mSaada: A Mobile Health Tool

Not Applicable

Suspended

• Conditions: mHealth; Cervical Cancer; HPV
• Interventions: Behavioral: mSaada

• Registration Number: NCT05848557
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-08
• Study Start: 2024-02-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mSaada platform	mSaada	Counseling, specimen tracking and case management will be facilitated using mSaada.

Primary Outcome Measures

Name	Time	Method
Change in risk perception of cervical cancer as measured by a risk perception scale between the arms	baseline, 6 months, 12 months	The Risk Perception Scale has a score range of 0 to 5, where a higher score indicates a higher perception of risk.
Community Health Volunteer (CHV) screening self-efficacy	18-months	Quantitative self-efficacy surveys with CHVs at the end of the c-RCT to compare self-efficacy across study arms. HPV Cervical Cancer Stigma Scale (HCCSS). Stigma mean scores are 0-3 with 3 representing a higher level of stigma.
Proportion of women in each arm who test HPV-positive and access treatment within 3 months of receiving their results	18-months
Number of Community Health Volunteers (CHVs) reporting a usability score greater than 60	Approximately 6 months	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).
Proportion of women in each arm who complete cervical cancer screening	18-months	Calculated by dividing the number of women screened by the number of women aged 30-65 living in each community assigned to the arm as determined by the door-to-door enumeration.
Change in knowledge level of cervical cancer as measured by a knowledge scale between the arms	baseline, 6 months, 12 months	The knowledge scale has a score range of 0 to 5, where a higher score indicates a higher level of knowledge.

Trial Locations

Locations (1)

Kenya Medical Research Institute; 🇰🇪 Kisumu, Kenya