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NCT05848557 | RECRUITING | Cervical Cancer

mSaada: A Mobile Health Tool
Sponsor:

Duke University

Brief 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.

Condition or disease

Cervical Cancer

HPV

mHealth

Intervention/treatment

mSaada

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 6000 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya
Actual Study Start Date : 2024-02-19
Estimated Primary Completion Date : 2027-06-30
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
    • mSaada: A Mobile Health Tool

    Location Details

    NCT05848557

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    Kenya,

    Kenya Medical Research Institute

    Kisumu, Kenya,