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Objective: The primary aim of this serial cross‐sectional analysis is to estimate the total number of prevented perinatal HIV transmissions from the time of the initial recommendation for perinatal zidovudine (ZDV) prophylaxis in 1994 through 2020 in the US. Methods: The estimated number of prevented transmissions was calculated as annual differences between expected and observed numbers of perinatal HIV transmissions. Annual expected number of transmissions was estimated by multiplying the annual number of births to women with HIV by 0.2255 (22.55%), i.e., the transmission rate of the control group in the ACTG Protocol 076 trial. We used published point estimates or, if only ranges were given, the midpoints of those ranges as the best estimates of the annual numbers of births to women with HIV and infants with perinatal HIV. When data were not available, we linearly interpolated or extrapolated the available data to obtain estimated numbers for each year. Results: Between 1978 and 2020, the approximate number of live births to women with HIV was 191 267 (95% confidence interval [CI] 190 392–192 110) and for infants with diagnosed perinatal HIV, it was 21 379 (95% CI 21 088–21 695). Since 1994, the annual number of infants born with HIV decreased from 1263 (95% CI 1194–1333) to 33 in 2019 (95% CI 22–45) and 36 in 2020 (95% CI 25–48), corresponding to a 97% reduction. Cumulatively, an estimated total of 22 732 (95% CI 21 340–24 462) perinatal HIV infections were prevented from 1994 through to 2020. Conclusion: The elimination of perinatal HIV transmission—accompanied by the cumulative number of prevented cases exceeding that of perinatal HIV infections—is a major public health achievement in the US. Synopsis: Annual numbers of perinatal HIV infections have decreased by 97% since 1994, and 22 732 perinatal HIV infections have been prevented in the US from 1994 through to 2020. [ABSTRACT FROM AUTHOR]

The HIV/AIDS epidemic has been one of the greatest challenges in global health, significantly affecting women of reproductive potential. Considerable advances in antiretroviral therapy for women living with HIV have contributed to improvements in quality of life, better reproductive and birth outcomes, and a reduced risk of perinatal transmission. Despite the progress made, persistent challenges in access and adherence to antiretroviral drugs may limit their benefits for some women. More pharmacokinetic and safety studies in pregnant and lactating women are urgently needed, as are prospective surveillance systems to evaluate associations between fetal and infant antiretroviral exposures, drug–drug interactions, and pregnancy outcomes. Multipurpose technologies, such as combined HIV and other STI or unintended pregnancy prevention, and innovative delivery methods, such as the development of long-acting antiretrovirals, have the potential to reduce adherence challenges and enhance quality of life for women with HIV. Parallel advances in drug safety testing and surveillance are needed to ensure the health and safety of women with or at risk for HIV and children at risk for perinatal transmission. [ABSTRACT FROM AUTHOR]

Pregnant persons with chronic health conditions often require pharmacotherapy to remain healthy. The Antiretroviral Pregnancy Registry is a prospective, international, voluntary, and exposure registry that collects information on antiretroviral (ARV) exposure; however, a minority of providers use the registry, leaving critical gaps to guide prescribing in this population. The Task Force for the Elimination of Perinatal HIV Transmission in the United States, funded by the Centers for Disease Control and Prevention, has identified the monitoring of ARV safety as a paramount concern in the ongoing mission to eliminate perinatal human immunodeficiency virus (HIV) transmission. As active members of this task force, we urge all healthcare providers who care for pregnant individuals to prioritize reporting all ARV exposures to the registry. [ABSTRACT FROM AUTHOR]

In 2012, the Centers for Disease Control and Prevention published a Framework for Elimination of Perinatal Transmission of HIV in the United States in Pediatrics, setting the goals of an incidence of <1 case of perinatal HIV per 100 000 live births, and a perinatal transmission rate of <1%. We used National HIV Surveillance System data to monitor the numbers of perinatally acquired HIV cases among US-born persons and perinatal HIV diagnosis rates per 100 000 live births to approximate incidence. Perinatal HIV transmission rates from 2010 to 2019 were calculated by using estimates of live births to women with an HIV diagnosis from the National Inpatient Sample, Healthcare Cost and Utilization Project. The annual estimated number of live births to women with diagnosed HIV decreased from 4587 in 2010 to 3525 in 2019, and the number of US-born infants with perinatally acquired HIV decreased from 74 in 2010 to 32 in 2019. Annual perinatal HIV diagnosis rates declined from 1.9 to 0.9 per 100 000 live births, and perinatal HIV transmission rates declined from 1.6% to 0.9%. Racial and ethnic disparities in HIV diagnosis rates persisted but declined substantially over the 10-year period. Both diagnosis and transmission rate elimination goals were first achieved in 2019. To maintain the elimination of perinatal HIV, and to eliminate racial disparities, the continued coordinated effort of health care and public health is required. The approach to perinatal HIV elimination is a public health model that can be replicated or expanded to areas beyond HIV. [ABSTRACT FROM AUTHOR]

Pregnancy is a condition of broad interest across many medical and health services research domains, but one not easily identified in healthcare claims data. Our objective was to establish an algorithm to identify pregnant women and their pregnancies in claims data. We identified pregnancy-related diagnosis, procedure, and diagnosis-related group codes, accounting for the transition to International Statistical Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis and procedure codes, in health encounter reporting on 10/1/2015. We selected women in Merative MarketScan commercial databases aged 15–49 years with pregnancy-related claims, and their infants, during 2008–2019. Pregnancies, pregnancy outcomes, and gestational ages were assigned using the constellation of service dates, code types, pregnancy outcomes, and linkage to infant records. We describe pregnancy outcomes and gestational ages, as well as maternal age, census region, and health plan type. In a sensitivity analysis, we compared our algorithm-assigned date of last menstrual period (LMP) to fertility procedure-based LMP (date of procedure + 14 days) among women with embryo transfer or insemination procedures. Among 5,812,699 identified pregnancies, most (77.9%) were livebirths, followed by spontaneous abortions (16.2%); 3,274,353 (72.2%) livebirths could be linked to infants. Most pregnancies were among women 25–34 years (59.1%), living in the South (39.1%) and Midwest (22.4%), with large employer-sponsored insurance (52.0%). Outcome distributions were similar across ICD-9 and ICD-10 eras, with some variation in gestational age distribution observed. Sensitivity analyses supported our algorithm's framework; algorithm- and fertility procedure-derived LMP estimates were within a week of each other (mean difference: -4 days [IQR: -13 to 6 days]; n = 107,870). We have developed an algorithm to identify pregnancies, their gestational age, and outcomes, across ICD-9 and ICD-10 eras using administrative data. This algorithm may be useful to reproductive health researchers investigating a broad range of pregnancy and infant outcomes. [ABSTRACT FROM AUTHOR]

Routine voluntary HIV testing with the right to decline (the 'opt-out' approach) is recommended for all pregnant women in the United States but not all are tested. We examined data from surveys of prenatal care providers to identify factors associated with universal testing among patients. Data are from a probability survey conducted in 1999 with prenatal care providers in four separate areas. Survey participants completed a self-administered questionnaire. We computed the percentage of providers reporting universal testing by characteristics of the provider's practice, medical specialty, how strongly they encouraged testing, perceptions of patients' risk, and whether they saw patients in public clinics. In the four locations (Brooklyn, New York; North Carolina; Connecticut; and Dade County, Florida) 95%-99% of providers reported that they routinely offered HIV testing to all pregnant women; the average percentage tested was 64%-89%. The percentage reporting that all of their patients were tested ranged from 12%-62%. The percent of providers reporting universal testing was positively associated with the degree to which testing was encouraged, particularly encouragement to women perceived to be low risk. In some areas, universal testing varied by medical profession, with obstetric physicians and residents, and nurse-midwives reporting a lower percentage of universal testing than family practice physicians and residents. To achieve the goal of routine HIV testing of all pregnant women, education and training must be delivered to all prenatal care providers. This training should emphasize the importance of routine testing. Even with the opt-out approach, many women may decline testing if their doctor does not recommend and encourage HIV testing.

The article discuses the guidelines formulated by the U.S. Centers for Disease Control and Prevention (CDC) for the clinicians regarding preexposure prophylaxis (PrEP) in order to prevent HIV infection in heterosexual adults. It informs that the guidelines by CDC mention the use of oral tenofovir disoproxil fumarate (TDC) as antiretroviral preexposure prophylaxis (PrEP) to reduce the risk for HIV infections in heterosexuals. It also presents the guidelines for clinicians which include the use of HIV antibody test, regular examining of the serum creatinine and PrEP medication and counseling. It also presents table depicting the measures of efficacy in PrEP trials with TDC.

The article discusses interim guidelines on the use of antiretroviral pre-exposure prophylaxis (PrEP) for the prevention of HIV infection in heterosexually-active adults which, issued by the U.S. Centers for Disease Control and Prevention (CDC). The guidelines is supported by data from randomized, double-blind, placebo-controlled, clinical trials of oral PrEP with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). The CDC advice clinicians and patients to use of this guidelines.

Objective: Examine whether false-positive HIV enzyme immunoassay (EIA) test results occur more frequently among pregnant women than among women who are not pregnant and men (others). Design: To obtain a large number of pregnant women and others tested for HIV, we identified specimens tested at a national laboratory using Genetic Systems HIV-1/HIV-2 Plus O EIA from July 2007 to June 2008. Methods: Specimens with EIA repeatedly reactive and Western blot-negative or indeterminate results were considered EIA false-positive. We compared the false-positive rate among uninfected pregnant women and others, adjusting for HIV prevalence. Among all reactive EIAs, we evaluated the proportion of false-positives, positive predictive value (PPV), and Western blot bands among indeterminates, by pregnancy status. Results: HIV prevalence was 0.06% among 921,438 pregnant women and 1.34% among 1,103,961 others. The false-positive rate was lower for pregnant women than others (0.14% vs. 0.21%, odds ratio 0.65 [95% confidence interval 0.61, 0.70]). Pregnant women with reactive EIAs were more likely than others (p<0.01) to have Western blot-negative (52.9% vs. 9.8%) and indeterminate results (17.0% vs. 3.7%) and lower PPV (30% vs. 87%). The p24 band was detected more often among pregnant women (p<0.01). Conclusions: False-positive HIV EIA results were rare and occurred less frequently among pregnant women than others. Pregnant women with reactive EIAs were more likely to have negative and indeterminate Western blot results due to lower HIV prevalence and higher p24 reactivity, respectively. Indeterminate results may complicate clinical management during pregnancy. Alternative methods are needed to rule out infection in persons with reactive EIAs from low prevalence populations. [ABSTRACT FROM AUTHOR]

The article highlights recommendations from the U.S. Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists for HIV testing of pregnant women and their infants and nonpregnant women. According to the authors, obstetricians and gynecologists are in a key position to offer HIV testing in a safe and nonstigmatizing way. They discuss types of HIV tests, preconception and interconception health care and the history of HIV testing in the country.

The dramatic reduction of perinatally transmitted HIV in the United States has been a striking success story in the HIV epidemic. Routine HIV screening during pregnancy followed by appropriate therapy has been extremely effective. This paper puts forth three strategies needed to maintain these gains and reach the goal of eliminating perinatal HIV: standardize medical interventions and policy changes that support perinatal HIV reduction; institute HIV screening in routine preconception care to identify HIV infection in women before pregnancy; and critically focus attention and resources on primary prevention of HIV infection in women. Healthcare providers should incorporate HIV prevention education and routine screening into women's primary health care. Public health leaders should support and fund prevention strategies directed at young women. Successful approaches that have nearly eliminated perinatal HIV transmission in the United States offer valuable lessons that should be applied to primary HIV prevention for women in the United States and globally.Journal of Public Health Policy (2007) 28, 249–260. doi:10.1057/palgrave.jphp.3200126 [ABSTRACT FROM AUTHOR]

Background: Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor. Methods: To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study. Results: In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study. Conclusions: We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions. [ABSTRACT FROM AUTHOR]

Objective: To examine HIV viral suppression during/after pregnancy.Design: Prospective observational cohort.Methods: We identified pregnancies from 1996 to 2015. We examined HIV RNA viral load (VL), VL suppression (≤500 copies/mL), and antiretroviral therapy (ART) status at pregnancy start, end, and 6 months postpartum. We estimated risk ratios (RRs) and 95% confidence intervals (CIs) for VL nonsuppression.Results: Among 253 pregnancies analyzed, 34.8% of women exhibited VL suppression at pregnancy start, 60.1% at pregnancy end, and 42.7% at 6 months postpartum. Median VL (log10 copies/mL) was 2.80 (interquartile range [IQR]: 1.40-3.85) at pregnancy start, 1.70 (IQR: 1.40-2.82) at pregnancy end, and 2.30 (IQR: 1.40-3.86) at postpartum. Risk of postpartum VL nonsuppression was also lower among women on ART and with VL suppression at pregnancy end (versus those not; adjusted RR = 0.30, 95% CI: 0.17-0.53).Conclusions: Maintaining VL suppression among US women remains a challenge, particularly during postpartum. Achieving VL suppression earlier during pregnancy benefits women subsequently. [ABSTRACT FROM AUTHOR]