vDOT + Financial Incentives for Latent Tuberculosis

Recruiting at 1 trial location

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Isoniazid, Rifapentine, Rifampin

Disqualifiers: Active TB, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

399 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people complete their treatment for latent tuberculosis (a dormant form of TB that can become active). It combines Video Directly Observed Therapy, where patients take their medication while monitored via video, with financial incentives. The trial includes three groups: one receiving usual care, one using video monitoring, and one using both video monitoring and financial rewards. Suitable participants have been diagnosed with latent TB, are starting treatment, and live in the Baltimore area. As an unphased trial, this study provides a unique opportunity to contribute to innovative treatment strategies for latent TB.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be prescribed specific TB treatments to participate.

What prior data suggests that this intervention is safe for promoting treatment completion in latent tuberculosis?

Research has shown that Video Directly Observed Therapy (vDOT) is a safe and effective method for helping people adhere to their tuberculosis (TB) treatment. Studies have found that vDOT is as effective as the traditional method, where patients meet with a nurse or doctor in person. This indicates that people using vDOT are just as likely to complete their TB treatment as those who have face-to-face visits.

Offering financial rewards with vDOT appears to further motivate patients to finish their treatment. No specific safety concerns have been reported with using vDOT or the financial rewards, suggesting that both components of the treatment plan are generally well-received by patients.

Overall, both vDOT and the combination of vDOT with financial rewards are considered safe based on current research. No major side effects or safety issues have been reported, making these options promising for helping people complete their TB treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to boost adherence to latent tuberculosis treatment by using video directly observed therapy (vDOT) and financial incentives. Unlike traditional care, which relies on in-person monitoring, vDOT allows patients to take their medication while being observed via video, providing a more flexible and less intrusive option. The addition of financial incentives is a unique approach aimed at further encouraging patients to stick to their medication schedule by rewarding them for their commitment. This trial hopes to demonstrate that these methods can improve treatment adherence, leading to better health outcomes for individuals with latent tuberculosis.

What evidence suggests that this trial's treatments could be effective for latent tuberculosis?

Research has shown that using Video Directly Observed Therapy (vDOT) with financial incentives can increase treatment completion rates for latent tuberculosis. In this trial, one group of participants will receive vDOT with financial incentives, an affordable method that helps patients take their medication on time without clinic visits. Financial rewards can further motivate patients to adhere to and complete their treatment. Another group will receive only vDOT, which is as effective as traditional methods for monitoring patient adherence. This trial studies whether this combination can improve health outcomes for people with latent tuberculosis. ^{6 7 8 9 10}

Who Is on the Research Team?

Maunank Shah, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in the Baltimore area, diagnosed with latent tuberculosis and prescribed specific treatments (Isoniazid/Rifapentine, Isoniazid/Rifampin, or Rifampin). Participants must speak English/Spanish or a language supported by consent forms. Pregnant women, those under 18, with active TB, or on alternative treatments are excluded.

Inclusion Criteria

I have been diagnosed with latent TB and my doctor agrees I should be treated for it.

I am on a 3-month TB treatment with Isoniazid/Rifapentine or Isoniazid/Rifampin, or a 4-month treatment with Rifampin.

reside in Baltimore metro area

Exclusion Criteria

participant's spoken language does not have a translated long or short consent form

I am under 18 years old.

I have been diagnosed with active tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment for latent tuberculosis using Video Directly Observed Therapy (vDOT) with or without financial incentives

Up to 6 months

Regular video submissions for monitoring

Follow-up

Participants are monitored for treatment completion and adherence using MEMS caps and video observation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Usual Care
• Video Directly Observed Therapy alone
• Video Directly Observed Therapy plus Financial Incentives

Trial Overview The study tests if Video Directly Observed Therapy (vDOT) combined with financial rewards helps people finish their latent tuberculosis treatment better than usual care alone. It's checking whether more patients complete treatment when they're watched via video and paid to stick to their regimen.

How Is the Trial Designed?

Group I: Video Directly Observed Therapy plus Financial Incentives Experimental Treatment 3 Interventions

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.

Group II: Usual Care Active Control 1 Intervention

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.

Group III: Video Directly Observed Therapy alone Active Control 2 Interventions

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)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

Video Directly Observed Therapy (vDOT) for tuberculosis treatment showed comparable medication adherence rates to in-person DOT (94% vs 98%), while allowing for greater flexibility and convenience for patients.

Implementing vDOT resulted in a cost savings of approximately $1391 per patient over a standard 6-month treatment course, making it a potentially more efficient option for TB care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Patient-Centered Care in Tuberculosis Management: A Mixed-Methods Appraisal of Video Directly Observed Therapy. Holzman, SB., Zenilman, A., Shah, M.[2022]

Video directly observed therapy (VDOT) for tuberculosis treatment showed a high treatment completion rate of 96.1%, comparable to 94.6% for traditional directly observed therapy (DOT), indicating that VDOT is as effective as DOT.

