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Objective To describe the characteristics and birth outcomes of women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as community spread in New York City was detected in March 2020. Methods We performed a prospective cohort study of pregnant women with laboratory-confirmed SARS-CoV-2 infection who gave birth from March 13 to April 12, 2020, identified at five New York City medical centers. Demographic and clinical data from delivery hospitalization records were collected, and follow-up was completed on April 20, 2020. Results Among this cohort (241 women), using evolving criteria for testing, 61.4% of women were asymptomatic for coronavirus disease 2019 (COVID-19) at the time of admission. Throughout the delivery hospitalization, 26.5% of women met World Health Organization criteria for mild COVID-19, 26.1% for severe, and 5% for critical. Cesarean birth was the mode of delivery for 52.4% of women with severe and 91.7% with critical COVID-19. The singleton preterm birth rate was 14.6%. Admission to the intensive care unit was reported for 17 women (7.1%), and nine (3.7%) were intubated during their delivery hospitalization. There were no maternal deaths. Body mass index (BMI) 30 or higher was associated with COVID-19 severity (P=.001). Nearly all newborns tested negative for SARS-CoV-2 infection immediately after birth (97.5%). Conclusion During the first month of the SARS-CoV-2 outbreak in New York City and with evolving testing criteria, most women with laboratory-confirmed infection admitted for delivery did not have symptoms of COVID-19. Almost one third of women who were asymptomatic on admission became symptomatic during their delivery hospitalization. Obesity was associated with COVID-19 severity. Disease severity was associated with higher rates of cesarean and preterm birth.

Objective: To compare etiologies of prolonged amenorrhea in a cohort of HIV-infected women with a cohort of similar uninfected at-risk women. Materials and Methods: Women from the Women's Interagency HIV Study were seen every 6 months, and completed surveys including questions about their menstruation. Those who reported no vaginal bleeding for at least 1 year (“prolonged amenorrhea”) with subsequent resumption of bleeding were compared with women in whom bleeding had stopped permanently (“menopause”). Characteristics associated with reversible prolonged amenorrhea were ascertained. Results: Of 828 women with prolonged amenorrhea, 37.6% had reversible amenorrhea and 62.4% never resumed menses. HIV-seropositive women with prolonged amenorrhea were significantly younger at cessation of menses than HIV-negative women (p

Background Primary human papillomavirus (HPV) screening (PHS) utilizes oncogenic human papillomavirus (oncHPV) testing as the initial cervical cancer screening method and typically, if positive, additional reflex-triage (eg, HPV16/18-genotyping, Pap testing). While US guidelines support PHS usage in the general population, PHS has been little studied in women living with HIV (WLWH). Methods We enrolled n = 865 WLWH (323 from the Women’s Interagency HIV Study [WIHS] and 542 from WIHS-affiliated colposcopy clinics). All participants underwent Pap and oncHPV testing, including HPV16/18-genotyping. WIHS WLWH who tested oncHPV[+] or had cytologic atypical squamous cells of undetermined significance or worse (ASC-US+) underwent colposcopy, as did a random 21% of WLWH who were oncHPV[−]/Pap[−] (controls). Most participants additionally underwent p16/Ki-67 immunocytochemistry. Results Mean age was 46 years, median CD4 was 592 cells/µL, 95% used antiretroviral therapy. Seventy WLWH had histologically-determined cervical intraepithelial neoplasia grade 2 or greater (CIN-2+), of which 33 were defined as precancer (ie, [i] CIN-3+ or [ii] CIN-2 if concurrent with cytologic high grade squamous intraepithelial lesions [HSILs]). PHS had 87% sensitivity (Se) for precancer, 9% positive predictive value (PPV), and a 35% colposcopy referral rate (Colpo). “PHS with reflex HPV16/18-genotyping and Pap testing” had 84% Se, 16% PPV, 30% Colpo. PHS with only HPV16/18-genotyping had 24% Colpo. “Concurrent oncHPV and Pap Testing” (Co-Testing) had 91% Se, 12% PPV, 40% Colpo. p16/Ki-67 immunochemistry had the highest PPV, 20%, but 13% specimen inadequacy. Conclusions PHS with reflex HPV16/18-genotyping had fewer unnecessary colposcopies and (if confirmed) could be a potential alternative to Co-Testing in WLWH.

