Cervical CancerNCT05848557
mSaada: A Mobile Health Tool
A study testing mSaada in people with Cervical Cancer and HPV, run by Duke University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, HPV, mHealth
- What is being tested?
- mSaada
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteKenya
- Study dates
- 19 Feb 2024to 30 Jun 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- be working in cervical cancer screening
- between 30 and 65 years old
- intact cervix and uterus
- able to provide informed consent.
- CHV participants must be employed by government clinics in Siaya County, and
- be able to provide informed consent.
Who cannot join
- 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)
Show all 20Show fewer
- 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
- 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).
- Does not understand the study purpose and details
- Is not willing to sign an informed consent
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
Kenya Medical Research Institute
Kisumu, Kisumu County
Elizabeth Bukusi, MD
About this study
Official title: mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya
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.
- Conditions
- Cervical Cancer, HPV, mHealth
- Being tested
- mSaada
- 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.
mSaadaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Counseling will be provided using standard Ministry of Health (MoH) items and screening data and specimen tracking will be done using MoH registers. |
| mSaada platform | Experimental | Counseling, specimen tracking and case management will be facilitated using mSaada. Receives: Behavioral: mSaada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Community Health Volunteers (CHVs) reporting a usability score greater than 60
mSaada Usability Survey with a range of 20-100, where a higher score indicates a higher level of acceptability (mean scores >60 is considered acceptable).
Measured: 1-day
Proportion of women in each arm who complete cervical cancer screening
Calculated by dividing the number of women screened by the number of eligible women attending health facilities
Measured: 1-day
Proportion of women in each arm who test HPV-positive and access treatment within 3 months of receiving their results
Calculated the number of women treated within 3 months of receiving their results by dividing the number of women who test HPV positive
Measured: 1-day
Difference in women's knowledge level of cervical cancer as measured by a knowledge scale between the arms
The knowledge scale has a score range of 0 to 5, where a higher score indicates a higher level of knowledge.
Measured: 1-day
Difference in women risk perception of cervical cancer as measured by a risk perception scale between the arms
The Risk Perception Scale has 3 Likert scale questions regarding risk perception.
Measured: 1-day
Difference in Community Health Promoter (CHP) screening self-efficacy, knowledge, usability between the arms
Quantitative self-efficacy, knowledge and usability survey with CHPs after participating in the study..
Measured: 1-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start19 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848557
- Sponsor's protocol ID
- Pro00108937
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya
- ClinicalTrials.gov ID
- NCT05848557
- Acronym / sponsor ID
- Pro00108937
- Conditions
- Cervical Cancer, HPV, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 May 2023 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Counseling will be provided using standard Ministry of Health (MoH) items and screening data and specimen tracking will be done using MoH registers. |
| mSaada platform | Experimental | Behavioral: mSaadaCounseling, specimen tracking and case management will be facilitated using mSaada. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| mSaadamSaada 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. | Behavioural | mSaada platform |
Primary outcome
Number of Community Health Volunteers (CHVs) reporting a usability score greater than 60
Time frame: 1-day
mSaada Usability Survey with a range of 20-100, where a higher score indicates a higher level of acceptability (mean scores >60 is considered acceptable).
Proportion of women in each arm who complete cervical cancer screening
Time frame: 1-day
Calculated by dividing the number of women screened by the number of eligible women attending health facilities
Proportion of women in each arm who test HPV-positive and access treatment within 3 months of receiving their results
Time frame: 1-day
Calculated the number of women treated within 3 months of receiving their results by dividing the number of women who test HPV positive
Difference in women's knowledge level of cervical cancer as measured by a knowledge scale between the arms
Time frame: 1-day
The knowledge scale has a score range of 0 to 5, where a higher score indicates a higher level of knowledge.
Difference in women risk perception of cervical cancer as measured by a risk perception scale between the arms
Time frame: 1-day
The Risk Perception Scale has 3 Likert scale questions regarding risk perception.
Difference in Community Health Promoter (CHP) screening self-efficacy, knowledge, usability between the arms
Time frame: 1-day
Quantitative self-efficacy, knowledge and usability survey with CHPs after participating in the study..
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 13 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mSaada in people with Cervical Cancer and HPV, run by Duke University 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 12 inclusion and 20 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 13 Aug 2026. 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 Megan Huchko, MD, MPH (919 613 5062, megan.huchko@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Community Health Volunteers (CHVs) reporting a usability score greater than 60 (time frame: 1-day). 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?
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 13 Aug 2026.