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vDOT + Financial Incentives for Latent Tuberculosis
N/A
Recruiting
Led By Maunank Shah, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years old or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing whether adding financial incentives to video-monitored treatment for latent TB will increase the number of people who finish treatment.
Who is the study for?
This trial is for adults over 18 living in the Baltimore area, diagnosed with latent tuberculosis and prescribed specific treatments (Isoniazid/Rifapentine, Isoniazid/Rifampin, or Rifampin). Participants must speak English/Spanish or a language supported by consent forms. Pregnant women, those under 18, with active TB, or on alternative treatments are excluded.Check my eligibility
What is being tested?
The study tests if Video Directly Observed Therapy (vDOT) combined with financial rewards helps people finish their latent tuberculosis treatment better than usual care alone. It's checking whether more patients complete treatment when they're watched via video and paid to stick to their regimen.See study design
What are the potential side effects?
While not explicitly listed for this trial, common side effects of the medications used (like Isoniazid and Rifampin) include liver problems, nausea, fever, rash or numbness in hands/feet. Financial incentives typically don't have medical side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment Completion
Secondary outcome measures
Adherence measurements
Cost-effectiveness of the incentive intervention
Costs of the incentive intervention
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Video Directly Observed Therapy plus Financial IncentivesExperimental Treatment3 Interventions
Participants in this group will receive the same treatments and education provided to Usual Care Control participants, as well as treatment viewed by video DOT. This arm will also earn financial contingent incentives. Participants will receive incentive payments when a submitted video is monitored by a staff member and deemed valid. If a participant fails to submit a video on a medication day or if a submitted video is deemed invalid (i.e., not the correct person or no appropriate ingestion of medication), the participant will not receive the scheduled incentive amount that day and the daily incentive value will be decreased.The participant will have opportunities the next day to again resume adherence. After taking the medication again for one week, participants will earn a reduced incentive until they adhere to the medication schedule for a week.
Group II: Usual CareActive Control1 Intervention
Participants will receive routine (non-study directed) medical care for latent tuberculosis infection according to published guidelines, including medication, nurse case management, Tuberculosis health education, and toxicity assessments.
Group III: Video Directly Observed Therapy aloneActive Control2 Interventions
Participants in this group will receive the same treatments and education provided to Usual Care Control participants, however treatment will be viewed by video directly observed therapy (video-DOT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,822,765 Total Patients Enrolled
8 Trials studying Latent Tuberculosis
87,268 Patients Enrolled for Latent Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,070 Total Patients Enrolled
9 Trials studying Latent Tuberculosis
8,998 Patients Enrolled for Latent Tuberculosis
Maunank Shah, MD, PhDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
306 Total Patients Enrolled
1 Trials studying Latent Tuberculosis
168 Patients Enrolled for Latent Tuberculosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I speak English, Spanish, or another language supported by the Johns Hopkins Medicine IRB.I am under 18 years old.I have been diagnosed with active tuberculosis.I have been diagnosed with latent TB and my doctor agrees I should be treated for it.I am on a 3-month TB treatment with Isoniazid/Rifapentine or Isoniazid/Rifampin, or a 4-month treatment with Rifampin.I am on a different treatment plan for latent TB.
Research Study Groups:
This trial has the following groups:- Group 1: Video Directly Observed Therapy plus Financial Incentives
- Group 2: Usual Care
- Group 3: Video Directly Observed Therapy alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for new participants to join this investigation?
"Affirmative. As detailed on clinicaltrials.gov, this study is currently recruiting participants to take part in the trial which was first posted on February 7th 2022 and recently updated on February 8th 2022. 399 patients need to be recruited from 1 location across the nation."
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