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Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy (Opt4Kids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03820323
Recruitment Status : Completed
First Posted : January 29, 2019
Results First Posted : December 27, 2022
Last Update Posted : December 27, 2022
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
University of Colorado, Denver
Information provided by (Responsible Party):
Rena Patel, University of Washington

Brief Summary:
Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as many as 40% of those living in resource limited settings have not achieved virologic suppression. Kenya, a The Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track and The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority country, has an estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90 goal for population-level viral suppression. Feasible, scalable and cost-effective approaches to maximizing durability of first-line ART and ensuring viral load (VL) suppression in HIV-infected children are urgently needed. This pilot study will evaluate two critical components related to viral suppression in children via: 1) Point-of-care (POC) VL testing (Aim 1) and 2) targeted drug resistance mutation (DRM) testing (Aim 2) among children on first-line ART at three facilities within a PEPFAR-funded HIV care and treatment program in Kenya. The hypotheses are: 1) viral suppression rates will be higher among children with access to POC VL testing and time to suppression shorter compared to children with standard VL testing and 2) DRM testing will shorten time to viral suppression and that the investigators will observe high levels of 1st line antiretroviral DRMs among children on ART without viral suppression. This proposal directly addresses the urgent need to find interventions to maximize viral suppression among children on ART and achieve the UNAIDS 90-90-90 goals.

Condition or disease Intervention/treatment Phase
Chronic HIV Infection Diagnostic Test: POC VL and targeted DRM testing. Diagnostic Test: SOC VL testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 704 participants
Allocation: Randomized
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
Primary Purpose: Diagnostic
Official Title: Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
Actual Study Start Date : March 7, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Diagnostic Test: 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.
Other Name: Kenyan National guidelines for viral load testing

Experimental: Intervention
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.

Primary Outcome Measures :
  1. Number of Participants With Viral Suppression [ Time Frame: 12 months after enrollment ]
    Viral Load <1000 copies/mL at 12 months after enrollment

Secondary Outcome Measures :
  1. 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.

  2. Number of Participants Who Underwent POC VL Testing [ Time Frame: Every 3 months within the 12 months study period ]
    The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.

  3. 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.

  4. Number of Children With Any or Major Drug Resistance Mutations (DRMs) [ Time Frame: 12 months post enrollment ]
    The number of children tested for DRMs with any or major mutations within each class of HIV drugs.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

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Kisumu, Kenya
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
University of Colorado, Denver
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Principal Investigator: Rena Patel, MD, MPH University of Washington
Principal Investigator: Lisa L Abuogi, MD, MSc University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by Rena Patel, University of Washington:
Study Protocol  [PDF] March 2, 2022
Statistical Analysis Plan  [PDF] March 11, 2022

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rena Patel, Assistant Professor, Division of Allergy and Infectious Disease, Department of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03820323    
Other Study ID Numbers: STUDY000004861
R34MH115769 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2019    Key Record Dates
Results First Posted: December 27, 2022
Last Update Posted: December 27, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcome measures will be made available after study completion
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After primary outcomes results are published.
Access Criteria: Contact PIs of the study and obtain institutional ethic review approvals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases