Mobile Health Intervention for Active Tuberculosis

Not Applicable

Completed

Interventions: Behavioral: Mobile phone TB treatment support app plus usual care
Other: Usual care

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.

Arm && Interventions

Group	Intervention	Description
Mobile phone TB treatment support app	Usual care	Daily use of the mobile phone TB treatment support app plus usual care. Participants will be asked to self-report daily TB medication administration, side-effects when applicable, and complete the direct adherence paper-based test randomly on 3-4 days of the week during the intensive treatment phase (first two months) and then 1-2 times per week during the maintenance phase (about month 3-6).
Mobile phone TB treatment support app	Mobile phone TB treatment support app plus usual care	Daily use of the mobile phone TB treatment support app plus usual care. Participants will be asked to self-report daily TB medication administration, side-effects when applicable, and complete the direct adherence paper-based test randomly on 3-4 days of the week during the intensive treatment phase (first two months) and then 1-2 times per week during the maintenance phase (about month 3-6).
Usual care	Usual care	Usual care consists of outpatient treatment management from the time of diagnosis (unless symptoms are severe and hospitalization is recommended), routine clinical and laboratory tests, and follow-up appointments determined by the clinician. In general, patients receive 1-2 month's supply of medication and are asked to return monthly for follow-up.

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.