vDOT + Financial Incentives for Latent Tuberculosis
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must be taking: Isoniazid, Rifapentine, Rifampin
Disqualifiers: Active TB, Pregnancy, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
23456How 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.
24578Eligibility 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 am 18 years old or older.
I speak English, Spanish, or another language supported by the Johns Hopkins Medicine IRB.
I have been diagnosed with latent TB and my doctor agrees I should be treated for it.
+2 more
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.
+2 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Video Directly Observed Therapy plus Financial IncentivesExperimental Treatment3 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 CareActive Control1 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 aloneActive Control2 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baltimore City Health Department, and Baltimore metropolitan area clinics and health departmentsBaltimore, MD
Baltimore City Health DepartmentBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
Telemedicine Technologies and Tuberculosis Management: A Randomized Controlled Trial. [2021]Background: Since 1990s, directly observed therapy (DOT) has been the standard-of-care for tuberculosis (TB), although it is cumbersome for patients as well as service providers. For raising implementation, an alternative delivery method with good potential is telehealth. The current study assessed the clinical and cost benefit of video directly observed therapy (VDOT), compared with DOT service. Methods: This prospective randomized controlled trial randomized adults with bacteriologically confirmed pulmonary TB to the intervention (VDOT) or control (DOT) group. The observation data for DOT and VDOT were updated by observers until the end of treatment or until the study concluded. The primary outcome was the TB treatment result defined by the World Health Organization (WHO) as used in some other studies conducted in North India and England as follows: good (cured and treatment completed), poor (death and failure), relocation, and lost to follow-up and others (refused, adverse reaction, not a TB case). Other secondary measures were treatment adherence, patient satisfaction, time and cost spent on DOT or VDOT. Results: On analyzing the results from 405 participants from each study arm, we found very high rates of treatment completion (96.1% with VDOT vs. 94.6% with DOT). The two observed treatment methods had no statistical differences, and all could accomplish their tasks well. Average time per dose observed was 16.5 min (standard deviation [SD] 12.1) for VDOT, while 44.1 min (SD 3.7) for DOT (including travel time), p < 0.01. And the cost incurred on VDOT was ￥34.3 (SD 3.8) manmo, which was statistically lower compared with ￥71.6 (SD 49.7) manmo in the DOT group, p < 0.01. Most of the patients in both groups believed that observed treatment (VDOT/DOT) helped them not to miss doses (185 [93.0%] vs. 171 [86.7%], p = 0.057). Patients in the VDOT group had a better experience compared with those in DOT group. They thought the way was convenient and comfortable (191 [96.0%] vs. 111 [56.6%], p < 0.001), would choose the original way if necessary (191 [96.0%] vs. 113 [57.7%], p < 0.001), and would recommend the method to other patients (191 [96.0%] vs. 113 [57.7%], p < 0.001). Conclusion: The study showed that VDOT enabled meaningful direct observation for TB patients through mobile devices, which was highly acceptable to patients and health care providers. It also saved time and is a cost-effective method, enabling the use of the saved money to other much-needed areas for TB.
Evaluation of recorded video-observed therapy for anti-tuberculosis treatment. [2021]BACKGROUND: Asynchronous video directly observed therapy (VDOT) may reduce tuberculosis (TB) program costs and the burden on patients. We compared VDOT performance across three cities in the United States, each of which have TB incidence rates above the national average.METHODS: Patients aged ≥18 years who are currently receiving directly observed anti-TB treatment were invited to use VDOT for monitoring treatment. Pre- and post-treatment interviews and medical records were used to assess site differences in treatment adherence and patient characteristics and perceptions.RESULTS: Participants were enrolled in New York City, NY (n = 48), San Diego, CA (n = 52) and San Francisco, CA, USA (n = 49). Overall, the mean age was 41 years (range 18-87); 59% were male; most were Asian (45%) or Hispanic/Latino (30%); and 77% were foreign-born. The median fraction of expected doses observed (FEDO) was 88% (IQR 76-96). At follow-up, 97% thought VDOT was "very or somewhat easy to use" and 95% would recommend VDOT to other TB patients. Age, race/ethnicity, annual income, and country of birth differed by city (P < 0.05), but FEDO and VDOT perceptions did not.CONCLUSIONS: TB programs in three large US cities observed a high FEDO using VDOT while minimizing staff time and travel. Similar findings across sites support VDOT adoption by other large, urban TB programs.
Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. [2021]Directly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but it is inconvenient for patients and service providers. Video-observed therapy (VOT) has been conditionally recommended by WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT.
Advancing Patient-Centered Care in Tuberculosis Management: A Mixed-Methods Appraisal of Video Directly Observed Therapy. [2022]Directly observed therapy (DOT) remains an integral component of treatment support and adherence monitoring in tuberculosis care. In-person DOT is resource intensive and often burdensome for patients. Video DOT (vDOT) has been proposed as an alternative to increase treatment flexibility and better meet patient-specific needs.
Recommendations for Use of Video Directly Observed Therapy During Tuberculosis Treatment - United States, 2023. [2023]U.S. clinical practice guidelines recommend directly observed therapy (DOT) as the standard of care for tuberculosis (TB) treatment (1). DOT, during which a health care worker observes a patient ingesting the TB medications, has typically been conducted in person. Video DOT (vDOT) uses video-enabled devices to facilitate remote interactions between patients and health care workers to promote medication adherence and clinical monitoring. Published systematic reviews, a published meta-analysis, and a literature search through 2022 demonstrate that vDOT is associated with a higher proportion of medication doses being observed and similar proportions of cases with treatment completion and microbiologic resolution when compared with in-person DOT (2-5). Based on this evidence, CDC has updated the recommendation for DOT during TB treatment to include vDOT as an equivalent alternative to in-person DOT. vDOT can assist health department TB programs meet the U.S. standard of care for patients undergoing TB treatment, while using resources efficiently.
Real-world implementation of video-observed therapy in an urban TB program in the United States. [2021]BACKGROUND: Video directly observed therapy (vDOT) was introduced to increase flexibility and meet patient-specific needs for TB treatment. This study aimed to assess the reach and effectiveness of vDOT for TB treatment under routine conditions in Alameda County, CA, USA, a busy, urban setting, from 2018 to 2020.METHODS: We prospectively evaluated routinely collected data to estimate 1) reach (proportion of patients initiated on vDOT vs. in-person DOT); and 2) effectiveness (proportion of prescribed doses with verified administration by vDOT vs. in-person DOT).RESULTS: Among 163 TB patients, 94 (58%) utilized vDOT during treatment, of whom 54 (57%) received exclusively vDOT. Individuals receiving vDOT were on average younger than those receiving in-person therapy (46 vs. 61 years; P < 0.001). The median time to vDOT initiation was 2.2 weeks (IQR 1.1-10.0); patients were monitored for a median of 27.0 weeks (IQR 24.6-31.9). vDOT led to higher proportions of verified prescribed doses than in-person DOT (68% vs. 54%; P < 0.001). Unobserved self-administration occurred for all patients on weekends based on clinic instructions, but a larger proportion of doses were self-administered during periods of in-person DOT than of vDOT (45% vs. 24%; P < 0.001).CONCLUSION: A TB program successfully maintained vDOT, reaching the majority of patients and achieving greater medication verification than in-person DOT.
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]Objectives. To assess costs of video and traditional in-person directly observed therapy (DOT) for tuberculosis (TB) treatment to health departments and patients in New York City, Rhode Island, and San Francisco, California.Methods. We collected health department costs for video DOT (VDOT; live and recorded), and in-person DOT (field- and clinic-based). Time-motion surveys estimated provider time and cost. A separate survey collected patient costs. We used a regression model to estimate cost by DOT type.Results. Between August 2017 and June 2018, 343 DOT sessions were captured from 225 patients; 87 completed a survey. Patient costs were lowest for VDOT live ($1.01) and highest for clinic DOT ($34.53). The societal (health department + patient) costs of VDOT live and recorded ($6.65 and $12.64, respectively) were less than field and clinic DOT ($21.40 and $46.11, respectively). VDOT recorded health department cost was not statistically different from field DOT cost in Rhode Island.Conclusions. Among the 4 different modalities, both types of VDOT were associated with lower societal costs when compared with traditional forms of DOT.Public Health Implications. VDOT was associated with lower costs from the societal perspective and may reduce public health costs when TB incidence is high.
Advantage in privacy protection by using synchronous video observed treatment enhances treatment adherence among patients with latent tuberculosis infection. [2020]Treatment of latent tuberculosis infection (LTBI) is an important strategy for active disease prevention. Conventional in-person DOT (CDOT) programs are challenged by patient dissatisfaction over problems of convenience and privacy. The present study assessed satisfaction to DOT program and treatment adherence of synchronous video observed treatment (SVOT) programs from patients' perspectives.