Sexual and Reproductive Health Among Cisgender Women With HIV Aged 18-44 Years.

INTRODUCTION: The sexual and reproductive health of cisgender women with HIV is essential for overall health and well-being. Nationally representative estimates of sexual and reproductive health outcomes among women with HIV were assessed in this study. METHODS: Data from the Centers for Disease Control and Prevention's Medical Monitoring Project-including data on sexual and reproductive health-were collected during June 2018-May 2021 through interviews and medical record abstraction among women with HIV and analyzed in 2023. Among women with HIV aged 18-44 years (n=855), weighted percentages were reported, and absolute differences were assessed between groups, highlighting differences ≥|5%| with CIs that did not cross the null. RESULTS: Overall, 86.4% of women with HIV reported receiving a cervical Pap smear in the past 3 years; 38.5% of sexually active women with HIV had documented gonorrhea, chlamydia, and syphilis testing in the past year; 88.9% of women with HIV who had vaginal sex used ≥1 form of contraception in the past year; and 53.4% had ≥1 pregnancy since their HIV diagnosis-of whom 81.5% had ≥1 unintended pregnancy, 24.6% had ≥1 miscarriage or stillbirth, and 9.8% had ≥1 induced abortion. Some sexual and reproductive health outcomes were worse among women with certain social determinants of health, including women with HIV living in households <100% of the federal poverty level compared with women with HIV in households ≥139% of the federal poverty level. CONCLUSIONS: Many women with HIV did not receive important sexual and reproductive health services, and many experienced unintended pregnancies, miscarriages/stillbirths, or induced abortions. Disparities in some sexual and reproductive health outcomes were observed by certain social determinants of health. Improving sexual and reproductive health outcomes and reducing disparities among women with HIV could be addressed through a multipronged approach that includes expansion of safety net programs that provide sexual and reproductive health service coverage.

Dolutegravir and pregnancy outcomes including neural tube defects in the USA during 2008-20: a national cohort study.

BACKGROUND: A study from Botswana identified an increased risk of neural tube defects (NTDs) in infants of mothers with HIV who were treated with dolutegravir around the time of conception. We aimed to examine associations of dolutegravir use with NTDs and pregnancy loss using large health-care claims databases from the USA, a country with folic acid fortification of food. METHODS: In this cohort study, we analysed health-care claims data, recorded in the Merative MarketScan commercial database (MarketScan data) and Centers for Medicare & Medicaid Services Medicaid database (Medicaid data) from Jan 1, 2008, to Dec 31, 2020. We identified pregnancies with enrolment during their entire duration among women aged 15-49 years and we estimated time of conception. For each pregnancy, we determined HIV status and periconceptional exposure to dolutegravir or other antiretroviral agents. We estimated and compared the incidence rate of NTDs, stillbirths, and pregnancy loss (ie, spontaneous or induced abortions) by type of periconceptional antiretroviral exposure. We calculated adjusted risk ratios of the adverse outcomes using Poisson models adjusting for demographic and clinical factors. FINDINGS: Of 4 489 315 pregnancies in MarketScan data and 14 405 861 pregnancies in Medicaid data that had full enrolment, we identified 69 pregnancies in MarketScan data and 993 pregnancies in Medicaid data that were associated with HIV and periconceptional dolutegravir exposure. For women without HIV, the NTD rate was 4·1 per 10 000 live births (95% CI 3·9-4·3) in MarketScan and 5·7 per 10 000 live births (5·6-5·8) in Medicaid. No NTD cases were found among those with dolutegravir or non- dolutegravir antiretroviral drug exposure in the MarketScan data; only one NTD case was identified among women with dolutegravir, and three among women with non-dolutegravir antiretroviral exposure in Medicaid. After adjusting for covariates, there were no significant differences in risk ratios of NTD between groups with periconceptional dolutegravir or non-dolutegravir antiretroviral exposure and the group without HIV. However, compared with women without HIV, the risk of pregnancy loss was higher among women exposed to antiretroviral therapy: for dolutegravir exposure the adjusted risk ratio was 1·73 (95% CI 1·20-2·49) in MarketScan data and 1·41 (1·30-1·54) in Medicaid data; for non-dolutegravir antiretroviral exposure the adjusted risk ratio was 1·23 (1·10-1·37) in MarketScan data and 1·11 (1·07-1·15) in Medicaid data. INTERPRETATION: We studied the largest US cohort of women with periconceptional or early-pregnancy dolutegravir exposure. Our results do not show an increased risk of NTDs in exposed infants in the USA. Administrative databases can be used, with rigorous methodology, to study correlates of rare outcomes, such as NTDs, and to monitor for adverse pregnancy outcomes in women who receive antiretrovirals. FUNDING: US Centers for Disease Control and Prevention.

Neural Tube Defects in Pregnancies Among Women With Diagnosed HIV Infection - 15 Jurisdictions, 2013-2017.

In May 2018, a study of birth defects in infants born to women with diagnosed human immunodeficiency virus (HIV) infection in Botswana reported an eightfold increased risk for neural tube defects (NTDs) among births with periconceptional exposure to antiretroviral therapy (ART) that included the integrase inhibitor dolutegravir (DTG) compared with other ART regimens (1). The World Health Organization* (WHO) and the U.S. Department of Health and Human Services† (HHS) promptly issued interim guidance limiting the initiation of DTG during early pregnancy and in women of childbearing age with HIV who desire pregnancy or are sexually active and not using effective contraception. On the basis of additional data, WHO now recommends DTG as a preferred treatment option for all populations, including women of childbearing age and pregnant women. Similarly, the U.S. recommendations currently state that DTG is a preferred antiretroviral drug throughout pregnancy (with provider-patient counseling) and as an alternative antiretroviral drug in women who are trying to conceive.§ Since 1981 and 1994, CDC has supported separate surveillance programs for HIV/acquired immunodeficiency syndrome (AIDS) (2) and birth defects (3) in state health departments. These two surveillance programs can inform public health programs and policy, linkage to care, and research activities. Because birth defects surveillance programs do not collect HIV status, and HIV surveillance programs do not routinely collect data on occurrence of birth defects, the related data have not been used by CDC to characterize birth defects in births to women with HIV. Data from these two programs were linked to estimate overall prevalence of NTDs and prevalence of NTDs in HIV-exposed pregnancies during 2013-2017 for 15 participating jurisdictions. Prevalence of NTDs in pregnancies among women with diagnosed HIV infection was 7.0 per 10,000 live births, similar to that among the general population in these 15 jurisdictions, and the U.S. estimate based on data from 24 states. Successful linking of data from birth defects and HIV/AIDS surveillance programs for pregnancies among women with diagnosed HIV infection suggests that similar data linkages might be used to characterize possible associations between maternal diseases or maternal use of medications, such as integrase strand transfer inhibitors used to manage HIV, and pregnancy outcomes. Although no difference in NTD prevalence in HIV-exposed pregnancies was found, data on the use of integrase strand transfer inhibitors in pregnancy are needed to understand the safety and risks of these drugs during pregnancy.

Cancer Among Children With Perinatal Exposure to HIV and Antiretroviral Medications--New Jersey, 1995-2010.

BACKGROUND: Concerns remain regarding the cancer risk associated with perinatal antiretroviral (ARV) exposure among infants. No excessive cancer risk has been found in short-term studies. METHODS: Children born to HIV-infected women (HIV-exposed) in New Jersey from 1995 to 2008 were identified through the Enhanced HIV/AIDS Reporting System and cross-referenced with data from the New Jersey State Cancer Registry to identify new cases of cancer among children who were perinatally exposed to ARV. Matching of individuals in the Enhanced HIV/AIDS Reporting System to the New Jersey State Cancer Registry was conducted based on name, birth date, Social Security number, residential address, and sex using AutoMatch. Age- and sex-standardized incidence ratio (SIR) and exact 95% confidence intervals (CIs) were calculated using New Jersey (1979-2005) and US (1999-2009) cancer rates. RESULTS: Among 3087 children (29,099 person-years; median follow-up: 9.8 years), 4 were diagnosed with cancer. Cancer incidence among HIV-exposed children who were not exposed to ARV prophylaxis (22.5 per 100,000 person-years) did not differ significantly from the incidence among children who were exposed to any perinatal ARV prophylaxis (14.3 per 100,000 person-years). Furthermore, the number of cases observed among individuals exposed to ARV did not differ significantly from cases expected based on state (SIR = 1.21; 95% CI: 0.25 to 3.54) and national (SIR = 1.27; 95% CI: 0.26 to 3.70) reference rates. CONCLUSIONS: Our findings are reassuring that current use of ARV for perinatal HIV prophylaxis does not increase cancer risk. We found no evidence to alter the current federal guidelines of 2014 that recommend ARV prophylaxis of HIV-exposed infants.

HIV screening practices in U.S. hospitals, 2009-2010.

