Behavior Change and Digital Health Interventions for Improved TB Treatment Outcomes

NCT04119375 | Completed

• 1 other identifier: Keheala Stage 2
• Study Type: interventional
• Target: 16,146
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Keheala; tuberculosis; adherence; behavior change; mobile health; mhealth; behavioral interventions; patient-centered care

Outcome Measures

Primary Outcomes (2)

• Unsuccessful Health Outcomes

  Composite metric of died, failed and loss to follow up outcomes.

  From date of randomization until the date of a documented treatment outcome, assessed up to 24 months after study enrollment date.

• Deaths

  A TB patient who dies for any reason during the course of treatment.

  From date of randomization until the date of a documented treatment outcome, assessed up to 24 months after study enrollment date.

Secondary Outcomes (1)

• Adherence

  Assessed daily from date of randomization until the date of a documented treatment outcome, up to 24 months after study enrollment date.

Other Outcomes (9)

• Unsuccessful treatment outcomes amongst multi-drug resistant patients.

  From date of randomization until the date of a documented treatment outcome, assessed up to 24 months after study enrollment date.

• Deaths amongst multi-drug resistant patients.

  From date of randomization until the date of a documented treatment outcome, assessed up to 24 months after study enrollment date.

• Survey responses: 1. Have you missed any additional time from work, school, household duties, or other activities because of your TB illness?

  Patients are surveyed one week after their randomization date and once more three months after a health outcome has been entered. Assessed up to 27 months after study enrollment date.

Study Arms (4)

Control

ACTIVE COMPARATOR

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.

Other: Standard of Care

SMS-Only

EXPERIMENTAL

Patients in the SMS reminder group will receive a single, medication reminder SMS once daily at their indicated treatment time. The reminder message will read "Please take the medication on time" consistent with messages used by Liu and colleagues (2015).

Behavioral: SMS Reminder

Social Behavior Change Communication (SBCC)

EXPERIMENTAL

Patients assigned to this intervention will have access to a mobile health platform that provides reminders, information and motivation - designed with behaviorally-informed strategies - but no follow up support from a human beyond what the standard of care allows. Further details of the intervention can be found in the study protocol section. The intervention will send automated motivational messages and regular prompts for patients to self-verify their adherence. Messages include reminders about the community benefits of adherence, and a measure of the patient's adherence performance relative to successful peers. Clinicians can view individual or aggregate patient histories to leverage limited resources.

Behavioral: Social and Behavior Change Communication (SBCC)

Keheala

EXPERIMENTAL

An automated system sends motivational messages and regular prompts for patients to self-verify their adherence. Messages include reminders about the community benefits of adherence, and a measure of the patient's adherence performance relative to successful peers. If a patient fails to correctly verify her compliance, the system automatically alerts the support-sponsor, who then intervenes with a supportive dialogue. Clinicians can view individual or aggregate patient histories to leverage limited resources. Further details of the intervention can be found in the study protocol section.

Behavioral: Keheala Mobile Health Platform and Behavioral Interventions

Interventions

Keheala Mobile Health Platform and Behavioral Interventions BEHAVIORAL

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.

Keheala

Social and Behavior Change Communication (SBCC) BEHAVIORAL

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.

Social Behavior Change Communication (SBCC)

SMS Reminder BEHAVIORAL

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

SMS-Only

Standard of Care OTHER

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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- subjects who do not consent to participate.
• Note that subjects are randomized into intervention groups or the control group after providing consent.
• Subjects who are enrolled but are found, retrospectively to not meet the criteria (i.e. they had less than two months remaining when they were enrolled) will be monitored as part of a, fifth "non-eligible" group, and will not count towards the enrollment targets.

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead
• Keheala: collaborator
• United States Agency for International Development (USAID): collaborator
• Kenya National Tuberculosis, Leprosy and Lung Disease Program: collaborator
• McGill University: collaborator

Study Sites (1)

Kenya National TB Program

Nairobi, Kenya

Location

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  RESULT

MeSH Terms

Conditions

Tuberculosis; Patient Compliance; Medication Adherence; Tuberculosis, Multidrug-Resistant

Interventions

Behavior Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Clinic staff are not explicitly informed of an individual's assignment, but it is not possible to mask them. It is also not possible to mask the study team members.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will employ a four-sided stratified RCT with 15,500 patients in total: a) 2,000 patients in the standard-of-care control group; b) 1,500 patients in the SMS intervention group; c) 6,000 patients in the SBCC intervention group (SBCC); 4) 6,000 patients in the Keheala intervention group.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: October 8, 2019
• Study Start: April 13, 2018
• Primary Completion: May 31, 2020
• Study Completion: July 30, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)