Objective
The objective of the study was to assess whether implementation of a statewide initiative was associated with changes in perinatal human immunodeficiency virus (HIV) testing practices.
Study Design
This was an observational cohort study of all 1,141,799 women who delivered in Illinois birthing hospitals over a 7 year period after the introduction of the Perinatal Rapid Testing Implementation in Illinois (PRTII) initiative. Changes in the frequencies of HIV status documentation, rapid test utilization, and newborns discharged with unknown HIV status were assessed.
Results
The comparison of annual data from 2005 to 2011 demonstrated a 63% decrease in women with undocumented HIV status (11.7% vs 4.3%, P < .001), a 98% decrease in women with unknown status who did not receive rapid testing (29.6% vs 0.5%, P < .001), and a greater than 99% decrease in newborns with undocumented status at discharge (2.74% vs 0.01%, P < .001).
Conclusion
This statewide initiative resulted in a significant and sustained increase in the frequency of maternal-baby pairs who were discharged from the hospital with documented HIV status.
The risk of perinatal transmission of human immunodeficiency virus (HIV) among women who are infected with HIV and who receive no prophylactic interventions ranges from 15% to 40% but can be decreased to 1–2% with the use of widely available interventions in well-resourced settings. Even in women not identified as HIV positive until they present in labor, the administration of antiretroviral treatment can reduce transmission by as much as 62%. Because the timely identification of HIV-infected parturients is critical to reducing perinatal infection, in 2006 the Centers for Disease Control and Prevention began to recommend universal screening in pregnant women unless they decline (ie, opt-out screening). Nevertheless, and as recently as 2008, 4% of HIV-infected pregnant women were not known to be positive at the time of delivery.
For Editors’ Commentary, see Contents
In August 2003, Illinois passed the Perinatal HIV Prevention Act (Public Law 95-702). This act mandated the following: (1) counseling about and screening for HIV in all pregnant women as early in prenatal care as possible, (2) documentation of HIV test results in prenatal, labor and delivery and newborn medical records, and (3) offering rapid HIV testing to pregnant women presenting in labor without documented HIV status. No increase in hospital reimbursement accompanied this legislation and providers are not penalized for noncompliance with the law. Six months after the act was passed, only 72% of women who presented to Illinois birthing hospitals had their HIV status documented, and only 38% of hospitals reported routine rapid HIV testing on labor and delivery for women with an undocumented status.
In 2004, the Illinois Department of Public Health funded the Perinatal Rapid Testing Implementation in Illinois (PRTII) initiative to operationalize the policy changes stipulated in the law and achieve complete and effective implementation of rapid testing. This initiative was modeled on the experience of the Mother-Infant Rapid Intervention at Delivery (MIRIAD) study, a multicenter study that offered voluntary rapid HIV testing on labor and delivery units. First, we conducted a statewide needs assessment surveying hospitals, conducting focus groups, and piloting implementation strategies to identify potential barriers to compliance. Second, 4 regional networks, each with a designated coordinator, were created to facilitate regional- and hospital-specific training that included the development of an implementation tool kit consisting of a manual, counseling flip chart, and templates of policies and consent forms. Third, a 24 hour a day, 7 day a week Illinois Perinatal Hotline was created to provide immediate assistance to hospitals caring for a woman with a positive rapid test by offering clinical management consultation, referral services, and case management services. The final component of the PRTII initiative involved ongoing surveillance and tracking of outcomes in a database linked to the Illinois Department of Public Health. The PRTII initiative started in 2004, and all Illinois birthing hospitals had implemented the protocol by September 2005.
The Perinatal HIV Prevention Act was revised in June 2006 to require testing of all neonates born to HIV-undocumented mothers within the first 12 hours postnatally. Fourteen other states have similarly passed legislation that requires HIV testing in pregnancy, 6 of which also mandate newborn testing if maternal status is undocumented. There are 2 reports that associate the initiation of a state mandate with lower mother-to-child HIV transmission rates. However, the quantitative changes in testing practices that led to this decrease were not fully described. Thus, there remains little information about the impact of state-initiated policies on clinical practice.
To understand whether the Illinois legislative mandates were associated with a change in clinical practice, this study was performed to investigate changes in perinatal HIV testing and in HIV status documentation among pregnant women in Illinois after the implementation of PRTII. We hypothesized that, after implementation, there would be progressive increases in both routine and rapid maternal testing for HIV and a decrease in the number of newborns tested after delivery. The sustainability of the intervention was also assessed.
Materials and Methods
The Illinois Perinatal HIV Prevention Act mandates that state birthing hospitals report monthly on the number of women who present with known HIV status, the number of pregnant women and newborn infants who undergo rapid HIV testing, and the number of preliminary and confirmatory positive test results. PRTII staff provided training to all 132 birthing hospitals in the state to collect and submit these data to the perinatal HIV database maintained by PRTII staff and supported by the Illinois Department of Public Health. The brand of rapid HIV test varied by birthing hospital.