OBJECTIVE: A 2004 national survey of hospitals showed that 23.4% of hospitals screened for HIV in at least one department, most frequently in labor and delivery departments. However, less than 2% of these hospitals screened patients in inpatient units, urgent care clinics, or emergency departments. In 2006, the Centers for Disease Control and Prevention (CDC) recommended HIV screening for all individuals 13-64 years of age in health-care settings. We determined the frequency of hospital adoption of these CDC recommendations. METHODS: We surveyed hospital infection-control personnel at a randomly selected sample of U.S. general medical and surgical hospitals in 2009-2010. RESULTS: Of the 1,476 hospitals selected for the survey, 754 (51.1%) responded to the survey; of those responding, 703 (93.2%) offered HIV tests for patients at the hospital and 206 (27.3%) screened for HIV in at least one department. Screening was most common in larger hospitals (45.7%), hospitals in large metropolitan areas (50.5%), and teaching hospitals (44.4%); it was least common in public hospitals (19.1%). By department, screening was most common in labor and delivery departments (34.6%) and substance abuse clinics (20.7%); it was least common in emergency departments (11.9%), inpatient units (9.6%), and psychiatry/mental health departments (9.4%). More than half of hospitals were not considering implementing CDC's recommendations within the next 12 months. CONCLUSIONS: Since 2004, HIV screening in hospitals increased overall and by department. However, the majority of U.S. hospitals have not adopted the CDC recommendations.

False-positive human immunodeficiency virus enzyme immunoassay results in pregnant women.

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.

Testing women for human immunodeficiency virus infection: who, when, and how?

Obstetrician-gynecologists provide comprehensive primary and preventive care for women and are ideally suited to provide human immunodeficiency virus (HIV) screening for their patients. This paper provides a summary and rationale for the current recommendations for HIV testing among women in the United States, emphasizing recommendations from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists [corrected] Who should receive HIV testing, when and how often testing should be conducted, and how testing should be offered are discussed. These recommendations are described separately for general populations (including nonpregnant women) and for pregnant women and their infants.

Recommendations for human immunodeficiency virus screening, prophylaxis, and treatment for pregnant women in the United States.

In the United States, current human immunodeficiency virus (HIV) testing guidelines recommend an opt-out approach for pregnant women, whereby HIV testing is incorporated routinely into the standard panel of prenatal tests with the option to decline. Current recommendations for the initiation of treatment of HIV infection in pregnant women are the same as those for nonpregnant women. However, the special circumstances of pregnancy raise additional issues that are related to potential drug toxicity to the mother and fetus, which affect the choice of antiretroviral drugs to be used. For HIV-infected pregnant women who do not require therapy for their own health, antiretroviral drugs are recommended for prevention of mother-to-child transmission. Highly active antiretroviral therapy is recommended for all women with HIV RNA levels of > or = 1000 copies/mL, along with consideration of elective cesarean delivery. For women with HIV RNA levels of < 1000 copies/mL, a 3-part zidovudine prophylaxis regimen (prenatal, intrapartum, and neonatal) should be used alone or in combination with other antiretroviral drugs.

Rapid human immunodeficiency virus-1 testing on labor and delivery in 17 US hospitals: the MIRIAD experience.

The objective of the study was to evaluate the feasibility, acceptability, and accuracy of rapid human immunodeficiency virus (HIV) testing during labor. The Mother-Infant Rapid Intervention at Delivery (MIRIAD) study was a prospective, multicenter study that offered voluntary, rapid HIV testing to women with undocumented HIV status at 17 hospitals in 6 cities. Of 12,481 eligible women, 74% were approached for participation and 85.5% of those approached accepted rapid HIV testing. Among 7753 women tested, MIRIAD identified 52 (0.7%) HIV-infected women. The time between obtaining the blood sample for the rapid test and reporting the results to the health care provider was shorter for hospitals utilizing point-of-care testing than in hospitals utilizing laboratory-based testing (30 minutes vs 68 minutes; P < .0001), and point-of-care testing strategies were 14 times more likely to have a short turnaround as laboratory testing strategies. Routine rapid testing during labor provides a feasible, acceptable, and accurate way to identify HIV-infected women before delivery.

An end to perinatal HIV: success in the US requires ongoing and innovative efforts that should expand globally.

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.

Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings.

These recommendations for human immunodeficiency virus (HIV) testing are intended for all health-care providers in the public and private sectors, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities, and primary care settings. The recommendations address HIV testing in health-care settings only. They do not modify existing guidelines concerning HIV counseling, testing, and referral for persons at high risk for HIV who seek or receive HIV testing in nonclinical settings (e.g., community-based organizations, outreach settings, or mobile vans). The objectives of these recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States. These revised recommendations update previous recommendations for HIV testing in health-care settings and for screening of pregnant women (CDC. Recommendations for HIV testing services for inpatients and outpatients in acute-care hospital settings. MMWR 1993;42[No. RR-2]:1-10; CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50[No. RR-19]:1-62; and CDC. Revised recommendations for HIV screening of pregnant women. MMWR 2001;50[No. RR-19]:63-85). Major revisions from previously published guidelines are as follows: For patients in all health-care settings HIV screening is recommended for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Persons at high risk for HIV infection should be screened for HIV at least annually. Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings. For pregnant women HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women. HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

Achieving universal HIV screening in prenatal care in the United States: provider persistence pays off.

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.