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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134689
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Makerere University
Information provided by (Responsible Party):
Juliet Nabbuye Sekandi, University of Georgia

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.


Condition or disease Intervention/treatment Phase
Tuberculosis Device: DOT Selfie Intervention Other: In-person DOT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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.
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Active Comparator: DOT Selfie Intervention Arm

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
This comprises a smart phone, the VDOT App, a prepaid weekly internet bundle and text message medication reminders
Other Name: VDOT (Video Observed Treatment)

Active Comparator: In-person DOT Control Arm.
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
Directly observed TB treatment by a health-worker either in a patient's home or at an agreed upon location within the community.
Other Name: Standard DOT




Primary Outcome Measures :
  1. Adherence level [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Sputum conversion [ Time Frame: 2, 4 and 6 months ]
    Proportion of patients with sputum conversion to treatment at 2, 4, and 6 months or end of treatment

  2. Treatment completion [ Time Frame: 6 months ]
    Proportion of patients completing their treatment

  3. Clinical response [ Time Frame: 2, 4 and 6 months ]
    Proportion of patients improving clinically (cough, weight gain, night sweats, fever, appetite) at 2, 4, and 6 months or end of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients eligible for the trial must comply with all of the following at randomization:

  1. 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),
  2. Age 18 to 65 years,
  3. Residents of Kampala within 30 km of study clinic (to facilitate close follow-up),
  4. Signed informed consent
  5. Ability to speak and read Luganda or English language.

Exclusion Criteria:

1. 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).

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134689


Contacts
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Contact: Juliet N Sekandi, MD, MS, DrPH (706) 542 -5257 juliet.sekandi@uga.edu
Contact: Esther Buregyeya +256704939242 eburegyeya@musph.ac

Locations
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Uganda
University of Makerere School of Public Health
Kampala, Uganda
Contact: Esther Buregyeya, MD,MPhil,PhD    +256704939242    eburegyeya@musph.ac   
Principal Investigator: Esther Buregyeya, MD,MPhil,PhD         
Sub-Investigator: Lynn M Atuyambe, MPH,PhD         
Sponsors and Collaborators
University of Georgia
Makerere University
Investigators
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Principal Investigator: Juliet N Sekandi, MD, MS, DrPH University of Georgia
Publications:

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Responsible Party: Juliet Nabbuye Sekandi, Assistant Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT04134689    
Other Study ID Numbers: PROJECT00000571
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will be uploaded to the NIH portal of funded projects, in compliance with NIH requirements.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juliet Nabbuye Sekandi, University of Georgia:
Tuberculosis,
Video Directly Observed Treatment
Directly Observed Treatment
Uganda
Treatment adherence
mHealth
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections