Call for Life Youth ART Adherence Study

NCT04718974 | Completed Results

• 3 other identifiers: IDI-SRC Ref: 031/2019UNCST Folio Number: HS576ESHDREC #REC Ref: 2019-083
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Study purpose: To assess effect of mHealth Call for life Uganda tool (CFLU) on ART adherence among youth measured by interactive voice response to daily adherence calls mapped in the database and proportion with viral suppression of copies below 1000 copies/mL. The intervention call for life Uganda (CFLU) uses IVR calls or text messages delivered via MOTECH™ based Connect for Life technology™. The calls are delivered in 4 languages (Luganda, English, Luo and Runyakitara) and the participant has to make a choice of the preferred language during registration to the system. The system offers adherence pill reminders, health message tips, visit appointment reminders and receipt of self-reported symptoms.

Conditions

ART Adherence; HIV-1-infection; mHealth

Keywords

Youth; Adherence; ART; mobile health; resource poor setting

Outcome Measures

Primary Outcomes (3)

• • Viral Load Suppression

  Viral load suppression as per Blood draws at 6 months for those on intervention and those on standard of care arm will be used to measure viral load at these time points

  • Viral load suppression at 6 months

• • Viral Load Suppression

  Viral load suppression as per Blood draws at 12 months for those on intervention and those on standard of care arm will be used to measure viral load status at these time points

  • Viral load suppression at 12 months

• Proportions Retained in Care

  Proportions of youth retained in care at 12 months for those on intervention in comparison to those on standard of care arm

  12 months

Study Arms (2)

intervention " Call for life- mHealth tool" with standard of care for PLHIV

EXPERIMENTAL

The system has options to either use interactive voice response or short message service and the user has to make a choice, get a secret pin code which ensures privacy to end user. The mHealth tool/system offers personalised pill reminder calls, health tip messages, clinic appointment reminders and remote symptom reporting

Other: mHealth call for life system/ tool using IVR ( interactive voice response)

Standard of care "usual care"

NO INTERVENTION

Standard • Care and support for people living with HIV, and the first line ART regimen is based on the Apr 2018, consolidated guidelines for prevention and treatment of HIV in Uganda (MoH, 2018), and will also follow the healthcare services package for PLHIV including the Adult Care and Treatment Package.

Interventions

mHealth call for life system/ tool using IVR ( interactive voice response) OTHER

The tool capitalises on a basic mobile phone's core utilities of voice and short messaging services. The system design, development, testing and evaluation was done by Janssen and the Grameen Foundation (http://motechsuite.org/index.php/implementations). In 2015, Janssen Global Public Health Research and Development, in close collaboration with the Infectious Diseases Institute Kampala (IDI), developed Call for Life Uganda (CFLU) tailored to the needs of PLHIV in Uganda

Also known as: Call for life -mHealth tool

intervention " Call for life- mHealth tool" with standard of care for PLHIV

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth living with HIV
• Documented HIV test result
• ART naïve or on ART since Jun 2019

You may not qualify if:

• Youth with Hearing loss,
• Youth with severe illness likely to shorten life span,
• Youth in boarding schools
• Inability to use a basic mobile phone

Sponsors & Collaborators

• Makerere University: lead
• Infectious Diseases Institute, Uganda: collaborator

Study Sites (1)

Kiryandongo

Kiryandongo, 256, Uganda

Location

Related Publications (1)

• Bwanika Naggirinya A, Meya DB, Nabaggala MS, Banturaki G, Kiragga A, Rujumba J, Waiswa P, Parkes-Ratanshi R. Effectiveness of interactive voice response-call for life mHealth tool on adherence to anti-retroviral therapy among young people living with HIV: A randomized trial in Uganda. PLoS One. 2024 Nov 19;19(11):e0308923. doi: 10.1371/journal.pone.0308923. eCollection 2024.

  PMID: 39561129 DERIVED

MeSH Terms

Interventions

CD56 Antigen

Intervention Hierarchy (Ancestors)

Neural Cell Adhesion Molecules; Cell Adhesion Molecules, Neuronal; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers

Results Point of Contact

• Title: Dr. Agnes Bwanika Naggirinya
• Organization: Infectious Diseases Institute, College of Health Sciences, Makerere University

anaggirinya@idi.co.ug

+256752521570

Study Officials

• Agnes B Naggirinya, MMed

  Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: 2 groups one on intervention of Call for life mHealth with standard of care and other on standard of care only. mHealth Call for life Tool using interactive voice response

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 22, 2021
• Study Start: August 12, 2020
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 21, 2024
• Results First Posted: February 21, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)