VDOT and Mobile Payments in Cambodia

NCT03547479 | Withdrawn

• 1 other identifier: TW010592-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Feasibility: % patients correctly using the system

  % patients correctly using the system without phone theft, breakages or discrepancies in incentive distribution

  6 months

Secondary Outcomes (4)

• Missed treatment

  6 months

• Compliance

  6 months

• Treatment default

  6 months

• Cure

  5 and 8 months

Study Arms (3)

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

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

Behavioral: VDOT + mobile money

Interventions

VDOT BEHAVIORAL

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 only

VDOT + mobile money BEHAVIORAL

The VDOT intervention above will be paired with financial incentives in the form of mobile payments in one of the experimental arms.

VDOT + mobile money incentives

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Southern California: lead
• Operation ASHA: collaborator
• National University of Singapore: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joanne Yoong

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Compliance Manager

Model Details: 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

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 6, 2018
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share