In 1994, the Pediatric Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group 076 demonstrated a 68% reduction in perinatal human immunodeficiency virus (HIV) transmission giving zidovudine (ZDV) during pregnancy, intrapartum, and to the neonate for the first six weeks after birth.1 The U.S. Public Health Service published guidelines2 that same year for use of this regimen to prevent perinatal transmission and, in 1995, published guidelines3 for universal HIV counseling and voluntary testing of pregnant women. Maternal highly active antiretroviral therapy (HAART) was recommended in 1998. The combination of HAART, avoidance of breastfeeding, and cesarean delivery when the viral load is >1,000 copies/milliliter subsequently reduced the transmission rate to 2%.4 The number of perinatally acquired AIDS cases reported in the United States decreased to 48 in 2002 from 945 in 1992.5 This decline in transmission rate suggested that more aggressive public health efforts can eliminate perinatal HIV infection. One important barrier to eliminating perinatal transmission is unknown HIV status among women who present in labor. The more recent advent of rapid HIV testing6 and short-course therapy7–11 provides opportunities for hospitals to target this particular subgroup of women for testing and treatment.
In January 2002, the New Jersey Department of Health and Senior Services (NJDHSS) disseminated its “Standard of Care for Women Who Present in Labor with Unknown HIV Serostatus”12 (hereafter, Standard of Care) after a hospital survey, administered in 2000, revealed that none of the selected New Jersey (NJ) hospitals had policies for rapid HIV testing or short-course therapy.13 The Standard of Care stated that a woman of unknown HIV status presenting in labor should be offered a rapid HIV test.
NJDHSS repeated the hospital survey in 2003 to see how the Standard of Care had impacted hospital HIV testing practices in labor and delivery (L&D).13 Almost all (96%) of the 24 respondent hospitals were aware of the Standard of Care, but only 67% used rapid HIV testing, and an additional 17% had plans to implement rapid HIV testing within the next six months. Eighty-nine percent of the hospitals that offered testing during labor offered short-course therapy if a rapid HIV test gave a preliminary positive result.
Both the national and NJ recommendations for rapid HIV testing and short-course therapy have had an impact on successfully reducing perinatal transmission in NJ. Every year, from July through September, NJDHSS administers its Survey of Childbearing Women, an anonymous, unlinked survey that screens for HIV and the presence of ZDV among random blood specimens left over from routine heel sticks of approximately 30,000 of the state's newborns.14 This survey estimates HIV seroprevalence among NJ's childbearing women and the frequency of ZDV use to prevent transmission. The 2004 Survey of Childbearing Women analysis showed a 55% decrease in perinatal HIV exposures from 1990 to 2002, and an increase in ZDV use for HIV-positive women, from 8% in 1993 to 91% in 2004.2 The decreased frequency of perinatal exposures reflected success in educating hospitals and patients about the need for HIV testing and treatment to prevent transmission. However, seven perinatally acquired HIV infections occurred in NJ in 2004, and there continue to be additional cases each year.13
The rapid HIV test is a valuable tool in reducing peri-natal transmission during labor because it can detect HIV infection with enough time to administer short-course therapy. It can target women who present in labor without having received any prenatal care (PNC), and whose HIV status is unknown. It is estimated that 25% of HIV-infected women in NJ do not receive PNC; in addition, some women have refused previous testing and others do not know their test results.16 In 2005, only 29% of U.S. hospitals with L&D departments provided rapid HIV tests during labor, and only 2% of hospitals provided rapid testing at the point of care (POC) (i.e., in the L&D unit).17,18
During that same year, we conducted a survey of NJ birthing hospitals. The purpose of the survey was twofold: (1) determine whether the NJDHSS Standard of Care guidelines have resulted in the implementation of rapid HIV testing in L&D for all women of unknown HIV status and (2) examine the barriers to implementation of HIV counseling, testing, and treatment policies throughout all stages of pregnancy and delivery. The results were used to devise additional training, education, and guidelines to achieve maximal reduction in perinatal transmission.
