Usual Care for Latent Tuberculosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Baltimore City Health Department, Baltimore, MD
Latent Tuberculosis+1 More
Usual Care - Behavioral
Eligibility
18+
All Sexes
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Study Summary

Economic Incentives and vDOT for Latent Tuberculosis Infection

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Eligible Conditions

  • Latent Tuberculosis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Usual Care will improve 1 primary outcome and 4 secondary outcomes in patients with Latent Tuberculosis. Measurement will happen over the course of Up to 6 months.

5 years
Cost-effectiveness of the incentive intervention
Costs of the incentive intervention
Up to 6 months
Adherence measurements
Treatment Completion
Treatment completion (alternative definition)

Trial Safety

Trial Design

3 Treatment Groups

Usual Care
1 of 3
Video Directly Observed Therapy alone
1 of 3
Video Directly Observed Therapy plus Financial Incentives
1 of 3
Active Control
Experimental Treatment

This trial requires 399 total participants across 3 different treatment groups

This trial involves 3 different treatments. Usual Care is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Video Directly Observed Therapy plus Financial IncentivesParticipants 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.
Usual Care
Behavioral
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.
Video Directly Observed Therapy aloneParticipants 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
2018
Completed Phase 4
~7710

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

Baltimore City Health Department - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years old or older
diagnosed with latent TB and determined to be appropriate for latent TB treatment by participants clinicians
reside in Baltimore metro area
speaks English or Spanish, or a language for which there is a short form available via the Johns Hopkins Medicine Institutional Review Board
prescribed 3 months Isoniazid/Rifapentine, prescribed 3 months Isoniazid/Rifampin, or 4 months Rifampin

Patient Q&A Section

What are common treatments for latent tuberculosis?

"A major obstacle to treatment of latent tuberculosis is the lack of an effective drug regimen in combination with reliable tests to monitor treatment. Current treatment regimens, such as monthly short courses of rifampicin and pyrazinamide, have poor treatment outcomes, but a more effective approach is to target treatment directly to people with TB disease and to develop novel drugs against dormant M. tuberculosis." - Anonymous Online Contributor

Unverified Answer

What causes latent tuberculosis?

"The exact cause of latent tuberculosis is not well known. It occurs when the bacilli that cause tuberculosis get trapped in the lymph nodes or lymphatics for years after infection. However, it is not clear why some individuals get latent while others do not. It is possible that different genes make some people more likely to develop either the active or latent forms of disease. On the other hand the risk of getting tuberculosis depends largely on environmental factors such as where an individual lives and where they spend most of their time." - Anonymous Online Contributor

Unverified Answer

How many people get latent tuberculosis a year in the United States?

"There is an alarming number of individuals new or formerly treated for tuberculosis and who have never received treatment. A high rate of these individuals has not been diagnosed or treated. A screening program of patients diagnosed with tuberculosis may help identify undetected new cases of tuberculosis that can be treated." - Anonymous Online Contributor

Unverified Answer

What are the signs of latent tuberculosis?

"The main clinical symptoms of LTBI included erythema induratum perpetuum, erythema nodosum, and a skin disease resembling leprosy. Patients with a positive tuberculin skin test, but who lacked clinical and histopathological evidence of tuberculosis, usually do well without treatment. However, such patients have a considerable risk of developing active tuberculosis at any time, and should therefore be treated as high-risk individuals with the most effective antituberculous medications." - Anonymous Online Contributor

Unverified Answer

What is latent tuberculosis?

"In addition to its obvious consequences for health and human dignity, TB can conceal or masquerade itself as more common ailments including heart disease and high blood pressure. The disease should be considered as a serious public health concern and preventive measures taken." - Anonymous Online Contributor

Unverified Answer

Can latent tuberculosis be cured?

"Data from a recent study, as reported in the press following the publication of its initial results in August 2012, shows that patients with active tuberculosis, regardless of their localization at admission and their treatment history, can clear latent tuberculosis infection. Furthermore, patients with a favorable prognosis (mortality was less than 1% with successful treatment) experienced good recovery from active disease." - Anonymous Online Contributor

Unverified Answer

Is video directly observed therapy plus financial incentives typically used in combination with any other treatments?

"These data suggest that a significant proportion of patients are not treated at all with medications or DOTS. Despite this, DOTS remains the most widely used strategy for treating tuberculosis. Although VDOT appears to be more expensive, it offers an important advantage of providing patients access to treatment." - Anonymous Online Contributor

Unverified Answer

Does latent tuberculosis run in families?

"Results from a recent clinical trial support the concept of a genetic component to disease susceptibility in families of patients with TB, and suggest that the disease-producing agents of TB may have a role in the regulation of immune functions." - Anonymous Online Contributor

Unverified Answer

What does video directly observed therapy plus financial incentives usually treat?

"In most instances, VADT+ FIT+ provides similar health outcomes to conventional care. Nonetheless, a randomized trial of VADT+ FIT+ among patients with M. tuberculosis-associated disease would help us more fully understand the value and risks of VADT+ FIT compared to TST+ referrals to public health tuberculosis programs in this setting." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving video directly observed therapy plus financial incentives?

"In South Korea, we find no evidence of this practice being widely used. Some of these trials did not use VDOT. Future research is needed to determine how frequently this technique is being used outside of South Korea." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of latent tuberculosis?

"It is more common for individuals to acquire latent tuberculosis due to their exposure to other people's secretions rather than environmental exposure. The transmission is commonly from people with active tuberculosis. The exact cause of latent tuberculosis cases is unknown. Doctors recommend that all people with Latent tuberculosis be treated every two weeks until latent tuberculosis is no longer contagious (4 weeks) to prevent or reduce chances of re-transmission. To find the exact cause of latent tuberculosis, visit the Power site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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