procedures. While there are population-based studies and other observational studies using historical controls [7] supporting routine, opt-out HIV test counseling, little is known about patient decision making, testing satisfaction and subsequent HIV knowledge with abbreviated counseling. Methods The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Checklist S1 and Protocol S1. Ethics Statement This study was conducted according to the principles expressed in the Declaration of Helsinki. The study was approved by the Institutional Review Board of the University of California San Francisco and San Francisco General Hospital. All patients provided written informed consent for the data collection and subsequent analysis. This was a randomized-controlled, non-inferiority trial evalu- ating decisional conflict, HIV knowledge and testing uptake associated with two HIV testing strategies among English and Spanish-speaking pregnant women. The strategies included nurse- performed, standard HIV pre-test counseling (control arm) and abbreviated, pre-test counseling (study arm). The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing. The intervention arm used a 2-sentence script which lasted approximately 30 seconds. See Appendix S1. We hypothesized that decisional conflict and testing uptake would not differ significantly among women in the abbreviated study arm and standard control arm. Eligible participants included English and Spanish -speaking women aged 16 or older initiating prenatal care at San Francisco General Hospital (SFGH) between October 3, 2006 and September 24, 2007. Women were considered ineligible if they were unable to give informed consent, known to be infected with HIV at initiation of prenatal care, or obtained an HIV test during the index pregnancy prior to initiation of prenatal care at SFGH. Research staff approached eligible women in the clinic immediately before their initial appointment at the SFGH Women’s Health Center. Study staff recruited and obtained written informed consent from all participants and the UCSF Committee on Human Research approved this study. Enrolled participants were randomized to either the standard or abbrevi- ated pre-test counseling strategy. At the onset of the prenatal appointment, the intake nurse gave all pregnant women, regardless of study enrollment, a low-literacy HIV educational brochure to be read at a later time. During the appointment, the nurse administered either the standard or abbreviated HIV pre- test counseling script, documented the woman’s decision to take or not take the HIV test and obtained written test consent or refusal from the woman as per California state law at the time of the study. Immediately following the appointment, blinded, bilingual study staff administered a structured questionnaire to each participant. The questionnaire included the 10-item O’Connor Low-Literacy Decisional Conflict Scale (DCS), a 9-item instru- ment assessing basic HIV knowledge (including HIV as the cause of AIDS, perinatal and non-perinatal modes of transmission, whether people with HIV always look and feel sick and whether there is a cure for HIV), a scale assessing perceived risk of being HIV positive, reasons for testing or not testing and satisfaction with information received and the decision-making process. [8–10] Pretest HIV Counseling Trial The O’Connor DCS was used in order to assess the level of certainty and satisfaction with the patient’s decision to undergo or not undergo HIV testing upon having received the nurse- performed abbreviated or standard pre-test counseling. The scale evaluates the extent to which patients feel informed about a medical decision, whether the patients’ assessment of the relative risks and benefits of each decision are consistent with their values, whether patients have enough support and advice to make a decision without pressure from others, and the certainty about the decision. See Table 1. Upon the patients’ return for the follow-up clinician visit, typically within 2–4 weeks, blinded study staff administered a second survey following HIV test result disclosure by the medical provider. The second survey included items adapted from Simpson et al. and evaluated overall satisfaction with the consent and results disclosure process as well as the decision to undergo HIV testing. [10] See Appendix S2. Randomization Study staff generated the randomization scheme using random number tables. HIV consenting scripts, each a single page and identical in weight, were sequentially numbered by study staff and sealed in opaque envelopes which were given to the nurse once the patient consented to participate in the study. Group assignment was not revealed to the study staff until after completion of the study. While participants were informed during the study consent process that they would receive either more or less pre-test counseling, they were not specifically told about their respective group assignment. The nurses were not blinded because they were administering the appropriate script to the patients as per random assignment. Statistical methods We compared differences between women in the control and study arms, including the proportion of women with low decisional conflict (DCS score#25), mean/median DCS scores, mean/ median knowledge scores, the proportion of women reporting overall satisfaction with their decision regarding HIV testing and the percentage of women undergoing HIV testing. We measured decisional conflict, the primary outcome of the study, using the English or Spanish-language Low-Literacy Decisional Conflict Scale. [8,9] We calculated a score for all study participants using the Low-Literacy Decisional Conflict Table 1. O’Connor Low-Literacy Decisional Conflict Scale [13] * Do you know which options are available to you? Do you know the benefits of each option? Do you know the risks and side effects of each option? Are you clear about which benefits matter most to you? Are you clear about which risks and side effects matter most to you? Do you have enough support from others to make a choice? Are you choosing without pressure from others? Do you have enough advice to make a choice? Are you clear about the best choice for you? Do you feel sure about what to choose? *All questions have 3 response categories: yes, no, unsure Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. doi:10.1371/journal.pone.0005166.t001 PLoS ONE | www.plosone.org 2 April 2009 | Volume 4 | Issue 4 | e5166