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Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a
Emma Sacks1,2, Jennifer Cohn3, Bernard Ochuka4
1Department of Global Health, George Washington School of Public Health, Washington, DC.
Insights
Point-of-care (POC) early infant diagnosis (EID) significantly improves the return of HIV test results for infants. This approach also speeds up treatment initiation for infants diagnosed with HIV.
Area of Science:
- Public Health
- Infectious Disease Epidemiology
- Diagnostic Technologies
Background:
- The World Health Organization recommends HIV-exposed infants receive early diagnostic testing.
- Timely return of results for early infant diagnosis (EID) remains a challenge, with few infants receiving results by 12 weeks.
- Point-of-care (POC) testing offers a potential solution to improve the timeliness of EID.
Purpose of the Study:
- To assess the impact of routine POC EID compared to laboratory-based EID on the return of results by 12 weeks of age.
- To evaluate the effect of POC EID on the time to results receipt and antiretroviral therapy (ART) initiation for HIV-infected infants.
Main Methods:
- A cluster-randomized stepped-wedge trial was conducted in Kenya and Zimbabwe.
- 18 health facilities in each country were randomized to the timing of POC implementation.
- 9,539 infants underwent testing: 5,115 with laboratory-based EID and 4,424 with POC EID.
Main Results:
- Caregivers were significantly more likely to receive EID results by 12 weeks with POC testing in both Kenya (1.29 times) and Zimbabwe (4.56 times).
- POC EID substantially reduced the time to results receipt by an average of 23.03 days in Kenya and 62.37 days in Zimbabwe.
- For HIV-infected infants, POC EID significantly increased ART initiation rates and reduced the time to treatment initiation.
Conclusions:
- POC EID offers a significant advantage in ensuring timely results for caregivers and improving treatment initiation for infected infants.
- POC EID should be implemented in integrated testing systems where laboratory-based EID cannot deliver rapid results.
- The study highlights the effectiveness of POC EID in resource-limited settings for improving infant HIV diagnosis and care.
Background:
Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age.
Methods:
This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation.
Findings:
Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe.
Conclusions:
POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.
