HIV Polymerase Chain Reaction Test Research Articles

Evaluation of an SMS-based mHealth intervention to enhance early infant diagnosis follow-up testing and assessment of postnatal prophylaxis.

BackgroundAdherence to infant antiretroviral (ARV) postnatal prophylaxis and early infant diagnosis (EID) uptake is low in Africa. Promoting EID and adherence are necessary for this age group.ObjectivesWe evaluated an SMS-based mobile health (mHealth) intervention to enhance adherence to ARV prophylaxis and knowledge of EID and prevention of mother-to-child transmission (PMTCT) among high-risk and low-risk mother–infant pairs.MethodTwo hundred and fifty-one mothers were recruited from King Edward VIII Hospital between December 2018 and October 2019. Participant information was captured, and SMS reminders were sent postnatally to promote immunisation attendance. Follow-up HIV polymerase chain reaction (PCR) test results were reviewed, and telephonic interviews were utilised for qualitative data.ResultsIn all, 73.3% of infants had HIV PCR tests performed at 10 weeks. This high rate could be attributed to the mHealth intervention as this is considerably higher than other national studies, though not statistically significant compared to rates reported in the district at the same time. Factors that have impacted follow-up EID rates include poor maternal knowledge of EID time points and inadequate implementation of national PMTCT protocols. High-risk mothers were younger, commenced antenatal clinic visit later, were less knowledgeable on prophylaxis and have lower-birthweight infants than lower-risk mothers.ConclusionmHealth can play an important role in improving EID by increasing maternal knowledge. Further studies should focus on whether maternal education over an mHealth platform can increase knowledge on PMTCT and subsequently increase EID.

The outcome of prevention of mother-to-child transmission of HIV infection at King Abdulaziz University Hospital, Western Region of Saudi Arabia: A Descriptive Study.

Objectives:To describe the effectiveness of HIV guidelines in prevention of mother-to-child transmission (PMTCT).Methods:A retrospective review from January 2009 to December 2018 at the King Abdulaziz University Hospital (KAUH), Jeddah, Kingdom of Saudi Arabia. The main outcome measures were characteristics of HIV-exposed patients and transmission rate.Results:A total of 18 HIV-positive mothers and their 26 infants were included. The mean age of mothers at delivery was 31.69 years, and 50% were under 30 years old. All mothers received lifelong ART, except one who was not diagnosed until the 27th week of gestation. Among the mothers, 83% complied with treatment regimens, and 11% had ART resistance. Human immunodeficiency virus polymerase chain reaction (PCR) was undetectable in 19 pregnancies. Seven mothers had opportunistic infections and treatment was immediately initiated. After reviewing the infants’ HIV PCR tests, the transmission rates of HIV were 0% for both spontaneous vaginal delivery and cesarean section.Conclusion:Many challenges face the efforts to decrease vertical HIV transmission, and a particular focus on the transitions between stages of care is needed. We believe that early screening, counseling, and regular follow-up have contributed to MTCT elimination.

Piloting the Feasibility and Preliminary Impact of Adding Birth HIV Polymerase Chain Reaction Testing to the Early Infant Diagnosis Guidelines in Kenya.

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.

Factors associated with the timely uptake of initial HIV virologic test among HIV-exposed infants attending clinics within a faith-based HIV program in Kenya; a cross-sectional study

BackgroundEarly infant diagnosis (EID) of HIV, followed by effective care including antiretroviral therapy (ART), reduces infant mortality by 76% and HIV progression by 75%. In 2015, 50% of 1.2 million HIV-exposed infants (HEI) in 21 priority countries received a virologic test within the recommended 2 months of birth. We sought to identify factors associated with timely uptake of virologic EID among HEI and gain insight into missed opportunities.MethodsThis was a cross-sectional study that used de-identified data from electronic medical records of 54 health facilities within the Christian Health Association of Kenya (CHAK) HIV Project database. All HEI who had their first HIV virologic test done between January 2015 and December 2017 were included in the study and categorized as either having the test within or after 8 weeks of birth. Multivariate linear mixed effects regression model was used to determine factors associated with uptake of the first HIV EID polymerase chain reaction (PCR). Predictor variables studied include sex, birth weight, the entry point into care, provision of ART prophylaxis for the infant, maternal ART at time of EID, mode of delivery, and place of delivery.ResultsWe included 2020 HEI of whom 1018 (50.4%) were female. A majority, 1596 (79.0%) had their first HIV PCR within 2 months of birth at a median age of 6.4 weeks (interquartile range 6–7.4). Overall, HIV positivity rate at initial test among this cohort was 1.2%. Delayed HIV PCR testing for EID was more likely to yield a positive result [adjusted odds ratio (aOR) = 1.29 (95% confidence interval (CI) 1.09–1.52) p = 0.003]. Infants of mothers not on ART at the time of HIV PCR test and infants who had not received prophylaxis to prevent vertical HIV transmission had significant increased odds of a delayed initial test [aOR = 1.27 (95% CI = 1.18–1.37) p = < 0.0001] and [aOR = 1.43 (95% CI 1.27–1.61) p = < 0.001] respectively.ConclusionAn initial HIV PCR test done after 8 weeks of birth is likely to yield a positive result. Barriers to accessing ART for treatment among HIV-infected pregnant and breastfeeding women, and prophylaxis for the HEI were associated with delayed EID. In order to ensure timely EID, programs need to incorporate both facility and community strategy interventions to ensure all pregnant women seek antenatal care and deliver within health facilities.

HIV testing at birth: Are we getting it right?

BackgroundBirth polymerase chain reaction (PCR) testing improves early detection of HIV and allows for early treatment initiation. National guidelines exist, but it is unknown whether these are being implemented correctly.ObjectivesTo determine whether HIV-exposed infants at the Mangaung University Community Partnership Programme Community Health Centre (MUCPP CHC) received PCR tests at birth, if HIV-positive infants were initiated on treatment, if follow-up dates were scheduled and the percentage of mothers or caregivers who returned to collect the results.MethodsThe study was a retrospective descriptive file audit (1304 files) of births from 01 January to 31 December 2016 at MUCPP CHC. The study sample was 428 infants born to HIV-positive mothers. The birth register was used to collect the infants’ HIV PCR test barcodes. The birth and 10-week PCR results were retrieved from an electronic database at the Virology Department, University of the Free State.ResultsIn total, 375 infants received a birth PCR test (87.6%) of which 4 (1.1%) tested HIV positive and 327 (87.2%) negative. Follow-up tests were not scheduled. However, 145 (44.3%) HIV-negative infants returned for a 10-week test. Irrespective of the PCR birth result, 157 (36.7%) infants were brought for a 10-week follow-up test at which time 3 (1.9%) tested positive and 151 (96.2%) negative.ConclusionThe majority of HIV-exposed infants received a PCR test at birth; however, the clinic is below the national target (90%) for HIV testing. A record-keeping system of infants’ visits does not exist at MUCPP CHC, making it impossible to determine whether HIV-positive infants were started on antiretroviral treatment.

Leveraging the Road to Health booklet as a unique patient identifier to monitor the prevention of mother-to-child transmission programme.

Currently there is no unique patient identification system in the South African public health sector. Therefore, routine laboratory data cannot effectively be de-duplicated, thereby hampering surveillance of laboratory-diagnosed diseases such as mother-to-child transmission of HIV. To determine the uptake of Road to Health booklet (RTHB) identifiers at HIV polymerase chain reaction (PCR) birth test and describe their performance in linking follow-up test results in the early infant diagnosis programme. Between May 2016 and May 2017, Tshwane District Clinical Services implemented a unique patient identifier pilot project in which a sticker-page of unique, readable, barcoded patient identifiers was incorporated in the patient-retained immunisation record (the RTHB) before distribution. Uptake of RTHB identifiers at birth was calculated as the proportion of HIV PCR tests in infants aged &lt;6 days registered with an RTHB identifier over the total number of registered HIV PCR tests. Descriptive analysis of demographic details was performed among infants with two registered HIV PCR tests linked by the RTHB identifier, and performance of the National Health Laboratory Service Corporate Data Warehouse (NHLS CDW)-linking algorithm in matching RTHB-linked results was calculated using a 2 × 2 table. A total of 5 309 HIV PCR birth tests registered with an RTHB identifier were extracted from the NHLS CDW over the 13-month period of the pilot project. The number of registered RTHB identifiers increased from 24 (2% of birth PCR tests) in May 2016, peaking at 728 (56% of birth PCR tests) in May 2017. Among infants with a registered RTHB identifier at birth, 635 (12%) had a subsequent linked HIV PCR test, as indicated by the same RTHB number registered for a later specimen. Demographic details at the time of birth and subsequent PCR test were compared, demonstrating that &lt;4% of infants had exact matches for name, surname, date of birth and sex; 74% of birth tests had variations such as 'born to' or 'baby of ' in place of a first name; surnames matched exactly in 61% of cases; 18% (n=116) of infants had both tests performed at the same facility, of which only 27% (n=31) had the same patient folder number on both test results. Leveraging RTHBs as unique patient identifiers, even if used temporarily until linkage to other future national unique identifiers, promises to be an effective scalable approach to laboratory-based surveillance, facilitating healthcare provider access to all test results from birth.

Introduction of Routine HIV Birth Testing in the South African National Consolidated Guidelines.

South Africa represents the first high-burden setting to introduce routine virologic testing at birth within its early infant diagnosis program, implemented in June 2015. National HIV birth testing coverage, intrauterine transmission rates and case rates for the first year since introduction of universal birth testing are reported. HIV polymerase chain reaction (PCR) test data from June 2015 to May 2016 were extracted from the National Health Laboratory Service's central data repository by year, month, age, result and geographic location. Birth testing was defined as all HIV PCR tests performed at <7 days of life; coverage as the proportion of all HIV-exposed neonates born who were tested at birth; estimated intrauterine transmission rate as the percentage of HIV PCR positive tests in HIV-exposed neonates tested and case rates as the number of HIV PCR positive tests per 100,000 total live births. Between June 2015 and May 2016, the South African national monthly birth testing coverage increased from 39% (8636 tests) to 93% (20,479 tests). During this period, the number of positive tests at birth increased from 114 to 234 per month, equating to a national intrauterine transmission rate of 1.1% and a birth case rate of 247 per 100,000 live births. Universal birth testing for all HIV-exposed neonates is rapidly being achieved in South Africa, facilitating earlier detection of intrauterine infected neonates. However, the successful linkage into care of HIV-infected neonates and their treatment outcomes remain to be assessed.

Antiretroviral Treatment Initiated in the First Month of Life.

Earlier diagnosis of HIV-infected infants facilitates earlier access to therapy and improved clinical outcomes. The aim of this study was to describe the management of infants who started antiretroviral therapy (ART) in the first month of life. A retrospective review was performed on HIV-infected neonates who started ART within the first month of life between January 2013 and March 2015. A total of 997 neonates had 1 HIV polymerase chain reaction test. Of the 997 neonates, 26 (2.6%) tested positive for HIV and 22 initiated therapy in the first month of life. The median age of first HIV polymerase chain reaction test was 7 days. Neonates were started on ART within a median of 7 days of their first HIV test, which equated to a median age of 13.5 [interquartile range (IQR) 7-20] days of life. Median gestational age was 35 weeks (IQR 33-38 weeks), and birth weight was 2170 g (IQR 1773-2480). Nineteen (86.4%) had low birth weight (<2.5 kg) and 16 (72.7%) were premature. Median baseline HIV viral loads were log 4.444 copies/mL (IQR 3.457-5.125), median CD4 counts were 1338 (IQR 803-1928) and CD4% percentages were 36.1% (22.2-45.4). All children initiated zidovudine and lamivudine, 10 with lopinavir/ritonavir and 12 with nevirapine. All children in care are now receiving lopinavir/ritonavir. Of the 22 neonates initiated on treatment, 11 are in care (mean age, 2.1 years), and 2 of these infants had a viral load of <50 copies/ mL when last measured. Early ART initiation in neonates is feasible. Challenges include safe, palatable regimens and continued close follow-up of mothers and infants.

Birth Point of Care (POC) HIV polymerase chain reaction testing in a primary care setting, South Africa

Birth Point of Care (POC) HIV polymerase chain reaction testing in a primary care setting, South Africa

Effectiveness of an SMS-based maternal mHealth intervention to improve clinical outcomes of HIV-positive pregnant women

ABSTRACTWe conducted a retrospective study to investigate the effectiveness of an mHealth messaging intervention aiming to improve maternal health and HIV outcomes. Maternal health SMSs were sent to 235 HIV-infected pregnant women twice per week in pregnancy and continued until the infant’s first birthday. The messages were timed to the stage of the pregnancy/infant age and covered maternal health and HIV-support information. Outcomes, measured as antenatal care (ANC) visits, birth outcomes and infant HIV testing, were compared to a control group of 586 HIV-infected pregnant women who received no SMS intervention. Results showed that intervention participants attended more ANC visits (5.16 vs. 3.95, p < 0.01) and were more likely to attend at least the recommended four ANC visits (relative risk (RR): 1.41, 95% confidence interval (CI): 1.15–1.72). Birth outcomes of intervention participants improved as they had an increased chance of a normal vaginal delivery (RR: 1.10, 95% CI: 1.02–1.19) and a lower risk of delivering a low-birth weight infant (<2500 g) (RR: 0.14, 95% CI: 0.02–1.07). In the intervention group, there was a trend towards higher attendance to infant polymerase chain reaction (PCR) testing within six weeks after birth (81.3% vs. 75.4%, p = 0.06) and a lower mean infant age in weeks at HIV PCR testing (9.5 weeks vs. 11.1 weeks, p = 0.14). These results add to the growing evidence that mHealth interventions can have a positive impact on health outcomes and should be scaled nationally following comprehensive evaluation.

Uptake of early infant diagnosis in Thailand's national program for preventing mother-to-child HIV transmission and linkage to care, 2008-2011.

IntroductionEarly infant diagnosis (EID) has been a component of Thailand's prevention of mother-to-child HIV transmission (PMTCT) programme since 2007. This study assessed the uptake, EID coverage, proportion of HIV-exposed infants receiving a definitive HIV diagnosis, mother-to-child transmission (MTCT) rates and linkage to HIV care and treatment.MethodsInfant polymerase chain reaction (PCR) testing data from the National AIDS Program database were analyzed. EID coverage was calculated as the percentage of number of HIV-exposed infants receiving ≥1 HIV PCR test divided by the number of HIV-exposed infants estimated from HIV prevalence and live-birth registry data. Definitive HIV diagnosis was defined as having two concordant PCR results. MTCT rates were calculated based on infants tested with PCR and applied as a best-case scenario, and a sensitivity analysis was used to adjust these rates in average and worst scenarios. We defined linkage to HIV care as infants with at least one PCR-positive test who were registered with Thailand's National AIDS Program. Chi-squared tests for linear trend were used to analyze changes in programme coverage.ResultsFor 2008 to 2011, the average EID coverage rate increased from 54 to 76% (p<0.001), with 65% coverage (13,761/21,099) overall. The number of hospitals submitting EID samples increased from 458 to 645, and the percentage of community hospitals submitting samples increased from 75 to 78% (p=0.044). A definitive HIV diagnosis was made for 10,854 (79%) infants during this period. The adjusted MTCT rates had significantly decreasing trends in all scenarios. Overall, an estimated 53% (429/804) of HIV-infected infants were identified through the EID programme, and 80% (341/429) of infants testing positive were linked to care. The overall rate of antiretroviral treatment (ART) initiation within one year of age was 37% (157/429), with an increasing trend from 28 to 52% (p<0.001).ConclusionsEID coverage increased and MTCT rates decreased during 2008 to 2011; however, about half of HIV-infected infants still did not receive EID. Most HIV-infected infants were linked to care but less than half initiated ART within one year of age. Active follow-up of HIV-exposed infants to increase early detection of HIV infection and early initiation of ART should be more widely implemented.

Time to implement 9-month infant HIV testing in South Africa.

South Africa (SA) is likely to meet the National Strategic Plan target of &lt;2% mother-to-child HIV transmission at 6 weeks of age in 2015. Children infected with HIV after 6 weeks often remain undiagnosed because of poor implementation of post-weaning and final outcome 18-month HIV testing. The World Health Organization recommends a screening HIV rapid test (HRT) in HIV-exposed infants at the 9-month immunisation visit to exclude postnatal infection, with a confirmatory HIV polymerase chain reaction (PCR) test if the HRT is positive. To evaluate the impact of substituting this recommendation for the post-weaning HIV testing recommended by SA guidelines. Rates of seroreversion and probability of infection at 9 months of age were applied to a theoretical population of 100 HIV-exposed infants, uninfected at birth and breastfed for 1 year with antiretroviral prophylaxis. Nine scenarios were developed and the number of HIV PCRs saved compared with current guidelines was calculated. Nine-month testing using the HRT reduced the number of follow-up PCR tests done in all scenarios by &gt;50%, with differences ranging from 51% to 59% and 81% to 89% for low and high seroreversion rates, respectively. Nine-month testing using HRT would increase identification and early treatment of HIV-infected infants, improve monitoring of postnatal transmission rates, and reduce the number of HIV PCR tests done with resultant cost saving. Training of healthcare workers implementing HRT would be required. Ongoing efforts to improve implementation and monitoring of testing at 9 and 18 months will be essential.

Infections in HIV-exposed uninfected children with focus on sub-Saharan Africa.

Infections in HIV-exposed uninfected children with focus on sub-Saharan Africa.

Identifying missed opportunities for early intervention among HIV-infected paediatric admissions at Chris Hani Baragwanath hospital, Soweto, South Africa

Background and design. HIV is a major contributor to childhood morbidity and mortality in South Africa. We describe HIV prevalence, disease profile, outcome and missed opportunities for early intervention in a cohort of HIV-infected children admitted to Chris Hani Baragwanath Hospital’s general paediatric wards between 1 October and 31 December 2007. &#x0D; &#x0D; Results. Of 1 510 admissions, 446 (29.5%) were HIV-infected. Many children (238, 54.1%) were newly diagnosed in hospital and most had advanced HIV disease (405, 92%). The principal admission diagnoses were pneumonia (165, 37.5%), gastro-enteritis (97, 22%), sepsis (86, 19.5%) and tuberculosis (92, 21%). Of children identified as HIV infected before admission, 128/202 (63.4%) were not accessing antiretroviral treatment (ART), although 121/128 (94.5%) met ART eligibility criteria. Of 364 ART-naïve eligible children, only 15 (4.1%) were commenced on ART as inpatients. Problems with PMTCT implementation in infants under 6 months (N=166) included lack of maternal antenatal HIV testing (51, 30.7%); poor uptake of maternal/infant nevirapine prophylaxis (60, 36.2%); limited use of co-trimoxazole (CTX) prophylaxis (44/147, 29.9%); and delayed infant HIV polymerase chain reaction testing (98/147, 87.5%). Of infants known to be HIV infected prior to hospitalisation, 37/51 (73%) had not initiated ART. The in-hospital case fatality rate (CFR) among HIV-infected children was triple that of the combined HIV-uninfected, exposed and unknown group (12% v. 3.6%). Infants

Optimal Time on HAART for Prevention of Mother-to-Child Transmission of HIV

To determine the impact of time between initiating highly active antiretroviral therapy (HAART) and delivery-duration of antenatal HAART-on perinatal HIV infection. We conducted a retrospective cohort analysis of pregnant HIV-infected women in Lusaka, Zambia. Women in our cohort were receiving HAART and had an infant HIV polymerase chain reaction test between 3 and 12 weeks of life. We examined factors associated with infant HIV infection and performed a locally weighted regression analysis to examine the effect of duration of antenatal HAART on perinatal HIV infection. : From January 2007 to March 2010, 1813 HIV-infected pregnant women met inclusion criteria. Mean gestational age at first antenatal visit was 21 weeks (SD ± 6), median CD4+ cell count was 231 cells per microliter (interquartile range: 164-329), and median duration of antenatal HAART was 13 weeks (interquartile range 8-19). Fifty-nine (3.3%) infants were HIV infected. Duration of antenatal HAART was the most important predictor of perinatal HIV transmission. Compared with women initiating HAART at least 13 weeks before delivery, women on HAART for ≤4 weeks had a 5.5-fold increased odds of HIV transmission (95% confidence interval: 2.6 to 11.7). Locally weighted regression analysis suggested limited additional prophylactic benefit beyond 13 weeks on antenatal HAART. Low rates of mother-to-child HIV transmission can be achieved within programmatic settings in Africa. Maximal effectiveness of prevention of mother-to-child transmission programs is achieved by initiating HAART at least 13 weeks before delivery.

Breastfeeding, Mother-to-Child HIV Transmission, and Mortality Among Infants Born to HIV-Infected Women on Highly Active Antiretroviral Therapy in Rural Uganda

Highly active antiretroviral therapy (HAART) drastically reduces mother-to-child transmission of HIV, but where breastfeeding is the only safe infant feeding option, HAART for the prevention of mother-to-child transmission needs to be evaluated in relation to both HIV transmission and infant mortality. One hundred and two > or = 18-year old women on HAART in rural Uganda who delivered one or more live infants between March 1, 2003 and January 1, 2007 were enrolled in a prospective study to assess HIV transmission and infant survival. All pregnant women were counseled to exclusively breastfeed for 3-6 months according to national guidelines at the time. Infants were followed-up for > or = 7 months and were offered HIV polymerase chain reaction testing quarterly from 6 weeks of age until > or = 6 weeks after complete weaning. Of 118 infants born during follow-up, 109 (92%) were breastfed. Median durations of exclusive and total breastfeeding were 4 months (interquartile range 3-6) and 5 months (interquartile range 3-7), respectively. None of the infants tested HIV polymerase chain reaction positive over follow-up but 16 infants died without a definitive HIV status at a median age of 2.6 months. In total, 23 (19%) infants died during follow-up at a median age of 3.7 months; 15 (65%) of whom with severe diarrhea and/or vomiting in the week preceding their death. In multivariate analysis, there was a 6-fold greater risk of death among infants breastfed for less than 6 months independent of maternal CD4 count closest to delivery, maternal marital status or maternal death (adjusted hazard ratio = 6.19; 95% confidence interval 1.41-27.0, P = 0.015). In resource-constrained settings, HIV-infected pregnant women should be assessed for HAART eligibility and treated as needed without delay, and should be encouraged to breastfeed their infants for at least 6 months.

Evaluation of a Regional Pilot Program to Prevent Mother-Infant HIV Transmission--Thailand, 1998-2000

This evaluation report summarizes an evaluation of the 2-year pilot program in Thailand initiated by the Ministry of Public Health in 1998-2000. The program was created to prevent mother-to-infant HIV transmission in a rural area in northeastern Thailand. It also highlights the rapid translation of research findings into a national public health prevention program in developing countries. The program involved the integration of routine antenatal counseling and voluntary confidential HIV testing into public antenatal clinic services. In addition HIV-infected women were offered zidovudine and free powdered infant formula for 12 months. Assessment of the programs coverage acceptability and impact involved an interview with women whose HIV status was not documented at delivery and with HIV-infected women. Meanwhile HIV polymerase chain reaction tests were used to assess the programs effectiveness in preventing HIV transmission. Overall the findings have indicated the high acceptance of HIV testing and adherence to zidovudine as well as reduction of HIV transmission. Moreover the findings demonstrate the feasibility of implementing programs for the prevention of mother-infant HIV transmission on a large scale in the country.

Vertical transmission of HIV in New York State: a basis for statewide testing of newborns.

Infants (n = 313) of HIV-infected mothers were enrolled (mean age 1.9 weeks, range 0-8 weeks) in a 3-year prospective study of vertical transmission. Fifty-six infants (17.9%) had laboratory and clinical evidence of HIV infection. Polymerase chain reaction (PCR) provided early and reliable identification of infected infants. Thirty-one of the 56 infected infants had specimens submitted when the infants were 4 weeks of age or less and 30 (97%) tested PCR positive. This percentage increased to 100% by 8 weeks of age when 51 of the 56 infected infants had specimens tested for that time period. Immune complex dissociation (ICD) antigen testing was a sensitive method for diagnosis of infection but only in infants older than 1 month. p24 antigen testing, although free of false positives, is less sensitive than either of the other methods. Among surrogate markers of HIV infection, elevation of soluble CD8 levels precedes an increase in immunoglobulin levels or a decline in CD4 T lymphocytes. Vertical transmission is significantly lower in Central and Western New York State than other regions. Transmission is significantly higher in low birthweight babies and in infants whose mothers have CD4 counts < 500. This study provided the basis for establishing a Pediatric HIV PCR Testing Service for the early diagnosis of HIV infection in neonates.