Clinical trial NCT05022862: Economic Incentives and vDOT for Latent Tuberculosis Infection
Official title: Economic Incentives and Video Directly Observed Therapy to Promote Adherence to Latent Tuberculosis Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Latent Tuberculosis
Keywords: Video Directly Observed Therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-08-26
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Treatment Completion
timeFrame: Up to 6 months
Secondary outcomes:
measure: Adherence measurements
timeFrame: Up to 6 months
measure: Treatment completion (alternative definition)
timeFrame: Up to 6 months
measure: Costs of the incentive intervention
timeFrame: 5 years
measure: Cost-effectiveness of the incentive intervention
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Health Department, and Baltimore metropolitan area clinics and health departments
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Maunank Shah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: