mSaada: A Mobile Health Tool

Study Overview
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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 cluster randomized controlled trial (c-RCT) to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness and implementation factors. Investigators will carry out a six-month c-RCT of mSaada in six 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 c-RCT 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.

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

Conditions
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Cervical Cancer, HPV, mHealth

Intervention / Treatment
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* Behavioral: mSaada


Participation Criteria
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Eligibility Criteria
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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: reside within Kisumu County, have access to government health facilities with capacity to provide HPV testing, 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 ability to provide informed consent. Eligibility criteria for CHV participants include: reside within Kisumu County, work in government health facilities that deliver cervical cancer screening and treatment to women, and 3) ability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Counseling will be provided using standard Ministry of Health (MoH) items and screening data and specimen tracking will be done using MoH registers. | |
| Experimental: mSaada platform<br>Counseling, specimen tracking and case management will be facilitated using mSaada. | Behavioral: mSaada<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Proportion of women in each arm who test HPV-positive and access treatment within 3 months of receiving their results |  | 18-months | 
| 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 | 
| 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 | 
| 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 |