Economic Incentives and vDOT for Latent Tuberculosis Infection

Not Applicable

Recruiting

• Conditions: Latent Tuberculosis
• Interventions: Behavioral: Usual Care; Behavioral: Video Directly Observed Therapy alone; Behavioral: Video Directly Observed Therapy plus Financial Incentives

• Registration Number: NCT05022862
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to evaluate a novel and scalable intervention that combines Video Directly Observed Therapy (vDOT) and financial incentives to promote completion of treatment for latent tuberculosis. Adult participants who are initiating treatment for latent tuberculosis will be recruited from the Baltimore City Health Department. The primary hypothesis is that the incentive intervention will increase the percentage of participants that complete the treatment for latent tuberculosis above the completion rates of participants receiving usual care.

Detailed Description

Identifying and treating individuals with latent tuberculosis (TB) (LTBI) is a key strategy to achieve the goal of TB elimination in the US but there are many challenges to achieving this goal. In Baltimore, where this research will be conducted, prior studies suggest 35% of non-US--born individuals may have latent TB. Individuals experiencing homelessness have also been found to be at higher risk for TB infection. However, socioeconomic factors such as poverty, access to care, health literacy, and language or cultural barriers present obstacles to treatment. Treatment for latent TB is rarely a priority for patients with many other competing needs. The length of treatment spans many months, and preliminary data shows that less than half will complete prescribed treatment. To date there are limited interventions shown to be effective in increasing adherence to LTBI therapy. Directly observed therapy (DOT) administered via video (Video-DOT, with case-management) has been shown to be effective at monitoring treatment in active TB, but there is limited data when applied to LTBI. Interventions that provide incentives to patients when they meet required therapeutic goals have been demonstrated extraordinarily effective in promoting therapeutic behavior change in diverse populations.

The goal of this randomized trial is to evaluate two adherence interventions ( Video DOT or Video DOT plus financial incentives) versus Usual Care to promote completion of treatment for latent TB among those found eligible and are prescribed short course therapy (isoniazid+Rifampin(3HR), Isoniazid+rifapentine(3HP), or Rifampin alone(4R)) for LTBI care.

The primary assessment of adherence will be treatment completion which is defined as taking 80% of the prescribed doses of medication, as determined by Medication Event Monitoring System (MEMS) caps (i.e., 10 of 12 doses for participants prescribed weekly doses of rifapentine and isoniazid; 96 of 120 doses for participants prescribed daily doses of rifampin; 67 of 84 doses of daily isoniazid and rifampin

Video directly observed therapy (video-DOT) will use the Electronic Mobile Comprehensive Health Application (emocha) platform. This system provides a HIPAA compliant approach for remote DOT combined with data collection that optimizes TB case management. The Video DOT system is comprised of a smart phone/tablet application used by patients, and a web-based dashboard used by the TB clinic. The patient-side application (app) reminds patients to take their medications on a schedule specified by the clinician. For those randomized to the Video-DOT plus incentives arm, additional financial incentives (provided in real-time) are delivered contingent on verification of medication ingestion by video observation.

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Study Start: 2022-02-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-04-15
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

• 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

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Exclusion Criteria

• younger than 18 years old
• diagnosed with active TB
• prescribed an alternative treatment regimen for latent TB
• pregnant women (as determined by non-study directed clinical evaluation; BCHD performs urine pregnancy testing on women of child bearing age when indicated)
• participant's spoken language does not have a translated long or short consent form

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	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 alone	Video Directly Observed Therapy alone	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)
Video Directly Observed Therapy alone	Usual Care	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)
Video Directly Observed Therapy plus Financial Incentives	Video Directly Observed Therapy alone	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.
Video Directly Observed Therapy plus Financial Incentives	Usual Care	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.
Video Directly Observed Therapy plus Financial Incentives	Video Directly Observed Therapy plus Financial Incentives	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.

Primary Outcome Measures

Name	Time	Method
Treatment Completion	Up to 6 months	The primary outcome measure, completion of treatment for latent TB, will be assessed for all participants through MEMS caps. A participant will be considered to have completed treatment for study purposes if he/she takes 80% of the prescribed doses of medication, as determined by MEMS caps (i.e., 10 of 12 doses for participants prescribed weekly doses of rifapentine and isoniazid; 96 of 120 doses for participants prescribed daily doses of rifampin; 67 of 84 doses of daily isoniazid and rifampin

Secondary Outcome Measures

Name	Time	Method
Treatment completion (alternative definition)	Up to 6 months	We will assess treatment completion using video observed therapy (video verification of ingestion) as an alternative measure of adherence in the intervention arms (i.e. comparing completion between video DOT arm, (80% of prescribed doses taken, and defined by accepted videos\] and Usual care \[80% of prescribed doses taken measured by MEMS caps\])
Costs of the incentive intervention	5 years	Assess the costs of the incentive intervention. To estimate the costs of the interventions and standard of care, we will utilize an ingredients approach (i.e. micro-costing) in which costs are determined based on unit prices and quantities used. The costs of administering the different components of video-DOT and the Incentives Interventions, and the Usual Care will be based on a combination of direct observations, project records, and clinic invoices.
Adherence measurements	Up to 6 months	We will assess how well adherence measured by video based observation of therapy correspond to MEMS caps data in the Intervention arm
Cost-effectiveness of the incentive intervention	5 years	We will utilize a decision-analytic model to evaluate and report the cost-effectiveness of the intervention, reported as the incremental cost-effectiveness ratio comparing the interventions to usual care, measured against currently accepted willingness to pay thresholds

Trial Locations

Locations (1)

Baltimore City Health Department, and Baltimore metropolitan area clinics and health departments; 🇺🇸 Baltimore, Maryland, United States