Latent TuberculosisNCT05022862
Economic Incentives and vDOT for Latent Tuberculosis Infection
A study testing Video Directly Observed Therapy alone and Video Directly Observed Therapy plus Financial Incentives in people with Latent Tuberculosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- Video Directly Observed Therapy alone and Video Directly Observed Therapy plus Financial Incentives
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baltimore City Health Department, and Baltimore metropolitan area clinics and health departments
Baltimore, Maryland, 21205
Principal Investigator
About this study
Official title: Economic Incentives and Video Directly Observed Therapy to Promote Adherence to Latent Tuberculosis Infection
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.
Read the 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.
- Conditions
- Latent Tuberculosis
- Being tested
- Usual Care, Video Directly Observed Therapy alone, Video Directly Observed Therapy plus Financial Incentives
- Keywords
- Video Directly Observed Therapy
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
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 aloneBehavioural
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 IncentivesBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. Receives: Behavioral: Usual Care; Behavioral: Video Directly Observed Therapy alone; Behavioral: Video Directly Observed Therapy plus Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Secondary outcomes (4)
Adherence measurements
We will assess how well adherence measured by video based observation of therapy correspond to MEMS caps data in the Intervention arm
Measured: Up to 6 months
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])
Measured: Up to 6 months
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.
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start7 Feb 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maunank Shah, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022862
- Sponsor's protocol ID
- IRB00183013
- Other IDs
- R01AI162888
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Incentives and Video Directly Observed Therapy to Promote Adherence to Latent Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT05022862
- Acronym / sponsor ID
- IRB00183013
- Conditions
- Latent Tuberculosis
- Keywords
- Video Directly Observed Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 399 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareParticipants 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. |
| Video Directly Observed Therapy alone | Active comparator | Behavioral: Usual Care, Behavioral: Video Directly Observed Therapy aloneParticipants 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) |
| Video Directly Observed Therapy plus Financial Incentives | Experimental | Behavioral: Usual Care, Behavioral: Video Directly Observed Therapy alone, Behavioral: Video Directly Observed Therapy plus Financial IncentivesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareMedication 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. | Behavioural | Usual Care, Video Directly Observed Therapy alone, Video Directly Observed Therapy plus Financial Incentives |
| Video Directly Observed Therapy aloneUsual 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). | Behavioural | Video Directly Observed Therapy alone, Video Directly Observed Therapy plus Financial Incentives |
| Video Directly Observed Therapy plus Financial IncentivesUsual 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. | Behavioural | Video Directly Observed Therapy plus Financial Incentives |
Primary outcome
Treatment Completion
Time frame: Up to 6 months
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
4 secondary outcomes
Adherence measurements
Time frame: Up to 6 months
Treatment completion (alternative definition)
Time frame: Up to 6 months
Costs of the incentive intervention
Time frame: 5 years
Cost-effectiveness of the incentive intervention
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maunank Shah, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Directly Observed Therapy alone and Video Directly Observed Therapy plus Financial Incentives in people with Latent Tuberculosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (443-287-0401, mshah28@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Completion (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.