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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

Must not have

younger than 18 years old

diagnosed with active TB

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have been diagnosed with active tuberculosis.

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I am on a different treatment plan for latent TB.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment Completion

Secondary study objectives

Adherence measurements

Cost-effectiveness of the incentive intervention

Costs of the incentive intervention

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 4Eligibility criteria met