Economic Incentives and vDOT for Latent Tuberculosis Infection

NCT05022862 | Recruiting

• 2 other identifiers: IRB00183013R01AI162888
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

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.

Conditions

Latent Tuberculosis

Keywords

Video Directly Observed Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 6 months

Secondary Outcomes (4)

• Adherence measurements

  Up to 6 months

• Treatment completion (alternative definition)

  Up to 6 months

• Costs of the incentive intervention

  5 years

• Cost-effectiveness of the incentive intervention

  5 years

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Video Directly Observed Therapy alone

ACTIVE COMPARATOR

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)

Behavioral: Usual Care; Behavioral: Video Directly Observed Therapy alone

Video Directly Observed Therapy plus Financial Incentives

EXPERIMENTAL

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.

Behavioral: Usual Care; Behavioral: Video Directly Observed Therapy alone; Behavioral: Video Directly Observed Therapy plus Financial Incentives

Interventions

Usual Care BEHAVIORAL

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.

Usual Care; Video Directly Observed Therapy alone; Video Directly Observed Therapy plus Financial Incentives

Video Directly Observed Therapy alone BEHAVIORAL

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).

Video Directly Observed Therapy alone; Video Directly Observed Therapy plus Financial Incentives

Video Directly Observed Therapy plus Financial Incentives BEHAVIORAL

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.

Video Directly Observed Therapy plus Financial Incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Baltimore City Health Department, and Baltimore metropolitan area clinics and health departments

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Maunank Shah, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

443-287-0401; mshah28@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: February 7, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

US (1)