Real-time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda

Summary

With an estimated 60,000 people diagnosed with TB (Tuberculosis) annually, Uganda holds the 16th position of the 22 countries with highest cases of TB in the world. The Uganda national target of utilizing the DOTS (Direct Observed Treatment Short Course) to successfully treat 85% of patients diagnosed with TB has not been met. Currently, the country only detects 49.6% TB case detection, of which it successfully treats 73%. The DOTS strategy has suffered many socioeconomic challenges, which have resulted into its abandonment by many of the Ugandan hospitals. Poor TB medication adherence greatly attribute to the many cases of TB in Uganda. Causes of non-adherence to TB medication include lack of patient follow-up, patients' lack of transport to go to the clinics to pick up drugs, patients' forgetfulness. There is evidence that real time adherence monitoring linked with SMS reminders and social support notifications can address barriers to sustained ART (antiretroviral therapy) adherence. Such novel interventions addressing TB medication adherence challenges in low resource settings to date are limited. The prevailing SMS-based studies for TB medication adherence report mixed results, do not strategically link interventions with missed doses, and have largely been implemented in developed countries. To date, little is known about the use of real-time adherence monitoring technologies for TB medication adherence in resource-limited settings.

The goal of this research is to investigate the use of real time adherence monitoring technology linked with SMS reminders and notifications for TB medication adherence in rural southwestern Uganda.

The investigator will develop and quantitatively test a real-time adherence monitoring intervention with 60 individuals initiating TB treatment, and 40 social supporters. The investigator will randomize participants (1:1:1) to the following arms: 1) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months.

Conditions

• Tuberculosis

Interventions

OTHER

Daily SMS reminders for TB patients

Daily SMS Medication reminders will be sent to TB patients to remind them take their medications.

OTHER

SMS Notifications for social supporters

SMS Notifications will be sent to social supporters to assit TB patients take their medication

OTHER

Weekly SMS remiders

Weekly SMS reminders sent to TB patients to remind them take medication

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Mbarara University of Science and Technology

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-10

Primary Completion

2021-06-30

Completion

2021-07-31

Countries

• Uganda

Study Locations