Self-verification and Support Via Mobile Phones Drastically Improves Tuberculosis Treatment Success in LMIC Settings
NCT03135366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1190
Last updated 2019-07-23
Summary
Each year, 10.4 million patients are diagnosed with and 1.8 million people die from Tuberculosis (TB). Despite the availability of highly effective and accessible medications in the developing world where TB is endemic, the 6-18 month treatment regimen is often thwarted as patients fail to comply due to a lack of knowledge about the disease, desire for privacy, and/or stigma avoidance. Inappropriate medication use leading to multi-drug resistant (MDR) TB infects 5% of all TB patients, yet accounts for a significant proportion of all spending. In Kenya, the burden of TB is among the highest in the world with a prevalence rate of 558 cases per 100,000 people. There is a great need for the development of alternative protocols, which reduce the costs of treatment and burden of adherence, and more effectively motivate patients to adhere to the program. A substantial and growing literature in the social sciences demonstrates the potential of behavioral interventions for generating large increases in contributions to public goods.
This 1200 participant, Randomized Controlled Trial (RCT) explores the capacity of Keheala, a feature-phone and Internet-based digital platform that uses Unstructured Supplementary Service Data (USSD) technology, to deliver behavioral interventions for improving treatment adherence, outcomes and quality of life for TB patients in Nairobi, Kenya. Keheala taps into this underutilized potential by developing a powerful, cost-effective platform for better engaging patients' sense of responsibility to their community in order to increase adherence.
Conditions
Interventions
- BEHAVIORAL
-
Keheala
- OTHER
-
Standard of Care
Patients receive medication for a week or two weeks at a time. They are assigned a friend or family member 'supporter' to verify the patient's at-home treatment and instructed to return to the clinic with the patient during medication refills.
Sponsors & Collaborators
-
United States Agency for International Development (USAID)
collaborator FED -
Keheala
collaborator UNKNOWN -
MIT's Applied Cooperation Team
collaborator UNKNOWN -
Kenya National Tuberculosis, Leprosy and Lung Disease Program
collaborator UNKNOWN -
Yale University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-04
- Primary Completion
- 2016-12-31
- Completion
- 2017-04-14
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