To estimate the incidence of invasive cervical cancer (ICC) across up to 21 years of follow-up among women with human immunodeficiency virus (HIV) and to compare it to that among HIV-uninfected women, we reviewed ICC diagnoses from a 20-year multi-site U.S. cohort study of HIV infected and uninfected women who had Pap testing every 6 months. Incidence rates were calculated and compared to those in HIV-negative women. Incidence ratios standardized to age-, sex-, race-, and calendar-year specific population rates were calculated. After a median follow-up of 12.3 years, four ICCs were confirmed in HIV seropositive women, only one in the last 10 years of observation, and none in seronegative women. The ICC incidence rate did not differ significantly by HIV status (HIV seronegative: 0/100,000 person-years vs. HIV seropositive: 19.5/100,000 person-years; p = 0.53). The standardized incidence ratio for the HIV-infected WIHS participants was 3.31 (95% CI: 0.90, 8.47; p = 0.07). Although marginally more common in women without HIV, for those with HIV in a prevention program, ICC does not emerge as a major threat as women age.

Objective Cigarette smoking during pregnancy increases risks of poor pregnancy outcomes including miscarriage and stillbirth (pregnancy loss), but the effect of smoking on pregnancy loss among HIV-infected women has not been explored. Here, investigated the impact of smoking on risk of pregnancy loss among HIV-positive and HIV-negative women, and estimated the potential impact of realistic smoking cessation interventions on risk of pregnancy loss among HIV-positive women. Design We analyzed pregnancy outcomes in HIV-positive and HIV-negative participants in the Women's Interagency HIV Study between 1994 and 2014. Methods We estimated effects of current smoking at or immediately before pregnancy on pregnancy loss; we controlled for confounding using regression approaches, and estimated potential impact of realistic smoking cessation interventions using a semiparametric g-formula approach. Results Analysis examined 1033 pregnancies among 659 women. The effect of smoking on pregnancy loss differed dramatically by HIV status: adjusted for confounding, the risk difference comparing current smokers to current nonsmokers was 19.2% (95% confidence limit 10.9-27.5%) in HIV-positive women and 9.7% (95% confidence limit 0.0-19.4%) in HIV-negative women. These results were robust to sensitivity analyses. We estimated that we would need to offer a realistic smoking cessation intervention to 36 women to prevent one pregnancy loss. Conclusion Smoking is a highly prevalent exposure with important consequences for pregnancy in HIV-positive pregnant women in the United States, even in the presence of potent highly active antiretroviral therapy. This evidence supports greater efforts to promote smoking cessation interventions among HIV-positive women, especially those who desire to become pregnant.

Relatively little is known about the frequency and factors associated with miscarriage among women living with HIV.The objective of the study was to evaluate factors associated with miscarriage among women enrolled in the Women's Interagency HIV Study.We conducted an analysis of longitudinal data collected from Oct. 1, 1994, to Sept. 30, 2017. Women who attended at least 2 Women's Interagency HIV Study visits and reported pregnancy during follow-up were included. Miscarriage was defined as spontaneous loss of pregnancy before 20 weeks of gestation based on self-report assessed at biannual visits. We modeled the association between demographic, behavioral, and clinical covariates and miscarriage (vs live birth) for women overall and stratified by HIV status using mixed-model logistic regression.Similar proportions of women living with and without HIV experienced miscarriage (37% and 39%, respectively, P = .638). In adjusted analyses, smoking tobacco (adjusted odds ratio, 2.0), alcohol use (adjusted odds ratio, 4.0), and marijuana use (adjusted odds ratio, 2.0) were associated with miscarriage. Among women living with HIV, low HIV viral load (4 log10 copies/mL) (adjusted odds ratio, 0.5) and protease inhibitor (adjusted odds ratio, 0.4) vs the nonuse of combination antiretroviral therapy use were protective against miscarriage.We did not find an increased odds of miscarriage among women living with HIV compared with uninfected women; however, poorly controlled HIV infection was associated with increased miscarriage risk. Higher miscarriage risk among women exposed to tobacco, alcohol, and marijuana highlight potentially modifiable behaviors. Given previous concern about antiretroviral therapy and adverse pregnancy outcomes, the novel protective association between protease inhibitors compared with non-combination antiretroviral therapy and miscarriage in this study is reassuring.

Background Eliminating mother-to-child transmission (MTCT) of HIV has been one of New York State's public health priorities, and the goal has been virtually accomplished by meeting criteria established by the Centers for Disease Control and Prevention. Methods We use a return on investment (ROI) approach, from the perspective of the state, to compare expenditures incurred to prevent MTCT of HIV in NYS during the period 1998-2013 to benefits realized, as expressed as HIV treatment costs saved from averting an estimated number of HIV infections among newborns. Extrapolating from the 11.5% incidence rate of HIV-infected newborns in 1997, we projected the number of cases of MTCT of HIV that were averted over the 16-year period. A published estimate of lifetime HIV treatment costs was used to estimate HIV treatment costs saved from the averted infections; expenditures for clinical protocols and other services directly associated with preventing MTCT of HIV were also estimated. The ROI was then calculated by dividing program benefits by the expenditures incurred to achieve these benefits. Results We estimate that 898 cases of MTCT of HIV were averted between 1998 and 2013, resulting in a savings of $321.03 million in HIV treatment costs. Expenditures to achieve these benefits totaled $81.07 million, yielding an ROI of $3.96. Conclusions Aside from the human suffering from MTCT of HIV that is averted, expenditures for treatment protocols and interventions to prevent MTCT of HIV are relatively inexpensive and can result in almost 4 times their value in HIV treatment cost savings realized.

Background The Rwanda Human Resources for Health Program (HRH Program) is a 7-year (2012-2019) health professional training initiative led by the Government of Rwanda with the goals of training a large, diverse, and competent health workforce and strengthening the capacity of academic institutions in Rwanda. Methods The data for this organizational case study was collected through official reports from the Rwanda Ministry of Health (MoH) and 22 participating US academic institutions, databases from the MoH and the College of Medicine and Health Sciences (CMHS) in Rwanda, and surveys completed by the co-authors. Results In the first 5 years of the HRH Program, a consortium of US academic institutions has deployed an average of 99 visiting faculty per year to support 22 training programs, which are on track to graduate almost 4600 students by 2019. The HRH Program has also built capacity within the CMHS by promoting the recruitment of Rwandan faculty and the establishment of additional partnerships and collaborations with the US academic institutions. Conclusion The milestones achieved by the HRH Program have been substantial although some challenges persist. These challenges include adequately supporting the visiting faculty; pairing them with Rwandan faculty (twinning); ensuring strong communication and coordination among stakeholders; addressing mismatches in priorities between donors and implementers; the execution of a sustainability strategy; and the decision by one of the donors not to renew funding beyond March 2017. Over the next 2 academic years, it is critical for the sustainability of the 22 training programs supported by the HRH Program that the health-related Schools at the CMHS significantly scale up recruitment of new Rwandan faculty. The HRH Program can serve as a model for other training initiatives implemented in countries affected by a severe shortage of health professionals.

