Economic Incentives and vDOT for Latent Tuberculosis Infection

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05022862
Status
Recruiting
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Conditions

  • Latent Tuberculosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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 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.

Study Details

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.

Key Dates

Start date
Feb 7, 2022
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
399 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Treatment Completion [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baltimore City Health Department, and Baltimore metropolitan area clinics and health departmentsBaltimoreMaryland21205
Principal Investigator

Find similar trials in Baltimore, MD

By research site
Baltimore City Health Department, and Baltimore metropolitan area clinics and health departments· Baltimore, MD

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