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

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Behavioral: SMS; Behavioral: Phone call; Behavioral: Mobile money incentive

• Registration Number: NCT05964842
• Lead Sponsor: Makerere University

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 Timeline

• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-28
• Study Start: 2023-08-14
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2355

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMS and mobile money incentives	Mobile money incentive	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.
SMS and mobile money incentives	SMS	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.
Phone call and mobile money incentives	Phone call	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.
SMS only	SMS	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.
Phone call only	Phone call	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.
Phone call and mobile money incentives	Mobile money incentive	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.

Primary Outcome Measures

Name	Time	Method
Completion of TB diagnosis	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	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

Name	Time	Method
Median time to initiating treatment	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	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
Initiation of TB treatment	30 days after being confirmed with TB	This will include initiating treatment within 30 days after being confirmed with TB

Trial Locations

Locations (5)

Luwero General Hospital; 🇺🇬 Luwero, Kasana, Uganda

Kiruddu National Referral Hospital; 🇺🇬 Kampala, Makindye, Uganda

Mukono General Hospital; 🇺🇬 Mukono, Uganda

Entebbe Regional Referral Hospital; 🇺🇬 Wakiso, Uganda

Wakiso Health Center IV; 🇺🇬 Wakiso, Uganda