CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
DOT Selfie Intervention +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04134689
NCT04134689N/ACompleted

DOT Selfie: A Mobile Health Intervention With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: A Randomized Control Trial.

University of Georgia·interventional·Posted Oct 22, 2019·Updated Jul 25, 2023

In Brief

A clinical study evaluating DOT Selfie Intervention and In-person DOT for Tuberculosis. Completed, enrolled 144 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesUganda
CollaboratorsMakerere University

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 22, 2019
Enrollment StartJul 13, 2020
Primary CompletionMar 31, 2022
Study CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.7 years ago

Interventions

DOT Selfie Interventiondevice

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

In-person DOTother

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