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

NCT05656287 | Recruiting

• 1 other identifier: MUST-2021-102
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; mobile health; mobile money; adherence

Outcome Measures

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

  6 months

Secondary Outcomes (5)

• Number of patients who used the intervention

  6 months

• TB treatment completion

  6 months

• Clinic Attendance

  6 months

• Mortality

  6 months

• Cure rate

  6 months

Study Arms (3)

Arm A

EXPERIMENTAL

(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

Arm B

EXPERIMENTAL

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

Arm C- Control

EXPERIMENTAL

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

Other: Wisepill device for medication monitoring only

Interventions

SMS texts + incentives + Wisepill device for medication monitoring OTHER

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.

Arm A

SMS texts only + Wisepill device for medication monitoring OTHER

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.

Arm B

Wisepill device for medication monitoring only OTHER

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.

Arm C- Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, Uganda

RECRUITING

Related Publications (20)

• World Health Organisation., Global tuberculosis control: WHO report 2000, in Global tuberculosis control:WHO report 2000. 2000.

  BACKGROUND

• 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.

  PMID: 26605929 BACKGROUND

• 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.

  PMID: 24244364 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31788561 BACKGROUND

• 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.

  PMID: 18482424 BACKGROUND

• Charness, G. and U. Gneezy, Incentives to exercise. Econometrica, 2009. 77(3): p. 909-931.

  BACKGROUND

• 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.

  PMID: 25987190 BACKGROUND

• 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.

  PMID: 29962550 BACKGROUND

• 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.

  PMID: 26884501 BACKGROUND

• 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.

  PMID: 29663958 BACKGROUND

• 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.

  PMID: 19175285 BACKGROUND

• 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.

  PMID: 26760452 BACKGROUND

• 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.

  PMID: 27671479 BACKGROUND

• 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.

  PMID: 28421356 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24320014 BACKGROUND

• 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.

  PMID: 35722172 BACKGROUND

• Musiimenta A, Tumuhimbise W, Atukunda E, Mugaba A, Linnemayr S, Haberer J. Digital Adherence Technologies Linked to Mobile Money Incentives for Medication Adherence Among People Living With Tuberculosis: Mixed Methods Feasibility and Acceptability Study. JMIR Hum Factors. 2024 May 31;11:e47996. doi: 10.2196/47996.

  PMID: 38819905 DERIVED

• Musiimenta A, Tumuhimbise W, Atukunda E, Mugaba A, Linnemayr S, Haberer J. Digital Adherence Technologies and Mobile Money Incentives for Management of Tuberculosis Medication Among People Living With Tuberculosis: Mixed Methods Formative Study. JMIR Form Res. 2023 Apr 12;7:e45301. doi: 10.2196/45301.

  PMID: 37043263 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Angella Musiimenta, PhD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angella Musiimenta, PhD

CONTACT

0776820598; amusiimenta@must.ac.ug

Aaron Mugaba, MBA

CONTACT

0772865984; amugaba@must.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: December 19, 2022
• Study Start: April 14, 2022
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

UG (1)