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Obstetrics & Gynecology 2004;104:134-137
© 2004 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

The Effectiveness of a Verbal Opt-Out System for Human Immunodeficiency Virus Screening During Pregnancy

Peter Breese, MSPH, William Burman, MD, Judith Shlay, MD, MSPH and Debra Guinn, MD

From the Departments of Public Health, Community Health Services, and Obstetrics and Gynecology, Denver Health and Hospital Authority; and the Departments of Medicine (Division of Infectious Diseases), Family Medicine, and Obstetrics and Gynecology, University of Colorado Health Science Center, Denver, Colorado.

Address reprint requests to: William Burman, MD, 605 Bannock Street, Denver, CO 80204; e-mail: bburman{at}dhha.org.


    ABSTRACT
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE: We sought to evaluate the use of human immunodeficiency virus (HIV) screening during pregnancy in a health care system using the verbal opt-out method, in which HIV screening was recommended during all pregnancies and women were given an opportunity to refuse testing.

METHODS: This was a retrospective cohort study of pregnancies resulting in delivery from 1998 through 2001 at Denver Health Medical Center, an urban public hospital. The main outcome measure was the proportion of documented HIV screening within 9 months before the delivery date.

RESULTS: Of 12,221 pregnancies resulting in delivery, HIV screening was completed in 12,000 (98.2%, 95% confidence interval 97.9–98.4%). Of the 221 women not screened for HIV, only 24 (10.9% of those not screened, 0.2% of all women in the study) were documented as refusing HIV testing. Patients not screened for HIV presented late in pregnancy, a median of 1 day before delivery, compared with a median of 176 days for those who were screened (P < .001).

CONCLUSION: A verbal opt-out system was very effective in promoting HIV screening during pregnancy. Late presentation in pregnancy was associated with not having HIV screening performed.

LEVEL OF EVIDENCE: II-3


Antiretroviral therapy has dramatically decreased the risk of perinatal human immunodeficiency virus (HIV) transmission. With the introduction of zidovudine monotherapy in pregnancy, the transmission rate decreased from 25.5% to 8.3%,1 and with more potent combination antiretroviral therapy, the risk of transmission has decreased to approximately 1%.2 The combination of HIV screening and antiretroviral therapy for those women identified as being infected with HIV has resulted in a dramatic reduction in the number of perinatally acquired immunodeficiency syndrome (AIDS) cases in the face of an increase in the number of women with HIV infection.3 Despite these advances, it is estimated that 280–370 cases of perinatal transmission of HIV continue to occur each year in the United States.4 Given the remarkable efficacy of combination antiretroviral therapy in reducing the perinatal HIV transmission rate, further reductions in perinatal acquisition of HIV will require improved screening programs.5

Previous studies have reported marked differences in the use of HIV-screening programs during pregnancy, with rates ranging from 25% to 98%.6,7 Rates of HIV screening during pregnancy have increased with time but remained less than 70% in 1999 in a nationwide study.6 Identification of factors that affect perinatal screening rates would have important public health implications. Therefore, we evaluated a program for screening for HIV during pregnancy in a large urban public health care system using the verbal opt-out system for obtaining permission for HIV testing. We hypothesized that use of the verbal opt-out system would result in a high rate of HIV screening.


    MATERIALS AND METHODS
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Denver Health is a large integrated healthcare system providing services to predominantly lower-income residents of Denver, Colorado. Approximately 25% of Denver residents receive health care at Denver Health. Diagnosis of pregnancy and prenatal care is available through 10 community health centers located in lower-income neighborhoods in Denver, 15 school-based clinics, and the Women's Care Clinic, which is adjacent to the hospital (Denver Health Medical Center). This study of the effectiveness of the verbal opt-out approach to HIV screening during pregnancy was approved by the Colorado Multiple Institutional Review Board.

Denver Health uses a verbal opt-out system for HIV screening during pregnancy. During the initial prenatal visit, pregnant women are told that a screening test for HIV is recommended during all pregnancies because treatment can markedly decrease the rate of perinatal transmission. This information can be presented by a Denver Health physician, nurse, or health care partner. There is no attempt to obtain a detailed risk assessment of the likelihood of prior HIV exposure. Patients are given an opportunity to refuse HIV testing; those who give verbal permission have an HIV test obtained at that same time that other standard prenatal laboratory tests are obtained. Because Spanish is commonly spoken in our patient population, bilingual staff is widely available. In addition, patients are given written information on HIV screening; this information is provided in Spanish and English and is written at the 5th-grade reading level. During the study period, all HIV testing was performed by using conventional enzyme-linked immunosorbent assay and Western blot testing; no rapid test was available.

