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

Sponsor

University of Georgia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04134689

Collaborator

Makerere University (Other)

144

Enrollment

Location

Arms

23.6

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

Eligible patients will be randomised in equal proportions between the DOT Selfie Intervention and In-person DOT Control arms. All patients will self-administer TB drugs daily for 6 months, or as prescribed by their physician. Once recruited, all patients will receive routine education on TB treatment, side-effects and the importance of adherence. They will also receive a baseline survey to collect data on demographics, personal, social and clinical characteristics, cell phone/smartphone ownership and prior experience with use of video camera features. Patients will be informed that regardless of the intervention allocation, they will be required to return to the clinic for study follow up at 2, 4 and 6 months to complete a follow-up interview with study staff (clinical and/ or sputum assessments).

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. The smart phone will be equipped with a camera that supports video recording. Additionally, it will have internet access, and an operating system capable of running downloaded applications. The VDOT App is a free, downloadable, passcode-protected mobile App provided by SureAdhere. It is equipped with video recording features and automatic, encrypted, time-stamped video uploads to a secure server. This enables patients to securely and confidentially document each medication dose taken. The VDOT system has a feature to adapt and personalize text messages either in English or Luganda. These text messages will include reminders for patients to take their medications, lists of common medication side effects and motivational messages to encourage patients to continue taking their medications and report any side effects.

Upon assignment to VDOT intervention arm, patients will receive detailed training (in English or Luganda) on VDOT use, using a detailed training manual provided by SureAdhere. Patients will also be trained on how to lay out each drug on a labelled laminated medication sheet with a space for each drug and take each drug type individually saying either the name of the drug or the color of the pills, size, and the number taken. Participants will be asked to show their mouth is empty by opening their mouth and sticking out their tongue and finally be asked to report any symptoms from a list of key side effects (which will be printed on the reverse of the laminated medication sheet - Appendix j). Any reported or observed side effects will be addressed by study nurses as indicated in Appendix k. Training will include watching of some test videos.

Once training is complete, the study will then begin with patients receiving the intervention (smart phone, the VDOT App, prepaid weekly internet bundle and text message medications reminders). Each patient will be required to record and submit daily videos as they self-administer their medication, when and where it works best for them. For each patient, Day 1 of the study will the mark the day the first dose of TB drugs was self-administered. Patients who successfully submit their videos for seven consecutive days will receive a weekly incentive in the form of social bundles of airtime minutes. Patients will be encouraged to try and maintain full compliance with daily drug regimen through personalized text message reminders such as "Taking your pills will help you get better and keep you from infecting family and friends." They will also be encouraged to report side effects and other related concerns through the VDOT system.

VDOT videos recorded by patients using the SureAdhere App, will be uploaded to 99DOT, a secure server and HIPAA compliant web portal used to review and track patients medication intake videos. These videos will be submitted automatically as soon as the phone is connected to a cellular data network (data plan provided with phone) or wireless network. At the clinic, a trained study nurse will log into the 99DOTs secured system via a tablet or laptop to download, review the patients' daily videos and document adherence according to a pre-specified protocol for VDOT. The nurse will view the date and time stamped videos on 99DOT, to document each medication dose taken. The nurse will thus be able to track missed videos, reported side-effects and follow-up with appropriate support advice to patients using actions specified in the study protocol. The nurse will log the time taken to contact the patient by phone, text, or in person to manage adherence problems or address any issues. VDOT videos will be read by a study nurse/VDOT observer daily during weekdays with weekend videos read on Mondays.

No incentives or travel costs will be provided but patients will be able to make use of study smartphone for e-mails, domestic telephone calls and internet searches (limited data downloads apply). Patients will be expected to return the smartphone to the clinic upon completion of their treatment.

In-person DOT Control Arm:

Patients in this arm will be managed according to usual clinical practice in Uganda. This will require prior arrangements to be made between the study nurse(s) and each patient, for a convenient meeting place (e.g. at the patient's work, home etc.) to be agreed upon. The study nurse will then be required to meet the patient daily at this location. At each daily meeting, the study nurse will provide the prescribed medication and the patient will swallow each TB medication as the study nurse directly observes and documents (date, time, drug dosing etc.) For each patient, Day 1 of the study will the mark the day the first dose of TB drugs was self-administered. Patients will be encouraged by the study nurse to report any side effects experienced, or any other related concerns. The study nurse will also encourage patients to maintain full compliance, by continuing to meet daily to have the nurse directly observe their self-administration of the drug. At the end of each meeting, the patient and nurse will agree on a convenient meeting place for the next day's dosing. The study nurse will record all of these and follow-up with appropriate support advice to manage adherence problems or other issues, using actions specified in the study protocol. The nurse will also log 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.

Study Design

Study Type:

Interventional

Anticipated 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.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.

Actual Study Start Date :

Jul 13, 2020

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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 Names: 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 Names: Standard DOT

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 Names:

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 Names:

Standard DOT

Outcome Measures

Primary Outcome Measures

Adherence level [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

Sputum conversion [2, 4 and 6 months]
Proportion of patients with sputum conversion to treatment at 2, 4, and 6 months or end of treatment
Treatment completion [6 months]
Proportion of patients completing their treatment
Clinical response [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

Previous history of TB, multidrug resistant (MDR) or extensively drug-resistant (XDR) TB
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).