Examining the effectiveness of an opt-in approach to prenatal human immunodeficiency virus screening

Article Outline

• Abstract
• Materials and Methods
• Results
• Comment
• Acknowledgment
• References
• Copyright

Objective

We sought to determine the prenatal human immunodeficiency virus (HIV) screening rate when using an opt-in policy and to find variables predictive of screening.

Study Design

This was a case-control study examining gravid women with a prenatal visit and a delivery at our hospital in 2005. Cases were defined as women who did not undergo HIV screening during the first or second prenatal visit. Our institution used an opt-in approach to HIV screening.

Results

Overall, 71% (291/412) of women underwent HIV screening at the first or second prenatal visit. Patient refusal was the most common reason for not being screened (15%; 62/412). Women who were ≤25 years old, were unmarried, and received care from maternal-fetal medicine attendings or family practitioners were more likely to undergo HIV screening.

Conclusion

With an opt-in approach, 29% of women were not screened for HIV during their early prenatal care. An opt-in policy also leads to screening rates that are provider dependent.

Key words: opt-in human immunodeficiency virus screening, prenatal screening, sexually transmitted disease

Identifying gravid women infected with human immunodeficiency virus (HIV) is important, as antepartum highly active antiretroviral therapy (HAART) reduces rates of vertical transmission from a baseline of 26%¹ down to 1-2%.² Yet, an estimated 882 cases of perinatal HIV transmission occurred between 2001-2004,³ and 92% of cases of acquired immunodeficiency syndrome among children <13 years of age in the United States were attributed to perinatal HIV transmission.⁴ Given the effectiveness of HAART, these cases were likely due to unrecognized HIV infection in gravid women.

The Centers for Disease Control and Prevention (CDC) recommends that HIV screening be part of the routine panel of prenatal tests for all pregnant women and that screening should follow an opt-out approach.⁵ The American College of Obstetricians and Gynecologists (ACOG) also recommends an opt-out approach and urges that all gravid women be screened for HIV as early as possible during each pregnancy.⁶ Despite these recommendations from the CDC and the ACOG, policies for prenatal HIV screening vary from state to state. A total of 22 states use an opt-out policy where HIV screening is a routine component of prenatal testing with women having the option to opt out.⁷ In the remaining 28 states, which includes Pennsylvania, a mandatory opt-in approach requires both detailed pretest HIV counseling and written informed consent.⁷ We sought to examine the impact of an opt-in policy on the rate of prenatal HIV screening among gravid women and to determine factors predictive of such screening.

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Materials and Methods 

Thomas Jefferson University Hospital, Philadelphia, PA, is an urban, tertiary referral, teaching facility with 4 prenatal clinics. In 2005, the Jefferson Center for Women's Medical Specialties and the Jefferson Center for Maternal-Fetal Medicine (MFM) were staffed by 9 obstetrics-gynecology (OB-GYN) and 4 MFM attending physicians, respectively. In all, 32 OB-GYN residents (supervised by OB-GYN attendings) managed the Jefferson Obstetrics and Gynecology Associates clinic. The Jefferson Family Medicine Associates prenatal clinic was staffed by 3 family medicine attendings and 27 family medicine residents.

Our institution's 4 prenatal clinics followed Pennsylvania state law's opt-in policy to prenatal HIV screening.⁸ All obstetric care providers in 2005 were required to provide women with detailed pretest HIV counseling and education and to obtain written informed consent before performing HIV screening. Pretest counseling and education was provided by individual physicians, as our clinics did not have staff dedicated to offering such counseling. Physicians were not provided with a scripted recommendation for counseling. If a woman did not desire HIV screening, she only needed to verbally decline testing and she was not required to provide an explanation. Yet, if a woman gave a reason for her refusal, physicians were allowed to document the reason in the chart, but they were not required to do so.

Using our university hospital's perinatal database, we identified all women with a documented delivery from Jan. 1, 2005, through Dec. 31, 2005. This search identified all women who had a live birth at any gestational age. Our search also identified women with stillbirths, but it was limited to identifying those who had one >28 weeks' gestation. Given that our search for women with stillbirths was restricted, we excluded them from the study. From the population of women with a documented delivery, we then identified those with at least 1 prenatal visit in our outpatient clinics prior to delivery. This was done by performing a query of the billing claims data.

We determined that a sample size of 384 gravid women would provide an acceptably precise interval estimate, ie, a 95% confidence interval equal to the sample proportion ± .05. We estimated a 10% nonresponse rate (missing chart or incomplete records), and thus required a sample of 423 women from the population of women with a documented delivery and at least 1 prenatal visit. To identify a random group, we used the simple random sampling technique. We calculated the required sampling fraction, ie, required sample size of 423 divided by the total number of cases in the population, and then used a software random number generator (Excel; Microsoft Corp, Redmond, WA) to identify the random sample.

Each chart was reviewed by a team of trained chart reviewers. Demographic information obtained from the chart included maternal age, race/ethnicity, marital status, and insurance. The clinic where a woman received her prenatal care determined the type of obstetric care provider. Our institution's 4 prenatal clinics were each primarily managed by a different type of provider in terms of specialty and level of training. The 3 OB-GYN clinics were staffed by OB-GYN attendings, OB-GYN residents, or MFM attendings. The family medicine prenatal clinic, on the other hand, was managed by both family medicine attendings and residents. Because we did not record the screening rates for individual providers, we combined the family medicine attendings and residents into a single “family practitioner” group.

From the chart, we also determined whether HIV screening was performed. This was accomplished by searching for documentation of an HIV antibody test result in the progress notes or by locating actual HIV antibody test results in the laboratory section of the chart. Only results from HIV screens ordered at the first or second prenatal visit were accepted as controls for our case-control study. We defined controls as such because both the CDC⁵ and the ACOG⁶ recommend HIV testing be performed as early as possible during prenatal care. For women who did not undergo HIV screening during the first 2 visits (cases), we attempted to find explanations from the chart.

Due to our study's primary focus on the rate of HIV screening and our desire to protect patient privacy in regard to HIV status, we did not record the results of the HIV screening tests. In Philadelphia, PA, the estimated incidence of HIV in 2006 among female individuals aged 13 years and older was 62 per 100,000 population.⁹ There were an estimated 4835 women living with HIV or acquired immunodeficiency syndrome in 2006.¹⁰ HIV data in Philadelphia, PA, were considered incomplete before 2006, as HIV name-based reporting started in October 2005.

All statistical tests were performed using software (SPSS 17.0; SPSS Inc, Chicago, IL). To analyze continuous variables, we used either Student t test or the analysis of variance test. The χ² test was used to analyze categorical variables. P < .05 was considered statistically significant. Both univariate and multivariate analyses were performed to identify categorical variables predictive of women undergoing HIV screening. For the multivariate analysis, we used a binary logistic regression model. Covariates in the binary logistic regression model included any variable from univariate analysis that was associated with HIV screening with P < .20. This cutoff value was chosen so that we could liberally include variables in the model and therefore assess confounding by more variables. Results from the binary logistic regression were reported as adjusted odds ratios with 95% confidence intervals. This study was approved by our institutional review board.

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Results 

In 2005, 2073 women had a delivery and at least 1 prenatal visit prior to their delivery at our university hospital. From this population, we identified a random sample of 423 women. Two charts had insufficient prenatal records, 4 women had a stillbirth, and 5 charts could not be located. Therefore, our study included 412 gravid women. Demographic characteristics are presented in Table 1. No woman in our random sample had a history of HIV infection.

TABLE 1. Characteristics of the study population

Variable	Controls: screened for HIV (n = 291)a	Cases: not screened for HIV (n = 121)a	P
Age, y	26.0±6.0	28.9±6.3	<.001b
Marital status
Unmarriedc	208(71)	66(55)	.001d
Married	83(29)	55(45)
Race/ethnicity
African American	165(57)	52(43)	.05d
Asian	33(11)	12(10)
Caucasian	68(23)	45(37)
Latina	11(4)	6(5)
Other or unknown	14(5)	6(5)
Insurance
Medicaid	156(54)	62(51)	.66d
Commercial	135(46)	59(49)
Obstetric care provider
Family practitionere	39(13)	1(1)	<.001d
MFM attending	24(8)	6(5)
OB-GYN resident	139(48)	63(52)
OB-GYN attending	89(31)	51(42)

HIV, human immunodeficiency virus; MFM, maternal-fetal medicine; OB-GYN, obstetrics-gynecology.

