Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04718974 |
| Other study ID # |
IDI-SRC Ref: 031/2019 |
| Secondary ID |
UNCST Folio Numb |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 12, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2023 |
| Source |
Makerere University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
