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RecruitingNCT05656287M_walletUpdated Dec 19, 2022

My Mobile Wallet: An Intervention for Tuberculosis Medication Adherence in Rural Uganda

An interventional study of SMS texts + incentives + Wisepill device for medication monitoring and SMS texts only + Wisepill device for medication monitoring in Tuberculosis, sponsored by Mbarara University of Science and Technology. Recruiting at 1 site in Uganda. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-12-19.

Sponsored by Mbarara University of Science and Technology · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Apr 2022, registered Sep 2022).
  • Started Apr 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tuberculosis

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Keywords

  • Tuberculosis
  • mobile health
  • mobile money
  • adherence
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's planned enrollment of 242 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Mbarara University of Science and Technology is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Newly diagnosed with TB per the clinic records (TB patients living with 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
242 participants (estimated)

Study arms

  • Experimental
    Arm A

    (Arm A): For the first two months, 54 participants will receive i) daily SMS medication reminders, ii) monthly mobile money for transport to the clinic, and iii) monthly mobile money incentives if \>90% medication adherence. For the remaining four months, the participants will receive: i) weekly medication SMS reminders, ii) monthly mobile money for transport to the clinic, iv) monthly mobile money incentives if \>90% medication adherence.

    Other: SMS texts + incentives + Wisepill device for medication monitoring

  • Experimental
    Arm B

    For the first 2 months, 54 participants will receive daily SMS medication reminders, ii). For the remaining 4 months, the participants will receive weekly medication SMS reminders.

    Other: SMS texts only + Wisepill device for medication monitoring

  • Experimental
    Arm C- Control

    Participants (54) in the Control (Arm C) will not receive SMS reminders or mobile money

    Other: Wisepill device for medication monitoring only

Interventions

  • OtherSMS texts + incentives + Wisepill device for medication monitoring

    For the first two months, 54 participants will receive i) daily SMS medication reminders, ii) monthly mobile money for transport to the clinic, and iii) monthly mobile money incentives if \>90% medication adherence. For the remaining four months, the participants will receive: i) weekly medication SMS reminders, ii) monthly mobile money for transport to the clinic, iv) monthly mobile money incentives if \>90% medication adherence.

  • OtherSMS texts only + Wisepill device for medication monitoring

    For the first 2 months, 54 participants will receive daily SMS medication reminders, ii). For the remaining 4 months, the participants will receive weekly medication SMS reminders. All participants will also receive a Wisepill device for medication monitoring.

  • OtherWisepill device for medication monitoring only

    Participants (54) in the Control arm will not receive SMS reminders or mobile money. All participants will also receive a Wisepill device for medication monitoring.

06

What researchers measure

Primary outcomes

  1. Medication adherence rates among patients

    Number of patients in the intervention arm with higher adherence as electronically ascertained by the Wisepill device

    Time frame: 6 months

Secondary outcomes

  1. Number of patients who used the intervention

    % of participants who used the intervention and reported technical problems. The intervention will be considered feasible if \>70% participants 1) receive mobile money, 2) utilize the transport incentive for transport to the clinic, 3) receive SMS reminders

    Time frame: 6 months

  2. TB treatment completion

    Number of patients who complete TB medication as ascertained by Medical records at the end of six months.

    Time frame: 6 months

  3. Clinic Attendance

    Number of patients with continuous hospital attendance by reviewing the TB clinic medical records and My Mobile wallet intervention.

    Time frame: 6 months

  4. Mortality

    Mortality rate as ascertained by medical records at the end of six months.

    Time frame: 6 months

  5. Cure rate

    Number of patients cured as ascertained by medical records from the TB clinic at the end of six months

