An interventional study of mSaada in Cervical Cancer, HPV and mHealth, sponsored by Duke University. Recruiting at 1 site in Kenya. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Duke University · Not applicable, Interventional, and Screening
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
R21
Aim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials
Inclusion Criteria:
Exclusion Criteria:
Women
Inclusion Criteria:
- between 30 and 65 years old
Exclusion Criteria:
Aim 2 Community health volunteers (CHVs)
Inclusion Criteria:
Exclusion Criteria:
Women
Inclusion Criteria:
Exclusion Criteria:
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:
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:
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Counseling will be provided using standard Ministry of Health (MoH) items and screening data and specimen tracking will be done using MoH registers.
Counseling, specimen tracking and case management will be facilitated using mSaada.
Behavioral: mSaada
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.
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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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..
Time frame: 1-day
Plan to share: Yes
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Jun 2027, 40 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 40 months is above that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.