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NCT Number: NCT05848557

mSaada: A Mobile Health Tool

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.

Recruiting

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms mHealth

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Kisumu, Kenya

Location status: Recruiting

Location contact

Elizabeth Bukusi, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mSaada

Behavioral

mSaada is an integrated digital platform to support patients, community health volunteers (CHVs), providers and health systems in an HPV-based cervical cancer screening strategy. mSaada is hosted on an open-source platform (Dimagi, CommCare) as a mobile health application to support patient data collection, protocol support and counseling aids. mSaada will include an education module, patient and specimen tracking, screening reminders, and messaging functionality.

Primary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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..

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Huchko, MD, MPH

CONTACT

[email protected]

919 613 5062

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 8, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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