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

NCT03135366 | Completed

• 1 other identifier: HarvardU
• Study Type: interventional
• Target: 1,190
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tuberculosis

Keywords

Tuberculosis; TB; Adherence; Mobile Health; mHealth; Behavior change; Social and Behavior Change Communication (SBCC); Drug-Resistance; Keheala

Outcome Measures

Primary Outcomes (1)

• Unsuccessful Treatment Outcomes

  The proportion of individuals who failed to successfully complete the treatment.

  One year

Study Arms (2)

Standard of Care (Control)

ACTIVE COMPARATOR

Other: Standard of Care

Keheala Intervention (Treatment)

EXPERIMENTAL

The intervention consisted of a daily request for self-verification of medication adherence, access to a supporter via a chat client, and information about TB.

Behavioral: Keheala

Interventions

Keheala BEHAVIORAL

Keheala Intervention (Treatment)

Standard of Care OTHER

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.

Standard of Care (Control)

Eligibility Criteria

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

You may qualify if:

• Clinically diagnosed with TB by smear microscopy, culture or Gene Xpert.
• Communicate in either Swahili or English.
• Already have access to a mobile phone.

You may not qualify if:

• \- Diagnosed with a drug-resistant strain of TB.

Sponsors & Collaborators

• Yale University: lead
• United States Agency for International Development (USAID): collaborator
• Keheala: collaborator
• MIT's Applied Cooperation Team: collaborator
• Kenya National Tuberculosis, Leprosy and Lung Disease Program: collaborator

Related Publications (25)

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Related Links

• Keheala - A mobile health platform that uses behavioral interventions to improve healthcare access and treatment outcomes.

MeSH Terms

Conditions

Tuberculosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

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: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist and Co-Director of the Applied Cooperation Team

Model Details: We will employ a randomized controlled trial (RCT) with 600 patients included in the treatment group and 600 patients included in the control group. We have selected this methodology for the following reasons: 1. RCTs are the gold-standard for providing evidence-based evaluation of medical interventions, and recommended when feasible. 2. Keheala is a new program, and cannot be studied using existing data. 3. We are working with researchers from Harvard's Program for Evolutionary Dynamics and Yale's Human Cooperation Lab, who have an established record of designing large-scale RCTs in real-world settings such as ours. This sample size was chosen to achieve 80% power in detecting improvements of 7.5% or more in the relevant health outcomes. To do this calculation, we employed Monte Carlo simulations of patient outcomes, based on the Kenyan Ministry of Health's 2013 TB Case Findings Report. Note: The sample size and outcomes were registered in December 2015 with the IRB.

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 1, 2017
• Study Start: January 4, 2016
• Primary Completion: December 31, 2016
• Study Completion: April 14, 2017
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share