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • World Health Organisation., Global tuberculosis control: WHO report 2000, in Global tuberculosis control:WHO report 2000. 2000.
  • Horsburgh CR Jr, Barry CE 3rd, Lange C. Treatment of Tuberculosis. N Engl J Med. 2015 Nov 26;373(22):2149-60. doi: 10.1056/NEJMra1413919. No abstract available. PubMed 26605929 ↗
  • Adane AA, Alene KA, Koye DN, Zeleke BM. Non-adherence to anti-tuberculosis treatment and determinant factors among patients with tuberculosis in northwest Ethiopia. PLoS One. 2013 Nov 11;8(11):e78791. doi: 10.1371/journal.pone.0078791. eCollection 2013. PubMed 24244364 ↗
  • MOH, Direct and Indirect costs due to Tuberculosis and proportion of Tuberculosis-affected households experiencing catastrophic costs due to TB in Uganda. Ministry of Health Uganda. 2019.
  • Musiimenta A, Tumuhimbise W, Mugaba AT, Muzoora C, Armstrong-Hough M, Bangsberg D, Davis JL, Haberer JE. Digital monitoring technologies could enhance tuberculosis medication adherence in Uganda: Mixed methods study. J Clin Tuberc Other Mycobact Dis. 2019 Aug 29;17:100119. doi: 10.1016/j.jctube.2019.100119. eCollection 2019 Dec. PubMed 31788561 ↗
  • Heil SH, Higgins ST, Bernstein IM, Solomon LJ, Rogers RE, Thomas CS, Badger GJ, Lynch ME. Effects of voucher-based incentives on abstinence from cigarette smoking and fetal growth among pregnant women. Addiction. 2008 Jun;103(6):1009-18. doi: 10.1111/j.1360-0443.2008.02237.x. PubMed 18482424 ↗
  • Charness, G. and U. Gneezy, Incentives to exercise. Econometrica, 2009. 77(3): p. 909-931.
  • Linnemayr S, Stecher C. Behavioral Economics Matters for HIV Research: The Impact of Behavioral Biases on Adherence to Antiretrovirals (ARVs). AIDS Behav. 2015 Nov;19(11):2069-75. doi: 10.1007/s10461-015-1076-0. PubMed 25987190 ↗
  • Richterman A, Steer-Massaro J, Jarolimova J, Luong Nguyen LB, Werdenberg J, Ivers LC. Cash interventions to improve clinical outcomes for pulmonary tuberculosis: systematic review and meta-analysis. Bull World Health Organ. 2018 Jul 1;96(7):471-483. doi: 10.2471/BLT.18.208959. Epub 2018 Jun 4. PubMed 29962550 ↗
  • Torrens AW, Rasella D, Boccia D, Maciel EL, Nery JS, Olson ZD, Barreira DC, Sanchez MN. Effectiveness of a conditional cash transfer programme on TB cure rate: a retrospective cohort study in Brazil. Trans R Soc Trop Med Hyg. 2016 Mar;110(3):199-206. doi: 10.1093/trstmh/trw011. PubMed 26884501 ↗
  • Ggita JM, Ojok C, Meyer AJ, Farr K, Shete PB, Ochom E, Turimumahoro P, Babirye D, Mark D, Dowdy D, Ackerman S, Armstrong-Hough M, Nalugwa T, Ayakaka I, Moore D, Haberer JE, Cattamanchi A, Katamba A, Davis JL. Patterns of usage and preferences of users for tuberculosis-related text messages and voice calls in Uganda. Int J Tuberc Lung Dis. 2018 May 1;22(5):530-536. doi: 10.5588/ijtld.17.0521. PubMed 29663958 ↗
  • Ware NC, Idoko J, Kaaya S, Biraro IA, Wyatt MA, Agbaji O, Chalamilla G, Bangsberg DR. Explaining adherence success in sub-Saharan Africa: an ethnographic study. PLoS Med. 2009 Jan 27;6(1):e11. doi: 10.1371/journal.pmed.1000011. PubMed 19175285 ↗
  • Haberer JE, Musiimenta A, Atukunda EC, Musinguzi N, Wyatt MA, Ware NC, Bangsberg DR. Short message service (SMS) reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016 May 15;30(8):1295-300. doi: 10.1097/QAD.0000000000001021. PubMed 26760452 ↗
  • Atukunda EC, Musiimenta A, Musinguzi N, Wyatt MA, Ashaba J, Ware NC, Haberer JE. Understanding Patterns of Social Support and Their Relationship to an ART Adherence Intervention Among Adults in Rural Southwestern Uganda. AIDS Behav. 2017 Feb;21(2):428-440. doi: 10.1007/s10461-016-1559-7. PubMed 27671479 ↗
  • Campbell JI, Aturinda I, Mwesigwa E, Burns B, Santorino D, Haberer JE, Bangsberg DR, Holden RJ, Ware NC, Siedner MJ. The Technology Acceptance Model for Resource-Limited Settings (TAM-RLS): A Novel Framework for Mobile Health Interventions Targeted to Low-Literacy End-Users in Resource-Limited Settings. AIDS Behav. 2017 Nov;21(11):3129-3140. doi: 10.1007/s10461-017-1765-y. PubMed 28421356 ↗
  • Linnemayr, S., Consumption smoothing and HIV/AIDS: The case of two communities in South Africa. Economic Development and Cultural Change, 2010. 58(3): p. 475-506.
  • Linnemayr S, Glick P, Kityo C, Mugyeni P, Wagner G. Prospective cohort study of the impact of antiretroviral therapy on employment outcomes among HIV clients in Uganda. AIDS Patient Care STDS. 2013 Dec;27(12):707-14. doi: 10.1089/apc.2013.0139. PubMed 24320014 ↗
  • Linnemayr S, Lawson BS, Glick P, Wagner G. Economic Status and Coping Mechanisms of Individuals Seeking HIV Care in Uganda. J Afr Econ. 2011 Jun;20(3):505-529. doi: 10.1093/jae/ejr014. Epub 2011 May 4. PubMed 35722172 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05656287
Lead sponsor
Mbarara University of Science and Technology
Responsible party
Sponsor
First posted
Dec 19, 2022
Start date
Apr 14, 2022
Primary completion
Dec 2025 (estimated)
Completion
May 2026 (estimated)
Last update
Dec 19, 2022

Study contacts

Angella Musiimenta, PhD
Contact
amusiimenta@must.ac.ug
0776820598 ext. +256
Aaron Mugaba, MBA
Contact
amugaba@must.ac.ug
0772865984 ext. +256
Angella Musiimenta, PhD
principal investigator · Mbarara University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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