mSaada mobile app to support HPV-based cervical screening and follow-up
mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya
This project will test whether the mSaada mobile app helps community health volunteers in Kenya increase HPV screening and ensure women aged 30–65 get follow-up and treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT05848557 on ClinicalTrials.gov |
What this trial studies
In the initial phase investigators will finalize the mSaada platform with stakeholders and developers, adding patient and specimen tracking to an existing prototype. They will run a six-month pilot with community units linked to two health facilities, collecting system usage metrics, workflow observations, and qualitative feedback. Performance data from the pilot will guide the design of a larger effectiveness trial and identify implementation needs. The planned later phase is an 18-month cluster-randomized trial across 12 facilities to measure the app's impact on screening uptake and treatment acquisition.
Who should consider this trial
Good fit: Ideal participants include community health volunteers and government clinic providers working in cervical cancer screening, and women aged 30–65 with an intact cervix who can give informed consent.
Not a fit: Women outside the 30–65 age range, those without an intact cervix, people not served by participating facilities, or anyone unable or unwilling to give informed consent are unlikely to benefit.
Why it matters
Potential benefit: If successful, mSaada could increase screening rates and improve timely linkage to treatment by helping health workers track patients and specimens.
How similar studies have performed: Previous mHealth and community health worker interventions have shown promising improvements in screening uptake and follow-up, but this specific patient- and specimen-tracking app represents a novel combination that still needs rigorous testing.
Eligibility criteria
Show full inclusion / exclusion criteria
R21 Aim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials Inclusion Criteria: * 18 years or older * be employed by a government clinic * be working in cervical cancer screening Exclusion Criteria: * Does not understand the study purpose and details * Is not willing to provide informed consent Women Inclusion Criteria: \- between 30 and 65 years old Exclusion Criteria: * Does not understand the study purpose and details * Is not willing to provide informed consent Aim 2 Community health volunteers (CHVs) Inclusion Criteria: * 18 years or older * be employed by a government clinic * be working in cervical cancer screening Exclusion Criteria: * Does not understand the study purpose and details * Is not willing to provide informed consent Women Inclusion Criteria: * between 30 and 65 years old * intact cervix and uterus * able to provide informed consent. Exclusion Criteria: * Does not understand the study purpose and details * Is not willing to provide informed consent R33 Women (knowledge and risk perception surveys) We plan to enroll approximately 600 women (50 per health facility) to complete a survey about cervical cancer and HPV knowledge, risk perception and screening awareness, acceptability and self-efficacy.\\ Eligibility criteria for women participants include: * Reside within Siaya County, in one of the study communities * Eligible for cervical cancer screening per the Kenya Ministry of Health guidelines and * Ability to provide informed consent. CHPs in both arms will be asked to complete a survey about their self-efficacy, knowledge of HPV and cervical cancer, and the usability of the mSaada app (CHPs in the intervention arm only). Inclusion: * CHV participants must be employed by government clinics in Siaya County, and * be able to provide informed consent. Exclusion: * Does not understand the study purpose and details * Is not willing to sign an informed consent
Where this trial is running
Kisumu
- Kenya Medical Research Institute — Kisumu, Kenya (Recruiting)
Study contacts
- Study coordinator: Megan Huchko, MD, MPH
- Email: megan.huchko@duke.edu
- Phone: 919 613 5062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.