Clinical trial NCT05848557: mSaada: A Mobile Health Tool
Official title: mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cervical Cancer
HPV
mHealth
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-08
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

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.

Primary outcomes:
measure: Number of Community Health Volunteers (CHVs) reporting a usability score greater than 60
timeFrame: Approximately 6 months
measure: Proportion of women in each arm who complete cervical cancer screening
timeFrame: 18-months
measure: Proportion of women in each arm who test HPV-positive and access treatment within 3 months of receiving their results
timeFrame: 18-months
measure: Change in knowledge level of cervical cancer as measured by a knowledge scale between the arms
timeFrame: baseline, 6 months, 12 months
measure: Change in risk perception of cervical cancer as measured by a risk perception scale between the arms
timeFrame: baseline, 6 months, 12 months
measure: Community Health Volunteer (CHV) screening self-efficacy
timeFrame: 18-months
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
References: