Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT05848557
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05848557
Study Brief:
Protocol Section:
NCT05848557