Deliveries at Denver Health Medical Center from January 1, 1998, through December 31, 2001, were identified from a computer data set containing discharge diagnosis codes. We then matched this cohort to billing information from another computer data set to determine whether a screening test for HIV (enzyme-linked immunosorbent assay) had been obtained during a 270-day period before hospitalization for delivery. The accuracy of using billing data to determine screening status was assessed in 2 ways. First, we reviewed charts for 100 pregnancies selected at random from those with a charge for HIV testing in the billing file. The sample size of 100 was chosen to provide a narrow 95% confidence interval (CI) around the estimate of the accuracy of the billing data. Second, we reviewed charts of all pregnancies for which there was not a charge for HIV testing. To be counted as having been screened for HIV infection during pregnancy, we required that a copy of the HIV test be available in the selected patient's medical record; a chart notation indicating that HIV screening had taken place but without further documentation was not accepted. Finally, we evaluated the duration of prenatal care (time from the first appointment for pregnancy care to delivery date) for 100 randomly selected women who did and 100 randomly selected women who did not have HIV screening during pregnancy (women who refused HIV testing were not included in this sample).

Data from chart reviews were entered into a Microsoft Excel spreadsheet (Microsoft, Renton, WA) and analyzed by using the SAS statistical package (SAS Institute, Inc, Cary, NC). Dichotomous variables were compared by using the {chi}2 test. The distribution of continuous variables was assessed by using the Shapiro–Wilk test for normality. Normally distributed variables were compared by using the Student t test; nonnormally distributed variables were evaluated by using the Wilcoxon rank sum test.


    RESULTS
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
From 1998 to 2001, there were 12,221 deliveries at Denver Health Medical Center. The median age of the study population was 24 years (range 13–46 years), and most (82%) were of Hispanic ethnicity (Table 1). Of the 12,221 deliveries, 11,217 (92%) had a charge in the billing file for HIV screening (Fig. 1). Screening for HIV was confirmed for all 100 deliveries randomly selected from the 11,217 with a match in the billing data. A chart review of the 1,004 pregnancies without a charge for HIV screening demonstrated that 783 (78%) had HIV screening performed during pregnancy. The majority of these patients were screened during initial prenatal care at another health institution before delivering at Denver Health Medical Center. Therefore, HIV screening was completed during 12,000 of the 12,221 pregnancies resulting in delivery (98.2%, 95% CI 97.9–98.4%). Notably, only 24 of the 221 (10.9%, 95% CI 7.2–15.9%) women not screened for HIV were documented in the medical record as having refused HIV testing. Considering the entire study population, the rate of documented refusal of HIV screening was very low (24 of 12,221; 0.2%; 95% CI 0.1–0.3%). The 24 women who refused HIV screening had demographic characteristics similar to those of the entire study population (Table 1). Records of 15 women had a date for an HIV test but no documentation of the result. Therefore, the lack of documentation of the HIV result was an uncommon reason to meet the study definition of not having HIV screening performed (15/221, 6.7%)


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Table 1. Comparison of Women Screened Versus Women Not Screened for Human Immunodeficiency Virus Prior to Delivery

 


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Fig. 1. Flow chart for the study illustrating the validation steps and overall effectiveness of the human immunodeficiency virus (HIV) screening program at Denver Health, 1998–2001.

Breese. Opt-Out System for HIV Screening. Obstet Gynecol 2004.

 

Women who were not screened for HIV during pregnancy were more often of African-American or Caucasian race/ethnicity, more often spoke English as a primary language, and were more often U.S. citizens than were women who were screened during pregnancy (Table 1). The most notable difference between women not screened for HIV versus those who had screening was in the estimated duration of prenatal care. The median time from diagnosis of pregnancy to delivery was only 1 day (interquartile range, 0–83 days) among the 100 randomly selected women not screened for HIV compared with 176 days (interquartile range, 121–199 days) among the 100 randomly selected women who were screened for HIV (P < .001, Wilcoxon rank-sum test).

Nine women were diagnosed with HIV as a result of screening during pregnancy; therefore, the yield of screening was 0.08%. An additional 11 women with a prior diagnosis of HIV infection delivered during the study period. The rate of perinatal HIV transmission was 5% (1/20), with the only known case of perinatal HIV transmission involving a woman who presented very late in pregnancy without any identified risk factors for HIV exposure. Because of her late presentation for medical care, the results of her positive HIV test did not return until after delivery.


    DISCUSSION
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
We found that use of the verbal opt-out technique resulted in a high rate of HIV screening during pregnancy. It is particularly notable that a small proportion of women (0.2%) had a documented refusal of HIV screening. The most characteristic feature of pregnancies in which HIV screening was not performed was the lack of prenatal care—the median time from presentation for prenatal care to delivery in a random sample from this group was only 1 day.

Recent studies have shown a correlation between HIV-screening rates and the way in which HIV screening is presented to pregnant women. Programs that require specific counseling and written consent ("opt-in") have substantially lower rates of HIV screening (25–83%) than do programs recommending HIV testing as a standard practice for all pregnancies, or "opt-out" (85–98%).7 Our study confirms the effectiveness of the opt-out testing strategy in a large urban hospital providing care for a diverse patient population. Although an HIV-screening rate during pregnancy of 98% is notable, it should be possible to improve this rate. The use of the recently approved rapid HIV test may improve the overall effectiveness of our screening system8,9 because the most common reason for lack of screening appeared to be lack of prenatal care and presentation during labor.

The major limitation of this study was the inability of a retrospective study based on computer and medical records to clearly delineate the reasons screening was not performed. Given the retrospective nature of this study, we were unable to ascertain whether failure to complete screening was caused by a failure to offer HIV testing or by refusal of testing that was not documented in the medical record. We did not attempt to assess attitudes among patients or care providers toward HIV screening. The chart review may have underestimated the rate of refusal of HIV screening if care providers did not document refusal in the medical record.

Despite limitations, this study demonstrated the effectiveness of the verbal opt-out system. Additional research is needed to clarify reasons for lack of HIV screening using the verbal opt-out system, but our results suggest that patient refusal of testing is a very uncommon reason. Further work should focus on improving HIV screening among women who present very late in pregnancy.


    Footnotes
 
Received December 24, 2003. Received in revised form March 22, 2004. Accepted April 1, 2004.

Presented in part at the National HIV Prevention Conference, July 2003, Atlanta, Georgia.

10.1097/01.AOG.0000129957.35105.d4


    REFERENCES
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
1. Sperling RS, Shapiro DE, Coombs RW, Todd JA, Herman SA, McSherry GD, et al. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med 1996;335:1621–9.[Abstract/Free Full Text]

2. Cooper ER, Charurat M, Burns DN, Blattner W, Hoff R. Trends in antiretroviral therapy and mother-infant transmission of HIV: The Women and Infants Transmission Study Group. J Acquir Immune Defic Syndr 2000;24:45–7.[Medline]

3. Lindegren ML, Byers RH Jr, Thomas P, Davis SF, Caldwell B, Rogers M, et al. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA 1999;282:531–8.[Abstract/Free Full Text]

4. Centers for Disease Control and Prevention. Revised recommendations for HIV screening of pregnant women. MMWR 2001;50:63–85.

5. Peters V, Liu KL, Dominguez K, Frederick T, Melville S, Hsu HW, et al. Missed opportunities for perinatal HIV prevention among HIV-exposed infants born 1996–2000, pediatric spectrum of HIV disease cohort. Pediatrics 2003;111:1186–91.[Abstract/Free Full Text]

6. Lansky A, Jones JL, Frey RL, Lindegren ML. Trends in HIV testing among pregnant women: United States, 1994–1999. Am J Public Health 2001;91:1291–3.[Abstract/Free Full Text]

7. Centers for Disease Control and Prevention. HIV testing among pregnant women—United States and Canada, 1998–2001. MMWR 2002;51:1013–6.[Medline]

8. Cohen MH, Olszewski Y, Branson B, Robey M, Love F, Jamieson DJ, et al. Using point-of-care testing to make rapid HIV-1 tests in labor really rapid. AIDS 2003;17:2121–4.[Medline]

9. Minkoff H, O'Sullivan MJ. The case for rapid HIV testing during labor. JAMA 1998;279:1743–4.[Free Full Text]




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