Tuberculosis Clinical Trial
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.
Verified date | July 2023 |
Source | University of Georgia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | April 30, 2023 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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). - |
Country | Name | City | State |
---|---|---|---|
Uganda | University of Makerere School of Public Health | Kampala |
Lead Sponsor | Collaborator |
---|---|
University of Georgia | Makerere University |
Uganda,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Sputum conversion | Proportion of patients with sputum conversion to treatment at 2, 4, and 6 months or end of treatment | 2, 4 and 6 months | |
Secondary | Treatment completion | Proportion of patients completing their treatment | 6 months | |
Secondary | Clinical response | Proportion of patients improving clinically (cough, weight gain, night sweats, fever, appetite) at 2, 4, and 6 months or end of treatment | 2, 4 and 6 months |
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