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The Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists recommend routine rapid HIV testing in labor and delivery (L&D) for women with undocumented HIV status using an opt-out approach. Identifying factors associated with declining a rapid HIV test in L&D will be helpful in developing strategies to improve rapid HIV testing uptake. Data from the Mother-Infant Rapid Intervention at Delivery study were analyzed. Women ≥24 weeks gestation, in labor, with undocumented HIV status were offered rapid HIV testing using informed consent. Women who declined rapid HIV testing (decliners) but agreed to be interviewed were compared to women who accepted testing (acceptors). 102 decliners and 478 acceptors met inclusion criteria for analysis. Decliners of rapid HIV testing were more likely to have had prenatal care (PNC), after adjusting for age, Hispanic ethnicity, high-school education and city of enrollment (adjusted OR 2.4, 95% CI 1.06-5.58). Having had PNC was collinear with prior HIV education and previous offer of an HIV test during the current pregnancy, so these factors were not part of the model. During PNC, standard informed consent may involve discussions that negatively affect later uptake of testing in L&D. Therefore an opt-out approach to testing may improve testing rates. Furthermore, decliners may have felt that testing in L&D was redundant because of previous testing during PNC; however, if previous testing occurred, this was undocumented at L&D. Documentation and timely communication of HIV status is critical to provide appropriate HIV prophylaxis.

Objective: To evaluate factors associated with receiving prenatal care among women who present in labor without human immunodeficiency virus documentation using the results of a previous study, Mother-Infant Rapid Intervention at Delivery., Design: Prospective, multicenter study., Setting: Eighteen hospitals in the United States., Participants: The present analysis is based on 667 peripartum women who completed a face-to-face interview after delivery. For purposes of this analysis, human immunodeficiency virus-infected and human immunodeficiency virus-uninfected women were considered together as the "study group.", Methods: The original study, Mother-Infant Rapid Intervention at Delivery, offered rapid human immunodeficiency virus testing to women in labor without human immunodeficiency virus testing documentation at 18 hospitals in the United States. This secondary study evaluated factors related to prenatal care, among participants who agreed to an interview after delivery., Results: Interviews were completed by 667 women. Of these, 26.8% reported no prenatal care before admission to labor and delivery. These women were more likely to have been born in the United States, have other children, used alcohol, and reported being unhappy. Those who reported receiving prenatal care were more likely to have had Medicaid, stronger social support, and reported good health., Conclusion: Women who are unlikely to receive prenatal care lack social support and are more likely to have additional social stressors. Medicaid may provide an important safety net to enhance access to care, because those with Medicaid were more likely to receive prenatal care. Further research is necessary to identify nontraditional models of care to enhance outreach to women at risk for no prenatal care.

Objective: To evaluate the acceptability and feasibility of rapid human immunodeficiency virus testing in obstetric outpatient settings., Study Design: The Mother-Infant Rapid Intervention at Delivery (MIRIAD) study was a prospective, multicenter study. Women were offered rapid and conventional human immunodeficiency virus testing if they presented to outpatient settings late in pregnancy with undocumented human immunodeficiency virus status. We compared median times between conventional and rapid testing and between rapid point-of-care and rapid laboratory-based testing., Results: Among eligible women who were offered participation, 90% accepted testing. The median time from blood draw to result available was faster for rapid testing (25 minutes) than conventional testing (23 hours; P < .0001). For rapid tests, point-of-care testing was faster than laboratory-based testing (24 minutes vs 35 minutes; P < .0001). Almost 96% of rapid test results were available within 1 hour., Conclusion: Rapid human immunodeficiency virus testing is acceptable, feasible, and provides results far sooner than conventional testing in obstetric outpatient settings.

