Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03547479
Study type Interventional
Source University of Southern California
Contact Joanne Yoong, PhD
Phone +6583327955
Email jyoong@usc.edu
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date December 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06084715 - The INSTITUT Study
Terminated NCT03028129 - Prevention of Tuberculosis in Prisons Phase 4
Not yet recruiting NCT06253715 - Shortened Regimen for Drug-susceptible TB in Children Phase 3
Withdrawn NCT03862248 - Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More Phase 3
Completed NCT03271567 - Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
Completed NCT03199313 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Phase 1
Recruiting NCT04919239 - Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB) Phase 2
Active, not recruiting NCT03251196 - TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
Recruiting NCT05926466 - BTZ-043 Dose Evaluation in Combination and Selection Phase 2
Recruiting NCT04752592 - Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB N/A
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Not yet recruiting NCT04968886 - TuBerculosis Viability Interregional Study and Agreement on Biological Tests
Not yet recruiting NCT04485156 - Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3) Phase 3
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT01364324 - Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Active, not recruiting NCT04179500 - A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers Phase 2
Completed NCT05899400 - A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
Recruiting NCT04938596 - Airborne Preventive Measures to Reduce New TB Infections in Household Contacts N/A
Recruiting NCT05455112 - Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis Phase 2
Completed NCT03044158 - GeneXpert Performance Evaluation for Linkage to Tuberculosis Care N/A