A retrospective, population-based study was performed to analyze data submitted to this statewide database from January 2005 to December 2011. Data were collected from birthing hospitals ( Figure 1 ) regarding the total number of women who delivered ( Figure 1 , box a) and the number who presented with documented ( Figure 1 , box b) and undocumented ( Figure 1 , box c) HIV status. A woman was considered to have undocumented status if she had not been tested in the current pregnancy or if her test result could not be confirmed by available prenatal records. Among women who had undocumented HIV status, the number who received rapid testing prior to delivery ( Figure 1 , box d) or immediately postpartum ( Figure 1 , box e) was ascertained (excluding women diagnosed with a fetal demise), as was the number of newborns who received rapid testing because maternal rapid testing was not performed ( Figure 1 , box f).
The number of newborns eligible for rapid testing included multiple gestations and those who were transported to the hospital after delivery but did not have documented maternal HIV status. Pregnant women with undocumented status at delivery who did not have rapid testing were categorized as declined ( Figure 1 , box g) if they were offered testing but refused or as missed ( Figure 1 , box h) if they were not offered the rapid testing prior to delivery (whether because of a clinical oversight or because their duration in the labor and delivery suite because of a precipitous delivery was too short to allow the rapid test). Women were identified as HIV positive if the confirmatory Western blot test also was positive. Finally, the number of newborns discharged from the hospital with an undocumented status was also determined ( Figure 1 , box i).
All data were stratified by quarter of each calendar year. Trends in frequency across years were assessed using χ 2 for trend, whereas comparisons of proportions were done with χ 2 analysis. Relative risks and 95% confidence intervals were calculated as appropriate. A value of P < .05 was used to define statistical significance, and all tests were 2 tailed. All analyses were performed with Minitab 13 (Minitab, Inc, State College, PA) and EpiInfo 7 (Centers for Disease Control and Prevention, Atlanta, GA). Prior to initiation, this study was approved by the Northwestern University Institutional Review Board.
Results
During the 7 year study period, 1,141,799 women delivered in the 132 birthing hospitals in Illinois. The Table presents data for these women, stratified by year, with regard to the testing they received and their HIV serostatus. Of these women, 72,344 (6.3%) presented to a hospital with undocumented HIV status. This frequency was highest during the first year of the study period and declined 63% over the study period (11.7% in 2005 to 4.3% in 2011, P < .001). The proportion of women with unknown status who did not receive rapid testing also significantly declined from 29.6% to 0.5% ( P < .001), a 98% reduction. This decline was due to decreases in both the proportion of women who declined testing (27.0% to 0.3%, P < .001) and the proportion of women in whom rapid testing was missed (2.7% to 0.2%, P < .001).
Variable | 2005 | 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | Total |
---|---|---|---|---|---|---|---|---|
Total deliveries | 141,773 | 175,230 | 175,160 | 171,473 | 160,050 | 159,483 | 155,355 | 1,141,799 |
Undocumented HIV status at presentation, n (%) b | 16,575 (11.7) | 12,902 (7.4) | 10,672 (6.1) | 9502 (5.5) | 8557 (5.4) | 7356 (4.6) | 6878 (4.3) | 72,344 (6.3) |
Rapid testing not performed, n (%) b , c | 4909 (29.6) | 1932 (15.0) | 179 (1.7) | 105 (1.1) | 93 (1.1) | 48 (0.7) | 36 (0.5) | 7302 (10.1) |
Declined, n (%) b , c | 4470 (27.0) | 1845 (14.3) | 110 (1.0) | 65 (0.7) | 61 (0.7) | 32 (0.4) | 19 (0.3) | 6602 (9.1) |
Missed, n (%) b , c | 439 (2.6) | 87 (0.7) | 69 (0.7) | 40 (0.4) | 32 (0.4) | 16 (0.2) | 17 (0.2) | 700 (1.0) |
Rapid testing performed, n (%) b , c | 11,867 (71.6) | 11,161 (86.5) | 10,621 (99.5) | 9478 (99.8) | 8532 (99.7) | 7341 (99.8) | 6863 (99.8) | 65,863 (91.0) |
Maternal, before delivery b | 11,625 | 10,970 | 10,493 | 9397 | 8464 | 7308 | 6842 | 65,099 |
Maternal, after delivery | 0 | 16 | 22 | 14 | 10 | 0 | 5 | 67 |
Neonatal b | 242 | 175 | 106 | 67 | 58 | 33 | 16 | 697 |
Preliminary positive rapid test, n (%) c | 31 (0.19) | 26 (0.20) | 23 (0.22) | 14 (0.15) | 22 (0.26) | 8 (0.11) | 18 (0.26) | 142 (0.20) |
Confirmed positive rapid test, n (%) c | 23 (0.14) | 14 (0.11) | 21 (0.20) | 10 (0.11) | 18 (0.21) | 5 (0.07) | 13 (0.19) | 104 (0.14) |
Documented HIV positive at presentation, n (%) d | 131 (0.10) | 132 (0.08) | 140 (0.09) | 132 (0.08) | 157 (0.10) | 127 (0.08) | 130 (0.09) | 949 (0.64) |
Neonatal unknown HIV status at discharge, n (%) b | 3886 (2.74) | 1732 (0.99) | 42 (0.02) | 26 (0.02) | 19 (0.01) | 14 (0.01) | 8 (0.01) | 5727 (0.50) |