Using novel point-of-care HIV drug resistance testing to optimize viral suppression rates among children living with HIV (Opt4Kidsplus)
Rena Patel, MD, MPH
BACKGROUND: Children living with HIV under 15 years of age receiving antiretroviral treatment (ART) and living in resource-limited settings have suboptimal virologic suppression, the hallmark of successful HIV treatment. Among children with virologic failure in Kenya, over 90% have drug resistance mutations, putting them at risk for clinical deterioration and limiting future drug options.
GAP: Drug resistance testing in Kenya is currently very limited thus leaving clinicians without critical information that impacts the clinical management of children with HIV. Point-of-care drug resistance mutation testing may have the potential to significantly improve the management of children with HIV who are failing treatment by rapidly informing clinicians on what drugs will be effective.
HYPOTHESIS: We hypothesize that a novel point-of-care drug resistance test, OLA Simple, will identify resistance mutations with sensitivity and specificity comparable to traditional resistance testing. Further, we hypothesize that OLA Simple’s usability will be rated highly, and its costs/sample tested will be lower than traditional consensus sequence testing.
METHODS: We propose to leverage the NIH-funded Opt4Kids study-a randomized, controlled study to pilot the use of point-of-care viral load testing among 700 children aged 1-14 years on ART in Kisumu, Kenya- to validate the use of OLA Simple through retrospective batch testing of already collected blood samples and explore usability and costs of OLA Simple through prospective pilot testing in Kenya.
IMPACT: Findings from this study will help prepare the OLA Simple technology for clinical use, where rapid return of HIV resistance testing results, within the same clinical visit, could lead to change in clinical management. This study will also directly inform treatment monitoring algorithms in resource limited settings for children with HIV and help achieve the UNAIDS 90-90-90 goals.