RecruitingNot ApplicableNCT05848557

mSaada: A Mobile Health Tool

mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya


Sponsor

Duke University

Enrollment

6,000 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In the R21 phase of this project, investigators will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness in assisting community health volunteer-led home-based HPV screening, and implementation factors. Investigators will carry out a six-month pilot of mSaada with community units in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a to determine effectiveness. In the R33 phase of the project, investigators plan to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. Investigators anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a mobile health app called mSaada to help community health volunteers and clinics improve cervical cancer screening rates for women in Kenya, making it easier for women to learn about HPV and access screening. You may be eligible (as a community health worker) if: you are 18 or older; you work at a government clinic; and you are involved in cervical cancer screening. You may be eligible (as a woman) if: you are between 30 and 65 years old; you have a cervix (uterus intact); and you are able to give your informed consent. You may NOT be eligible if: you do not understand the study purpose; or you are unwilling to sign the informed consent. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALmSaada

mSaada is an integrated digital platform to support patients, community health volunteers (CHVs), providers and health systems in an HPV-based cervical cancer screening strategy. mSaada is hosted on an open-source platform (Dimagi, CommCare) as a mobile health application to support patient data collection, protocol support and counseling aids. mSaada will include an education module, patient and specimen tracking, screening reminders, and messaging functionality.


Locations(1)

Kenya Medical Research Institute

Kisumu, Kenya

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NCT05848557


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