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mSaada: A Mobile Health Tool

NCT05848557 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2025-11-14

No results posted yet for this study

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 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

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Duke University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848557 on ClinicalTrials.gov