With global guidelines shifting to universal antiretroviral therapy (ART) for HIV+ children, strategies are needed to scale-up ART efficiently while ensuring good clinical outcomes. Data on children initiating ART at high CD4 counts are particularly limited. We evaluated retention in care, viral suppression, and safety in asymptomatic HIV+ children starting ART at CD4> 500 cells/μl in rural African clinics using a streamlined ART delivery system.
In 16 rural Ugandan and Kenyan clinics, HIV+ adults and children were offered ART (SEARCH Study, NCT:01864603) in 2013-15. We studied children 2-14 years old who initiated ART with CD4 >500 cells/μl and were ineligible for ART by country guidelines. Streamlined care included: (1) nurse-driven triage and visits focused on symptom-based ART toxicity screening, (2) on-site nurse referral of complex cases to a physician, (3) a patient-centered care system, fostering a welcoming/ supportive environment, (4) viral load (VL) measurement and structured VL counseling, (5) provision of 3 months’ ART refills, and (6) appointment reminders and patient tracking. Patients had visits at baseline, 4, 12, then every 12 weeks. VL and basic safety laboratory tests were assessed at baseline, 24 and 48 weeks.
Overall, 77 HIV+ children initiated ART. Median age was 8 years (IQR 6-11), 56% were female, and 34% were orphans from mother/father/both. No prior + HIV test was reported by 43/77(56%). At baseline, children had a median VL of 14,851 copies/ml (IQR 1,651-66,479) and a median CD4 count of 847 cells/μl (IQR 659-1,103). Overall, 74/77(96%) of children were retained at week 48. Two children withdrew consent when they moved out of the study area and one because the parent declined ART. One child was last seen at enrollment, another at 12 weeks. There were no deaths. Overall, 3/77 (4%) patients had grade III or IV clinical adverse events, including thrombocytopenia(III), and neutropenia (III) and rash(IV). One patient each switched from nevirapine and abacavir due to rash. Viral suppression was achieved in 62/68 (91%) children tested at 48 weeks (see table).
HIV+ children 2-14 years old with CD4>500 cells/μl receiving ART in rural African clinics employing streamlined ART delivery had 94% retention in care at 48 weeks with 91% viral suppression among those tested. This suggests that as nations adopt universal ART, streamlined nurse-driven care systems can safely and effectively deliver ART to HIV+ children.