Tuberculosis, Pulmonary Clinical Trial
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.
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.
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