Recruiting

Economic Incentives

Sponsor:

Johns Hopkins University

Code:

NCT05022862

Conditions

Latent Tuberculosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual Care

Video Directly Observed Therapy alone

Video Directly Observed Therapy plus Financial Incentives

Study Details

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

Study ID

NCT05022862

Start date

Feb 7, 2022

Status verified date

Apr, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

399 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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)

experimental: 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.

Interventions

Usual Care

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.

Video Directly Observed Therapy alone

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 plus Financial Incentives

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

  • Treatment Completion [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Principal Investigator

443-287-0401mshah28@jhmi.edu

Locations

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

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Video Directly Observed Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-04.