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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 years or older

• be employed by a government clinic

• be working in cervical cancer screening

⁃ \- between 30 and 65 years old

• 18 years or older

• be employed by a government clinic

• be working in cervical cancer screening

• between 30 and 65 years old

• intact cervix and uterus

• able to provide informed consent.

Locations
Other Locations
Kenya
Kenya Medical Research Institute
RECRUITING
Kisumu
Contact Information
Primary
Megan Huchko, MD, MPH
megan.huchko@duke.edu
919 613 5062
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 6000
Treatments
No_intervention: Usual care
Counseling will be provided using standard Ministry of Health (MoH) items and screening data and specimen tracking will be done using MoH registers.
Experimental: mSaada platform
Counseling, specimen tracking and case management will be facilitated using mSaada.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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