mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 6,000
- Locations
- 1
- Primary Endpoint
- Proportion of women in each arm who complete cervical cancer screening
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
- •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
- •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).
- •CHV participants must be employed by government clinics in Siaya County, and
- •be able to provide informed consent.
- •Does not understand the study purpose and details
- •Is not willing to sign an informed consent
Arms & Interventions
Usual care
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
Counseling, specimen tracking and case management will be facilitated using mSaada.
Intervention: mSaada (Behavioral)
Outcomes
Primary Outcomes
Proportion of women in each arm who complete cervical cancer screening
Time Frame: 1-day
Calculated by dividing the number of women screened by the number of eligible women attending health facilities
Proportion of women in each arm who test HPV-positive and access treatment within 3 months of receiving their results
Time Frame: 1-day
Calculated the number of women treated within 3 months of receiving their results by dividing the number of women who test HPV positive
Difference in women's knowledge level of cervical cancer as measured by a knowledge scale between the arms
Time Frame: 1-day
The knowledge scale has a score range of 0 to 5, where a higher score indicates a higher level of knowledge.
Difference in women risk perception of cervical cancer as measured by a risk perception scale between the arms
Time Frame: 1-day
The Risk Perception Scale has 3 Likert scale questions regarding risk perception.
Difference in Community Health Promoter (CHP) screening self-efficacy, knowledge, usability between the arms
Time Frame: 1-day
Quantitative self-efficacy, knowledge and usability survey with CHPs after participating in the study..
Number of Community Health Volunteers (CHVs) reporting a usability score greater than 60
Time Frame: 1-day
mSaada Usability Survey with a range of 20-100, where a higher score indicates a higher level of acceptability (mean scores \>60 is considered acceptable).
Secondary Outcomes
No secondary outcomes reported