Clinical versus rapid molecular HIV diagnosis in hospitalized african infants: A randomized controlled trial simulating point-of-care infant testing

OBJECTIVE: Many African infants fail to receive their diagnostic HIV molecular test results and subsequently, antiretroviral therapy (ART). To determine whether a point-of-care molecular HIV test increases ART access for hospitalized Malawian infants, we simulated a point-of-care test using rapid HIV RNA polymerase chain reaction (Rapid PCR) and compared patient outcomes with an optimized standard care that included assessment with the World Health Organization clinical algorithm for HIV infection plus a DNA PCR with a turnaround time of several weeks (standard care). DESIGN: Randomized controlled trial. METHODS: Hospitalized HIV-exposed Malawian infants aged <12 months were randomized into Rapid PCR or standard care. Rapid PCR infants obtained molecular test results within 48 hours to facilitate immediate ART, similar to a point-of-care test. Standard care infants meeting clinical criteria were also offered inpatient ART. The primary outcome was appropriate in-hospital ART for DNA or RNA PCR-confirmed HIV-infected infants. RESULTS: Three hundred infants were enrolled. A greater proportion of HIV-infected infants receiving Rapid PCR, versus standard care, started inpatient ART (72.3% vs 47.8%, P = 0.016). Among molecular test-negative infants, 26.9% receiving standard care unnecessarily initiated inpatient ART, versus 0.0% receiving Rapid PCR (P < 0.001). Rapid PCR modestly reduced the median days to ART (3.0 vs 6.5, P = 0.001) but did not influence outpatient follow-up for HIV-infected infants (78.1% vs 82.4%, P = 0.418). CONCLUSIONS: Rapid PCR, versus an optimized standard care, increased the proportion of hospitalized HIV-infected infants initiating ART and reduced ART exposure in molecular test-negative infants, without meaningfully impacting time to ART initiation or follow-up rates.