Objective: To determine if women with undocumented HIV status in late pregnancy or at labor and delivery who are rapidly tested and identified as HIV infected have high-risk behaviors and psychosocial obstacles hindering postpartum follow-up., Methods: Consenting participants (women with undocumented HIV status and > or =24 weeks gestational age (GA) and imminent delivery or > or =34 weeks GA) in 6 cities were rapidly tested and interviewed. HIV-positive women were offered follow-up., Results: From 2001-2005, 54 HIV-infected women were identified: median age 26 years; 91% African American; 11 (20%) lost custody of their infants; 30 (56%) knew they or their partner were HIV-infected, but had no antenatal HIV care; 25 met criteria for starting antiretroviral therapy. Comparison between 48 HIV-infected and 130 HIV-negative women, tested and interviewed at the same hospitals, showed HIV-infected women more likely to be African American (P < .01) and report no prenatal care (P < .001), use street drugs (P < .01), have unstable residency (P < .05), not live with the father of their infant (P < .001), and have children in foster care (P < .01). Sixteen women (30%) and 17 (31%) infants did not remain in follow-up study due to relocation, child protective custody, and psychosocial issues including frequent substance use., Conclusion: Over half of HIV-infected women knew they or their partner were infected with HIV, but did not initially disclose their status. Increased support services and substance abuse treatment are critical to facilitate better continuity of care for these socially marginalized women.

Objective: To determine factors associated with prenatal HIV testing in women who accepted rapid testing at delivery., Methods: The mother-infant rapid intervention at delivery (MIRIAD) protocol offered counseling and voluntary HIV testing in six US cities including New York City (NYC). These hospitals are required to document the HIV status of pregnant women or their infants. From January 2002 to January 2005, 653 HIV-negative women were interviewed post-partum., Results: 63% of women reported prior HIV testing during the index pregnancy, although their results were not available at delivery. Multivariate logistic modeling identified receipt of prenatal care and delivery in NYC as being associated with having been offered prenatal HIV testing. In a model restricted to women receiving medical care, emergency department (ED) use and delivery outside of NYC were associated with not having been offered testing. In a model restricted to women who were offered prenatal testing, acceptance was associated with delivery outside of NYC., Conclusions: Improved documentation of prenatal test results, expanded prenatal testing in non-traditional settings like EDs, and routine voluntary "opt-out" testing during pregnancy may further reduce perinatal HIV transmission.

Objective: The purpose of this study was to describe characteristics of pregnant women with newly acquired human immunodeficiency virus (HIV) infection that was identified by repeat testing., Study Design: The Centers for Disease Control and Prevention-sponsored Mother-Infant Rapid Intervention at Delivery (MIRIAD) study, which was conducted in 6 US cities, encouraged repeat HIV testing during pregnancy to identify primary infections., Results: Fifty-four HIV-infected women were identified. Four primary HIV infections were recognized, with median estimated seroconversion at 22 weeks of gestation. All 4 women denied new sex partners, alcohol, and illegal drug use during pregnancy. Three of the 4 mother-infant pairs received antiretroviral medications. One infant was infected perinatally, with positive HIV DNA polymerase chain reaction at birth. Questionnaire data identified 2 additional women with HIV that was likely acquired during pregnancy (identified by rapid testing at labor and delivery), which suggests that 6 of 54 HIV-infected women (11%) in the MIRIAD study had primary infection during pregnancy., Conclusion: Repeat HIV testing in pregnancy can identify opportunities for antiretroviral prophylaxis and should be used in areas of high HIV prevalence.

Context: Timely testing of women in labor with undocumented human immunodeficiency virus (HIV) status could enable immediate provision of antiretroviral prophylaxis., Objectives: To determine the feasibility and acceptance of rapid HIV testing among women in labor and to assess rapid HIV assay performance., Design, Setting, and Patients: The Mother-Infant Rapid Intervention At Delivery (MIRIAD) study implemented 24-hour counseling and voluntary rapid HIV testing for women in labor at 16 US hospitals from November 16, 2001, through November 15, 2003. A rapid HIV-1 antibody test for whole blood was used., Main Outcome Measures: Acceptance of HIV testing; sensitivity, specificity, and predictive value of the rapid test; time from blood collection to patient notification of results., Results: There were 91,707 visits to the labor and delivery units in the study, 7381 of which were by eligible women without documentation of HIV testing. Of these, 5744 (78%) women were approached for rapid HIV testing and 4849 (84%) consented. HIV-1 test results were positive for 34 women (prevalence = 7/1000). Sensitivity and specificity of the rapid test were 100% and 99.9%, respectively; positive predictive value was 90% compared with 76% for enzyme immunoassay (EIA). Factors independently associated with higher test acceptance included younger age, being black or Hispanic, gestational age less than 32 weeks, and having had no prenatal care. Lower acceptance was associated with being admitted between 4 pm and midnight, particularly on Friday nights, but this may be explained in part by fewer available personnel. Median time from blood collection to patient notification of result was 66 minutes (interquartile range, 45-120 minutes), compared with 28 hours for EIA (P<.001)., Conclusions: Rapid HIV testing is feasible and delivers accurate and timely test results for women in labor. It provides HIV-positive women prompt access to intrapartum and neonatal antiretroviral prophylaxis, proven to reduce perinatal HIV transmission, and may be particularly applicable to higher-risk populations.

Background: Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor., Methods: To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study., Results: In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study., Conclusions: We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions.

Objective: To describe the extent of adherence to the recommended neonatal zidovudine (ZDV) regimen administered to infants who have been exposed to the human immunodeficiency virus (HIV) to prevent mother-to-child transmission of HIV and to determine which maternal factors are associated with compliance., Methods: HIV-infected women (n = 87) who were participating in a larger study of perinatal transmission at 3 inner-city New York City hospitals were interviewed 2 to 6 weeks' postpartum to assess adherence to neonatal prophylaxis, social support, social network factors, and depression. In addition, plasma samples of 45 of their infants were assayed for ZDV levels., Results: A majority of women (71%) administered all of the prescribed 4 daily doses in the previous week, as measured by interview; self-reported adherence was not associated with any maternal characteristics. In contrast, poor adherence, as measured by lower infant ZDV plasma levels, was associated with asymptomatic HIV illness in the mother and having 2 or more other children; good adherence, as indicated by higher ZDV levels, was associated with the presence of a maternal social support network, disclosure of HIV infection, and mothers' adherence to their own ZDV regimens during pregnancy. In multivariate regression analyses, maternal asymptomatic status (beta = -0.40) was associated with lower infant ZDV levels, and maternal adherence during pregnancy (beta = 0.37) was associated with higher levels., Conclusions: Women who are HIV asymptomatic and lack a social support network are more likely not to comply with the recommended neonatal prophylactic regimen of antiretroviral therapy. Future studies should address the prenatal period and social network factors, such as disclosure of serostatus, and the custody of other children.

To evaluate the feasibility of offering voluntary counseling and expedited human immunodeficiency virus (HIV) testing to women in labor, and to assess the characteristics of two rapid HIV assays compared with results from an expedited standard enzyme immunoassay (EIA), with Western blot confirmation, as indicated, we undertook a pilot study immediately prior to enactment of New York State regulations (August 1999) requiring expedited testing of laboring women (or newborns) with undocumented HIV status. From June 9, 1999 through July 2, 1999, we offered HIV counseling and testing (C&T) to all medically stable women in active labor, 106 of 125 (85%) of whom accepted. One woman was confirmed HIV-1 seropositive. Rapid assay sensitivity and specificity were: SUDS 100 and 98%, and Multispot 100 and 100%, respectively in comparison with 100 and 99% for the standard EIA. The positive predictive values (PPV) were SUDS 33%; Multispot 100%; and EIA 50%. While our sample size was small, it appears that the accuracy of rapid and expedited HIV assays may be improved by requiring two different reactive assays before informing women of HIV-seropositive results or initiating antiretroviral treatment.