RECRUITINGINTERVENTIONAL

mSaada: A Mobile Health Tool

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

About This Trial

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.

Who May Be Eligible (Plain English)

R21 Aim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials Who May Qualify: - 18 years or older - be employed by a government clinic - be working in cervical cancer screening Who Should NOT Join This Trial: - Does not understand the study purpose and details - Is not willing to provide willing to sign a consent form Women Who May Qualify: \- between 30 and 65 years old Who Should NOT Join This Trial: - Does not understand the study purpose and details - Is not willing to provide willing to sign a consent form Aim 2 Community health volunteers (CHVs) Who May Qualify: - 18 years or older - be employed by a government clinic - be working in cervical cancer screening Who Should NOT Join This Trial: - Does not understand the study purpose and details - Is not willing to provide willing to sign a consent form Women Who May Qualify: - between 30 and 65 years old - intact cervix and uterus - able to provide willing to sign a consent form. Who Should NOT Join This Trial: - Does not understand the study purpose and details - Is not willing to provide willing to sign a consent form R33 Women (knowledge and risk perception surveys) We plan to enroll approximately 600 women (50 per health facility) to complete a survey about cervical cancer and HPV knowledge, risk perception and screening awareness, acceptability and self-efficacy.\\ Eligibility criteria for women participants include: - Reside within Siaya County, in one of the study communities - Eligible for cervical cancer screening per the Kenya Ministry of Health guidelines and - Ability to provide willing to sign a consent form. CHPs in both arms will be asked to complete a survey about their self-efficacy, knowledge of HPV and cervical cancer, and the usability of the mSaada app (CHPs in the intervention arm only). Inclusion: - CHV participants must be employed by government clinics in Siaya County, and ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 Women (knowledge and risk perception surveys) We plan to enroll approximately 600 women (50 per health facility) to complete a survey about cervical cancer and HPV knowledge, risk perception and screening awareness, acceptability and self-efficacy.\\ Eligibility criteria for women participants include: * Reside within Siaya County, in one of the study communities * Eligible for cervical cancer screening per the Kenya Ministry of Health guidelines and * Ability to provide informed consent. CHPs in both arms will be asked to complete a survey about their self-efficacy, knowledge of HPV and cervical cancer, and the usability of the mSaada app (CHPs in the intervention arm only). Inclusion: * CHV participants must be employed by government clinics in Siaya County, and * be able to provide informed consent. Exclusion: * Does not understand the study purpose and details * Is not willing to sign an informed consent

Treatments Being Tested

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 (1)

Kenya Medical Research Institute

Kisumu, Kenya