mSaada: A Mobile Health Tool

Duke University

Status: Enrolling

Conditions: HPV; mHealth; Cervical Cancer

Treatments: Behavioral: mSaada

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05848557

Pro00108937

Details and patient eligibility

About

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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,000 participants in 2 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

Counseling, specimen tracking and case management will be facilitated using mSaada.

Treatment:

Behavioral: mSaada