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

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Tuberculosis Behavioral: SMS Behavioral: Phone call Behavioral: Mobile money incentive Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1548 participants
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
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
Actual Study Start Date : August 14, 2023
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.
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.

 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: 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.
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964842


Contacts
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Contact: Esther Buregyeya, PhD 0752420555 eburegyeya@musph.ac.ug
Contact: Rebecca Nuwematsiko, MPH 0781507824 rnuwematsiko@musph.ac.ug

Locations
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Uganda
Luwero General Hospital Recruiting
Luwero, Kasana, Uganda
Contact: Rebecca Nuwematsiko, MPH    0781507824    rnuwematsiko@musph.ac.ug   
Kiruddu National Referral Hospital Recruiting
Kampala, Makindye, Uganda
Contact: Rebecca Nuwematsiko, MPH    0781507824    rnuwematsiko@musph.ac.ug   
Mukono General Hospital Recruiting
Mukono, Uganda
Contact: Rebecca Nuwematsiko, MPH    0781507824    rnuwematsiko@musph.ac.ug   
Entebbe Regional Referral Hospital Recruiting
Wakiso, Uganda
Contact: Rebecca Nuwematsiko, MPH    0781507824    rnuwematsiko@musph.ac.ug   
Wakiso Health Center IV Recruiting
Wakiso, Uganda
Contact: Rebecca Nuwematsiko, MPH    0781507824    rnuwematsiko@musph.ac.ug   
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Esther Buregyeya, PhD Makerere University
More Information
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Additional Information:

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT05964842    
Other Study ID Numbers: MILEAGE4TB
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: February 2024
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Makerere University:
Tuberculosis
Presumptive TB
Loss to follow-up
SMS
Phone call
 Cash incentives
Mobile health (mHealth)
Pre-treatment loss to follow-up
Pre-diagnosis loss to follow-up
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections