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mSaada: A Mobile Health Tool

NCT ID: NCT05848557

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer HPV mHealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

mSaada platform

Counseling, specimen tracking and case management will be facilitated using mSaada.

Group Type EXPERIMENTAL

mSaada

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kenya Medical Research Institute

Kisumu, , Kenya

Site Status RECRUITING

Countries

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Kenya

Central Contacts

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Megan Huchko, MD, MPH

Role: CONTACT

Phone: 919 613 5062

Email: [email protected]

Facility Contacts

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Elizabeth Bukusi, MD

Role: primary

Other Identifiers

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Pro00108937

Identifier Type: -

Identifier Source: org_study_id