Behavior Change and Digital Health Interventions for Improved TB Treatment Outcomes

Summary

Each year, 10.4 million patients are diagnosed with and 1.7 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. Successful TB treatment is critical for reducing transmission, the selection of drug-resistant strains and treatment costs. Mobile health interventions promise to increase treatment success, especially in regions where directly observed treatment (DOT) is impractical. The most promising interventions attempted thus far employ a combination of SMS reminders and medication monitors. However, there is relatively little high-quality evidence on their impact, and what evidence there is shows mixed success.

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. Keheala, a feature-phone and Internet-based digital platform that uses Unstructured Supplementary Service Data (USSD) technology to register a patient's self-verification of medication adherence alongside support and motivation, based on proven techniques from the behavioral sciences, was shown in a 1,200-patient randomized controlled trial (RCT) to reduce the unsuccessful TB treatment outcomes in Kenya by two-thirds compared to the standard of care protocol.

This 15,500 patient RCT will compare Keheala's scalability, cost-effectiveness and social impact to alternative interventions across diverse regions of Kenya.

Conditions

• Tuberculosis
• Adherence, Patient
• Adherence, Medication
• Drug-resistant Tuberculosis

Interventions

BEHAVIORAL

Keheala Mobile Health Platform and Behavioral Interventions

Keheala is a mobile health company that delivers powerful behavior change interventions from the social sciences across basic feature phones or smartphones to address the nonmedical drivers of disease, which exist away from health facilities. The intervention includes automated reminders, remote self-verification of doses, accessible TB information and individualized follow-up.

BEHAVIORAL

Social and Behavior Change Communication (SBCC)

Automated reminders, remote self-verification of doses and accessible TB information. All interactions are behaviorally-informed but do not include regular adherence support/follow-up from study team members as the Keheala intervention does.

BEHAVIORAL

SMS Reminder

Patients receive a single daily SMS message to take their medication.

OTHER

Standard of Care

The standard-of-care protocol in Kenya includes diagnosis, the provision of medications - typically administered for a 1-2 week period at which point patients are expected to return to the clinical site - periodic on-the-ground follow-up by community health volunteers (CHVs)(at the discretion of local clinicians and CHVs) and nutritional support, as is sometimes provided.

Sponsors & Collaborators

• Keheala

  collaborator UNKNOWN

• United States Agency for International Development (USAID)

  collaborator FED

• Kenya National Tuberculosis, Leprosy and Lung Disease Program

  collaborator UNKNOWN

• McGill University

  collaborator OTHER

• Massachusetts Institute of Technology

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-13

Primary Completion

2020-05-31

Completion

2021-07-30

Countries

• Kenya

Study Locations