VDOT significantly reduced the average time spent per dose observed (16.5 minutes) and costs incurred (￥34.3) compared to DOT (44.1 minutes and ￥71.6), making it a more convenient and cost-effective option for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine Technologies and Tuberculosis Management: A Randomized Controlled Trial. Guo, P., Qiao, W., Sun, Y., et al.[2021]

In a study of 163 TB patients from 2018 to 2020, 58% utilized video directly observed therapy (vDOT), which was found to be more effective than in-person therapy, with 68% of doses verified compared to 54% for in-person DOT.

vDOT was particularly beneficial for younger patients and allowed for greater flexibility in treatment, achieving higher medication adherence while reducing the proportion of self-administered doses during treatment periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world implementation of video-observed therapy in an urban TB program in the United States. Perry, A., Chitnis, A., Chin, A., et al.[2021]

Patients using synchronous video observed treatment (SVOT) for latent tuberculosis infection (LTBI) reported higher satisfaction regarding convenience and privacy compared to conventional in-person directly observed treatment (CDOT), leading to a treatment completion rate of 91.25%.

The SVOT program significantly reduced the likelihood of patients quitting treatment (1.25% in SVOT vs. 12.50% in CDOT), highlighting its effectiveness in improving adherence and suggesting it as a valuable alternative for LTBI management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantage in privacy protection by using synchronous video observed treatment enhances treatment adherence among patients with latent tuberculosis infection. Chen, SH., Wang, I., Hsu, HL., et al.[2020]

Video directly observed therapy (VDOT) for tuberculosis treatment resulted in significantly lower societal costs compared to traditional in-person methods, with VDOT live costing $6.65 and VDOT recorded costing $12.64, while in-person methods ranged from $21.40 to $46.11.

The study analyzed 343 DOT sessions from 225 patients over nearly a year, indicating that VDOT could be a cost-effective alternative, potentially reducing public health expenses during high TB incidence periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost of Tuberculosis Therapy Directly Observed on Video for Health Departments and Patients in New York City; San Francisco, California; and Rhode Island (2017-2018). Beeler Asay, GR., Lam, CK., Stewart, B., et al.[2021]

Asynchronous video directly observed therapy (VDOT) for tuberculosis treatment showed a high median fraction of expected doses observed (FEDO) at 88%, indicating effective treatment adherence among patients in three major US cities.

Patients reported high satisfaction with VDOT, with 97% finding it easy to use and 95% recommending it to others, suggesting that VDOT could be a beneficial alternative to traditional directly observed therapy in urban TB programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of recorded video-observed therapy for anti-tuberculosis treatment. Garfein, RS., Liu, L., Cuevas-Mota, J., et al.[2021]

Video Directly Observed Therapy (vDOT) is an effective alternative to in-person Directly Observed Therapy (DOT) for tuberculosis treatment, showing similar rates of treatment completion and microbiologic resolution.

The CDC now recommends vDOT as an equivalent option to in-person DOT, allowing for more efficient use of resources in TB treatment while ensuring adherence to medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for Use of Video Directly Observed Therapy During Tuberculosis Treatment - United States, 2023. Mangan, JM., Woodruff, RS., Winston, CA., et al.[2023]

In a study involving 226 tuberculosis patients, video-observed therapy (VOT) significantly improved treatment observation rates, with 70% of VOT patients completing 80% of scheduled observations compared to only 31% for directly observed treatment (DOT).

VOT not only proved to be more effective but also offered a more convenient and acceptable method for patients, suggesting it could be a preferable alternative to DOT in various healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. Story, A., Aldridge, RW., Smith, CM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10877938/

Patient perceptions of video directly observed therapy for ... From Holzman [13]: “Our results suggest that vDOT is able to more effectively measure TB treatment adherence, compared with in-person DOT”. “VDOT increased ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11045025/

Asynchronous Video Directly Observed Therapy to Monitor ... Latent tuberculosis infection treatment completion was similar between participants monitored by standard-of-care directly observed therapy and asynchronous ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405579424000585

Investigating the efficacy of integrating video-directly ... VDOT was found to be non-inferior to DOT as implemented by the Florida TB program for the monitoring of treatment adherence in patients with tuberculosis. In ...

4. cdc.gov cdc.gov/high-impact-prevention/php/case-studies/directly-observed-therapy-tb.html

Electronic Directly Observed Therapy for Active TB Disease Electronic directly observed therapy is an effective alternative to traditional DOT methods of treating TB disease.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05022862

Economic Incentives and vDOT for Latent Tuberculosis ... Directly observed therapy (DOT) administered via video (Video-DOT, with case-management) has been shown to be effective at monitoring treatment in active TB, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38665171/

Asynchronous Video Directly Observed Therapy to Monitor ... VDOT has been shown to be a cost-effective alternative to in-person directly observed therapy (DOT) for monitoring adherence to treatment for tuberculosis ...

7. cdc.gov cdc.gov/tb/hcp/treatment/vdot.html

Treating Tuberculosis Using Video Directly Observed ... Through vDOT, TB programs observe a patient ingesting TB medication through either live (synchronous) or recorded (asynchronous) videos.

8. vdh.virginia.gov vdh.virginia.gov/content/uploads/sites/175/2020/02/Recommendations-for-Video-Enhanced-Therapy_2020-final_.pdf

Recommendations for Video Enhanced Therapy This document provides recommendations for using VET for carefully selected clients under care for tuberculosis disease. Reporting the total number of DOT doses ...

9. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(18)32993-3/fulltext

Smartphone-enabled video-observed versus directly ... Here, we report results from a randomised trial comparing treatment observation with asynchronous VOT versus in-person DOT for supporting ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1876034120304147

Advantage in privacy protection by using synchronous ... (A) Satisfaction toward directly observed treatment (DOT) program stratified by either the participants finished or quit the latent tuberculosis infection ...