METHODS
In 2004, the Health Research and Educational Trust (HRET), an affiliate of the American Hospital Association, developed and conducted a nationwide survey19 of rapid HIV testing and short-course therapy in L&D. The HRET survey was modified to obtain information specific to NJ hospitals' policies and practices in relation to HIV counseling, testing, and treatment during PNC, L&D, and postpartum. Hospital demographic data—including the number of beds, number of births, perinatal care level, teaching status, Ryan White Title IV status, hospital catchment areas, county poverty level, county per capita income, and region—were linked to survey responses using grouped categories to preclude identifying individual institutions.
The University of Medicine and Dentistry of New Jersey Institutional Review Board and NJDHSS's Institutional Review Board granted an exemption because the survey responses would not be linked to identifying information on the hospitals or the survey respondents.
The survey, conducted electronically by the HRET of the New Jersey Hospital Association using Web Surveyor,20 was e-mailed to the vice presidents of nursing at all 66 hospitals with obstetric services. One survey could be completed for each individual hospital, incorporating information from multiple units within the hospital. The vice presidents of nursing, or other knowledgeable staff in each facility, were asked to discuss the questions with appropriate units so as to reflect the policies and activities of the entire organization. The hospitals could complete and submit the anonymous survey online, via e-mail, or by fax.
Hospitals were given two weeks to complete the survey. Follow-up e-mail reminders were sent after the first week and two days before the deadline. To improve the response rate, additional e-mails from the six Maternal and Child Health Consortia members were sent to encourage the nurse managers at nonrespon-dent hospitals to complete the survey. Data collection was conducted from July through mid-September of 2005.
We analyzed a database of responses with identifiers removed using SAS® version 9.1.21 We calculated frequencies for each variable to determine how many hospitals were following the NJDHSS and Centers for Disease Control and Prevention (CDC) recommendations for counseling and testing policies, rapid HIV testing, treatment, and follow-up protocol; and to examine the use of the rapid HIV test in relation to testing, treatment, and birth outcomes. We used Fisher's exact tests to examine the differences in characteristics among hospitals with and without rapid HIV tests. Seven hospitals were excluded from the analysis because they were not providing birthing services.
RESULTS
Characteristics of respondent hospitals
Fifty-nine completed surveys were returned, for a 100% response rate. Where responding hospitals omitted answers to selected survey questions, we indicated that the denominator was <59. Characteristics of the responding hospitals (Table) were provided by the HRET/New Jersey Hospital Association. These characteristics (e.g., number of beds and number of births) were not significantly associated with whether or not rapid HIV testing was routinely implemented within the hospitals' L&D departments.
Table.
Characteristics of New Jersey birthing hospitals, 2005 (n=59)
aP-values were calculated using the number 56 because data were missing for three hospitals with respect to availability of rapid testing.
bHospitals were categorized to care levels from basic to regional based on their authorization to provide expected care to neonates by gestational age and weight and to maternity patients by increasing risk level.
HIV = human immunodeficiency virus
df = degree of freedom
HIV counseling, testing, and barriers
Hospitals were queried on whether they had established counseling and testing policies and practices. Fifty-six hospitals (94.9%) had PNC counseling and testing policies. Forty-three hospitals (72.9%) incorporated the HIV test in a routine prenatal battery of tests. Fourteen hospitals (23.7%) tested all women without HIV test results in their record, and two hospitals (3.4%) tested women based on risk factors.
Fifty-six hospitals (94.9%) reported having a policy for routine written documentation of HIV status in L&D. All three hospitals (5.1%) that did not have documentation policies reported testing fewer than half of their L&D patients with unknown HIV status. Thirty-four hospitals (57.6%) had a policy for counseling women with unknown HIV status in L&D, and 39 hospitals (66.1%) had a policy for testing. The three hospitals (5.1%) that did not have counseling available in L&D had PNC counseling policies. One hospital (1.7%) with routine PNC testing had no testing available in L&D.
Seven hospitals (11.9%) included HIV testing in a routine panel of tests for all women presenting in L&D, while 46 hospitals (78.0%) tested all women without results in their record, four hospitals (6.8%) did risk-based testing, one hospital (1.7%) did not offer the test in L&D, and one hospital (1.7%) with an L&D testing policy did not report its protocol. Hospitals with routine testing in L&D tested a greater percentage of patients of unknown HIV status (χ2 [degree of freedom (df)] = 4, p =0.025). Of those 46 hospitals offering the HIV test to all women without HIV test results in the prenatal record, 26% tested <50% of those of unknown status, 5% tested 50%-80% of unknown status, 10% tested 81%-90% of unknown status, 33% tested 91%–99% of unknown status, 5% tested 100% of unknown status, and 21% did not know the percentage of patients of unknown HIV status tested in L&D.
Twenty-one of 59 hospitals (35.6%) reportedly did not provide HIV testing as part of routine L&D care. Of these 21 hospitals, 15 (71.4%) provided information on barriers to providing routine HIV testing in L&D (Figure 1). These barriers reflect the tendency for health-care providers to view legislation and regulation as a limitation to HIV testing, rather than a facilitator of it, and to follow outdated policy by testing based on perceived risk.
Figure 1.
Barriers for New Jersey hospitals that did not provide routine HIV testing in labor and delivery to women of undocumented HIV status (n=15) in 2005
HIV = human immunodeficiency virus
Forty hospitals (67.8%) counseled and tested the mother with her consent postpartum if she hadn't been tested before delivery. Five hospitals (8.5%) did not offer counseling, and seven hospitals (11.9%) did not perform testing postpartum. Hospitals without postpartum counseling or testing were less likely to routinely test for HIV in L&D (p<0.05).
Consent policies
The majority of the 59 NJ birthing hospitals used an opt-in approach to HIV testing by requiring written informed consent in PNC (89.8%) and L&D (94.9%) (Figure 2).
Figure 2.
Informed consent policy in prenatal care and labor and delivery among New Jersey hospitals with HIV testing available in labor and delivery (n=56) in 2005
HIV = human immunodeficiency virus
PNC = prenatal care
L&D = labor and delivery
HIV rapid testing and barriers in L&D
Of the 56 hospitals (94.9%) with HIV testing available in L&D, 36 (64.3%) used the rapid HIV test for initial screening, and 20 (35.7%) did not use the rapid HIV test in L&D at all. Of these 20 hospitals without rapid testing in L&D, 10 had enzyme immunoassays available for initial screening and 10 respondents did not specify their initial screening test.
The availability of the rapid HIV test was not significantly associated with rates of testing women of unknown HIV status, and it was not significantly associated with whether hospitals incorporated a policy for routine documentation of HIV status in L&D. Hospitals with rapid HIV testing in L&D were more likely to receive HIV test results in a timely manner: 51.5% of hospitals with rapid HIV testing and 0% of hospitals without it received results in less than one hour (χ2 [df] = 3, p =0.0001). Of the hospitals with rapid HIV testing capabilities, those that never conducted rapid HIV testing in L&D were more likely to receive results in more than 24 hours.
When asked where rapid HIV testing was performed for women in L&D, 12 out of 56 (21.4%) hospitals with HIV testing capability answered “at the point of care” (POC). Twenty-seven (48.2%) hospitals performed the rapid HIV test in the hospital laboratory and five (8.9%) hospitals used an offsite laboratory. One (1.8%) hospital selected both L&D and hospital laboratory, three (5.4%) hospitals selected both hospital laboratory and offsite, and eight (14.3%) hospitals did not know where rapid HIV testing was performed. Ten of the 56 hospitals (17.9%) always performed the rapid HIV test at the POC. Those hospitals that always performed the rapid test at the POC were significantly more likely to have policies for testing patients of unknown HIV status in L&D than those hospitals that used POC testing <100% of the time (χ2 [df] = 2, p =0.0323). The percentage of patients showing up in L&D with unknown HIV status was not significantly associated with whether or not rapid HIV testing was performed at the POC.
