A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia

Author:

Chibwesha Carla J12ORCID,Mollan Katie R3,Ford Catherine E12,Shibemba Aaron4,Saha Pooja T3,Lusaka Mildred2,Mbewe Felistas2,Allmon Andrew G3,Lungu Rose2,Spiegel Hans M L5,Mweni Emmanuel2,Mwape Humphrey2,Kankasa Chipepo6,Chi Benjamin H12,Stringer Jeffrey S A12

Affiliation:

1. Division of Global Women’s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

2. UNC Global Projects–Zambia, Lusaka, Zambia

3. Biostatistics Core, Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

4. Department of Pathology and Microbiology, University Teaching Hospital, Lusaka, Zambia

5. Kelly Services, Rockville, Maryland, USAand

6. Department of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia

Abstract

Abstract Background Point-of-care (POC) early infant diagnosis (EID) provides same-day results and the potential for immediate initiation of antiretroviral therapy (ART). Methods We conducted a pragmatic trial at 6 public clinics in Zambia. HIV-exposed infants were individually randomized to either (1) POC EID (onsite testing with the Alere q HIV-1/2 Detect) or (2) enhanced standard of care (SOC) EID (off-site testing at a public laboratory). Infants with HIV were referred for ART and followed for 12 months. Our primary outcome was defined as alive, in care, and virally suppressed at 12 months. Results Between March 2016 and November 2018, we randomized 4000 HIV-exposed infants to POC (n=1989) or SOC (n=2011). All but 2 infants in the POC group received same-day results, while the median time to result in the SOC group was 27 (interquartile range: 22–30) days. Eighty-one (2%; 95% confidence interval [CI]: 1.6–2.5%) infants were diagnosed with HIV. Although ART initiation was high, there were 15 (19%) deaths, 15 (19%) follow-up losses, and 31 (38%) virologic failures. By 12 months, only 20 of 81 (25%; 95% CI: 15–34%) infants with HIV were alive, in care, and virally suppressed: 13 (30%; 16–43%) infants in the POC group vs 7 (19%; 6–32%) in the SOC group (RR: 1.56; .7–3.50). Conclusions POC EID eliminated diagnostic delays and accelerated ART initiation but did not translate into definitive improvement in 12-month outcomes. In settings where centralized EID is well functioning, POC EID is unlikely to improve pediatric HIV outcomes. Clinical Trials Registration This trial is registered at https://clinicaltrials.gov (NCT02682810).

Funder

National Institutes of Health

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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