Clinical trial NCT05964842: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 2355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Completion of TB diagnosis
timeFrame: 30 days (from being identified as presumptive TB patient)
measure: Median time to completing TB diagnosis
timeFrame: Up to 30 days. Determined as Time from when the patient is enrolled on the study to when they complete TB diagnosis
Secondary outcomes:
measure: Initiation of TB treatment
timeFrame: 30 days after being confirmed with TB
measure: Median time to initiating treatment
timeFrame: Up to 30 days. Determined as Time from when the patient is confirmed to have TB to when they initiate TB treatment
measure: Acceptability of the intervention
timeFrame: Through study completion, an average of two months
Other outcomes:
Locations:
city: Luwero
country: Uganda
facility: Luwero General Hospital
state: Kasana
city: Kampala
country: Uganda
facility: Kiruddu National Referral Hospital
state: Makindye
city: Mukono
country: Uganda
facility: Mukono General Hospital
city: Wakiso
country: Uganda
facility: Entebbe Regional Referral Hospital
city: Wakiso
country: Uganda
facility: Wakiso Health Center IV
Study officials:
affiliation: Makerere University
name: Esther Buregyeya, PhD
role: PRINCIPAL_INVESTIGATOR
References: