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Economic Incentives and vDOT for Latent Tuberculosis Infection

ConditionLatent Tuberculosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

399 Participants
are divided into 3 treatment groups
Group A: Usual CareActive comparator 1 intervention
Group B: Video Directly Observed Therapy aloneActive comparator 2 interventions
Group C: Video Directly Observed Therapy plus Financial IncentivesExperimental treatment 3 interventions

Trial outcomes

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

Time frame
Up to 6 months

Secondary outcomes

1

Adherence measurements

We will assess how well adherence measured by video based observation of therapy correspond to MEMS caps data in the Intervention arm

Time frame
Up to 6 months
2

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 \[80% of prescribed doses taken measured by MEMS caps\])

Time frame
Up to 6 months
3

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.

Time frame
5 years
4

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

Time frame
5 years

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov
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