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ORIGINAL RESEARCH |
From the Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention; and the Economics Department, Georgia State University, Atlanta, Georgia.
Address reprint requests to: Stephanie L. Sansom, PhD, MPH, Centers for Disease Control and Prevention, 1600 Clifton Road, MS E-45, Atlanta, GA 30333; E-mail: sos9{at}cdc.gov.
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ABSTRACT |
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METHODS: We used a decision tree in this cost-effectiveness analysis to model outcomes among pregnant women in high-risk communities and nationwide who received an initial, negative HIV antibody test during the first trimester. The main outcome measure was discounted costs per year of infant life saved.
RESULTS: In high-risk communities with estimated HIV incidence of 6.2 per 1000 person-years, a second HIV test compared with no second test would detect 192 infections in women, prevent approximately 37 infant infections, and save 655 infant life-years per 100,000 women tested. Net savings would be $5.2 million. Applied to an estimated national incidence of .17 per 1000 person-years, a second test would detect 5.3 infections in women, prevent 1.3 infant infections, and save 23.3 infant life-years per 100,000 women tested. Net costs would be $1.06 million, or $45,708 for each year of infant life saved. A second test would result in net savings in populations with HIV incidence of 1.2 per 1000 person-years or higher.
CONCLUSION: Health care providers serving women in communities with an HIV incidence of 1 per 1000 person-years or higher should strongly consider implementing a second voluntary universal HIV test during the third trimester. Providers serving lower-risk communities should pilot second testing to assess community-specific costs.
Testing pregnant women for human immunodeficiency virus (HIV) antibodies is an important strategy in the effort to prevent perinatal HIV transmission in the United States.1 The US Public Health Service recommends universal, voluntary HIV testing early in pregnancy.1 With the use of zidovudine and other preventive therapies, this initial universal testing has been critical in preventing perinatal transmission and protecting women’s health. Perinatal HIV transmissions have fallen in the United States from an estimated 1000 to 2000 cases per year in the early 1990s to an estimated 280 to 370 cases in 2000.1 Primary HIV infections, however, might go undetected among women who continue to practice risky behaviors during pregnancy and those whose initial test occurred before HIV antibodies developed. According to one study of 407 HIV-positive mothers, eight (2%) apparently seroconverted after a negative test result during or just before pregnancy. The eight maternal seroconversions resulted in three of the 35 perinatal HIV transmissions that occurred during the study.2
United States Public Health Service guidelines recommend that high-risk women be offered HIV testing again in the third trimester, preferably before 36 weeks’ gestation, and suggest routine retesting in the third trimester in facilities where the seroprevalence of HIV among women of childbearing years is high.1 Strategies that attempt to test individual women at high risk of contracting HIV during pregnancy can be difficult to implement ( Krasinski K, Borkowsky W, Bebenroth D, Moore T. Failure of voluntary testing for human immunodeficiency virus to identify infected parturient women in a high-risk population [letter]. N Engl J Med 1988;318:185[Medline]).3–5 Even when a mother’s HIV infection is discovered late in pregnancy, the use of antiretroviral therapies, and in some cases, elective cesarean delivery, might result in substantial reductions in HIV transmission ( Bulterys M, Orloff S, Abrams E, Nesheim S, Palumbo P, Vink P, et al. Impact of zidovudine post-perinatal exposure prophylaxis on vertical HIV-1 transmission: A prospective cohort study in 4 US cities [abstract]. In: Program and abstracts of the Second International Conference on Global Strategies for the Prevention of HIV Transmission from Mothers to Infants; Montreal, Canada; September 1999:015).2,6–10
The detection of HIV infection also alerts mothers to avoid breast-feeding, further reducing the risk of transmission.11 Because of the recognized importance of identifying women infected with HIV, even late in pregnancy, combined with potential problems of selecting for testing individual women at high risk, universal repeat testing could be an important preventive strategy. However, the cost-effectiveness of such a strategy has not been evaluated.
To estimate the costs and effectiveness associated with a universal voluntary second HIV test during the third trimester of pregnancy, we developed a model that compares this strategy with that of no retesting. Although we focused on the cost-effectiveness for estimated HIV incidence rates nationwide and in a hypothetic high-risk community, we also determined cost-effectiveness ratios for a wide range of incidence rates.
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MATERIALS AND METHODS |
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). Test sensitivity and specificity also were taken into account with the use of published estimates of test parameters.13
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Because data were not available on HIV incidence rates among pregnant women, we used data on HIV incidence among women of child-bearing years combined with data on prenatal care patterns of several populations of women and on HIV risk behaviors of pregnant women. Our estimated HIV incidence rates among women of childbearing years were 6.2 per 1000 person-years in high-risk communities and .17 per 1000 person-years nationwide (Table 1). The high-risk incidence, from a study of inner-city women,14 is supported by other studies of high-risk communities.15–19 The national incidence, based on a report of HIV diagnoses in 1998 among US women 20–44 years old in 25 HIV-reporting states, represents what we believe to be the best estimate of national HIV incidence among women of childbearing years.20 We adjusted incidence to reflect the 22-week period under consideration.
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In the sensitivity analysis, we also adjusted incidence rates to account for potential reductions in risky behavior by women who have learned that they are pregnant and who might have received HIV risk-reduction counseling when they were first tested.22–25 In our baseline analysis we did not allow for a reduction in incidence during pregnancy related to behavioral change, based on published findings, but in sensitivity analyses we allowed for up to a 40% reduction.
We included medical case costs, such as those associated with HIV counseling and testing and treatment of infected women, including elective cesarean delivery, treatment of infected infants, and testing of exposed infants to determine their HIV status. We also included the cost of patient time associated with counseling and testing. Our baseline estimates of counseling and testing costs including patient time, for HIV-positive and uninfected women, were derived from work by Varghese and Branson ( Varghese B, Branson BM. Cost and cost-effectiveness of oral fluid HIV testing compared to serum testing [abstract]. In: Program and abstracts the XIII International Conference on AIDS; Durban, South Africa; July 9–14, 2000:424). The baseline value for the lifetime treatment costs for infected infants was based on work by Mrus et al,26 which updated earlier estimates to include the use of highly active antiretroviral drugs. We also tested a wide variation of lifetime treatment costs in our sensitivity analysis.27,28 We estimated the costs of antiretroviral treatment (Combivir [GlaxoSmithKline, Research Triangle Park, NC] and nelfinavir) for the mother and intrapartum and neonatal zidovudine. Drug types and dosage were based on the Guidelines for the Use of Anti-Retroviral Agents in HIV-Positive Adults and Adolescents and the Physician’s Desk Reference.29,30 Prices were based on the 2001 Red Book.31 All costs were expressed in year 2000 US dollars. Future costs associated with the medical care of HIV-positive infants and future years of life were discounted at a 3% rate.32 Previously published cost estimates were updated according to the medical care component of the Consumer Price Index.33
We assumed women who tested positive during retesting and who accepted antiretroviral therapy would receive combination therapy (a protease inhibitor and the three-part zidovudine regimen of the Pediatric AIDS Clinical Trial Group – Protocol 076).34 We assumed these women would be offered an elective cesarean delivery, based on the likelihood that the 6 weeks between the second test at 32 weeks and the recommended time of elective cesarean delivery at 38 weeks might be insufficient to obtain test results, initiate antiretroviral therapy, and document sufficient viral load suppression to make elective cesarean delivery unnecessary.
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RESULTS |
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).
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In a threshold analysis, 1.2 per 1000 person-years was the incidence rate at which the costs of a national voluntary second test were offset by averted medical costs. At that incidence, a universal second test detected 38.2 infections among 100,000 women, prevented 7.3 infant infections and saved 158.4 infant life-years (Figure 2).
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DISCUSSION |
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Nationally, our models suggest that a second voluntary HIV test during the third trimester would cost $45,708 per year of infant life saved. Other life-saving strategies comparable in cost include annual cervical cancer testing in all women beginning at age 21 ($64,500 per year of life saved)35 and prophylactic zidovudine for health care workers after needlestick injuries ($52,890 per year of life saved).36 In a review of more than 500 life-saving interventions, Tengs et al37 reported that the median cost was $54,180 per year of life saved.
We found that a second HIV test in the third trimester could prevent perinatal transmissions at a net savings to society when HIV incidence among women of child-bearing years is 1.2 or higher per 1000 person-years. At an incidence of 1 per 1000 person-years, we estimate the cost per year of infant life saved would be $2318. Inner-city health care facilities are particularly likely to serve populations with incidence rates close to this range or higher.14–16,19,38
Nationwide, cost-effectiveness was most affected by the cost of retesting the large number of women who will be HIV-negative. Our baseline estimate for testing HIV-negative women included assumptions that a registered nurse drew blood for the test and provided brief counseling before and after the test, and that a laboratory technologist performed the test. These costs could be reduced if women consented to the second test when they consented to the first, if pretest counseling time were reduced or eliminated, if lower-wage personnel performed counseling and testing, or a combination of these factors. We also believe a second HIV test during the third trimester could be conducted at less expense if it were done at the same time as other repeat screening tests, such as for syphilis. The availability of rapid testing in providers’ offices could reduce the costs of testing women by eliminating the need for a laboratory to conduct enzyme immunoassays. Rapid testing also would increase effectiveness by allowing women who are HIV-positive to begin treatment more quickly.39
Varying assumptions about the timing of prenatal care initiation and behavioral change during pregnancy, both of which affected the HIV incidence rates in our model, also influenced cost effectiveness. For our analyses, we used widely accepted baseline estimates; in the absence of widely accepted estimates, we used conservative estimates. We did not attempt to compare the cost effectiveness of a universal second HIV test during pregnancy with a strategy of retesting individually selected women. Low success rates of 14–29% have been reported when providers have attempted to identify HIV-positive women on the basis of risk factors ( Krasinski K, et al. N Engl J Med 1988;318:185).3–5 Difficulties in selecting individual women for testing led the US Public Health Service in 1995 to change its recommendation regarding an initial HIV test from selecting individual high-risk pregnant women to offering testing and counseling to all pregnant women.40
Our estimated benefits of a second HIV test do not take into account the potential increased longevity and improved quality of life for women who become infected with HIV during pregnancy and who, as a result of a second HIV test, receive therapy soon after seroconversion.41,42 A woman’s awareness of her infection might also cause her to change her behavior to protect sex partners.43 Nor did we consider the effect that repeat testing might have on ensuring that all women who receive prenatal care are offered at least one HIV test. If a second HIV test in the third trimester provides these additional benefits, this strategy would be more cost effective than our results indicate. Our analysis, because it focuses on women in prenatal care during the first and third trimesters, does not include those women who do not receive any prenatal care and who may be at particularly high risk for HIV. Other studies have documented the benefits that a rapid HIV test during labor would offer to these women and their infants.44,45 We did not estimate costs per quality-adjusted life year for infants because we believe existing pediatric quality-adjusted life year measures do not accurately reflect the current disease progression of perinatally acquired HIV.
Given the results of our study, we strongly recommend that health care providers serving high-risk women consider offering a universal voluntary second HIV test during the third trimester of pregnancy. Although a national repeat HIV test during pregnancy seems to be cost-effective when compared with the costs of other life-saving interventions, uncertainties about testing costs, in particular, lead us to recommend that providers serving lower-risk women consider piloting second-test programs in their communities. Overall, our study indicates that a second HIV test during pregnancy could be an important tool for preventing perinatal transmission in high-risk populations of women and might be a cost-effective intervention nationwide.
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Footnotes |
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Received December 4, 2002. Received in revised form March 7, 2003. Accepted April 14, 2003.
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REFERENCES |
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| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
The incidence rate is adjusted for the likelihood that women at risk for HIV infection during pregnancy would receive an initial HIV test in the first trimester.