Trial Outcomes & Findings for Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy (NCT NCT03820323)
NCT ID: NCT03820323
Last Updated: 2024-04-10
Results Overview
Viral Load \<1000 copies/mL at 12 months after enrollment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
704 participants
Primary outcome timeframe
12 months after enrollment
Results posted on
2024-04-10
Participant Flow
The study was conducted in Kisumu County, western Kenya, with the second-highest prevalence of pediatric HIV infections in Kenya. The study was implemented at five low-resource, high-HIV burden public sector facilities from March 2019 to December 2020. We chose the study facilities to leverage existing POC technologies, specifically the GeneXpert® platform.
Participant milestones
| Measure |
Standard of Care
Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
POC VL and targeted DRM testing.
POC VL and targeted DRM testing.: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Overall Study
STARTED
|
355
|
349
|
|
Overall Study
COMPLETED
|
315
|
313
|
|
Overall Study
NOT COMPLETED
|
40
|
36
|
Reasons for withdrawal
| Measure |
Standard of Care
Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
POC VL and targeted DRM testing.
POC VL and targeted DRM testing.: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Missed 12-month visit
|
22
|
14
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Transferred out
|
13
|
11
|
|
Overall Study
Terminated
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
Baseline Characteristics
Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
Baseline characteristics by cohort
| Measure |
Standard of Care
n=355 Participants
Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
n=349 Participants
POC VL and targeted DRM testing.
POC VL and targeted DRM testing.: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL\>1000 copies/mL) is detected.
|
Total
n=704 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
355 Participants
n=99 Participants
|
349 Participants
n=107 Participants
|
704 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
9 years
n=99 Participants
|
9 years
n=107 Participants
|
9 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=99 Participants
|
184 Participants
n=107 Participants
|
344 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
195 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
360 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
355 Participants
n=99 Participants
|
349 Participants
n=107 Participants
|
704 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
355 Participants
n=99 Participants
|
349 Participants
n=107 Participants
|
704 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Kenya
|
355 Participants
n=99 Participants
|
349 Participants
n=107 Participants
|
704 Participants
n=206 Participants
|
|
Virological suppression at enrollment
Yes (viral load <1000 copies per mL)
|
274 Participants
n=99 Participants
|
262 Participants
n=107 Participants
|
536 Participants
n=206 Participants
|
|
Virological suppression at enrollment
No (viral load >=1000 copies per mL)
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Virological suppression at enrollment
No viral load recorded or missing
|
42 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months after enrollmentViral Load \<1000 copies/mL at 12 months after enrollment
Outcome measures
| Measure |
Standard of Care
n=315 Participants
Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
n=313 Participants
Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Number of Participants With Viral Suppression
|
289 participants
|
283 participants
|
SECONDARY outcome
Timeframe: 12 months post enrollmentAmong children newly initiating ART or initially virologically unsuppressed, we then evaluated the virological suppression status at 12 months post-enrollment.
Outcome measures
| Measure |
Standard of Care
n=59 Participants
Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
n=60 Participants
Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed
|
42 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Every 3 months within the 12 months study periodPopulation: Of note, during the 6- and 9-month study visits, COVID-19 related restrictions in travel and routine care greatly affected our ability to obtain samples for VL testing leading to varying numbers analyzed per month.
The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.
Outcome measures
| Measure |
Standard of Care
n=355 Participants
Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
n=349 Participants
Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Number of Participants Who Underwent POC VL Testing
0 months
|
167 participants
|
349 participants
|
|
Number of Participants Who Underwent POC VL Testing
3 months
|
185 participants
|
301 participants
|
|
Number of Participants Who Underwent POC VL Testing
6 months
|
131 participants
|
177 participants
|
|
Number of Participants Who Underwent POC VL Testing
9 months
|
143 participants
|
186 participants
|
|
Number of Participants Who Underwent POC VL Testing
12 months
|
135 participants
|
286 participants
|
SECONDARY outcome
Timeframe: Every 3 months within the 12 months study periodThe time it takes for viral load results to be received by health care providers and participants.
Outcome measures
| Measure |
Standard of Care
n=355 Participants
Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
n=349 Participants
Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Turn-around Time for the VL Testing Results
|
15 days
Interval 10.0 to 21.0
|
1 days
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 12 months post enrollmentPopulation: Of 120 samples in the intervention group in which we requested a DRM test, 13 (11%) failed to amplify. We are not able to elucidate reasons why five of the samples in the Standard of Care group were selected for DRM testing or why three of the five requested DRM tests were not performed successfully.
The number of children tested for DRMs with any or major mutations within each class of HIV drugs.
Outcome measures
| Measure |
Standard of Care
n=2 Participants
Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
n=107 Participants
Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Any DRM
|
2 participants
|
107 participants
|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
NRTI
|
1 participants
|
61 participants
|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
NNRTI
|
2 participants
|
88 participants
|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Protease Inhibitor
|
1 participants
|
9 participants
|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Any major DRM
|
2 participants
|
91 participants
|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Major NRTI
|
1 participants
|
61 participants
|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Major NNRTI
|
2 participants
|
88 participants
|
|
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Major protease Inhibitor
|
1 participants
|
9 participants
|
Adverse Events
Standard of Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard of Care
n=355 participants at risk
Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
|
Intervention
n=349 participants at risk
POC VL and targeted DRM testing.
POC VL and targeted DRM testing.: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL\>1000 copies/mL) is detected.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
0.28%
1/355 • Number of events 1 • The adverse events were reported from enrollment to approximately 12 months after enrollment for each participant.
|
0.00%
0/349 • The adverse events were reported from enrollment to approximately 12 months after enrollment for each participant.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place