NCT05848557Recruiting
mSaada: A Mobile Health Tool
mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 6000 (estimated)
- First submitted
- 14 Apr 2023
- Start date
- 19 Feb 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Duke University
- Diseases
- Cervical cancer
- NCT number
- NCT05848557
What you commit to
- Study type: Interventional
- Planned participants: 6000
- From 19 Feb 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
- 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:
Other
- Does not understand the study purpose and details
- Is not willing to provide informed consent
- Women
- Does not understand the study purpose and details
- Is not willing to provide informed consent
- Aim 2 Community health volunteers (CHVs)
- Does not understand the study purpose and details
- Is not willing to provide informed consent
- Women
- Does not understand the study purpose and details
- Reside within Siaya County, in one of the study communities
- 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
Who the study is looking for
- 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.
Criteria the registry did not label
- R21
- Aim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute Coordinator of this site? Confirm its status | Kisumu | Kenya | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.