Data are presented as mean ± SD, or n (%).

Almario. Effectiveness of an opt-in approach to prenatal HIV screening. Am J Obstet Gynecol 2010.

OB-GYN attendings and OB-GYN residents provided care for 140 of 412 (34%) and 202 of 412 (49%) women, respectively. MFM attendings and family practitioners treated 30 of 412 (7%) and 40 of 412 (10%) women, respectively. Table 2 shows the characteristics of the population seen by each obstetric care provider group. Women seen by OB-GYN residents and family practitioners tended to be younger, unmarried, and on Medicaid when compared to those treated by OB-GYN and MFM attendings. OB-GYN residents and family practitioners also provided care for a population with a higher proportion of African Americans.

TABLE 2. Characteristics of the population seen by each obstetric care provider group

Variable	OB-GYN attending (n = 140)	MFM attending (n = 30)	OB-GYN resident (n = 202)	Family practitionera (n = 40)	P
Age, y	30.1±5.5	32.2±5.2	24.3±5.5	24.1±4.8	<.001b
Marital status
Unmarriedc	56(40)	9(30)	177(88)	32(80)	<.001d
Married	84(60)	21(70)	25(12)	8(20)
Race/ethnicity
African American	52(37)	8(27)	127(63)	30(75)	<.001d
Asian	11(8)	5(17)	24(12)	5(13)
Caucasian	64(46)	16(53)	30(15)	3(8)
Latina	5(4)	1(3)	9(4)	2(5)
Other or unknown	8(6)	0(0)	12(6)	0(0)
Insurance
Medicaid	0(0)	2(7)	189(94)	27(68)	<.001d
Commercial	140(100)	28(93)	13(6)	13(33)

MFM, maternal-fetal medicine; OB-GYN, obstetrics-gynecology.

Data are presented as mean ± SD, or n (%).

Percent totals may not equal 100 due to rounding.

Almario. Effectiveness of an opt-in approach to prenatal HIV screening. Am J Obstet Gynecol 2010.

With an opt-in approach to prenatal HIV screening, 291 of 412 (71%) women underwent HIV screening at the first or second prenatal visit (controls). Reasons detailing why 121 of 412 (29%) women did not receive HIV screening during the first 2 visits (cases) are included in Table 3. Refusal to be screened was the most common explanation (62/121; 51%).

TABLE 3. Reasons human immunodeficiency virus screening was not performed at first or second prenatal visit (n = 121)

Reason	n (%)
Patient refused to be screened	62(51)
Patient reported recent HIV screeninga	17(14)
Patient did not receive pretest HIV counseling and education	16(13)
HIV screen ordered by physician at first or second prenatal visit:
Screening not done due to patient noncompliance	3(2)
Results unavailable	12(10)
HIV screen done, but not at first or second prenatal visit	11(9)

HIV, human immunodeficiency virus.

Data are presented as n (%).

Percent totals may not equal 100 due to rounding.

Almario. Effectiveness of an opt-in approach to prenatal HIV screening. Am J Obstet Gynecol 2010.

Table 4 presents unadjusted and adjusted odds ratios for variables predictive of HIV screening. Through a univariate analysis, we found that women were significantly more likely to have been screened for HIV at the first or second prenatal visit if they were treated by family practitioners, ≤25 years of age, unmarried, and African American. No association was found between type of insurance and screening (P = .66). However, after adjusting for confounders with a logistic regression, the variables that remained predictive of HIV screening were age ≤25 years, unmarried status, and receiving care from a MFM attending or family practitioner.

TABLE 4. Variables predictive of human immunodeficiency virus screening during the first or second prenatal visit

Variable	Screened for HIV, n (%)	Unadjusted OR (95% CI)	Adjusted ORa (95% CI)
Obstetric care provider
Family practitionerb	39/40(98)	22.3(3.0–167.6)	13.2(1.7–101.8)
MFM attending	24/30(80)	2.3(0.9–6.0)	2.8(1.1–7.5)
OB-GYN resident	139/202(69)	1.3(0.8–2.0)	0.6(0.3–1.1)
OB-GYN attending (reference)	89/140(64)	1	1
Age, yc
≤25	148/187(79)	2.2(1.4–3.4)	1.8(1.03–3.1)
>25 (reference)	143/225(64)	1	1
Marital status
Unmarriedd	208/274(76)	2.1(1.3–3.2)	2.0(1.1–3.7)
Married (reference)	83/138(60)	1	1
Race/ethnicitye
African American	165/217(76)	2.1(1.3–3.4)	1.6(0.9–2.8)
Asian	33/45(73)	1.8(0.9–3.9)	2.0(0.9–4.7)
Latina	11/17(65)	1.2(0.4–3.5)	0.8(0.3–2.6)
Caucasian (reference)	68/113(60)	1	1

CI, confidence interval; HIV, human immunodeficiency virus; MFM, maternal-fetal medicine; OB-GYN, obstetrics-gynecology; OR, odds ratio.

Almario. Effectiveness of an opt-in approach to prenatal HIV screening. Am J Obstet Gynecol 2010.

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Comment 

With an opt-in approach to prenatal HIV screening, only 71% of women underwent screening during their early prenatal care. Women who were ≤25 years of age, unmarried, and received care from a MFM attending or family practitioner were more likely to have been screened for HIV.

Our study has a number of interesting findings. By evaluating individual chart-level data, we identified specific shortcomings of the opt-in approach, including the details of why women did not undergo HIV screening. Most notably, we found that 15% of women declined to be tested for HIV. This refusal rate is considerably higher than the refusal rates reported in studies examining the opt-out approach (0.2-5%).¹¹, ¹² Another 4% of women in our cohort were not screened simply because physicians did not provide pretest HIV counseling. These women likely would have been screened had an opt-out policy been used.

The aspect of our study that significantly differentiates it from prior institution-level investigations of the opt-in approach was our comparison of the actual HIV screening rates among 4 different types of obstetric care providers. Even after using a logistic regression that adjusted for age, race/ethnicity, and marital status, we found that women treated by MFM attendings and family practitioners were still significantly more likely to undergo screening when compared to women cared for by OB-GYN attendings. We were unable to determine why this difference existed, but we suspect it was related to the opt-in approach's requirement for pretest HIV counseling and education. At our institution, individual physicians were responsible for providing pretest counseling, which inherently led to variability in the quality of the counseling offered to women. As pretest counseling has been found to strongly influence a woman's decision for screening,¹³, ¹⁴ it was not surprising that the variability in the quality of counseling at our institution consequently led to variability in screening acceptance. Namely, the HIV screening rates at our 4 prenatal clinics ranged from 64-98%. The literature reports an even wider range of opt-in screening rates, which were as low as 25% to as high as 83%.¹⁵ The opt-out approach, on the other hand, does not require pretest counseling and is thereby less dependent on the provider. As a result, the opt-out approach leads to higher, more consistent rates of prenatal HIV screening (85-98%).¹¹, ¹⁵, ¹⁶, ¹⁷

The opt-in approach has additional shortcomings aside from leading to rates of screening that are heavily dependent on physicians' pretest counseling. With this approach, a patient's own bias regarding her perceived risk of HIV infection plays a significant role in her decision to be screened. If a woman deems herself at low risk for HIV, she will be less likely to opt in to screening. Yet, some may underestimate their true risk because of denial or lack of knowledge regarding which activities increase the risk for HIV. Others may be hesitant to opt in to screening for fear that their obstetric care provider will pass judgment on them for simply accepting the test. Similarly, the opt-in approach may allow a physician's bias about a patient's risk for HIV to become an issue. Some physicians may “label” women without recognized HIV risk factors as low risk for HIV and may consequently provide ineffective pretest counseling or simply fail to offer the test. This is problematic because only 8-58% of HIV-positive gravid women have identifiable risk factors.¹⁸, ¹⁹, ²⁰

