Using SMS Reminders, Phone Calls and Money Incentives to Enhance Linkage to Care of Presumptive TB Patients in Uganda (MILEAGE4TB)

• ClinicalTrials.gov Identifier: NCT05964842
• Recruitment Status: Recruiting
• First Posted: July 28, 2023
• Last Update Posted: February 9, 2024
• Sponsor: Makerere University
• Information provided by (Responsible Party): Makerere University

Tracking Information

• First Submitted Date: June 4, 2023
• First Posted Date: July 28, 2023
• Last Update Posted Date: February 9, 2024
• Actual Study Start Date: August 14, 2023
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 19, 2023)

• Completion of TB diagnosis [ Time Frame: 30 days (from being identified as presumptive TB patient) ]
  This will include completing TB diagnosis using laboratory investigations (GeneXpert) 30 days after being identified as presumptive. This will also include the patient receiving results when ready.
• Median time to completing TB diagnosis [ Time Frame: Up to 30 days. Determined as Time from when the patient is enrolled on the study to when they complete TB diagnosis ]
  The time a participant took to complete diagnosis from when they were presumed for TB.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 19, 2023)

• Initiation of TB treatment [ Time Frame: 30 days after being confirmed with TB ]
  This will include initiating treatment within 30 days after being confirmed with TB
• Median time to initiating treatment [ Time Frame: Up to 30 days. Determined as Time from when the patient is confirmed to have TB to when they initiate TB treatment ]
  The time a participant took to initiate treatment once confirmed to have TB
• Acceptability of the intervention [ Time Frame: Through study completion, an average of two months ]
  This will refer to how acceptable the short message service, phone call and mobile money incentives intervention is in terms of performance, effort, social norms, and facilitating conditions. This will be a post intervention qualitative evaluation

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Using SMS Reminders, Phone Calls and Money Incentives to Enhance Linkage to Care of Presumptive TB Patients in Uganda
• Official Title: Using Short Message Service Reminders, Phone Calls and Mobile Money Incentives to Enhance Linkage to Care of Presumptive Tuberculosis Patients in Uganda: a Randomised Controlled Trial

Brief Summary

The major challenge in meeting the WHO's End TB Strategy- reducing tuberculosis (TB) deaths by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB care. A systematic review found high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are infectious and can transmit TB to others and not starting TB treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally important as monitoring treatment outcomes. Short message service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving health outcomes such as uptake of immunization, adherence to TB treatment and antiretroviral therapy (ART). However, there is limited knowledge their effect in increasing linkage to care and treatment for presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB patients.

This will be a five arm multi-center individual randomized controlled trial implemented in selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The study population will be presumptive TB patients aged 18 years and above identified within the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis will refer to submitting a sample and obtaining results from the test. Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will result in increase in the proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that initiate treatment.

Detailed Description

The major challenge in meeting the WHO's End TB Strategy- reducing TB deaths by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB care. Patients can be lost to follow-up after being identified as presumptive TB cases and never get to test for TB (pre-diagnosis LTFU) or those who test and are confirmed to have TB, can also be lost and never start TB treatment (pre-treatment LTFU). A systematic review found high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are infectious and can transmit TB to others and not starting TB treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally important as monitoring treatment outcomes. Short message service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving health outcomes such as uptake of immunization, adherence to TB treatment and ART. However, there is limited knowledge their effect in increasing linkage to care and treatment for presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB patients.

This will be a five arm multi-center individual randomized controlled trial implemented in selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The study population will be presumptive TB patients aged 18 years and above identified within the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis will refer to submitting a sample and obtaining results from the test.

The study arms will include; i) Standard of care (SOC - control group) ii) SMS only iii) phone call only iv) SMS and MM incentive v) Phone call and MM incentive

Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will result in increase in the proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that initiate treatment.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This will be an individual randomized controlled trial with five arms. The study arms will include; i) Standard of care (SOC - control group) ii) SMS only iii) phone call only iv) SMS and mobile money incentive v) Phone call and mobile money incentive

Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:

Due to the nature of the intervention, participants will not be blinded to the study arm though data analysis will be blindly conducted.

Primary Purpose: Screening

• Condition: Tuberculosis

Intervention

• Behavioral: SMS
  Participants in this arm will receive three SMS reminders. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
• Behavioral: Phone call
  Participants in this arm will receive three phone call reminders. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
• Behavioral: Mobile money incentive
  Once participants in the study arms with mobile money complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.

Study Arms

• No Intervention: Standard of care (Control)
  Patients in this arm will receive the routine TB care, according to the Uganda Ministry of Health guidelines, that is; i) Patient screened for TB ii) Patient identified as presumptive and registered in the presumptive TB register iii) Patient referred for TB testing iv) Patient expected to return and pick results on their own drive vi) Positive TB patients initiated on treatment.
• Experimental: SMS only
  In addition to standard of care, participants in this arm will receive three SMS reminders. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  Intervention: Behavioral: SMS
• Experimental: Phone call only
  In addition to standard of care, participants in this arm will receive three phone call reminders to complete TB diagnosis. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  Intervention: Behavioral: Phone call
• Experimental: SMS and mobile money incentives

  In addition to standard of care, participants in this arm will receive three SMS reminders and a transport refund once they complete TB diagnosis. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.

  Once participants in this study arm complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.

  Interventions:

  • Behavioral: SMS
  • Behavioral: Mobile money incentive
• Experimental: Phone call and mobile money incentives

  In addition to standard of care, participants in this arm will receive three phone call reminders and a transport refund once they complete TB diagnosis. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.

  Once participants in this study arm complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.

  Interventions:

  • Behavioral: Phone call
  • Behavioral: Mobile money incentive

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 19, 2023): 1548
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2024
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Presumptive TB patient (cough, fever, night sweats, weight loss)
• Requested to have GeneXpert testing
• Aged between 18 and 65 years
• Current resident in the study districts
• Willing to sign informed consent
• Owning a mobile phone
• Able to read

Exclusion Criteria:

• Participant plans to move out of the study area in the next 3 months
• Participation in another related study such as SMS, phone call or mobile money incentive and others

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Esther Buregyeya, PhD; 0752420555; eburegyeya@musph.ac.ug

Contact: Rebecca Nuwematsiko, MPH; 0781507824; rnuwematsiko@musph.ac.ug

• Listed Location Countries: Uganda

Administrative Information

• NCT Number: NCT05964842
• Other Study ID Numbers: MILEAGE4TB
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Individual participant data will be made available to other researchers upon a written request with justification. The study team will review the request and either approve or deny as they deem necessary. Approved requests will only receive patient de-identified data.

• Current Responsible Party: Makerere University
• Original Responsible Party: Same as current
• Current Study Sponsor: Makerere University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Esther Buregyeya, PhD; Makerere University

• PRS Account: Makerere University
• Verification Date: February 2024