Real-time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda

NCT03800888 | Unknown

• 1 other identifier: MUST-16/10-16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

With an estimated 60,000 people diagnosed with TB (Tuberculosis) annually, Uganda holds the 16th position of the 22 countries with highest cases of TB in the world. The Uganda national target of utilizing the DOTS (Direct Observed Treatment Short Course) to successfully treat 85% of patients diagnosed with TB has not been met. Currently, the country only detects 49.6% TB case detection, of which it successfully treats 73%. The DOTS strategy has suffered many socioeconomic challenges, which have resulted into its abandonment by many of the Ugandan hospitals. Poor TB medication adherence greatly attribute to the many cases of TB in Uganda. Causes of non-adherence to TB medication include lack of patient follow-up, patients' lack of transport to go to the clinics to pick up drugs, patients' forgetfulness. There is evidence that real time adherence monitoring linked with SMS reminders and social support notifications can address barriers to sustained ART (antiretroviral therapy) adherence. Such novel interventions addressing TB medication adherence challenges in low resource settings to date are limited. The prevailing SMS-based studies for TB medication adherence report mixed results, do not strategically link interventions with missed doses, and have largely been implemented in developed countries. To date, little is known about the use of real-time adherence monitoring technologies for TB medication adherence in resource-limited settings. The goal of this research is to investigate the use of real time adherence monitoring technology linked with SMS reminders and notifications for TB medication adherence in rural southwestern Uganda. The investigator will develop and quantitatively test a real-time adherence monitoring intervention with 60 individuals initiating TB treatment, and 40 social supporters. The investigator will randomize participants (1:1:1) to the following arms: 1) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months.

Conditions

Tuberculosis

Keywords

Real-time; Medication Adherence; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Percent adherence

  SPSS (statistical package for social scientists) will be used, to determine the mean (standard deviation), median (interquartile range), number of late doses, number of missed doses, and number of hour gaps in adherence as determined by Wisepill for each stage of the intervention, as well as for the control group. The Investigator will compare adherence during each type of SMS reminder with adherence during the matched time period for the control group using T-tests (or Mann-Whitney U tests, depending on the normality of the data) for continuous data and chi-squared tests for categorical data.

  12 Weeks

Secondary Outcomes (1)

• Treatment success rate.

  24 Weeks

Study Arms (3)

Arm A

EXPERIMENTAL

Participants in Arm A will receive a Wisepill device for Real- time monitoring plus Daily SMS reminders plus Social Supporter notifications (for 3 months) sent according to participant's preferred time and then shall receive Linked SMS for missed dose (Right after missed dose) plus Social Support notifications (3 months).

Other: Daily SMS reminders for TB patients; Other: SMS Notifications for social supporters

Arm B

EXPERIMENTAL

Participants in Arm B will receive a wisepill device for Real-time monitoring plus Weekly SMS reminders plus Social support notifications (for 3 months) sent according to participant's preferred time and date and then shall receive Linked SMS for missed dose (Right after missed dose) plus Social Support notifications (3 months).

Other: SMS Notifications for social supporters; Other: Weekly SMS remiders

Arm C

NO INTERVENTION

Participants in Arm C will receive only the Wise pill device (No SMS)

Interventions

Daily SMS reminders for TB patients OTHER

Daily SMS Medication reminders will be sent to TB patients to remind them take their medications.

Arm A

SMS Notifications for social supporters OTHER

SMS Notifications will be sent to social supporters to assit TB patients take their medication

Arm A; Arm B

Weekly SMS remiders OTHER

Weekly SMS reminders sent to TB patients to remind them take medication

Arm B

Eligibility Criteria

• Age: 18 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
• Starting TB treatment now or within the next two weeks
• Age 18 years and older
• Live in the Mbarara District (20 km from MRRH)
• Own a cell phone for personal use and have reliable cellular phone reception at home on networks (MTN or Airtel) supported by the technology used in this study
• Know how to use SMS
• Willing and able to give consent
• Willing and able to name one or two social supporters who are able to use SMS and have cellular phones using network provider (MTN or Airtel) supported by the technology used in this study.

You may not qualify if:

• Unable to use SMS (The investigators will train and test this skill at recruitment)
• Unwilling to receive SMS reminder
• Severe mental condition limiting the ability to provide consent
• Cellular phone reception is not reliable
• Know a Wisepill participant and be aware s/he has TB
• Have provided help to that Wisepill participant at least once, i.e,
• Helping him/her get to clinic by loaning or giving money, driving the patient , or taking care of his/her job or children while he/she is away
• Helping the patient take medicines through encouragement or reminders
• Motivating the patient to take medicines, including addressing cognitive and behavioral barriers such as depression and alcohol use
• Age 18 years or older
• Live in Mbarara District (within 20 KM from MRRH)
• Willing and able to provide consent.
• Unable to use SMS (Investigators will train and test this skill at recruitment)
• Unwilling to receive SMS reminder
• Severe mental condition limiting the ability to provide consent

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• Massachusetts General Hospital: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, Uganda

RECRUITING

Related Publications (6)

• Musiimenta A. Social and Institutional issues in the Adoption of School-based Technology-aided Sexual Health Education Program. Online J Public Health Inform. 2013 Jul 1;5(2):213. doi: 10.5210/ojphi.v5i2.4654. Print 2013.

  PMID: 23923098 BACKGROUND

• Musiimenta A. A Controlled Pre-Post Evaluation of a Computer-based HIV/AIDS Education on Students' Sexual Behaviors, Knowledge and Attitudes. Online J Public Health Inform. 2012;4(1):ojphi.v4i1.4017. doi: 10.5210/ojphi.v4i1.4017. Epub 2012 May 17.

  PMID: 23569630 BACKGROUND

• Musiimenta A. Contextual Mediators influencing the Effectiveness of Behavioural Change Interventions: A Case of HIV/AIDS Prevention Behaviours. Online J Public Health Inform. 2012;4(2):ojphi.v4i2.3988. doi: 10.5210/ojphi.v4i2.3988. Epub 2012 Sep 14.

  PMID: 23569636 BACKGROUND

• Liu X, Lewis JJ, Zhang H, Lu W, Zhang S, Zheng G, Bai L, Li J, Li X, Chen H, Liu M, Chen R, Chi J, Lu J, Huan S, Cheng S, Wang L, Jiang S, Chin DP, Fielding KL. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial. PLoS Med. 2015 Sep 15;12(9):e1001876. doi: 10.1371/journal.pmed.1001876. eCollection 2015 Sep.

  PMID: 26372470 BACKGROUND

• Nglazi MD, Bekker LG, Wood R, Hussey GD, Wiysonge CS. Mobile phone text messaging for promoting adherence to anti-tuberculosis treatment: a systematic review. BMC Infect Dis. 2013 Dec 2;13:566. doi: 10.1186/1471-2334-13-566.

  PMID: 24295439 BACKGROUND

• Musiimenta A, Tumuhimbise W, Atukunda EC, Mugaba AT, Musinguzi N, Muzoora C, Bangsberg D, Davis JL, Haberer JE. The feasibility, acceptability, and preliminary impact of real-time monitors and SMS on tuberculosis medication adherence in southwestern Uganda: Findings from a mixed methods pilot randomized controlled trial. PLOS Glob Public Health. 2023 Dec 5;3(12):e0001813. doi: 10.1371/journal.pgph.0001813. eCollection 2023.

  PMID: 38051699 DERIVED

MeSH Terms

Conditions

Tuberculosis; Medication Adherence

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Angella Musiimenta, PhD

CONTACT

+256776820598; amusiimenta@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) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 11, 2019
• Study Start: January 10, 2019
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)