- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820323
Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy (Opt4Kids)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Intervention Arm:
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kisumu, Kenya
- Rtcp-Faces
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children aged 1-14 years living with HIV (documented HIV positive)
- On first-line ART per Kenyan National Guideline or
- Newly initiating ART
Exclusion Criteria:
- On second-line, third-line, or non-standard first-line ART
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 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.
Other Names:
|
Experimental: Intervention
POC VL and targeted DRM testing.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Viral Suppression
Time Frame: 12 months after enrollment
|
Viral Load <1000 copies/mL at 12 months after enrollment
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12 months after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed
Time Frame: 12 months post enrollment
|
Among children newly initiating ART or initially virologically unsuppressed, we then evaluated the virological suppression status at 12 months post-enrollment.
|
12 months post enrollment
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Number of Participants Who Underwent POC VL Testing
Time Frame: Every 3 months within the 12 months study period
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The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.
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Every 3 months within the 12 months study period
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Turn-around Time for the VL Testing Results
Time Frame: Every 3 months within the 12 months study period
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The time it takes for viral load results to be received by health care providers and participants.
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Every 3 months within the 12 months study period
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Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Time Frame: 12 months post enrollment
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The number of children tested for DRMs with any or major mutations within each class of HIV drugs.
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12 months post enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rena Patel, MD, MPH, University of Washington
- Principal Investigator: Lisa L Abuogi, MD, MSc, University of Colorado, Denver
Publications and helpful links
General Publications
- Patel RC, Oyaro P, Thomas KK, Wagude J, Mukui I, Brown E, Hassan SA, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Karauki E, Yongo N, Otieno L, John-Stewart GC, Abuogi LL. Point-of-care HIV viral load and targeted drug resistance mutation testing versus standard care for Kenyan children on antiretroviral therapy (Opt4Kids): an open-label, randomised controlled trial. Lancet Child Adolesc Health. 2022 Oct;6(10):681-691. doi: 10.1016/S2352-4642(22)00191-2. Epub 2022 Aug 18.
- Patel RC, Oyaro P, Odeny B, Mukui I, Thomas KK, Sharma M, Wagude J, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, John-Stewart GC, Abuogi LL. Optimizing viral load suppression in Kenyan children on antiretroviral therapy (Opt4Kids). Contemp Clin Trials Commun. 2020 Oct 27;20:100673. doi: 10.1016/j.conctc.2020.100673. eCollection 2020 Dec.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY000004861
- R34MH115769 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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