VDOT and Mobile Payments in Cambodia

Not Applicable

Withdrawn

• Conditions: Tuberculosis, Pulmonary
• Interventions: Behavioral: VDOT + mobile money; Behavioral: VDOT

• Registration Number: NCT03547479
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-06
• Study Start: 2019-05
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VDOT + mobile money incentives	VDOT + mobile money	Participants receive daily DOTS treatment with video-enabled mobile monitoring supplemented with mobile money incentives, but also maintain regular supervisory checks
VDOT only	VDOT	Participants receive daily DOTS treatment with video-enabled mobile monitoring, but also maintain regular supervisory checks

Primary Outcome Measures

Name	Time	Method
Feasibility: % patients correctly using the system	6 months	% patients correctly using the system without phone theft, breakages or discrepancies in incentive distribution

Secondary Outcome Measures

Name	Time	Method
Cure	5 and 8 months	Sputum smear-conversion at month 5 and 8
Missed treatment	6 months	Any missed treatment for 10 subsequent days or more
Compliance	6 months	Number of pills taken relative to total prescribed
Treatment default	6 months	Missed treatment for 2 subsequent months or more