Patient Perspectives with Abbreviated versus Standard Pre-Test HIV Counseling in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial Deborah Cohan1*, Elvira Gomez1, Mara Greenberg2, Sierra Washington1, Edwin D. Charlebois3 1 Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America, 2 Department of Obstetrics and Gynecology, Stanford University, Palo Alto, California, United States of America, 3 Department of Medicine, University of California San Francisco, San Francisco, California, United States of America Abstract Background: In the US, an unacceptably high percentage of pregnant women do not undergo prenatal HIV testing. Previous studies have found increased uptake of prenatal HIV testing with abbreviated pre-test counseling, however little is known about patient decision making, testing satisfaction and knowledge in this setting. Methodology/Findings: A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco. A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse- performed HIV test counseling at the initial prenatal visit. Patient decision making experience was compared between abbreviated versus standard HIV counseling strategies among a sample of low-income, urban, ethnically diverse prenatal patients. The primary outcome was the decisional conflict score (DCS) using O’Connor low-literacy scale and secondary outcomes included satisfaction with test decision, basic HIV knowledge and HIV testing uptake. We conducted an intention-to- treat analysis of 278 women – 134 (48.2%) in the abbreviated arm (AA) and 144 (51.8%) in the standard arm (SA). There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: 20.65, 8.41) did not exceed the non-inferiority margin. HIV testing uptake was very high (97. 8%) and did not differ significantly between the 2 groups (99.3% in AA vs. 96.5% in SA, p = .12). Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36). However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, p,0.01). Conclusions/Significance: This study suggests that streamlining the pre-test counseling process, while associated with slightly lower knowledge, does not compromise patient decision making or satisfaction regarding HIV testing. Trial Registration: ClinicalTrials.gov NCT00503308 Citation: Cohan D, Gomez E, Greenberg M, Washington S, Charlebois ED (2009) Patient Perspectives with Abbreviated versus Standard Pre-Test HIV Counseling in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial. PLoS ONE 4(4): e5166. doi:10.1371/journal.pone.0005166 Editor: Margaret Lampe, Centers for Disease Control and Prevention, United States of America Received August 8, 2008; Accepted February 26, 2009; Published April 15, 2009 Copyright: 2009 Cohan et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: Pfizer Pharmaceuticals Investigator-initiated research grant NIH-K23DA016174. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist. * E-mail: cohand@obgyn.ucsf.edu Introduction Approximately 40% of HIV-infected infants in the United States in 2000 were born to women not diagnosed with their HIV prior to delivery. [1] There are now effective medical therapies to dramatically reduce the risk of perinatal transmission, including anti-retroviral therapy, but this intervention is most effective when women are diagnosed prior to delivery. The Centers for Disease Control and Prevention (CDC), United States Preventive Services Task Force and Institute of Medicine (IOM) have published strong recommendations for universal HIV-antibody testing of pregnant women. [2–5] A recent meta-analysis also demonstrated strong evidence supporting routine prenatal HIV testing. [4] There are currently two common testing strategies. In an opt- out approach, all women are informed of the inclusion of HIV testing in the standard battery of prenatal labs and may decline such testing. On the other hand, standard, opt-in strategies use more traditional voluntary HIV counseling and testing techniques, which typically include pre-test counseling and/or risk assessment. In a recent CDC retrospective analysis, prenatal HIV testing uptake differed widely according to testing strategy used in various regions in the United States and Canada.[3] Prenatal HIV testing was most common in areas with an opt-out approach, with up to 98% of pregnant women testing. In regions using an opt-in approach, testing frequencies were as low as 25%. In September 2006, the CDC published revised recommendations for HIV testing in US healthcare settings. [6] In addition to recommending routine, opt-out prenatal HIV screening, the authors advocated streamlined consenting with removal of requirements for preven- tion counseling as part of screening and diagnostic HIV testing PLoS ONE | www.plosone.org 1 April 2009 | Volume 4 | Issue 4 | e5166