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Obstetrics & Gynecology 2001;98:1104-1108
© 2001 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Evaluation of a New Testing Policy for Human Immunodeficiency Virus to Improve Screening Rates

Elizabeth M. Stringer, MD, Jeffrey S. A. Stringer, MD, Suzanne P. Cliver, Robert L. Goldenberg, MD and Alice R. Goepfert, MD

From the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.

Address reprint requests to: Alice R. Goepfert, MD, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street, OHB 450, Birmingham, AL 35249-7333; E-mail: aliceg{at}uab.edu.


    ABSTRACT
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE: To assess the effect of a change in human immunodeficiency virus (HIV) testing policy on HIV testing rates in an urban maternity clinic population.

METHODS: Since 1995, our institution has provided pretest counseling and voluntary HIV testing to all pregnant women. After the 1999 Institute of Medicine recommendation of HIV testing with patient notification as a routine component of prenatal care, we conducted a prospective study to determine whether this policy would increase our HIV screening rates. The intervention incorporated HIV testing into the routine battery of tests drawn at antenatal care. Not to be tested required active refusal. The intervention group was comprised of all women receiving an initial antenatal visit in one of our eight maternity clinics between August 1, 1999, and July 30, 2000. The control group was comprised of all women presenting for prenatal care in the same clinics during the year before the intervention.

RESULTS: The 3415 women in the intervention group and 3778 controls were similar with respect to most demographic and risk factors. After the intervention, HIV testing increased from 75% to 88% (P < .001). Among all women in both years of the study, women who were in the intervention group, less than 20 years of age, or who had a history of substance abuse, were more likely not to refuse testing.

CONCLUSION: After implementation of a policy of routine HIV testing with active patient refusal, HIV testing rates increased among pregnant women in our large, urban obstetric clinic population.

In the United States, nearly all new pediatric human immunodeficiency virus (HIV) cases result from mother-to-child transmission of the virus.1 Fortunately, studies performed within the last decade have demonstrated that perinatal HIV infection is largely preventable with antiretroviral therapy. The use of highly active combination antiretroviral regimens (three or more drugs, with the goal of complete suppression of HIV RNA in the plasma) can reduce the risk of transmission to 1% or below, irrespective of mode of delivery (Blattner W, Cooper E, Charurat M, Thompson B, Hanson C, Mofenson L, et al. Effectiveness of potent antiretroviral therapies on reducing perinatal transmission of HIV-1. XIII International AIDS Conference, July 12, 2000, Durban, South Africa). Because of the prophylactic efficacy of modern antiviral chemotherapy, the largest risk of perinatal HIV infection in the United States is borne by infants whose mothers never learn their serostatus in pregnancy.2 Thus, the effort to increase HIV screening among women in prenatal care has obvious appeal from the standpoint of perinatal risk reduction. It also represents an important opportunity on two additional fronts. First, it allows HIV-infected women who are generally healthy and who otherwise have little interaction with the health care system to be identified early in the course of their disease, and thus avail themselves of the known benefits of early diagnosis.3 Second, women who test negative for HIV infection can be given general HIV education and counseled on known effective risk reduction strategies.

The ideal way to counsel and test for HIV in pregnancy has yet to be determined, and recommendations have changed frequently over the past several years. The different approaches to testing in pregnancy span a large spectrum from mandatory testing of all presenting gravidas to routine voluntary testing in which patients are counseled regarding the test and then allowed to decide whether they want to be tested or not. In 1995, ACOG advocated voluntary testing.4 In 2000, ACOG recommended moving away from this time-consuming and provider-dependent method of testing (ACOG Today, Vol. 45, Issue 5, May/June 2000), and embraced the 1999 recommendations of the Institute of Medicine (IOM) — universal HIV testing of all pregnant women with patient notification as a routine component of prenatal care.5 Under this strategy, women are tested for HIV unless they actively refuse and an extensive counseling process does not occur. Other methods of testing also exist that may be a hybrid of these different methods. Currently, different states have different policies for testing.

Since 1995, our eight maternity health clinics have used the ACOG guidelines of the same year as a model for voluntary HIV counseling and testing. However, our HIV screening rates have been disappointingly low, particularly at two of our clinics. In the year before this study, the overall rate of antenatal HIV testing uptake was 75%, and lower than 60% at two of the clinics in our system. We hypothesized that a change in policy from standard voluntary counseling and testing to one of routine testing with patient notification and active patient refusal would increase HIV screening by: 1) eliminating provider bias, 2) reducing the stigma associated with HIV testing because it would be offered to everyone, and 3) making patients aware of the potential impact of refusing testing after they had been thoroughly counseled on the benefits of learning one’s HIV status.


    MATERIALS AND METHODS
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Our obstetric system provides antenatal services at eight clinic facilities throughout Birmingham and Jefferson County, Alabama. Women followed in these clinics are delivered by the faculty and residents of the Department of Obstetrics and Gynecology at the University of Alabama at Birmingham. The Institutional Review Boards at the University of Alabama at Birmingham and at the Jefferson County Department of Health approved this study before implementation. A prospective intervention comprised of several parts was conducted at the eight maternity clinics from August 1, 1999, to July 30, 2000. Initially, a didactic HIV update for all maternity providers (predominantly nurse practitioners and certified nurse midwives) within the county prenatal clinic system was conducted in July 1999. The update was organized by the study investigators and included presentations by faculty obstetricians, pediatricians, and other local HIV experts to review the benefits of HIV screening, current drug therapy for HIV-infected adults, therapy to reduce perinatal HIV transmission, and recent advances in the field of HIV research. In addition, the study investigators discussed the proposed change in policy related to HIV screening planned for implementation on August 1, 1999. The new policy included making HIV testing part of routine prenatal care for all pregnant women seeking care in the clinics. Previously, at their initial prenatal encounter, all women had been given written information about HIV testing and were counseled by the maternity providers. At that time, they were asked to decide whether they wanted HIV testing or not. Under the new policy, the maternity providers were instructed to refer women to the written materials about HIV and simply notify them that an HIV test would be performed as part of the routine battery of prenatal laboratory tests. At this point, all women signed consent for treatment, and those women who agreed to HIV testing signed a consent specifically for the HIV test. This approach diverges slightly from the recent IOM recommendations, but is a requirement under Alabama Medicaid law. Women declining testing were counseled further. To structure the encounter, we constructed a one-page counseling form that outlined in lay language what HIV is, how it is transmitted, and the benefits of knowing one’s HIV status (including prevention of mother-to-child transmission.) At the bottom of the form, patients were requested to indicate their understanding in the event that they still did not desire testing. If women declined testing because they had recently been tested elsewhere, the document allowed them to give written permission for the release of those records. For Spanish-speaking patients, a Spanish-language counseling form was used, and written background materials were provided in Spanish as well.

All study data were then extracted from our computerized perinatal database, an information system that links the obstetric records of all women receiving antenatal and/or delivery care within our system. Statistical analysis was performed using SAS 8.0 (SAS Institute, Cary, NC). Rates of HIV testing and demographic information were compared using the {chi}2 test. Logistic regression analysis adjusting for factors that may have differed between the 2 years was used to calculate an adjusted odds ratio for receiving testing.


    RESULTS
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
The intervention cohort (N = 3415) included all women having their first antenatal visit in our system between August 1, 1999, and July 30, 2000. The control cohort (N = 3778) included all women seeking antenatal care in our system during the year before the intervention (August 1, 1998, to July 30, 1999). The intervention cohort and controls were similar with regard to most demographic and risk factor characteristics, including maternal age, proportion who were primiparous, self-reported smoking and substance abuse (alcohol and illicit drug) history, and proportion diagnosed with a sexually transmitted disease (syphilis, gonorrhea, chlamydia, hepatitis B) during the index pregnancy (Table 1Go). The percent of women not completing high school in the intervention cohort was slightly lower than the control group (42% versus 45%, P = .01), whereas the relative proportion of nonwhite, nonblack (predominantly Hispanic) women was slightly higher (10.4% versus 6.5%, P < .001). Women who refused testing in both pre- and post-intervention groups were similar with respect to age, race, years of education, smoking, alcohol, or drug use. However, the women in the intervention group did have fewer than seven prenatal visits than women in the control group (57% versus 64%, P = .008).


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Table 1. Demographic and Risk Factor Characteristics of Women in the Intervention Group Compared With Women in the Same Clinic System in the Year Before the Intervention (Control Group)
 
Overall, the rate of HIV screening in the intervention cohort increased from 75% in the year before our intervention to 88% in the year after the intervention (P < .001). Therefore, women in the intervention year were 16% more likely to be tested (relative risk 1.16, 95% confidence interval 1.14, 1.19). When the data were stratified by clinic, each individual facility within the system was found to have experienced an improvement in its rate of testing acceptance, except for Clinic A, which had a rate of 96% before the intervention (Table 2Go). The intervention year is the first year that all clinics had HIV testing acceptance rates of more than 80% with the majority closer to 90%. Various demographic factors and other potential risk factors for refusal to accept HIV testing, such as age, education, ethnicity, smoking history, substance use, and sexually transmitted disease history, were evaluated in both univariable and multivariable analyses. Using logistic regression and adjusting for the factors listed above, women who were in the intervention cohort, women who were less than 20 years of age, or who reported a substance abuse history were significantly more likely to be tested for HIV, whereas nonwhite, nonblack (predominantly Hispanic) women were significantly less likely to be tested (Table 3Go).


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Table 2. HIV Screening Rates by Jefferson County Department of Health Clinics the Year Before the Intervention Compared With the Year After the Intervention
 

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Table 3. Odds Ratio and 95% Confidence Intervals for Covariates Associated With Patient Acceptance of HIV Screening
 

    DISCUSSION
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Recommendations regarding HIV testing in pregnant women have repeatedly changed since the United States Public Health Service6 and ACOG4 promoted universal HIV counseling and voluntary testing of pregnant women in 1995. The Ryan White Care Act was subsequently passed mandating that states achieve certain levels of HIV screening or risk losing federal HIV funding.7 However, recommendations for how states were to meet these goals were not described. In 1999, the IOM convened an expert panel and published a report recommending a national policy of universal HIV testing, with patient notification, as a routine component of prenatal care.5 The IOM specifically emphasized the universal component of this strategy (applying it to all pregnant women, irrespective of their perceived risk status) as well as the routine component (integrating it into the standard battery of prenatal tests). This was the most stringent of recommendations to date, and ACOG has modified its original guidelines to conform to those of the IOM.

This study suggests that a policy of routine HIV testing with patient notification and active refusal may be a more effective approach to HIV screening than the standard model of voluntary counseling and testing. Our report confirms the findings of other studies that women are more likely to accept testing if they are young or have not received education beyond high school.8 Interestingly, we found that women who reported substance abuse were more likely to accept testing, whereas non-white, nonblack (predominantly Hispanic) women were more likely to refuse testing.

We decided to change our HIV screening policy in 1999. In the process, we considered a variety of approaches, and ultimately settled on that recommended by the IOM. However, to conform to Alabama Medicaid law (which mandates written consent for all HIV testing) and also to ensure standardized counseling of all women within the system who declined HIV testing, we decided to study a slight modification of the IOM-sanctioned approach. The resultant strategy required a simple signature at enrollment and included the distribution of written material on HIV in pregnancy at a reading level most patients could understand. In addition, the strategy allowed us to: 1) standardize the message given to all patients, 2) reduce the time spent on extensive pretest counseling in a population where the prevalence of HIV infection is quite low, and 3) ensure appropriate and standardized counseling of women who initially refused testing.

A major strength of this strategy is that it relieves the provider of the responsibility of offering testing. It also requires the patient to make an active decision to refuse HIV testing after the acknowledgment of its known benefits. Although there is some potential for abuse of the IOM recommendations by not informing women of the intent to test for HIV at all, our slight revision of the IOM strategy mitigates against this concern by asking for a simple signature. Indeed, this signature is mandated by Alabama Medicaid law. In systems where written consent for HIV testing is not required, an interesting possibility would be to provide women with a printed list of all routine prenatal laboratory tests to be drawn at the initial visit. This practice would allow women the opportunity to ask questions regarding testing and ensure notification of HIV testing.

We chose to perform a population-based study in which a policy change was made in our system, and its effects measured on the entire population of women we serve. Strengths of the study include its prospective nature, its large size, and its conduct within a stable urban clinic environment. A notable weakness of our design is that we do not have a contemporaneous comparison group, and we therefore cannot know with absolute confidence that the observed increase in screening uptake occurred as a result of our intervention. On the other hand, any other design would have almost certainly required individual informed consent to be obtained. Such a requirement could have severely affected the external validity of our results; those women who would not consent for such a study would likely differ considerably from those who would consent in their willingness to be tested for HIV. Another weakness of the design we chose is that without individual informed consent, we were unable to collect information outside that normally gathered as a routine part of antenatal care. As a result, although we were able to determine who declined HIV testing, we do not know why they did so.

The strategy that we have studied shifts most of the responsibility from the provider to the patient to refuse HIV testing. This approach to HIV screening is more time efficient because much of the pretest HIV counseling process has been eliminated. Clearly, this is only appropriate in very low-prevalence settings, such as the United States. Studies have shown that women would accept the idea of including HIV testing with other prenatal laboratory tests with one written consent for all tests.9 Surprisingly, a recent study by Walter et al showed that almost 50% of pregnant women who were offered HIV testing did not know that interventions exist to prevent perinatal transmission of HIV.10 Therefore, if HIV testing is to become a routine part of prenatal laboratory testing, our method of counseling women who decline testing appears to be important as it allows those women to make an informed decision about whether they should be tested or not. In the future, we believe HIV testing should become a routine part of prenatal care with proper counseling to allow for potentially improved treatment for women and the potential for the virtual eradication of pediatric HIV infection in the United States.


    Footnotes
 
PII S0029-7844(01)01631-3

Received April 23, 2001. Received in revised form August 17, 2001. Accepted August 23, 2001.


    REFERENCES
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
1. Centers for Disease Control and Prevention. AIDS among children—United States, 1996. MMWR 1996;45:1005–10.[Medline]

2. Mofenson LM. Can perinatal HIV infection be eliminated in the United States? JAMA 1999;282:577–9.[Free Full Text]

3. Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, et al. A controlled trial of two nucleoside analogs plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic milliliter or less. N Engl J Med 1997;337: 725–33.[Abstract/Free Full Text]

4. Hale RW, Zinberg S. ACOG’s position on HIV testing. ACOG Clin Rev 1997;2:1.

5. Stoto MA, Almario DA, McCormick MC, eds. Reducing the odds. Preventing perinatal transmission of HIV in the United States. New York: National Academy Press, 1999.

6. Centers for Disease Control and Prevention. United States Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women. MMWR 1995;44:1–15.[Medline]

7. Division of HIV Services, Bureau of Health Resources Development, Health Resources Services Administration. A compilation of the Ryan White Care Act of 1990, as amended by the Ryan White Care Act amendments of 1996. Rockville, MD: US Department of Health and Human Services, 1996:18–20.

8. Lindsay M. Determinants of acceptance of routine voluntary human immunodeficiency virus testing in an inner-city prenatal population. Obstet Gynecol 1991;78: 678–80.[Abstract/Free Full Text]

9. Carusi D. Human immunodeficiency virus test refusal in pregnancy: A challenge to voluntary testing. Obstet Gynecol 1998;91:540–5.[Abstract]

10. Walter E, Royce R, Fernandez M, Dehovitz J, Ickovics J, Lampe M. New mother’s knowledge and attitudes about perinatal human immunodeficiency virus infection. Obstet Gynecol 2001;97:70–6.[Abstract/Free Full Text]




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