Trial Outcomes & Findings for Call for Life Youth ART Adherence Study (NCT NCT04718974)
NCT ID: NCT04718974
Last Updated: 2024-02-21
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
206 participants
Primary outcome timeframe
• Viral load suppression at 6 months
Results posted on
2024-02-21
Participant Flow
Recruitment started on 12th Aug 2020. Reccruitment was from three HIV/ART clinics in Kiryandongo District
The participants must have registered in either of the three study site. They should have been between 15-24 years and on ART for 6 months or less.
Participant milestones
| Measure |
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
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
103
|
|
Overall Study
COMPLETED
|
91
|
77
|
|
Overall Study
NOT COMPLETED
|
12
|
26
|
Reasons for withdrawal
| Measure |
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
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
|
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
20
|
|
Overall Study
Transferred out
|
2
|
4
|
Baseline Characteristics
Call for Life Youth ART Adherence Study
Baseline characteristics by cohort
| Measure |
Intervention " Call for Life- mHealth Tool" With Standard of Care for PLHIV
n=103 Participants
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
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
|
Standard of Care "Usual Care"
n=103 Participants
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.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 1.9 • n=93 Participants
|
22.2 years
STANDARD_DEVIATION 2.3 • n=4 Participants
|
22.3 years
STANDARD_DEVIATION 2.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
167 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
103 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
206 Participants
n=27 Participants
|
|
Region of Enrollment
Uganda
|
103 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
206 Participants
n=27 Participants
|
|
Viral load detection at baseline
|
46 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: • Viral load suppression at 6 monthsViral 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
Outcome measures
| Measure |
Intervention " Call for Life- mHealth Tool" With Standard of Care for PLHIV
n=96 Participants
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
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
|
Standard of Care "Usual Care"
n=87 Participants
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.
|
|---|---|---|
|
• Viral Load Suppression
|
61 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: • Viral load suppression at 12 monthsViral 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
Outcome measures
| Measure |
Intervention " Call for Life- mHealth Tool" With Standard of Care for PLHIV
n=91 Participants
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
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
|
Standard of Care "Usual Care"
n=77 Participants
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.
|
|---|---|---|
|
• Viral Load Suppression
|
67 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: 12 monthsProportions of youth retained in care at 12 months for those on intervention in comparison to those on standard of care arm
Outcome measures
| Measure |
Intervention " Call for Life- mHealth Tool" With Standard of Care for PLHIV
n=103 Participants
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
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
|
Standard of Care "Usual Care"
n=103 Participants
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.
|
|---|---|---|
|
Proportions Retained in Care
|
91 Participants
|
77 Participants
|
Adverse Events
Intervention " Call for Life- mHealth Tool" With Standard of Care for PLHIV
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care "Usual Care"
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Intervention " Call for Life- mHealth Tool" With Standard of Care for PLHIV
n=103 participants at risk
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
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
|
Standard of Care "Usual Care"
n=103 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Death
|
0.00%
0/103 • Adverse event data were collected from participant randomization until exit. This period was 1year and 9 months.
ICH E6 Section 1.2. 5. • An adverse event can be any unfavorable and unintended sign, symptom, or disease that occurs to a study participant, even if not related to the intervention under study. An AE becomes serious if it results into: Death. A life-threatening adverse event. Inpatient hospitalization, or prolonged of existing hospitalization. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. A congenital anomaly/birth defect.
|
1.9%
2/103 • Number of events 2 • Adverse event data were collected from participant randomization until exit. This period was 1year and 9 months.
ICH E6 Section 1.2. 5. • An adverse event can be any unfavorable and unintended sign, symptom, or disease that occurs to a study participant, even if not related to the intervention under study. An AE becomes serious if it results into: Death. A life-threatening adverse event. Inpatient hospitalization, or prolonged of existing hospitalization. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. A congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Road traffic Accident
|
0.97%
1/103 • Number of events 1 • Adverse event data were collected from participant randomization until exit. This period was 1year and 9 months.
ICH E6 Section 1.2. 5. • An adverse event can be any unfavorable and unintended sign, symptom, or disease that occurs to a study participant, even if not related to the intervention under study. An AE becomes serious if it results into: Death. A life-threatening adverse event. Inpatient hospitalization, or prolonged of existing hospitalization. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. A congenital anomaly/birth defect.
|
0.00%
0/103 • Adverse event data were collected from participant randomization until exit. This period was 1year and 9 months.
ICH E6 Section 1.2. 5. • An adverse event can be any unfavorable and unintended sign, symptom, or disease that occurs to a study participant, even if not related to the intervention under study. An AE becomes serious if it results into: Death. A life-threatening adverse event. Inpatient hospitalization, or prolonged of existing hospitalization. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. A congenital anomaly/birth defect.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Agnes Bwanika Naggirinya
Infectious Diseases Institute, College of Health Sciences, Makerere University
Phone: +256752521570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place