BACKGROUND: Prevention of mother-to-child transmission of human immunodeficiency virus (HIV) with antiretroviral therapy (ART) has been highly successful. However, HIV-exposed uninfected (HIV-EU) infants might be at increased risk for low birth weight and/or preterm birth. We compared the birth weights and gestational ages of HIV-EU infants to those of HIV-unexposed control infants in Bronx, New York, an epicenter of the HIV epidemic in the United States. METHODS: This study was performed with a retrospective cohort of HIV-EU infants born at Montefiore Medical Center between 2008 and 2012 and HIV-unexposed control infants. Each HIV-EU infant was matched according to year of birth with 5 HIV-unexposed controls from the New York City Department of Health and Mental Hygiene birth certificate database. We used regression models to assess the association between HIV exposure and birth weight while controlling for potential confounders. A secondary analysis was performed to determine the association of maternal protease inhibitor–based ART use and birth weight among HIV-EU infants. RESULTS: We included 155 HIV-EU infants born between 2008 and 2012 (51% female, 61% black, 32% Hispanic) and 775 HIV-unexposed infants. The mean (± standard deviation) unadjusted birth weights were 2971 ± 616 g (HIV-EU infants) and 3163 ± 644 g (HIV-unexposed infants) (P < .01). Multivariable regression revealed significantly lower birth weight for the HIV-EU infants (difference, −101.5 g [95% confidence interval, −181.4 to −21.6]). We found no difference in mean birth weight or gestational age with maternal protease inhibitor–based ART use when compared to the use of other regimens. CONCLUSIONS: We found significantly lower birth weight among HIV-EU infants. Long-term prospective studies are necessary to determine the implications of this finding on infant growth and development.

Background. To evaluate the effects of HIV viral load, measured cross-sectionally and cumulatively, on the risk of miscarriage or stillbirth (pregnancy loss) among HIV-infected women enrolled in the Women’s Interagency HIV Study between 1994 and 2013.Methods. We assessed three exposures: most recent viral load measure before the pregnancy ended, log10copy-years viremia from initiation of antiretroviral therapy (ART) to conception, and log10copy-years viremia in the two years before conception.Results. The risk of pregnancy loss for those with log10viral load >4.00 before pregnancy ended was 1.59 (95% confidence interval (CI): 0.99, 2.56) times as high as the risk for women whose log10viral load was ≤1.60. There was not a meaningful impact of log10copy-years viremia since ART or log10copy-years viremia in the two years before conception on pregnancy loss (adjusted risk ratios (aRRs): 0.80 (95% CI: 0.69, 0.92) and 1.00 (95% CI: 0.90, 1.11), resp.).Conclusions. Cumulative viral load burden does not appear to be an informative measure for pregnancy loss risk, but the extent of HIV replication during pregnancy, as represented by plasma HIV RNA viral load, predicted loss versus live birth in this ethnically diverse cohort of HIV-infected US women.

In order to estimate the incidence of invasive cervical cancer (ICC) across up to 21 years of follow-up among women with human immunodeficiency virus (HIV) and to compare it to that among HIV-uninfected women, we reviewed ICC diagnoses from a 20-year multi-site U.S. cohort study of HIV infected and uninfected women who had Pap testing every six months. Incidence rates were calculated and compared to those in HIV-negative women. Incidence ratios standardized to age-, sex-, race-, and calendar-year specific population rates were calculated. After a median follow-up of 12.3 years, four ICCs were confirmed in HIV seropositive women, only one in the last 10 years of observation, and none in seronegative women. The ICC incidence rate did not differ significantly by HIV status (HIV seronegative: 0/100,000 person-years vs. HIV seropositive: 19.5/100,000 person-years; p=0.53). The standardized incidence ratio for the HIV-infected WIHS participants was 3.31 (95% CI: 0.90, 8.47; p=0.07). Although marginally more common in women without HIV, for those with HIV in a prevention program, ICC does not emerge as a major threat as women age.

Background Little is known about fertility choices and pregnancy outcome rates among HIV-infected women in the current combination antiretroviral treatment era. Objective We sought to describe trends and factors associated with live-birth and abortion rates among HIV-positive and high-risk HIV-negative women enrolled in the Women's Interagency HIV Study in the United States. Study Design We analyzed longitudinal data collected from Oct. 1, 1994, through Sept. 30, 2012, through the Women's Interagency HIV Study. Age-adjusted rates per 100 person-years live births and induced abortions were calculated by HIV serostatus over 4 time periods. Poisson mixed effects models containing variables associated with live births and abortions in bivariable analyses ( P Results There were 1356 pregnancies among 2414 women. Among HIV-positive women, age-adjusted rates of live birth increased from 1994 through 1997 to 2006 through 2012 (2.85-7.27/100 person-years, P trend P trend = .09). Significantly lower live-birth rates occurred among HIV-positive compared to HIV-negative women in 1994 through 1997 and 1997 through 2001, however rates were similar during 2002 through 2005 and 2006 through 2012. Higher CD4 + T cells/mm 3 (≥350 adjusted incidence rate ratio, 1.39 [95% CI 1.03-1.89] vs + T-cell count, combination antiretroviral treatment use, and viral load were not associated with abortion rates. Conclusion Unlike earlier periods (pre-2001) when live-birth rates were lower among HIV-positive women, rates are now similar to HIV-negative women, potentially due to improved health status and combination antiretroviral treatment. Abortion rates remain unchanged, illuminating a need to improve contraceptive services.

Women with HIV and prior exposure to combination antiretroviral therapy (cART) solely for prevention of mother-to-child transmission (pMTCT) need to know whether they can later be treated successfully with a commonly used regimen of efavirenz (EFV) and coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF).Nonpregnant women with plasma HIV-1 RNA of ≥500 copies per milliliter, previously cART exposed for pMTCT only, were eligible if they were off ART for ≥24 weeks before entry, were without evidence of drug resistance on standard genotyping, and were ready to start EFV plus FTC/TDF. The primary endpoint was virologic response (defined as plasma HIV RNA400 copies/mL) at 24 weeks.Fifty-four women were enrolled between October 2007 and December 2009; 52 of 54 completed 24 weeks of follow-up. Median baseline CD4 T-cell count was 265/mm and baseline plasma HIV-1 RNA was 4.6 log10 copies per milliliter. Median prior cART duration was 14 weeks, and median time elapsed from the last pMTCT dose to entry was 22 months. Virologic response at 24 weeks was observed in 42 of 52 women or 81% (exact 95% confidence interval: 68% to 90%). There were no differences in response by country, by number, or class of prior pMTCT exposures. Although confirmed virologic failure occurred in 8 women, no virologic failures were observed in women reporting perfect early adherence.In this first prospective clinical trial studying combination antiretroviral retreatment in women with a history of pregnancy-limited cART, the observed virologic response to TDF/FTC and EFV at 24 weeks was 81%. Virologic failures occurred and correlated with self-reported nonadherence.

To estimate the long term cumulative risk for cervical intraepithelial neoplasia grade 3 or worse after an abnormal cervical Pap test and to assess the effect of HIV infection on that risk. Participants in the Women's Interagency HIV Study were followed semiannually for up to 10 years. Pap tests were categorized according to the 1991 Bethesda system. Colposcopy was prescribed within 6 months of any abnormality. Risk for biopsy-confirmed CIN3 or worse after abnormal cytology and at least 12 months follow-up was assessed using Kaplan-Meier curves and compared using log-rank tests. Risk for CIN2 or worse was also assessed, since CIN2 is the threshold for treatment. After a median of 3 years of observation, 1,947 (85%) women subsequently presented for colposcopy (1,571 [81%] HIV seropositive, 376 [19%] seronegative). CIN2 or worse was found in 329 (21%) of HIV seropositive and 42 (11%) seronegative women. CIN3 or worse was found in 141 (9%) of seropositive and 22 (6%) seronegative women. In multivariable analysis, after controlling for cytology grade HIV seropositive women had an increased risk for CIN2 or worse (H.R. 1.66, 95% C.I 1.15, 2.45) but higher risk for CIN3 or worse did not reach significance (H.R. 1.33, 95% C.I. 0.79, 2.34). HIV seropositive women with abnormal Paps face a marginally increased and long-term risk for cervical disease compared to HIV seronegative women, but most women with ASCUS and LSIL Pap results do not develop CIN2 or worse despite years of observation.

