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

NCT05964842 | Completed DMC

• 1 other identifier: MILEAGE4TB
• Study Type: interventional
• Target: 2,355
• Locations: 1 country
• Sites: 5

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.

Conditions

Tuberculosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Completion of TB diagnosis

  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.

  30 days (from being identified as presumptive TB patient)

• Median time to completing TB diagnosis

  The time a participant took to complete diagnosis from when they were presumed for TB.

  Up to 30 days. Determined as Time from when the patient is enrolled on the study to when they complete TB diagnosis

Secondary Outcomes (3)

• Initiation of TB treatment

  30 days after being confirmed with TB

• 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

• Acceptability of the intervention

  Through study completion, an average of two months

Study Arms (5)

Standard of care (Control)

NO INTERVENTION

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.

SMS only

EXPERIMENTAL

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

Phone call only

EXPERIMENTAL

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

SMS and mobile money incentives

EXPERIMENTAL

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; Behavioral: Mobile money incentive

Phone call and mobile money incentives

EXPERIMENTAL

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; Behavioral: Mobile money incentive

Interventions

SMS BEHAVIORAL

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.

SMS and mobile money incentives; SMS only

Phone call BEHAVIORAL

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.

Phone call and mobile money incentives; Phone call only

Mobile money incentive BEHAVIORAL

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.

Phone call and mobile money incentives; SMS and mobile money incentives

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (5)

Luwero General Hospital

Luwero, Kasana, Uganda

Location

Kiruddu National Referral Hospital

Kampala, Makindye, Uganda

Location

Mukono General Hospital

Mukono, Uganda

Location

Entebbe Regional Referral Hospital

Wakiso, Uganda

Location

Wakiso Health Center IV

Wakiso, Uganda

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Esther Buregyeya, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants will not be blinded to the study arm though data analysis will be blindly conducted.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: July 28, 2023
• Study Start: August 14, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (5)