Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy (Opt4Kids)
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|ClinicalTrials.gov Identifier: NCT03820323|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2019
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic HIV Infection||Diagnostic Test: POC VL and targeted DRM testing.||Not Applicable|
The study design will be a randomized, controlled study to pilot the use of POC VL and DRM testing in children aged 1-14 years on first-line ART. Children enrolling at each site will be randomized 1:1 to two study arms.
Standard of Care Arm:
Participants in the Standard-of-Care (SOC) control arm will receive the standard-of-care VL and DRM testing based on the existing Kenyan national guidelines. VL testing will be 6 months after ART initiation (then every 3 months if unsuppressed, otherwise every 12 months) with DRM testing only if failing second-line ART. Children who have a high lab-based HIV VL (≥1,000 copies/mL) will receive intensive adherence counseling and be asked to return to the clinic in 3 months for repeat HIV VL testing. If the HIV VL remains high (≥1,000 copies/mL), the children will be managed per Kenya national guidelines.
Children in the intervention arm will undergo POC VL testing every 3 months for a total of 12 months. "Targeted" DRM testing will include DRM testing for each child on the first detection of lack of viral suppression (VL > 1000 copies/mL) and in children newly initiating ART.
The investigators will follow the viral outcomes 12 months after the implementation of POC VL testing and compare VL suppression rates, defined as VL <1000 copies/mL by the Kenyan national guidelines, among intervention vs. control arms, accounting for pre-intervention VL suppression rates.
The primary outcome for Aim 1 is rates of viral suppression (defined as VL <1000 copies/mL) at 12 months after POC VL testing implementation at the three facilities. The secondary outcome for Aim 1 is time to viral suppression among those children without viral suppression at their 1st POC VL testing or newly initiating ART after POC VL testing implementation. In Aim 2, the investigators intend to evaluate the impact of targeted HIV DRM testing on viral suppression in the intervention arm only. The investigators will also explore how sociodemographic, behavioral, clinical, and facility factors may be contributing to the DRM patterns they observe.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||704 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized control trial of two study arms|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Investigators and those conducting the analysis will be blinded to arm allocation|
|Official Title:||Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy|
|Actual Study Start Date :||March 7, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: Standard of Care
Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines. DRM testing will be done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.
POC VL and targeted DRM testing.
Diagnostic Test: 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.
- Rates of viral suppression [ Time Frame: 12 months after point-of-care viral load testing ]Viral Load <1000 copies/mL at 12 months after point-of-care viral load testing
- Time to viral suppression [ Time Frame: 12 months post enrollment ]Time needed to viral suppression among those children without viral suppression at their 1st POC VL testing or newly initiating ART after POC VL testing implementation.
- Feasibility of POC VL testing [ Time Frame: Every 3 months within the 12 months study period ]The proportion of children undergoing VL testing within each group at the scheduled intervals.
- Turn-around time for the VL testing results [ Time Frame: Every 3 months within the 12 months study period ]The time it takes for viral load results to be received by health care providers and participants.
- Retention-in-care [ Time Frame: 12 months after point-of-care viral load testing ]proportion of children in care at the end of the study
- Proportion of children switched to 2nd line ART [ Time Frame: 12 months after point-of-care viral load testing ]Proportion of children on 2nd line ART tab the 12- month study visit
- Time to switch to 2nd line ART [ Time Frame: 12 months post enrollment ]The time it takes to switch to 2nd line ART after Virological failure
- Proportion of children with drug resistance mutations (DRMs) [ Time Frame: 12 months post enrollment ]The proportion of children tested for DRMs with significant mutations within each class of HIV drugs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820323
|Principal Investigator:||Rena Patel, MD, MPH||University of Washington|
|Principal Investigator:||Lisa L Abuogi, MD, MSc||University of Colorado, Denver|