NCT03135366

Self-verification and Support Via Mobile Phones Drastically Improves Tuberculosis Treatment Success in LMIC Settings

Completed NA Last updated 23 July 2019

What this trial tests

NA trial testing Keheala in Tuberculosis in 1,190 participants. Completed in 14 April 2017.

Timeline

4 January 2016

Primary endpoint
31 December 2016

14 April 2017

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,190
Start date	4 January 2016
Primary completion	31 December 2016
Estimated completion	14 April 2017

Drugs / interventions tested

• Keheala
• Standard of Care

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Yale University

Who can join

Eligibility, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Can digital adherence technologies reduce inequity in tuberculosis treatment success? Evidence from a randomised controlled trial.
   Boutilier JJ, Yoeli E, Rathauser J, Owiti P, et al · · 2022 · cited 14× · PMID 36455988 · DOI 10.1136/bmjgh-2022-010512
2. Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial.
   Lewis JJ, Liu X, Zhang Z, Thomas BV, et al · · 2018 · cited 14× · PMID 30045757 · DOI 10.1186/s13063-018-2650-3