Clinical trial NCT05656287: My Mobile Wallet: An Intervention for Tuberculosis Medication Adherence in Rural Uganda
Official title: My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and Medication Adherence in Rural Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis
mobile health
mobile money
adherence
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized using the 1:1:1 allocation ratio to the following arms: 1) SMS + incentives (Arm A) 2) SMS only (Arm B), and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to develop My Mobile Wallet- a behavioral and economic intervention to support tuberculosis treatment adherence in rural southwestern Uganda. The main question\[s\] it aims to answer are: • Determine the optimal design and develop My Mobile Wallet as an intervention to support tuberculosis medication adherence • Assess the initial feasibility and acceptability of using My Mobile Wallet to support tuberculosis medication. Participants will use My Mobile Wallet intervention for a period of six months. Researchers will compare My Mobile Wallet intervention versus standard care to see if there is an impact on tuberculosis medication adherence.

Detailed description: Tuberculosis is a serious public health concern which kills more people annually than HIV and malaria combined. Worldwide, nearly 10 million people develop tuberculosis and nearly 2 million people die from tuberculosis annually. Low-income countries account for more than 90% of tuberculosis cases and deaths. Uganda faces a high burden of tuberculosis with a prevalence rate of 253 per 100,000 people and an incidence rate of 201 per 100,000 people. Additionally, tuberculosis is a leading cause of death among individuals living with HIV/AIDS.

Poor treatment adherence limits the success of tuberculosis treatment and increases tuberculosis transmission. The treatment success rate in Uganda stands at 75%, below the national target of 90%. Poor tuberculosis medication adherence can lead to treatment failure, development of drug-resistant TB, and secondary transmission. Importantly, treatment for multi-drug resistant (MDR) tuberculosis is difficult to tolerate, prolonged, and expensive.

Uganda currently spends US$105 (on transport refund and food incentives) per month on each MDR-TB patient from the time they are discharged (after the initial six months of hospitalization) until treatment completion (one year). This translates to a cost of $1,260 per patient for the 12 months of treatment. Currently, Uganda has about 16,000 MDR-TB patients. The My Mobile Wallet intervention supports treatment adherence, potentially preventing drug resistance, thereby relieving the country of the financial burden associated with MDR-TB treatment. Importantly, treatment for MDR-TB is difficult to tolerate, prolonged, and leads to productivity loss for patients and their caregivers, which negatively affects the economic development of the country.

Socio-economic determinants of health are a major driver of tuberculosis infection and non-adherence. Although tuberculosis treatment that works well has existed since the 1940s, many people delay seeking treatment, struggle with medication adherence, and/or do not complete their treatment because of behavioral and socio-economic factors. Preliminary data from the ongoing K43 (K43TW010388) study indicate that financial insecurity constrains medication adherence. Tuberculosis leads to the loss of productivity of patients and their caregivers, resulting in additional costs for patients (e.g., in form of transport to the clinic), and may lead to loss of employment for fear of spreading the disease to other people.

Moreover, having tuberculosis is associated with other negative socioeconomic consequences, such as divorce, school interruptions for children, and social exclusion, in addition to the hardship of deteriorating health. Currently in Uganda, 53% of tuberculosis patients take loans and/or sell property to meet the costs of their tuberculosis care. Two in every 10 people (21% of the population) live on $1.25 a day or less in Uganda, making saving for health difficult amidst other immediate competing interests. Because tuberculosis disproportionately affects the poorest in the population, its poverty-aggravating effects are felt more by those who are already vulnerable. Interventions are necessary to overcome the poverty-based structural barriers to tuberculosis treatment, including unconditional transportation to clinic.

Despite the great potential of financial incentives in improving tuberculosis care, research to date is limited, remains largely inconclusive, and has mainly focused on high- and middle-income countries, where financial incentives may have less effect. The World Health Organization End Tuberculosis strategy recommends using reimbursements and social protection schemes to lower the social and economic burden of tuberculosis and address social determinants of health. Although literature in this area is limited, a monthly financial incentive package improved tuberculosis treatment success and reduced loss to follow-up among poor people in Nigeria.

A literature review indicates that cash transfer interventions for patients in low- and middle-income countries initiating tuberculosis treatment may improve clinical outcomes. This review notes that to date, there is limited research utilizing incentives in tuberculosis care, findings from the modest existing research remain largely inconclusive, and research has mainly focused on high- and middle-income countries, where tuberculosis is not a priority, and where financial incentives may have less effect. For instance, in Brazil, cash transfers improved rates of tuberculosis cure by 82.1%. However, these studies use face-to-face approaches to provide incentives, which may be limited by geographical boundaries, are time consuming, and involve transport costs. My Mobile Wallet will provide opportunities for patients in low resource settings to electronically receive and spend money for TB-related treatment.

