Clinical trial NCT03547479: VDOT and Mobile Payments in Cambodia
Official title: Combined Phone Based Video DOT and Mobile Payments for TB Treatment in Cambodia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tuberculosis, Pulmonary
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Operation ASHA
name: National University of Singapore
name: London School of Hygiene and Tropical Medicine
First posted: 2018-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: PROPOSED PATIENT INCLUSION CRITERIA

1. Age 21 years or more;
2. Diagnosis of TB at healthcare facility (Clinical symptoms consistent with pulmonary TB and sputum test positive);
3. Willing to comply with the study procedures;
4. Resident at a fixed address within feasible travelling distance to the site and likely to remain resident there for the foreseeable future;
5. Willing to have directly observed therapy;
6. Willing and able to provide written informed consent in English/Khmer.

PROPOSED PATIENT EXCLUSION CRITERIA

1. Extra-pulmonary TB or suspected rifampicin resistance;
2. Underlying serious chronic diseases (such as liver or kidney disease, active malignancy, poorly-controlled diabetes);
3. History of myocardial infarction, congestive cardiac failure, cardiac arrhythmias or family history of Long QT Syndrome;
4. Current alcohol or drug abuse;
5. Pregnancy;
6. Inability to take oral medication or known allergy to one or more of the study drugs.
7. 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;

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Primary outcomes:
measure: Feasibility: % patients correctly using the system
timeFrame: 6 months
Secondary outcomes:
measure: Missed treatment
timeFrame: 6 months
measure: Compliance
timeFrame: 6 months
measure: Treatment default
timeFrame: 6 months
measure: Cure
timeFrame: 5 and 8 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Joanne Yoong
role: PRINCIPAL_INVESTIGATOR
References: