Tuberculosis Clinical Trial
Official title:
Delivering Community-based Interventions and Disease Management Tools Across a Digital Platform in Order to Increase TB Treatment Adherence in LMICs
NCT number | NCT03135366 |
Other study ID # | HarvardU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 4, 2016 |
Est. completion date | April 14, 2017 |
Verified date | July 2019 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1190 |
Est. completion date | April 14, 2017 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Clinically diagnosed with TB by smear microscopy, culture or Gene Xpert. - Communicate in either Swahili or English. - Already have access to a mobile phone. Exclusion Criteria: - Diagnosed with a drug-resistant strain of TB. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yale University | Keheala, Kenya National Tuberculosis, Leprosy and Lung Disease Program, MIT's Applied Cooperation Team, United States Agency for International Development (USAID) |
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* Note: There are 25 references in all — Click here to view all references
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