mSaada: A Mobile Health Tool

Trial Title: mSaada: A Mobile Health Tool

NCT ID: NCT05848557

Condition: Cervical Cancer
HPV
mHealth

Conditions: Official terms:
Uterine Cervical Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: mSaada
Description: 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.
Arm group label: mSaada platform

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.

Criteria for eligibility:
Criteria:
R21 Aim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials Inclusion Criteria: - 18 years or older - be employed by a government clinic - be working in cervical cancer screening Exclusion Criteria: - Does not understand the study purpose and details - Is not willing to provide informed consent Women Inclusion Criteria: - between 30 and 65 years old Exclusion Criteria: - Does not understand the study purpose and details - Is not willing to provide informed consent Aim 2 Community health volunteers (CHVs) Inclusion Criteria: - 18 years or older - be employed by a government clinic - be working in cervical cancer screening Exclusion Criteria: - Does not understand the study purpose and details - Is not willing to provide informed consent Women Inclusion Criteria: - 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 R33 Eligibility criteria for women participants include: 1. reside within Kisumu County, 2. have access to government health facilities with capacity to provide HPV testing, 3. are eligible for cervical cancer screening per the Kenya Ministry of Health guidelines (women who are between ages 30-65 and have an intact uterus and cervix) and 4. ability to provide informed consent. Eligibility criteria for CHV participants include: 1. reside within Kisumu County, 2. work in government health facilities that deliver cervical cancer screening and treatment to women, and 3) ability to provide informed consent.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Kenya Medical Research Institute

Address:
City: Kisumu
Country: Kenya

Status: Recruiting

Contact:
Last name: Elizabeth Bukusi, MD

Start date: February 19, 2024

Completion date: June 30, 2027

Lead sponsor:
Agency: Duke University
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Duke University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05848557