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

Trial Summary

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 data supports the effectiveness of the treatment Video Directly Observed Therapy (vDOT) with Financial Incentives for Latent Tuberculosis?

Research shows that Video Directly Observed Therapy (vDOT) is as effective as in-person observation for tuberculosis treatment, with high rates of treatment completion and patient satisfaction. It is also more convenient and cost-effective, making it a promising alternative to traditional methods. ^{1 2 3 4 5}

Is Video Directly Observed Therapy (vDOT) safe for humans?

The research on Video Directly Observed Therapy (vDOT) for tuberculosis treatment shows it is generally safe for humans, as it is recommended as an alternative to in-person therapy and has been successfully implemented in various settings without safety concerns. ^{1 3 4 5 6}

How does the vDOT with financial incentives treatment for latent tuberculosis differ from other treatments?

The vDOT with financial incentives treatment for latent tuberculosis is unique because it uses video technology to allow patients to take their medication remotely while being observed, which is more convenient and less costly than traditional in-person observation. Additionally, offering financial incentives can further encourage patients to adhere to their treatment schedule, potentially improving treatment outcomes. ^{1 3 5 7 8}

What is the purpose of 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.

Research Team

Maunank Shah, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Advancing Patient-Centered Care in Tuberculosis Management: A Mixed-Methods Appraisal of Video Directly Observed Therapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Telemedicine Technologies and Tuberculosis Management: A Randomized Controlled Trial. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Evaluation of recorded video-observed therapy for anti-tuberculosis treatment. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Recommendations for Use of Video Directly Observed Therapy During Tuberculosis Treatment - United States, 2023. [2023]

6. France pubmed.ncbi.nlm.nih.gov

Real-world implementation of video-observed therapy in an urban TB program in the United States. [2021]

7. United States 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). [2021]

8. England pubmed.ncbi.nlm.nih.gov

Advantage in privacy protection by using synchronous video observed treatment enhances treatment adherence among patients with latent tuberculosis infection. [2020]