search
Back to results

Economic Incentives and vDOT for Latent Tuberculosis Infection

Primary Purpose

Latent Tuberculosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Video Directly Observed Therapy alone
Video Directly Observed Therapy plus Financial Incentives
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Latent Tuberculosis focused on measuring Video Directly Observed Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baltimore City Health Department, and Baltimore metropolitan area clinics and health departmentsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Usual Care

Video Directly Observed Therapy alone

Video Directly Observed Therapy plus Financial Incentives

Arm Description

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.

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)

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.

Outcomes

Primary Outcome Measures

Treatment Completion
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

Adherence measurements
We will assess how well adherence measured by video based observation of therapy correspond to MEMS caps data in the Intervention arm
Treatment completion (alternative definition)
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
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.
Cost-effectiveness of the incentive intervention
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

Full Information

First Posted
August 20, 2021
Last Updated
February 9, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT05022862
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
April 15, 2026 (Anticipated)
Study Completion Date
October 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
Video Directly Observed Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
399 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Video Directly Observed Therapy alone
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Video Directly Observed Therapy plus Financial Incentives
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Medication is dispensed to participant at each visit in 30-60 day supplies by Baltimore City Health Department (BCHD) nurses. For study participants, medication dispensation will occur in medication bottles with MEMS Caps, supplied by the study.
Intervention Type
Behavioral
Intervention Name(s)
Video Directly Observed Therapy alone
Intervention Description
Usual care plus Video-DOT using the emocha platform, a HIPAA compliant commercial platform for video based DOT. The app allows a secure/encrypted video recording to be taken as the participant ingests the medication. Electronic text reminders will be sent to the participant on the smart phone when it is time to take the medication. The participant will record a video of the pill ingestion process. Study staff will verify each video to confirm the video shows the correct person and that the pill was ingested appropriately (according to standardized approach involving visualization of the pills, ingestion and observation of an empty mouth after ingestion).
Intervention Type
Behavioral
Intervention Name(s)
Video Directly Observed Therapy plus Financial Incentives
Intervention Description
Usual care plus video-DOT and financial incentives contingent on adherence verified by video DOT. The amount of the financial incentive that can be earned for future verified doses decreases after a missed dose (video). The amount of the financial incentives increases incrementally back to baseline amount after verification of medication ingestion according to the prescribed schedule for several consecutive doses.
Primary Outcome Measure Information:
Title
Treatment Completion
Description
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
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Adherence measurements
Description
We will assess how well adherence measured by video based observation of therapy correspond to MEMS caps data in the Intervention arm
Time Frame
Up to 6 months
Title
Treatment completion (alternative definition)
Description
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])
Time Frame
Up to 6 months
Title
Costs of the incentive intervention
Description
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.
Time Frame
5 years
Title
Cost-effectiveness of the incentive intervention
Description
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
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Principal Investigator
Phone
443-287-0401
Email
mshah28@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maunank Shah, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore City Health Department, and Baltimore metropolitan area clinics and health departments
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Economic Incentives and vDOT for Latent Tuberculosis Infection

We'll reach out to this number within 24 hrs