Mobile Health Intervention for Active Tuberculosis

Not Applicable

Completed

Brief Summary: The purpose of this study is to evaluate and further refine a mobile support tool for patients receiving treatment for active tuberculosis. Half of participants will receive support and monitoring using a mobile phone software application and usual care, while the other half will receive usual care.

Detailed Description: Tuberculosis (TB) remains a top ten leading cause of death globally despite it being a largely curable disease. New effective treatment supervision strategies are needed particularly in low-resource high TB burden settings and a potential solution is in the hands of nearly every patient - a mobile phone. Modern modular design mobile phone software applications ("apps") hold great promise to address this unmet need.

Current technologies allows for rapid design modification based on end user needs, implementation of native operating system (e.g., Android) versions for users with inconsistent internet access, and the integration of the patients' experiences with electronic health records using industry standards. Apps can perform multiple functions (e.g., automated reminders, symptom tracking, secure messaging, multi-media education). To date, few TB related apps have focused on patients as users, and none support patient engagement in self-management of their care or direct adherence monitoring. The research objectives are to understand end user needs and other stakeholder needs to build, refine, and pilot test an app to support patients self-administering treatment for active TB.

Recruitment & Eligibility

Inclusion Criteria

Subject is starting TB treatment for the first time
Subject has no known TB drug resistance
Subject is HIV negative (self-reported or documented)
Subject owns or has regular access to a mobile phone that can access the Internet and is able to operate the mobile phone to communicate or have someone able to assist.

Exclusion Criteria

Severely ill (i.e., requiring hospitalization)
Reside in the same household with another study participant
History of known drug resistance and HIV co-infection because their care is managed separately and the treatment regimens and duration differ.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Success	6 months	Treatment outcomes will be measured using standard definitions set by the World Health Organization (WHO) Standards of TB treatment. Treatment success based on WHO definitions: completed (without bacteriological confirmation) or cured (negative sputum smear at 6 months and at least once prior to 6 months)). Other treatment outcomes include: failed (sputum smear positive at 5 months or later), died, defaulted (treatment interruption for ≥ 2 months), lost to follow-up (diagnosed, treatment outcome not documented), or transferred out (transferred to another reporting unit and treatment outcome is unknown).

Secondary Outcome Measures

Name	Time	Method
Engagement: Average Number of Days Participants Reported Through the App	6 months	Level of engagement using the app measured by the average number of days reporting treatment adherence over 180 days of treatment.

Locations (1): Hospital Dr. Antonio A. Cetrángolo
🇦🇷
Vicente López, Province Of Buenos Aires, Argentina
Hospital Dr. Antonio A. Cetrángolo
🇦🇷Vicente López, Province Of Buenos Aires, Argentina