Tuberculosis, PulmonaryNCT03547479
VDOT and Mobile Payments in Cambodia
A study testing VDOT and VDOT + mobile money in people with Tuberculosis, Pulmonary, run by University of Southern California.
Trial summary
This project proposes to develop and pilot a novel smart phone-based intervention to improve tuberculosis (TB) treatment adherence in Cambodia, which integrates video-enabled Directly Observed Treatment (vDOT) with an automated rewards system that transfers mobile money and eventual phone ownership to compliant… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- VDOT and VDOT + mobile money
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PROPOSED PATIENT INCLUSION CRITERIA
- Age 21 years or more;
- Diagnosis of TB at healthcare facility (Clinical symptoms consistent with pulmonary TB and sputum test positive);
- Willing to comply with the study procedures;
- Resident at a fixed address within feasible travelling distance to the site and likely to remain resident there for the foreseeable future;
- Willing to have directly observed therapy;
- Willing and able to provide written informed consent in English/Khmer.
PROPOSED PATIENT EXCLUSION CRITERIA
- Extra-pulmonary TB or suspected rifampicin resistance;
- Underlying serious chronic diseases (such as liver or kidney disease, active malignancy, poorly-controlled diabetes);
- History of myocardial infarction, congestive cardiac failure, cardiac arrhythmias or family history of Long QT Syndrome;
- Current alcohol or drug abuse;
- Pregnancy;
- Inability to take oral medication or known allergy to one or more of the study drugs.
- Any other significant condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial or lead to poor compliance with study visits and protocol requirements; -
About this study
Official title: Combined Phone Based Video DOT and Mobile Payments for TB Treatment in Cambodia
This project proposes to develop and pilot a novel smart phone-based intervention to improve tuberculosis (TB) treatment adherence in Cambodia, which integrates video-enabled Directly Observed Treatment (vDOT) with an automated rewards system that transfers mobile money and eventual phone ownership to compliant patients. The results will be of immediate relevance to Cambodia's National TB Control Program (which is partnering with us), the major implementing field partner Operation ASHA (a leading TB-focused nonprofit organization), as well as other TB control programs seeking new alternatives to improving adherence, especially where traditional DOT may be infeasible or costly, and outside the area of TB where adherence to treatment is critical, such as HIV, and will provide key insights into mobile health (mHealth) programs in a setting relevant to other developing countries. The project will involve building new capacity in Cambodia for behavioral research, mHealth,and communications through hands-on training for study staff in-country, and through general training sessions for internal and external stakeholders.
Read the detailed description
Tuberculosis (TB) remains one of the leading causes of death from infectious disease worldwide, and treatment adherence a persistent challenge. This is particularly pressing in high-burden, low-resource settings such as Cambodia, where approximately two-thirds of people carry the TB bacterium, one of the highest rates in the world. The investigators propose to develop and pilot a novel smart phone-based intervention to improve TB treatment adherence, integrating video-enabled Directly Observed Therapy (VDOT) with transfers of mobile money and phone ownership to compliant patients. This intervention aims to directly address two of the key barriers to TB treatment adherence in low resource settings where DOT is costly or impractical. First, the video component has the potential to substitute direct in-person observation with time-stamped videos of patients taking their medication. Second, the proposed intervention incorporates incentives to patients for treatment adherence and equipment preservation in the form of mobile money and eventual phone ownership upon treatment completion.
In partnership with the National Tuberculosis Program (NTP), the investigators will assess the feasibility of this intervention and of a future randomized study in two districts of Cambodia. First, the team will extend and adapt an existing platform for video-enabled medication monitoring (Mobile Interactive Supervised Therapy (MIST)) to incorporate mobile cash payments conditional upon compliance. Outstanding technical and usability issues with the platform will be identified and addressed by conducting an initial 1-month test of the intervention with 10 TB patients. Finally, the investigators will conduct an 8-month demonstration study among 50 households in our study locations to assess the acceptability, implementation, and potential for scale up of the intervention. We also aim to assess the practicalities and challenges of a future randomized controlled effectiveness and cost-effectiveness trial.
To the best of our knowledge, this study is the first to examine a mHealth intervention for TB that integrates both adherence monitoring and patient incentives into a single platform. The results will be of immediate relevance to the NTP as well as other TB control programs seeking new alternatives to improving adherence, especially where traditional DOT may be infeasible or costly. These results will also be of interest outside the area of TB where adherence to treatment is critical, such as HIV. More generally, the study will provide key insights into mHealth programs in a setting relevant to other developing countries. This project will involve building new capacity in Cambodia for behavioral research, mHealth, and communications through training to the study personnel and general training on conducting TB and/or mHealth research to study partners and other stakeholders in the country.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- VDOT, VDOT + mobile money
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDOTBehavioural
In VDOT, reminder notifications are sent x minutes prior to the scheduled pill time, and continue every y minutes until the user sends a video of themselves taking their pill via the app. Instructions will be provided in Khmer. The web system has an administrator component whereby a healthcare provider can log in via the Internet to monitor and validate all the videos received that day, and reasons for non-submission.
VDOT + mobile moneyBehavioural
The VDOT intervention above will be paired with financial incentives in the form of mobile payments in one of the experimental arms.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receive current standard of care (DOTS) |
| VDOT only | Experimental | Participants receive daily DOTS treatment with video-enabled mobile monitoring, but also maintain regular supervisory checks Receives: Behavioral: VDOT |
| VDOT + mobile money incentives | Experimental | Participants receive daily DOTS treatment with video-enabled mobile monitoring supplemented with mobile money incentives, but also maintain regular supervisory checks Receives: Behavioral: VDOT + mobile money |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: % patients correctly using the system
% patients correctly using the system without phone theft, breakages or discrepancies in incentive distribution
Measured: 6 months
Secondary outcomes (4)
Missed treatment
Any missed treatment for 10 subsequent days or more
Measured: 6 months
Compliance
Number of pills taken relative to total prescribed
Measured: 6 months
Treatment default
Missed treatment for 2 subsequent months or more
Measured: 6 months
Cure
Sputum smear-conversion at month 5 and 8
Measured: 5 and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study startMay 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: The PI is no longer at the University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design consists of (a) 4 qualitative focus groups (b) a pretest of 10 patient (c) a pilot randomised study of 60 patients and (d) interviews of stakeholders including healthcare professionals and policymakers
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Operation ASHA, National University of Singapore, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Michelle Cullen, University of Southern California
- Investigators
- Joanne Yoong, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547479
- Sponsor's protocol ID
- TW010592-01
- Status last verified
- Apr 2024
- First submitted
- 22 May 2018
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Phone Based Video DOT and Mobile Payments for TB Treatment in Cambodia
- ClinicalTrials.gov ID
- NCT03547479
- Acronym / sponsor ID
- TW010592-01
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI is no longer at the University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Operation ASHA, National University of Singapore, London School of Hygiene and Tropical Medicine
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Jun 2018 (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.
This project proposes to develop and pilot a novel smart phone-based intervention to improve tuberculosis (TB) treatment adherence in Cambodia, which integrates video-enabled Directly Observed Treatment (vDOT) with an automated rewards system that transfers mobile money and eventual phone ownership to compliant patients. The results will be of immediate relevance to Cambodia's National TB Control Program (which is partnering with us), the major implementing field partner Operation ASHA (a leading TB-focused nonprofit organization), as well as other TB control programs seeking new alternatives to improving adherence, especially where traditional DOT may be infeasible or costly, and outside the area of TB where adherence to treatment is critical, such as HIV, and will provide key insights into mobile health (mHealth) programs in a setting relevant to other developing countries. The project will involve building new capacity in Cambodia for behavioral research, mHealth,and communications through hands-on training for study staff in-country, and through general training sessions for internal and external stakeholders.
