Enrollment

565

Start Date

2022-05-17

Completion Date

2026-04-26

Study Type

INTERVENTIONAL

Official Title

Implementation and Scale Up of a Single-visit, Screen-and-treat Approach With Thermal Ablation for Sustainable Cervical Cancer Prevention Services in Kenya

Interventions

Thermal Ablation

Conditions

Cervical Cancer

Eligibility

Age Range

21 Years – 60 Years

Sex

ALL

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

Outcome Measures

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 4 years

HPV Clearance post treatment with TA

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

Time frame: 6 months after treatment

Secondary Outcomes

Cost impact of SVA-SAT_TA

Quantify the programmatic costs of SVA-SAT for treatment of pre-cancer lesions of the cervix.

Time frame: 4 years

Locations

Phrd-Ccr-Kemri, Thika, Kenya

Linked Papers

2023-06-26

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

Abstract Background An important cervical cancer prevention strategy in low- and middle-income countries (LMICs) has been single-visit screen-and-treat (SV-SAT) approach, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. While SV-SAT with VIA and cryotherapy have established efficacy, its population level coverage and impact on reducing cervical cancer burden remains low. In Kenya, the estimated cervical cancer screening uptake among women aged 30–49 is 16% and up to 70% of screen-positive women do not receive treatment. Thermal ablation for treatment of precancerous lesions of the cervix is recommended by the World Health Organization and has the potential to overcome logistical challenges associated with cryotherapy and facilitate implementation of SV-SAT approach and increase treatment rates of screen-positive women. In this 5-year prospective, stepped-wedge randomized trial, we plan to implement and evaluate the SV-SAT approach using VIA and thermal ablation in ten reproductive health clinics in central Kenya. Methods The study aims to develop and evaluate implementation strategies to inform the national scale-up of SV-SAT approach with VIA and thermal ablation through three aims: (1) develop locally tailored implementation strategies using multi-level participatory method with key stakeholders (patient, provider, system-level), (2) implement SV-SAT approach with VIA and thermal ablation and evaluate clinical and implementation outcomes, and (3) assess the budget impact of SV-SAT approach with VIA and thermal ablation compared to single-visit, screen-and-treat method using cryotherapy. Discussion Our findings will inform national scale-up of the SV-SAT approach with VIA and thermal ablation. We anticipate that this intervention, along with tailored implementation strategies will enhance the adoption and sustainability of cervical cancer screening and treatment compared to the standard of care using cryotherapy. Trial registration NCT05472311.

Linked Investigators

Lynda Myra Oluoch