mSaada: A Mobile Health Tool

Cervical Cancer Clinical Trial

Official title:

mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848557
• Other study ID #: Pro00108937
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: Megan Huchko, MD, MPH
• Phone: 919 613 5062
• Email: megan.huchko[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• HPV
• mHealth
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Approximately 6 months
Primary	Proportion of women in each arm who complete cervical cancer screening	Calculated by dividing the number of women screened by the number of women aged 30-65 living in each community assigned to the arm as determined by the door-to-door enumeration.	18-months
Primary	Proportion of women in each arm who test HPV-positive and access treatment within 3 months of receiving their results		18-months
Primary	Change in 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.	baseline, 6 months, 12 months
Primary	Change in risk perception of cervical cancer as measured by a risk perception scale between the arms	The Risk Perception Scale has a score range of 0 to 5, where a higher score indicates a higher perception of risk.	baseline, 6 months, 12 months
Primary	Community Health Volunteer (CHV) screening self-efficacy	Quantitative self-efficacy surveys with CHVs at the end of the c-RCT to compare self-efficacy across study arms. HPV Cervical Cancer Stigma Scale (HCCSS). Stigma mean scores are 0-3 with 3 representing a higher level of stigma.	18-months