Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy

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

Interventions

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.

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Kenya Medical Research Institute

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Rena Patel, MD, MPH · University of Alabama at Birmingham

• Lisa L Abuogi, MD, MSc · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-07

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Kenya

Study Locations