CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,190 enrolled
Drug / intervention
Keheala +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03135366
NCT03135366N/ACompleted

Delivering Community-based Interventions and Disease Management Tools Across a Digital Platform in Order to Increase TB Treatment Adherence in LMICs

Yale University·interventional·Posted May 1, 2017·Updated Jul 23, 2019

In Brief

A clinical study evaluating Keheala and Standard of Care for Tuberculosis. Completed, enrolled 1,190 participants.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 1, 2017
Enrollment StartJan 4, 2016
Primary CompletionDec 31, 2016
Study CompletionApr 14, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.2 years ago

Interventions

Kehealabehavioral

Standard of Careother

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.