Background:
Early mortality among infants with HIV is high and peaks at 2-3 months of age. Late diagnosis delays access to antiretroviral treatment (ART), often past the mortality peak. We assessed the impact of a point-of-care (PoC) HIV early infant diagnosis (EID) test & treat strategy at birth on viral suppression and mortality up to 24 weeks of age among HIV-infected infants in Mozambique and Tanzania.
Methods:
We conducted a cluster-randomized trial at 28 public health facilities. Intervention arm A sites (n=14) provided PoC EID and immediate nurse-directed, physician-supported ART initiation for positive infants at birth, while control arm B sites (n=14) offered PoC EID and linkage to ART from 4-6 weeks of age. Infant ART at birth included nevirapine-based regimens, and by 4-6 weeks infants were switched or started on lopinavir/r granule-based regimens. Study visits were conducted at birth, 4-6 weeks, 12 weeks and 24 weeks. The Kaplan-Meier method was used to compare survival between arms. Mixed-effects Cox proportional-hazards models adjusted for time of HIV infection with standard errors clustered at the health facility level were used to estimate hazard ratios (aHR). Proportions of infants virally suppressed (< 1000 copies/ml) at 24 weeks of age between arms are reported.
Results:
Among 6606 infants enrolled, 3298 in arm A and 3308 in arm B, 124 were diagnosed HIV-infected by 12 weeks of age (transmission rate 1.88%; 95% CI: 1.56, 2.23). HIV infection was detected at birth, 6 weeks and 12 weeks in 64 (51.6%), 40 (32.3%), and 20 (16.1%) infants, respectively. Overall, ART was initiated in 116 (93.5%) infants within 2 days of diagnosis, including 35/38 (92.1%) infants diagnosed at birth. Proportions of infants virally suppressed at 24 weeks of age did not differ between arms, and were 7/30 (23.3%) in arm A and 6/22 (27.3%) in arm B with available viral load. After a median follow-up time of 23.9 weeks (IQR: 12.9, 26.3), 4 (5.8%) infants in arm A died at median 17.6 weeks, significantly lower than 8 (14.5%) in arm B at median 14.9 weeks (aHR 0.27; 95% CI: 0.08, 0.90; Figure 1).
Conclusions:
PoC test & treat at birth was feasible in resource-limited settings and resulted in a relative reduction of 73% in early mortality among HIV-infected infants. The combination of PoC EID at birth with dolutegravir-based infant ART might improve the poor viral suppression observed with LPV/r granules, potentially further enhancing the beneficial impact of birth test & treat on infant mortality.
Figure 1: Survival over time according to intervention group (A: PoC EID and ART initiation from birth; B: PoC EID and linkage to ART initiation at 4-6 weeks of age), with follow-up duration of 24 weeks of age (total n=124). Censored values (+) indicate last known follow-up time for infants still at risk. 