Call for Life Youth ART Adherence Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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ART Adherence, HIV-1-infection, mHealth

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups one on intervention of mHealth with standard of care and other on standard of care only. mHealth using interactive voice response
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention  Call for life- mHealth tool with standard of care for PLHIV<br>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)<br>* 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<br>* Other names: Call for life -mHealth tool;|
| No Intervention: Standard of care usual care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Viral load | 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 | Blood draws at 12 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 12 months | 
| Retention in care | proportion of youth retained in care for 12 months for the those on intervention in comparison to those on standard of care arm | 12 months | 
| Adherence scores | ART adherence scores as assessed by HIV Care Card for those on SoC arm and Self- reported adherence to ART as depicted on the mHealth dash board. | Adherence scores at 6 and 12 months, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Youth, Adherence, ART, mobile health, resource poor setting