A phlebotomist performed POC rapid HIV testing at 10 of the 56 hospitals (17.9%), while six hospitals (10.7%) used a nurse, one (1.8%) used a resident physician, and one (1.8%) used an HIV counselor. Two hospitals (3.6%) used both a nurse and phlebotomist and one hospital (1.8%) used a phlebotomist, nurse, resident physician, and attending physician. Twenty-three hospitals (41.2%) never tested at the POC, and 12 hospitals (21.4%) did not know who performs the rapid HIV test at the POC. If a nurse performed the rapid HIV test in L&D, it was significantly more likely to be done at the POC (χ2 [df] = 1, p =0.031). A hospital laboratory director or designated laboratory personnel oversaw quality assurance for the rapid HIV test at the POC in 27 hospitals (48.2%), while the remaining hospitals with quality assurance programs used an overseer of unspecified title. One hospital (1.8%) did not have a quality assurance program for POC rapid HIV testing.
Forty-one hospitals (73.2%) provided information on why rapid HIV testing is not always conducted at the POC if it is being done in the hospital laboratory ( Figure 3). Important barriers to conducting the rapid HIV test at the POC were regulatory issues, organizational requirements, state or local laws, and privacy issues. NJ hospitals were less likely to have an issue with the administration of the rapid HIV test itself, obtaining a laboratory license, or quality control.
Figure 3.
New Jersey hospitals conducting rapid HIV testing in the laboratory in 2005: barriers to testing at the point of care (n=41)
HIV = human immunodeficiency virus
Clinical management
Forty of 51 responding hospitals (78.4%) provided HAART to mother and neonate as soon as possible, one (2.0%) gave HAART to the neonate only, three (5.9%) waited for confirmatory results, three (5.9%) did not have HAART available, one (2.0%) transferred to a tertiary hospital, two (3.9%) treated based on physician orders, and one (2.0%) did not know. The HAART varied from hospital to hospital.
Of the three hospitals without HAART in L&D, two had HAART available in their hospital pharmacy's formulary 24/7 and the third had HAART available in its hospital pharmacy formulary, but not 24/7.
The majority of hospitals had policies for informing the pediatrician of the newborn's HIV exposure, providing HAART, and educating the mother. However, seven of 58 responding hospitals (12.1%) did not always inform the pediatrician, 11 of 56 responding hospitals (19.6%) did not have policies and procedures to provide neonatal HAART, 13 of 56 responding hospitals (23.2%) did not provide maternal education about repeat testing for the newborn, 14 of 53 responding hospitals (26.4%) did not provide maternal education about medications for the child, 11 of 54 responding hospitals (20.4%) did not have policies to refer the exposed newborn to a physician with HIV expertise, and 12 of 54 responding hospitals (22.2%) did not have policies to refer the mother to a physician with HIV expertise.
DISCUSSION
Reducing perinatal HIV transmission remains a priority for NJDHSS. It is estimated that two out of every three females living with HIV/AIDS in NJ are currently 20-49 years of age.22 With an estimated 9,000 HIV-infected childbearing women, NJ has benefited from the availability of an effective intervention that prevents perinatal transmission. Although there has been great success in reducing transmission, its continued occur-rence indicates missed prevention opportunities and underscores the need to ensure adequate, appropriate PNC for all pregnant women. For women who have not received PNC, or whose HIV status is unknown, rapid HIV testing and short-course prophylaxis can effectively prevent HIV transmission to the neonate during L&D.
The majority of U.S. hospitals were using an opt-in consent approach in L&D, but many physicians felt that this strategy was burdensome and time-consuming.23 Data show that either an opt-out HIV testing approach or mandatory testing of all newborns results in increased HIV testing rates and, thus, more opportunities for intervention.24 The NJ Pregnancy Risk Assessment Monitoring System found higher rates of HIV counseling and testing among subgroups (e.g., black and uninsured populations) perceived to be at greater risk of HIV.25 Without universal HIV screening of pregnant women, HIV-positive women may be overlooked in low-risk subgroups.
CDC recommends universal opt-out testing that does not require written, informed consent specific for the HIV test; a second HIV test during the third trimester; opt-out rapid HIV screening for a woman whose HIV status is still unknown at the time of delivery; and rapid HIV testing of the newborn as soon as possible after birth, so HAART can be offered to the HIV-exposed infants.26 Data from 2008 show that 10 states mandate HIV testing for newborns.27 Twenty-two states use an opt-out approach, requiring that health-care providers test for HIV during pregnancy unless the woman refuses. Twenty-eight states, the District of Columbia, and Puerto Rico have opt-in consent; eight of those states recommend routine offering of an HIV test, and the rest have no specific requirement.
This 2005 survey revealed that not all NJ hospitals were uniformly following the Standard of Care and they were inconsistent in the ways they counseled and tested for HIV in L&D. Rapid HIV testing was still not available in all hospitals and was not always offered at the POC when available. Many health-care providers followed outdated protocols and tested pregnant women based on perceived risk; missed opportunities persisted. Our survey findings complemented epidemiologic data on persistent vertical transmission to bring about a revision of NJ law. Legislation signed into law in December 2007 became effective in June 2008 requiring opt-out testing of pregnant women during routine PNC, opt-out testing of women in labor with unknown HIV status, and mandatory testing of newborns whose HIV status is unknown.28,29 This new law reinforces the most recent CDC recommendations, including rapid HIV testing for women in labor. Under NJ's new legislation, providers should be more likely to screen as early as possible in the pregnancy, and for women with unknown HIV status, to provide rapid HIV testing in L&D. In cases where the mother refuses testing, testing and treatment of the newborn can still reduce transmission rates.
This survey assessed barriers to hospitals providing HIV testing. However, despite hospital policies, missed opportunities may persist due to patient barriers. HIV-positive women who know that they or their sexual partner is HIV-infected may not seek medical care for HIV during the index pregnancy or report the information to health-care providers.30 Patients may be reluctant to reveal their HIV status, thus underscoring the need for proper documentation and accessibility of HIV test results and an opt-out rapid testing policy in L&D. The most common reason for a woman to decline HIV testing in one study was that she had already been tested during pregnancy.18 However, antibody testing for HIV early in PNC may miss women who have an acute HIV infection at the time of testing.31 NJ's new law recommends a second HIV test during the third trimester as part of routine PNC to further reduce perinatal transmission.28
Limitations
This study was subject to several limitations. Due to the survey's anonymity, this study was limited in its ability to directly link information on testing policies to failures to identify HIV-positive mothers and babies and provide treatment. Although it is not certain whether NJ hospitals with rapid HIV testing had better outcomes than those without rapid HIV testing or whether routine testing gives better outcomes than risk-based testing, implementation of the new opt-out testing requirements in all NJ hospitals will likely further reduce the number of perinatally acquired HIV infections.
Another limitation of this anonymous survey was the inability to link policies to hospitals; therefore, training could not be targeted toward specific hospitals in need of policy implementation or change. The survey, which was conducted in 2005, also may not reflect the current status at NJ hospitals, particularly because the new legislation was enacted in late 2007. Training can now focus on uniform policies and practices, statewide, under the new law.
CONCLUSIONS
NJ has had great success in reducing perinatal transmission rates despite the variability in hospital counseling and testing practices. Although analysis of hospital characteristics did not reveal any significant differences among hospitals that did and did not routinely rapid test, it is likely that the hospitals that followed Standard of Care guidelines screened and treated the largest proportion of infected pregnant women in NJ. Otherwise, a greater number of HIV-infected infants would have been born.
With the goal of virtually eliminating perinatal HIV transmission in NJ, hospitals are now moving forward to implement the revised CDC recommendations against the backdrop of the recently implemented NJ legislation. In the future, a similar survey will be administered to evaluate policies, procedures, and practices for preventing HIV transmission. Our survey results have helped to improve the likelihood that NJ hospitals will further reduce perinatal HIV transmission from women of unknown HIV status presenting to hospitals in labor.
Acknowledgments
The authors acknowledge Linda Dimasi and Dr. Helene Cross for provision of the epidemiologic data related to perinatal human immunodeficiency virus transmission in New Jersey; Dr. Polly Thomas for her expert advice on this project; and Ellen Dufficy for assistance with data collection.
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