What this study is
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.
What's being tested
- Usual Care
Intervention · 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
Intervention · 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
Intervention · 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
- Official title
- Economic Incentives and Video Directly Observed Therapy to Promote Adherence to Latent Tuberculosis Infection
- Sponsor
- Johns Hopkins University
- Conditions
- Latent Tuberculosis
- Enrolling
- 399 people
- Starts
- 2022-02-07
- Est. completion
- 2027-12-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openBaltimore City Health Department, and Baltimore metropolitan area clinics and health departments
Baltimore, Maryland, United States
- Principal Investigator · Contact
Recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00183013
Principal investigator
Maunank Shah, MD, PhD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.