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Piloting the Feasibility and Preliminary Impact of Adding Birth HIV Polymerase Chain Reaction Testing to the Early
Sarah Finocchario-Kessler1, Catherine Wexler1, Melinda Brown1
1From the Department of Family Medicine, University of Kansas Medical Center, Kansas City, Missouri.
Insights
Adding polymerase chain reaction (PCR) testing at birth significantly increased early infant diagnosis (EID) for HIV-exposed infants in Kenya. A majority of infants received timely testing and early antiretroviral therapy initiation, improving outcomes.
Area of Science:
- Public Health
- Infectious Diseases
- Pediatrics
Background:
- Standard early infant diagnosis (EID) in Kenya using 6-week polymerase chain reaction (PCR) testing results in delayed treatment initiation for less than 20% of HIV-positive infants.
- New guidelines proposed adding PCR testing at birth, pending pilot study results, to improve early detection and treatment.
Purpose of the Study:
- To evaluate the feasibility and uptake of adding PCR testing at birth to the existing EID strategy in Kenya.
- To assess the proportion of infants tested at birth, 6 weeks, and both time points, and to determine the median age of results and antiretroviral therapy initiation.
Main Methods:
- A pilot study was conducted in 4 Kenyan hospitals between November 2017 and November 2018.
- HIV-exposed infants were offered point-of-care and PCR HIV testing at birth (0 to <4 weeks) and at 6 weeks (4-12 weeks).
- Data collected included testing proportions, age at results, seropositivity, and antiretroviral therapy initiation.
Main Results:
- Of 590 infants enrolled before 4 weeks, 76.6% completed birth testing, with 39.4% tested before hospital discharge.
- Mothers received birth PCR results at a median infant age of 5.4 weeks.
- 92.1% of all infants were tested at 6 weeks, and 66.8% received testing at both birth and 6 weeks. Four infants were diagnosed with HIV, and 3 were initiated on antiretroviral therapy before 12 weeks.
Conclusions:
- Uptake of PCR testing at birth was high in the pilot study.
- A majority of infants received repeat testing at 6 weeks, indicating successful integration into the EID program.
- Adding birth testing to the EID strategy shows promise for earlier HIV diagnosis and treatment initiation in infants.
Background:
In Kenya, standard early infant diagnosis (EID) with polymerase chain reaction (PCR) testing at 6-week postnatal achieves early treatment initiation (<12 weeks) in <20% of HIV+ infants. Kenya's new early infant diagnosis guidelines tentatively proposed adding PCR testing at birth, pending results from pilot studies.
Methods:
We piloted birth testing at 4 Kenyan hospitals between November 2017 and November 2018. Eligible HIV-exposed infants were offered both point-of-care and PCR HIV testing at birth (window 0 to <4 weeks) and 6 weeks (window 4-12 weeks). We report the: proportion of infants tested at birth, 6-week, and both birth and 6-week testing; median infant age at results; seropositivity and antiretroviral therapy initiation.
Results:
Final sample included 624 mother-infant pairs. Mean maternal age was 30.4 years, 73.2% enrolled during antenatal care and 89.9% had hospital deliveries. Among the 590 mother-infants pairs enrolled before 4 weeks postnatal, 452 (76.6%) completed birth testing before 4 weeks, with 360 (79.6%) testing within 2 weeks, and 178 (39.4%) before hospital discharge (0-2 days). Mothers were notified of birth PCR results at a median infant age of 5.4 weeks. Among all 624 enrolled infants, 575 (92.1%) were tested during the 6-week window; 417 (66.8%) received testing at both birth and 6-weeks; and 207 received incomplete testing (93.3% only 1 PCR and 6.7% no PCR). Four infants were diagnosed with HIV, and 3 infants were initiated on antiretroviral therapy early, before 12 weeks of age.
Conclusions:
Uptake of PCR testing at birth was high and a majority of infants received repeat testing at 6 weeks of age.
