Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy

NCT03820323 | Completed Results

• 2 other identifiers: STUDY000004861R34MH115769
• Study Type: interventional
• Target: 704
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic HIV Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Viral Suppression

  Viral Load \<1000 copies/mL at 12 months after enrollment

  12 months after enrollment

Secondary Outcomes (4)

• Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed

  12 months post enrollment

• Number of Participants Who Underwent POC VL Testing

  Every 3 months within the 12 months study period

• Turn-around Time for the VL Testing Results

  Every 3 months within the 12 months study period

• Number of Children With Any or Major Drug Resistance Mutations (DRMs)

  12 months post enrollment

Study Arms (2)

Standard of Care

OTHER

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

Intervention

EXPERIMENTAL

POC VL and targeted DRM testing.

Diagnostic Test: POC VL and targeted DRM testing.

Interventions

POC VL and targeted DRM testing. DIAGNOSTIC_TEST

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.

Intervention

SOC VL testing DIAGNOSTIC_TEST

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.

Also known as: Kenyan National guidelines for viral load testing

Standard of Care

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1-14 years living with HIV (documented HIV positive)
• On first-line ART per Kenyan National Guideline or
• Newly initiating ART

You may not qualify if:

• On second-line, third-line, or non-standard first-line ART

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator
• Kenya Medical Research Institute: collaborator
• University of Colorado, Denver: collaborator
• University of Washington: collaborator

Study Sites (1)

Rtcp-Faces

Kisumu, Kenya

Location

Related Publications (4)

• Scallon AJ, Hassan SA, Qian SR, Gao Y, Oyaro P, Brown E, Wagude J, Mukui I, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Yongo N, Karauki E, Otieno L, John-Stewart GC, Abuogi LL, Patel RC. "I feel drug resistance testing allowed us to make an informed decision": qualitative insights on the role of HIV drug resistance mutation testing among children and pregnant women living with HIV in western Kenya. BMC Health Serv Res. 2023 Aug 24;23(1):908. doi: 10.1186/s12913-023-09804-x.

  PMID: 37620855 DERIVED

• Qian SRW, Hassan SA, Scallon AJ, Oyaro P, Brown E, Wagude J, Mukui I, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Yongo N, Karauki E, Gao J, Otieno L, John-Stewart GC, Abuogi LL, Patel RC. "After viral load testing, I get my results so I get to know which path my life is taking me": qualitative insights on routine centralized and point-of-care viral load testing in western Kenya from the Opt4Kids and Opt4Mamas studies. BMC Health Serv Res. 2022 Dec 17;22(1):1540. doi: 10.1186/s12913-022-08593-z.

  PMID: 36528677 DERIVED

• 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.

  PMID: 35987208 DERIVED

• 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.

  PMID: 33195874 DERIVED

Limitations and Caveats

First, it is possible we had sample biased towards higher levels of viral suppression (VS). Second, though our package of POC VL testing, DRM testing, and clinical decision support was only offered to intervention group, the same providers cared for participants in intervention and control groups. Third, VS was assessed on different schedules for intervention and control, the intervention group participants had a greater number of opportunities to act on their test results and detect viremia.

Results Point of Contact

• Title: Rena C. Patel
• Organization: University of Washington

rcpatel@uw.edu

206-520-3800

Study Officials

• Rena Patel, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Lisa L Abuogi, MD, MSc

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and those conducting the analysis will be blinded to arm allocation
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial of two study arms

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 29, 2019
• Study Start: March 7, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 10, 2024
• Results First Posted: December 27, 2022

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After primary outcomes results are published.
• Access Criteria: Contact PIs of the study and obtain institutional ethic review approvals.

Locations

KE (1)