Rapidly expanding cellular networks across sub-Saharan Africa have greatly increased the capacity of cellular technology to serve as a novel solution to challenges and barriers in the tuberculosis epidemic. Cellular networks are becoming ubiquitous globally. According to Global System for Mobile Communications real-time intelligence data, there are currently over 5.1 billion people with mobile devices, and 8.97 billion mobile connections which exceeds the current world population of 7.7 billion. In Uganda specifically, mobile phone reception is available across the vast majority of the country, including many rural areas and among economically disadvantaged populations. A recent study from Uganda indicates that most tuberculosis patients (75%) own mobile phones and are willing to received TB-related support using mobile phones.

The use of mobile money-based approaches in low resource settings has shown considerable utility in the business sector and holds promise for health. The rapid evolution of mobile phones has enabled a mobile payment platform (often known as mobile money) which enables micro-banking financial transactions (e.g. sending, saving, paying, and receiving money) possible using simple mobile phones that are independent of Smartphone capabilities or internet access. Many people in Uganda are increasingly relying on mobile money as they lack access to formal banking services-more than 23.5 million people have mobile money subscriptions. The use of mobile money in rural areas has enabled farmers to address market failures, access financial services, pay utility bills, and settle supply costs, thus, unlocking opportunities to reach the underserved populations.

The use of mobile money for saving and making payment for pregnancy-related care was beneficial and feasible among pregnant women in Madagascar. Among hard-to-reach populations, mobile money has helped enable routine payment of health insurance and improve access to family planning. However, there is lack of evidence around mobile money to support tuberculosis treatment adherence.

Tuberculosis medication adherence interventions that work well in low resource settings to date are limited; however, SMS-based interventions show promise. The directly observed therapy (DOT) strategy recommended by the World Health Organization, which requires that patients take their medication under physical supervision, has been abandoned by many clinics in Uganda, as it demands a significant time commitment from health workers and treatment supporters, generates substantial financial burdens, and inhibits patient autonomy. The World Health Organization End Tuberculosis Strategy 2017 suggests a suite of new interventions to improve adherence, including mobile phone-based short message service (SMS) messages.

The use of SMS in addressing tuberculosis medication adherence challenges in low-resource settings to date are limited. The prevailing SMS-based studies for tuberculosis medication adherence report mixed results, and have largely been implemented in developed countries, leaving little known about limited-resource countries, heavily burdened by TB. The formative findings from an on-going K43 (K43TW010388) show that SMS may provide acceptable alternative approaches to supporting tuberculosis medication. The effects of these SMS reminders could be greater if combined with economic incentives. No study has assessed the use of SMS linked with economic incentives in supporting tuberculosis medication adherence.

Adherence interventions based on real-time electronic monitoring are feasible, acceptable, have shown to improve HIV treatment adherence. The investigators demonstrated the feasibility, acceptability, and impact on adherence of cellular technology for HIV medication adherence in rural Uganda. The current real-time tuberculosis adherence monitoring intervention the investigators are assessing (K43TW010388) has promise for addressing additional barriers in social support and habit formation. For example, findings indicate that real-time adherence monitoring technology serves as a reminder for both tuberculosis and HIV treatment among co-infected patients. However, financial barriers remain. Thus, combining SMS, mobile money incentives, and real-time monitoring has the potential to overcome the majority of tuberculosis adherence barriers.

Client-centered design increases the likelihood of the intervention uptake and use, as the end user is centrally involved in the development process. Failure to target approaches to local needs and norms limit the utility of health technologies in low-resource settings. Most strategies involve a user interface, therefore, reversing this trend will require behavioural and social science evaluation of acceptability and use of novel technologies in target populations.

Summary: Tuberculosis is a serious public health concern which kills more people annually than HIV and malaria combined. Poor treatment adherence limits the success of tuberculosis treatment and increases tuberculosis transmission. SMS and real-time adherence monitoring may provide low-cost and acceptable alternative approaches to supporting tuberculosis medication especially in settings where DOT is difficult to implement. Financial incentives have shown promise for improving tuberculosis care, but the approach has mainly been implemented in countries where tuberculosis is not a public health priority; moreover, current approaches require costly face-to-face interaction. My Mobile Wallet is a novel intervention that use SMS to remind patients to take their medication, as well as sending mobile money to cover transport costs to tuberculosis clinic, and motivate medication adherence.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with TB per the clinic records (TB patients living with HIV will also be eligible)
* Starting TB treatment now or been on TB treatment for \<2 weeks
* Owning a mobile phone
* Aged 18 years and older
* Live in Mbarara District
* Willing to grow hair on the head and to allow a small thatch of it/hair (10-25 strands/0.02 ng/mg) to be cut at month 2 and 4 in the study
* Willing and able to give consent.

Exclusion Criteria:

* Unable to use mobile money-based SMS (train and test this skill at recruitment)
* Severe mental condition limiting the ability to provide consent

Primary outcomes:
measure: Medication adherence rates among patients
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients who used the intervention
timeFrame: 6 months
measure: TB treatment completion
timeFrame: 6 months
measure: Clinic Attendance
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
measure: Cure rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
affiliation: Mbarara University of Science and Technology
name: Angella Musiimenta, PhD
role: PRINCIPAL_INVESTIGATOR
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