Call for Life Youth ART Adherence Study

NCT ID: NCT04718974

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2022-06-30

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.

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).

Conditions

ART Adherence; HIV-1-infection; mHealth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Call for life -mHealth tool

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Infectious Diseases Institute, Uganda

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnes B Naggirinya, MMed

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases Institute

Locations

Kiryandongo

Kiryandongo, , Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 39561129 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UNCST Folio Number: HS576ES

Identifier Type: OTHER

Identifier Source: secondary_id

HDREC #REC Ref: 2019-083

Identifier Type: OTHER

Identifier Source: secondary_id

IDI-SRC Ref: 031/2019

Identifier Type: -

Identifier Source: org_study_id