Call for Life Youth ART Adherence Study (C4L-Youth)

Acceptability, Effect and Cost of Mobile-health on ART Adherence Among Youths: A Mixed Methods Sequential Study in Kiryandongo

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.

Study Overview

• Status: Completed
• Conditions: mHealth; HIV-1-infection; ART Adherence
• Intervention / Treatment: Other: mHealth call for life system/ tool using IVR ( interactive voice response)

Detailed Description

The intervention is mobile phone based IVR. However, the CLFU trial found that, it was observed that a good number of participants (50 of 256) at the urban site were not enrolled due to absence of a basic mobile phone, or had malfunctioning phone keyboards (for Poster Exhibition at the 20th International Conference on AIDS and STIs in Africa (ICASA 2019). Therefore, we shall provide a basic mobile phone to everyone in the study (SoC and intervention arm). To avoid stigma associated with a particular phone, we shall get 4 or more types of basic phones. Issues regarding simcard registration will be dealt with by the individuals.

Four study questionnaires will be administered at baseline and 6-monthly until the 12-month exit visit.

The questionnaires will capture:

• Sociodemographic and medical history
• Stigma scores
• Knowledge assessment
• Sexual behavior assessment
• Knowledge of COVID-19 ( only at baseline) The data will be entered using REDCap. Blood for viral load will be collected at baseline and at the 6 and 12-month visit.

Intervention: mHealth CFLU tool 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. The CFLU system follows the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security rules. While the Privacy rules deals with electronic Protected Health Information, the security rule covers administrative, physical and technical safeguards to ensure confidentiality, integrity and security of electronic protected health information. Data transaction between patient and system is encrypted when it comes to human subjects. The system is password protected, and interaction of system and patient is personalised with a secret code. The system interacts with the patient through a basic mobile phone via a keypad and with the health worker through a web-based interface. 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 enduser.

Screening-Enrolment procedures:

All potential participants will be written on the screening log, and a screening form completed, reasons for screen failure will be documented on the screening log. Following successful screening, the participant will be referred to the Research Assistant (RA) to receive a thorough explanation of the study so and informed consent is obtained. The RA then administers the stigma questionnaire along with the sociodemographic and medical information, , HIV knowledge and sexual behaviour questionnaires. A client locater form will be completed which will help in physical contact tracing, and the participant will be registered on the enrolment log.

Randomisation will follow (see details of randomisation procedure below) thereafter and the result in the sealed envelope will dictate whether the patient will be registered onto the Call for Life System for the intervention or continue with standard of care as per Ministry of Health HIV Management guidelines.

Registration onto the CFLU system: Refer to Standard operating procedures on registration.

However, all patients will be registered onto the electronic and hard copy of the enrolment log and a next appointment date is given to them. Finally, the lab request forms are filled and the patient sent for a blood draw. The patient returns from the lab, receives their transport refund of UGX 20,000, with a basic mobile phone (only at baseline visit, to all participants) and is allowed to go home.

No intervention: Standard of care arm The Ministry of Health developed a minimum healthcare services package for PLHIV to standardize the programming, implementation and delivery of integrated HIV services in Uganda The standard of care arm 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 (Uganda. MoH, September 2014).

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kiryandongo, Uganda, 256
    • Kiryandongo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention " Call for life- mHealth tool" with standard of care for PLHIV; 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); 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; Other Names: Call for life -mHealth tool
No Intervention: Standard of care "usual care"; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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

Collaborators and Investigators

• Sponsor: Makerere University
• Collaborators: Infectious Diseases Institute, Uganda
• Investigators: Principal Investigator: Agnes B Naggirinya, MMed, Infectious Diseases Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; mobile health; Youth; ART; resource poor setting
• Other Study ID Numbers: IDI-SRC Ref: 031/2019; UNCST Folio Number: HS576ES (Other Identifier: UNCST( Uganda National Council for Science & Technology)); HDREC #REC Ref: 2019-083 (Other Identifier: School of Medicine,Higher Degrees Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No