mSaada: A Mobile Health Tool

NCT05848557 | Recruiting

• 1 other identifier: Pro00108937
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief 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

Cervical Cancer; HPV; mHealth

Outcome Measures

Primary Outcomes (6)

• 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).

  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

  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

  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.

  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.

  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..

  1-day

Study Arms (2)

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.

Behavioral: mSaada

Interventions

mSaada 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.

mSaada platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• be employed by a government clinic
• be working in cervical cancer screening

You may not qualify if:

• Does not understand the study purpose and details
• Is not willing to provide informed consent
• Women
• \- between 30 and 65 years old
• Does not understand the study purpose and details
• Is not willing to provide informed consent
• Aim 2 Community health volunteers (CHVs)
• years or older
• be employed by a government clinic
• be working in cervical cancer screening
• Does not understand the study purpose and details
• Is not willing to provide informed consent
• Women
• between 30 and 65 years old
• intact cervix and uterus

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Megan Huchko, MD, MPH

CONTACT

919 613 5062; megan.huchko@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 8, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

KE (1)