Related Experiment Video
Updated: Oct 15, 2025
Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model
Published on: October 31, 2010
A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia
Carla J Chibwesha1,2, Katie R Mollan3, Catherine E Ford1,2
1Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Insights
Point-of-care (POC) early infant diagnosis (EID) offers rapid results for HIV-exposed infants, speeding up antiretroviral therapy (ART) initiation. However, this study found POC EID did not significantly improve 12-month health outcomes compared to standard care.
Area of Science:
- Pediatric infectious diseases
- Public health interventions
- HIV/AIDS research
Background:
- Early infant diagnosis (EID) of HIV is crucial for timely antiretroviral therapy (ART) initiation.
- Point-of-care (POC) EID offers same-day results, potentially reducing diagnostic delays.
Purpose of the Study:
- To evaluate the impact of POC EID on 12-month health outcomes in HIV-exposed infants.
- To compare POC EID with enhanced standard of care (SOC) EID in Zambia.
Main Methods:
- A pragmatic trial randomized 4000 HIV-exposed infants to POC EID or SOC EID.
- Infants diagnosed with HIV were referred for ART and followed for 12 months.
- The primary outcome was defined as alive, in care, and virally suppressed at 12 months.
Main Results:
- POC EID provided same-day results, significantly reducing the time to diagnosis compared to SOC EID (median 27 days).
- ART initiation was high in both groups, but only 25% of infants with HIV achieved the primary outcome by 12 months.
- There was a trend towards better outcomes in the POC EID group (30% vs 19%), but this did not reach statistical significance.
Conclusions:
- POC EID effectively eliminates diagnostic delays and accelerates ART initiation.
- Despite faster diagnosis, POC EID did not translate into a significant improvement in 12-month pediatric HIV outcomes in this setting.
- In areas with well-functioning centralized EID systems, POC EID may not be necessary to improve outcomes.
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).