While there are many disadvantages associated with the opt-in approach, achieving high rates of prenatal HIV screening with this approach is still possible. In our study, 98% and 80% of women seen by family practitioners and MFM attendings, respectively, underwent HIV screening. Although an opt-out approach is preferable due to its consistently higher screening rates, 28 states still require women to opt in to screening.⁷ In these states, practitioners should focus on providing thorough and informative pretest HIV counseling and education to maximize the rate of screening. Royce et al¹³ found that women were more likely to undergo prenatal HIV screening if they perceived a strong recommendation for testing from their clinician. Moreover, Jha et al¹⁴ discovered that the most common reason women opted in to screening was the perceived benefit. Another way for opt-in institutions to maximize their screening rate is to use health professionals dedicated to providing pretest counseling to women at the first prenatal visit. This allows for a more standardized approach to pretest counseling that consistently explains to women the benefits of screening.

Limitations of our study include those inherent to the retrospective study design. Also, our study represented only 412 of 2073 women eligible for the study. However, our cohort of 412 women was selected randomly from the overall population, and we do not suspect that women included in the study were managed differently from those not included. Our study was also limited by the fact that we did not look at the screening practices of individual providers. Another limitation involves the 4% of women who were not screened because they reported recent HIV testing. We were unable to determine when their previous testing occurred. However, relying on patient-reported HIV test results, no matter how recent, is questionable. O'Campo et al²¹ found that only 42% of women who reported prior HIV testing at their hospital had the reports confirmed. Lastly, for the women who declined HIV screening, we were unable to determine the reasoning behind their refusal. Previous studies found that gravid women most often refused screening because they did not perceive a need for the test.¹³, ¹⁴, ²², ²³

In summary, our findings lend further support to the literature that an opt-in approach to prenatal HIV screening consistently leads to lower rates of screening compared to those reported with the opt-out approach. We also found that the opt-in approach leads to provider-dependent rates of screening as well as a patient refusal rate (15%) >3 times that found at opt-out institutions (0.2-5%).¹¹, ¹² Although the CDC⁵ and the ACOG⁶ both recommend an opt-out approach to prenatal HIV screening, 28 states currently require women to opt in to screening.⁷ Given the higher HIV testing rates attained through an opt-out approach combined with the effectiveness of HAART in preventing vertical transmission, these states should strongly consider adopting an opt-out policy to prenatal HIV screening.

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Acknowledgment 

We thank and acknowledge the support and guidance provided by Drs Joshua H. Barash and Thomas A. Klein at the Jefferson Medical College of Thomas Jefferson University.

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References 

1. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment: pediatric AIDS clinical trials group protocol 076 study group. N Engl J Med. 1994;331:1173–1180
   • View In Article
   • MEDLINE
   • CrossRef
2. Cooper ER, Charurat M, Mofenson L, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002;29:484–494
   • View In Article
   • MEDLINE
   • CrossRef
3. Centers for Disease Control and Prevention (CDC). Epidemiology of HIV/AIDS–United States, 1981-2005. MMWR Morb Mortal Wkly Rep. 2006;55:589–592
   • View In Article
4. Centers for Disease Control and Prevention (CDC). Achievements in public health: reduction in perinatal transmission of HIV infection–United States, 1985-2005. MMWR Morb Mortal Wkly Rep. 2006;55:592–597
   • View In Article
5. Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55:1–17
   • View In Article
6. American College of Obstetrics and Gynecology Committee on Obstetric Practice. ACOG committee opinion no. 418: prenatal and perinatal human immunodeficiency virus testing; expanded recommendations. Obstet Gynecol. 2008;112:739–742
   • View In Article
   • CrossRef
7. Henry J Kaiser Family Foundation. HIV testing for mothers and newborns, February 2008. http://www.statehealthfacts.org/comparetable.jsp?ind=563&cat=11Accessed March 9, 2009
   • View In Article
8. National HIV/AIDS Clinicians' Consultation Center. State HIV testing laws compendium. http://www.nccc.ucsf.edu/StateLaws/State%20Laws/Pennsylvania.pdfAccessed March 9, 2009
   • View In Article
9. AIDS Activity Coordinating Office Surveillance Unit of the Philadelphia Department of Public Health. Philadelphia HIV/AIDS epidemiological update 2007: cases reported through June 2008. http://www.phila.gov/Health/units/aaco/pdfs/Final_Dec2007.pdfAccessed June 5, 2009
   • View In Article
10. AIDS Activity Coordinating Office Surveillance Unit of the Philadelphia Department of Public Health. Philadelphia HIV/AIDS epidemiological update: cases reported through June 2007. http://www.phila.gov/Health/units/aaco/pdfs/DEC06-Final.pdfAccessed June 5, 2009
    • View In Article
11. Breese P, Burman W, Shlay J, Guinn D. The effectiveness of a verbal opt-out system for human immunodeficiency virus screening during pregnancy. Obstet Gynecol. 2004;104:134–137
    • View In Article
    • MEDLINE
    • CrossRef
12. Jayaraman GC, Preiksaitis JK, Larke B. Mandatory reporting of HIV infection and opt-out prenatal screening for HIV infection: effect on testing rates. CMAJ. 2003;168:679–682
    • View In Article
    • MEDLINE
13. Royce RA, Walter EB, Fernandez MI, et al. Barriers to universal prenatal HIV testing in 4 US locations in 1997. Am J Public Health. 2001;91:727–733
    • View In Article
    • MEDLINE
    • CrossRef
14. Jha S, Gee H, Coomarasamy A. Women's attitudes to HIV screening in pregnancy in an area of low prevalence. BJOG. 2003;110:145–148
    • View In Article
    • MEDLINE
    • CrossRef
15. Centers for Disease Control and Prevention (CDC). HIV testing among pregnant women–United States and Canada, 1998-2001. MMWR Morb Mortal Wkly Rep. 2002;51:1013–1016
    • View In Article
    • MEDLINE
16. Yudin MH, Moravac C, Shah RR. Influence of an “opt-out” test strategy and patient factors on human immunodeficiency virus screening in pregnancy. Obstet Gynecol. 2007;110:81–86
    • View In Article
    • CrossRef
17. Stringer EM, Stringer JS, Cliver SP, Goldenberg RL, Goepfert AR. Evaluation of a new testing policy for human immunodeficiency virus to improve screening rates. Obstet Gynecol. 2001;98:1104–1108
    • View In Article
    • MEDLINE
    • CrossRef
18. Lewis R, O'Brien JM, Ray DT, Sibai BM. The impact of initiating a human immunodeficiency virus screening program in an urban obstetric population. Am J Obstet Gynecol. 1995;173:1329–1333
    • View In Article
    • Abstract
    • Full-Text PDF (464 KB)
    • CrossRef
19. Barbacci M, Repke JT, Chaisson RE. Routine prenatal screening for HIV infection. Lancet. 1991;337:709–711
    • View In Article
    • Abstract
    • CrossRef
20. Landesman S, Minkoff H, Holman S, McCalla S, Sijin O. Serosurvey of human immunodeficiency virus infection in parturients: implications for human immunodeficiency virus testing programs of pregnant women. JAMA. 1987;258:2701–2703
    • View In Article
    • MEDLINE
21. O'Campo P, de Boer M, Faden R, Kass N, Gielen A, Barbacci M. Confirmation of self-report of HIV testing among a cohort of pregnant women. J Clin Epidemiol. 1997;50:57–61
    • View In Article
    • Abstract
    • Full-Text PDF (556 KB)
    • CrossRef
22. Fernandez MI, Wilson TE, Ethier KA, Walter EB, Gay CL, Moore J. Acceptance of HIV testing during prenatal care: perinatal guidelines evaluation project. Public Health Rep. 2000;115:460–468
    • View In Article
    • MEDLINE
    • CrossRef
23. Carusi D, Learman LA, Posner SF. Human immunodeficiency virus test refusal in pregnancy: a challenge to voluntary testing. Obstet Gynecol. 1998;91:540–545
    • View In Article
    • MEDLINE
    • CrossRef