Eliminating mother-to-child transmission (MTCT) of HIV has been one of New York State's public health priorities, and the goal has been virtually accomplished by meeting criteria established by the Centers for Disease Control and Prevention.We use a return on investment (ROI) approach, from the perspective of the state, to compare expenditures incurred to prevent MTCT of HIV in NYS during the period 1998-2013 to benefits realized, as expressed as HIV treatment costs saved from averting an estimated number of HIV infections among newborns. Extrapolating from the 11.5% incidence rate of HIV-infected newborns in 1997, we projected the number of cases of MTCT of HIV that were averted over the 16-year period. A published estimate of lifetime HIV treatment costs was used to estimate HIV treatment costs saved from the averted infections; expenditures for clinical protocols and other services directly associated with preventing MTCT of HIV were also estimated. The ROI was then calculated by dividing program benefits by the expenditures incurred to achieve these benefits.We estimate that 898 cases of MTCT of HIV were averted between 1998 and 2013, resulting in a savings of $321.03 million in HIV treatment costs. Expenditures to achieve these benefits totaled $81.07 million, yielding an ROI of $3.96.Aside from the human suffering from MTCT of HIV that is averted, expenditures for treatment protocols and interventions to prevent MTCT of HIV are relatively inexpensive and can result in almost 4 times their value in HIV treatment cost savings realized.

OBJECTIVE To estimate the prevalence, incidence, and clearance of abnormal vaginal cytology and vaginal intraepithelial neoplasia (VAIN) in human immunodeficiency virus (HIV)-seropositive women. METHODS Pap tests were done semiannually for 335 HIV-seropositive and 75 HIV-seronegative women with prior hysterectomy in the prospective Women's Interagency HIV Study cohort. End points included abnormal Pap test results after hysterectomy and VAIN regardless of hysterectomy. RESULTS Over a median of 5.6 years of follow-up, vaginal Pap test results were abnormal at 1,076 (29%; 95% confidence interval [CI] 25-33%) of 3,700 visits among HIV-seropositive compared with 31 (4%; 95% CI 2-8%) of 763 visits among HIV-seronegative women (P

Depression is common among HIV-infected women, predicts treatment nonadherence, and consequently may impact vertical transmission of HIV. We report findings from a study evaluating preconception, pregnancy, and postpartum depressive symptoms in HIV-infected vs. at-risk, HIV-uninfected women.We examined the prevalence and predictors of elevated perinatal (i.e., pregnancy and/or postpartum) depressive symptoms using a Center for Epidemiological Studies-Depression (CES-D) scale score of ≥16 in 139 HIV-infected and 105 HIV-uninfected women (62% African American) from the Women's Interagency HIV Study (WIHS).The prevalence of elevated perinatal depressive symptoms did not differ by HIV serostatus (HIV-infected 44%, HIV-uninfected 50%, p=0.44). Among HIV-infected women, the strongest predictor of elevated symptoms was preconception depression (odds ratio [OR] 5.71, 95% confidence interval [CI] 2.67-12.19, p0.001); crack, cocaine, and/or heroin use during preconception was marginally significant (OR 3.10, 95% CI 0.96-10.01, p=0.06). In the overall sample, additional significant predictors of perinatal depression included having multiple sex partners preconception (OR 2.20, 95% CI 1.12-4.32, p=0.02), use of preconception mental health services (OR 2.51, 95% CI 1.03-6.13, p=0.04), and not graduating from high school (OR 1.92, 95% CI 1.06-3.46, p=0.03).Elevated perinatal depressive symptoms are common among HIV-infected and at-risk HIV-uninfected women. Depressive symptoms before pregnancy were the strongest predictor of perinatal symptoms. Findings underscore the importance of early and ongoing assessment and treatment to ensure low vertical transmission rates and improving postpregnancy outcomes for mothers and children.

