Cervical CancerTIBANCT05472311
Cervical Cancer Elimination -Using Implementation Science to Evaluate Deliver and Cost Introduction of Thermal Ablation
A study testing Thermal Ablation in people with Cervical Cancer, run by University of Washington at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Thermal Ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 565 participants
- Where
- 1 siteKenya
- Study dates
- 17 May 2022to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- -Any individual who declines to participate or have their data collected for purpose of research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Phrd-Ccr-Kemri
Thika, Kiambu County
Lynda Oluoch, MD, Lynda@pipsthika.org
Catherine Kiptiness, catherine@pipsthika.org
About this study
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
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.
Read the detailed description
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.
Population: Mixed population: Reproductive health care workers, health manager's, women seeking services for cervical cancer screening and women who screen positive for pre-cancerous lesions of the cervix.
Objective 1:
Develop a dissemination and implementation strategy to introduce SVA-SAT+TA that effectively accounts for the heterogeneity of the client, provider, and system inputs.
Approach: The project will use qualitative interviews with women seeking CC prevention services, reproductive health (RH) providers, RH managers, and key program stakeholders to identify actionable barriers and facilitators to SVA-SAT+TA uptake. These data will be presented at a stakeholder workshop to synthesize and contextualize strategies to effectively introduce the intervention and provide guidance for scale up.
Objective 2:
Deliver the SVA-SAT+TA intervention at scale in RH clinics and evaluate implementation using the RE-AIM framework.
Approach: The SVA-SAT+TA will be introduced into RH clinics using a stepped-wedge study design and using RE-AIM framework the process will be rigorously evaluated on how effective it is disseminated and implemented. Key endpoints will include:
- (REACH) Proportion of the clinics reached, providers trained;
- (EFFECTIVENESS) Intervention effect on SVA-SAT process measures: number of screen positive women identified per month, treatment completion rate compared to pre-intervention, and the patient-level TA fidelity of implementation assessed by testing Human Papillomavirus (HPV) clearance
- (ADOPTION) Proportion of the clinics incorporating TA into routine care
- (IMPLEMENTATION) Describe drivers of success/failure using the Consolidated Framework for Implementation Research (CFIR)
- (MAINTENANCE) Proportion of clinics that continue to provide and sustain SVA-SAT+TA services post intervention implementation.
Objective 3:
Compare the cost and budget impact of SVA-SAT+TA to SVA-SAT using cryotherapy. Approach: Using micro-costing techniques to quantify the programmatic costs of SVA-SAT with cryotherapy and with TA.
- Conditions
- Cervical Cancer
- Being tested
- Thermal Ablation
- Keywords
- invasive cervical cancer, cervical intra-epithelial lesion (CIN), human papillomavirus, single visit screen- and - treat (SVA-SAT), thermal ablation, implementation science
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal AblationOther
Also called TA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Thermal Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 years
HPV Clearance post treatment with TA
The number of screen positive women treated with TA that clear HPV infection post treatment
Measured: 6 months after treatment
Secondary outcomes (1)
Cost impact of SVA-SAT_TA
Quantify the programmatic costs of SVA-SAT for treatment of pre-cancer lesions of the cervix.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start17 May 2022
- Primary completion26 Apr 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using implementation science methods to evaluate the implementation of thermal ablation for treatment of pre-cancer lesions of the cervix in reproductive health clinics
- Masking
- None (open label)
- Enrolment
- 565 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kenya Medical Research Institute
- Responsible party
- Principal investigator, Nelly Mugo, University of Washington
- Investigators
- Nelly Mugo, MPH, MMed, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472311
- Sponsor's protocol ID
- STUDY00014200
- Other IDs
- R01CA258590-01
- Acronym
- TIBA
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified provider interviews will be shared with other Implementation Science researchers to improve healh care outcomes.
Publications
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. Implement Sci Commun. 2026 Feb 24;7(1):61. doi: 10.1186/s43058-026-00883-5.
PubMed 41731591Adhiambo 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.
PubMed 40709265Shin 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.
PubMed 37365575
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05472311
- Acronym / sponsor ID
- TIBA / STUDY00014200
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 565 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kenya Medical Research Institute
- Study start
- 17 May 2022 (actual)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Population: Mixed population: Reproductive health care workers, health manager's, women seeking services for cervical cancer screening and women who screen positive for pre-cancerous lesions of the cervix.
Objective 1:
Develop a dissemination and implementation strategy to introduce SVA-SAT+TA that effectively accounts for the heterogeneity of the client, provider, and system inputs.
Approach: The project will use qualitative interviews with women seeking CC prevention services, reproductive health (RH) providers, RH managers, and key program stakeholders to identify actionable barriers and facilitators to SVA-SAT+TA uptake. These data will be presented at a stakeholder workshop to synthesize and contextualize strategies to effectively introduce the intervention and provide guidance for scale up.
Objective 2:
Deliver the SVA-SAT+TA intervention at scale in RH clinics and evaluate implementation using the RE-AIM framework.
Approach: The SVA-SAT+TA will be introduced into RH clinics using a stepped-wedge study design and using RE-AIM framework the process will be rigorously evaluated on how effective it is disseminated and implemented. Key endpoints will include:
- (REACH) Proportion of the clinics reached, providers trained;
- (EFFECTIVENESS) Intervention effect on SVA-SAT process measures: number of screen positive women identified per month, treatment completion rate compared to pre-intervention, and the patient-level TA fidelity of implementation assessed by testing Human Papillomavirus (HPV) clearance
- (ADOPTION) Proportion of the clinics incorporating TA into routine care
- (IMPLEMENTATION) Describe drivers of success/failure using the Consolidated Framework for Implementation Research (CFIR)
- (MAINTENANCE) Proportion of clinics that continue to provide and sustain SVA-SAT+TA services post intervention implementation.
Objective 3:
Compare the cost and budget impact of SVA-SAT+TA to SVA-SAT using cryotherapy. Approach: Using micro-costing techniques to quantify the programmatic costs of SVA-SAT with cryotherapy and with TA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using implementation science methods to evaluate the implementation of thermal ablation for treatment of pre-cancer lesions of the cervix in reproductive health clinics
| Arm | Type | Receives |
|---|---|---|
| Treat with thermal ablation | Other | Other: Thermal AblationWomen 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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- -Any individual who declines to participate or have their data collected for purpose of research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal AblationAlso: TAThermal 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. | Other | Treat with thermal ablation |
Primary outcome
Index of barriers to introduction of SAT_SVA+TA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months after treatment
The number of screen positive women treated with TA that clear HPV infection post treatment
1 secondary outcome
Cost impact of SVA-SAT_TA
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 41731591Adhiambo 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.
- Derived from this study: PubMed 40709265Adhiambo 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.
- Derived from this study: PubMed 37365575Shin 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.
- Individual participant dataSharing planned: No. De-identified provider interviews will be shared with other Implementation Science researchers to improve healh care outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nelly Mugo, MPH, MMed principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Ablation in people with Cervical Cancer, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynda Oluoch, MBChB, MPH (206-520-3866, lynda@pipsthika.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of barriers to introduction of SAT_SVA+TA (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472311, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.