DOT Selfie: A Mobile Technology Intervention to Evaluate Treatment Adherence Among Tuberculosis Patients

NCT04134689 | Completed DMC

• 1 other identifier: PROJECT00000571
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial (RCT) to determine whether Video Observed Treatment (VDOT) using social internet bundle incentives for tuberculosis (TB) is an effective way to improve medication adherence in TB treatment, compared with standard in-person treatment (home-/ community-based). The study will include two study arms: one will receive TB treatment using the standard in-person DOT, and the other through VDOT. All patients (regardless of study arm) will receive daily TB treatment under home- or community-based observation . For patients in the In-person DOT arm, this will be observed and recorded daily by a study nurse. Patients in the VDOT arm however, will be required to record and upload their daily medication intake using a mobile phone App. As a form of incentive, these patients will be rewarded with social internet bundles for every 7 consecutive video uploads. Additionally, they will be sent motivational text messages to encourage treatment compliance. Regardless of study arm, all patients will have 2,4, and 6 monthly clinic visits for clinical and/or sputum assessments. Each patient will also complete a Morisky Medication Adherence Scale (MMAS) questionnaire at treatment completion.

Conditions

Tuberculosis

Keywords

Tuberculosis,; Video Directly Observed Treatment; Directly Observed Treatment; Uganda; Treatment adherence; mHealth

Outcome Measures

Primary Outcomes (1)

• Adherence level

  Calculated as the number of observed doses (by videos or by a DOT worker) divided by the number of prescribed doses over the 6-month treatment period.

  6 months

Secondary Outcomes (3)

• Sputum conversion

  2, 4 and 6 months

• Treatment completion

  6 months

• Clinical response

  2, 4 and 6 months

Study Arms (2)

DOT Selfie Intervention Arm

ACTIVE COMPARATOR

The DOT Selfie Intervention will comprise a smart phone, the VDOT App, a prepaid weekly internet bundle and text message medication reminders. Patients in this arm will receive detailed training (in English or Luganda) on VDOT use prior to starting treatment. Each patient will be required to record and submit daily videos as they self-administer their medication. Patients who successfully submit their videos for seven consecutive days will receive a weekly incentive in the form of social bundles of airtime minutes. A prepaid internet bundle will also be uploaded to each mobile phone weekly to allow for daily video uploads. Additionally, patients will receive text message medication reminders to encourage treatment compliance.

Device: DOT Selfie Intervention

In-person DOT Control Arm.

ACTIVE COMPARATOR

Patients in this arm will be managed according to the usual clinical practice in Uganda i.e. community- or home-based directly observed treatment .Patients in this arm will make prior arrangements with a study nurse to determine a convenient meeting place (e.g. at the patient's work, home etc.) The study nurse will then meet the patient at this location. At each daily meeting, the patient will self-administer the TB drugs as the study nurse directly observes and documents (date, time, drug dosing etc.) At the end of each meeting, the patient and nurse will agree on a convenient meeting place for the next day's dosing. These daily meetings will continue until treatment completion. The study nurse will record patient's medication intake, as well as the time taken to reach the patient, amount of money spent on round-trip transportation, and total amount of time spent during each patient encounter.

Other: In-person DOT

Interventions

DOT Selfie Intervention DEVICE

This comprises a smart phone, the VDOT App, a prepaid weekly internet bundle and text message medication reminders

Also known as: VDOT (Video Observed Treatment)

DOT Selfie Intervention Arm

In-person DOT OTHER

Directly observed TB treatment by a health-worker either in a patient's home or at an agreed upon location within the community.

Also known as: Standard DOT

In-person DOT Control Arm.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for the trial must comply with all of the following at randomization:
• New patients with clinically and/or microbiologically-confirmed TB or those who initiated treatment within one month (the investigators chose to enrol new cases because of lower likelihood of drug-resistant disease),
• Age 18 to 65 years,
• Residents of Kampala within 30 km of study clinic (to facilitate close follow-up),
• Signed informed consent
• Ability to speak and read Luganda or English language.

You may not qualify if:

• \. Previous history of TB, multidrug resistant (MDR) or extensively drug-resistant (XDR) TB 2. Very ill patients 3. A cognitive or physical disability that prevents full participation in VDOT (e.g., vision, hearing, physically challenged, inability to swallow medications).

Sponsors & Collaborators

• University of Georgia: lead
• Makerere University: collaborator

Study Sites (1)

University of Makerere School of Public Health

Kampala, Uganda

Location

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• Sekandi JN, Buregyeya E, Zalwango S, Nakkonde D, Kaggwa P, Quach THT, Asiimwe D, Atuyambe L, Dobbin K. Effectiveness of a Mobile Health Intervention (DOT Selfie) in Increasing Treatment Adherence Monitoring and Support for Patients With Tuberculosis in Uganda: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 16;13:e57991. doi: 10.2196/57991.

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MeSH Terms

Conditions

Tuberculosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Health Behavior; Behavior

Study Officials

• Juliet N Sekandi, MD, MS, DrPH

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is an open-label parallel pilot RCT where adult male and female patients with a new diagnosis of TB (N=144) will be randomized to DOT selfie (n=72) and standard in-person DOT (n=72). Patients in the DOT selfie arm will receive the intervention, which will comprise a smart phone, the VDOT App, a prepaid weekly internet bundle and text message medication reminders. Patients receiving sin-person DOT will serve as the control arm.

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: July 13, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)