mSaada mobile app to support HPV-based cervical screening and follow-up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In the initial phase investigators will finalize the mSaada platform with stakeholders and developers, adding patient and specimen tracking to an existing prototype. They will run a six-month pilot with community units linked to two health facilities, collecting system usage metrics, workflow observations, and qualitative feedback. Performance data from the pilot will guide the design of a larger effectiveness trial and identify implementation needs. The planned later phase is an 18-month cluster-randomized trial across 12 facilities to measure the app's impact on screening uptake and treatment acquisition.

Why it matters

Who can join: the full rules

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

Where it's running

• Kenya Medical Research Institute
  Kisumu, Kisumu County, Kenya Recruiting

Study contacts

• Study coordinator: Megan Huchko, MD, MPH
• Email: megan.huchko@duke.edu
• Phone: 919 613 5062

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CHW4CervixHealth: HPV self-collection kits with community health workers

  This project will test whether giving self-collection HPV kits during community workshops led by community health workers helps increase screening among under-screened women aged 25–65 and will first compare kit results to clinical Pap smears.

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• Treatment approaches for HPV-related lesions in women

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• Automated cervical cancer screening using a smartphone AI classifier

  This study is testing a smartphone app that uses AI to help improve cervical cancer screening in low- and middle-income countries by making it more accurate and easier for healthcare providers.

  Recruiting University Hospital, Geneva · Dschang, Menoua · NCT04859530

• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

  This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.

  Recruiting University of California, San Diego · Nairobi · NCT07925307

• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

  This study tests whether placing an absorbable hydrogel spacer between the cervix/vagina and rectum before definitive radiotherapy can reduce rectal radiation exposure for women with cervical cancer.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07904182

• How cinema sessions during chemotherapy might help cervical cancer patients

  We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07902180

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.