Detailed description
Tuberculosis (TB) remains one of the leading causes of death from infectious disease worldwide, and treatment adherence a persistent challenge. This is particularly pressing in high-burden, low-resource settings such as Cambodia, where approximately two-thirds of people carry the TB bacterium, one of the highest rates in the world. The investigators propose to develop and pilot a novel smart phone-based intervention to improve TB treatment adherence, integrating video-enabled Directly Observed Therapy (VDOT) with transfers of mobile money and phone ownership to compliant patients. This intervention aims to directly address two of the key barriers to TB treatment adherence in low resource settings where DOT is costly or impractical. First, the video component has the potential to substitute direct in-person observation with time-stamped videos of patients taking their medication. Second, the proposed intervention incorporates incentives to patients for treatment adherence and equipment preservation in the form of mobile money and eventual phone ownership upon treatment completion.
In partnership with the National Tuberculosis Program (NTP), the investigators will assess the feasibility of this intervention and of a future randomized study in two districts of Cambodia. First, the team will extend and adapt an existing platform for video-enabled medication monitoring (Mobile Interactive Supervised Therapy (MIST)) to incorporate mobile cash payments conditional upon compliance. Outstanding technical and usability issues with the platform will be identified and addressed by conducting an initial 1-month test of the intervention with 10 TB patients. Finally, the investigators will conduct an 8-month demonstration study among 50 households in our study locations to assess the acceptability, implementation, and potential for scale up of the intervention. We also aim to assess the practicalities and challenges of a future randomized controlled effectiveness and cost-effectiveness trial.
To the best of our knowledge, this study is the first to examine a mHealth intervention for TB that integrates both adherence monitoring and patient incentives into a single platform. The results will be of immediate relevance to the NTP as well as other TB control programs seeking new alternatives to improving adherence, especially where traditional DOT may be infeasible or costly. These results will also be of interest outside the area of TB where adherence to treatment is critical, such as HIV. More generally, the study will provide key insights into mHealth programs in a setting relevant to other developing countries. This project will involve building new capacity in Cambodia for behavioral research, mHealth, and communications through training to the study personnel and general training on conducting TB and/or mHealth research to study partners and other stakeholders in the country.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study design consists of (a) 4 qualitative focus groups (b) a pretest of 10 patient (c) a pilot randomised study of 60 patients and (d) interviews of stakeholders including healthcare professionals and policymakers
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive current standard of care (DOTS) |
| VDOT only | Experimental | Behavioral: VDOTParticipants receive daily DOTS treatment with video-enabled mobile monitoring, but also maintain regular supervisory checks |
| VDOT + mobile money incentives | Experimental | Behavioral: VDOT + mobile moneyParticipants receive daily DOTS treatment with video-enabled mobile monitoring supplemented with mobile money incentives, but also maintain regular supervisory checks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| VDOTIn VDOT, reminder notifications are sent x minutes prior to the scheduled pill time, and continue every y minutes until the user sends a video of themselves taking their pill via the app. Instructions will be provided in Khmer. The web system has an administrator component whereby a healthcare provider can log in via the Internet to monitor and validate all the videos received that day, and reasons for non-submission. | Behavioural | VDOT only |
| VDOT + mobile moneyThe VDOT intervention above will be paired with financial incentives in the form of mobile payments in one of the experimental arms. | Behavioural | VDOT + mobile money incentives |
Primary outcome
Feasibility: % patients correctly using the system
Time frame: 6 months
% patients correctly using the system without phone theft, breakages or discrepancies in incentive distribution
4 secondary outcomes
Missed treatment
Time frame: 6 months
Compliance
Time frame: 6 months
Treatment default
Time frame: 6 months
Cure
Time frame: 5 and 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joanne Yoong principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing VDOT and VDOT + mobile money in people with Tuberculosis, Pulmonary, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: % patients correctly using the system (time frame: 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 5 Apr 2024.