N/A
N=704
Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
Chronic HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT03820323 ↗Enrolled (actual)
704
Serious AEs
0.1%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants With Viral Suppression — 289; 283 participants — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- POC VL and targeted DRM testing. (Diagnostic_test); SOC VL testing (Diagnostic_test)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Viral Suppression |
289; 283 | 0.55 |
| SECONDARY Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed |
42; 36 | 0.28 |
| SECONDARY Number of Participants Who Underwent POC VL Testing |
167; 349; 185; 301; 131; 177 | — |
| SECONDARY Turn-around Time for the VL Testing Results |
15; 1 | — |
| SECONDARY Number of Children With Any or Major Drug Resistance Mutations (DRMs) |
2; 107; 1; 61; 2; 88 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03820323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.