Both the World Health Organization and the United States Department of Health and Human Services have recently substantially revised perinatal HIV treatment guidelines based on emerging data, much of it from the developing world. Management of HIV infection in pregnancy and delivery is complicated by concerns for maternal and fetal drug toxicity, acquisition of antiretroviral resistance, prior therapy, co-infections with other viruses, as well as incident opportunistic infections. Intrapartum and peripartum obstetric management, including the role of Caesarean section, continue to evolve in the setting of maternal HIV infection. Finally, new data have expanded the role of antiviral therapy in allowing safer infant feeding choices for HIV-infected mothers in resource-limited settings.

To determine the incidence rate of, and the relative time to pregnancy by HIV status in US women between 2002 and 2009.The Women's Interagency HIV Study (WIHS) is an ongoing, multicenter prospective cohort study of the natural and treated history of HIV infection and related outcomes among women with and without HIV.Eligible participants were 45 years of age or less; sexually active with male partner(s) or reported a pregnancy outcome within the past year; and never reported hysterectomy, tubal ligation, or oopherectomy. Poisson regression was conducted to compare pregnancy incidence rates over time by HIV status. Relative time to pregnancy was ascertained via Kaplan-Meier plots and generalized gamma survival analysis.Adjusting for age, number of male sex partners, contraception, parity, exchanging sex, and alcohol use, HIV infection was associated with a 40% reduction in the incidence rate of pregnancy [incidence rate ratio = 0.60, 95% confidence interval (CI) 0.46-0.78]. The time for HIV-infected women to become pregnant was 73% longer relative to HIV-uninfected women (relative time = 1.73, 95% CI 1.35-2.36). In addition to HIV infection, decreased parity and older age were independent predictors of lower pregnancy incidence.Despite the beneficial effects of modern antiretroviral therapy on survival and prevention of maternal-to-child transmission, our findings suggest that pregnancy incidence remains lower among HIV-infected women. Whether this lower incidence is due to behavioral differences or reduced biologic fertility remains an area worthy of further study.

Background The impact of HAART on the natural history of human papillomavirus (HPV) remains uncertain following conflicting reports. Prior studies, however, did not consider patients’ adherence to their regimen, or HAART effectiveness (viral suppression).

To estimate the frequency of and trends in abnormal Pap test results in women with human immunodeficiency virus (HIV) and HIV-uninfected women.In a cohort study of HIV-infected and uninfected women, Pap tests were obtained every 6 months. Results of atypical squamous cells of undetermined significance (ASC-US) or worse were considered abnormal.Over a median of 8.4 years, 23,843 Pap tests were obtained from 1,931 HIV-positive women with 6,828 Pap tests from 533 HIV-negative women (13 women seroconverted during the study). Among women with HIV, Pap test results were ASC-US in 4,462 (19%), low-grade squamous intraepithelial lesion (LSIL) in 3,199 (13%), high-grade squamous intraepithelial lesion (HSIL) in 267 (1%), and cancer in 11 (0.05%). The incidence of abnormal Pap test results was 179 in 1,000 person-years for HIV-positive and 75 in 1,000 person-years for HIV-negative women (incidence rate ratio 2.4, 95% confidence interval 2.0-2.8). The incidence of HSIL or cancer was 4.4 in 1,000 person-years for HIV-positive and 1.3 in 1,000 person-years for HIV-negative women (incidence rate ratio 3.4, 95% confidence interval 1.2-9.5).Among women with HIV in a cervical cancer prevention program, Pap test abnormalities are common, but high-grade abnormalities are infrequent.II.

Purpose To describe changes in knowledge of cervical cancer prevention, human papillomavirus (HPV), and HPV vaccination among women at high risk for cervical cancer in the first five years after introduction of HPV vaccination. Methods In 2007, 2008–9, and 2011, women in a multicenter U.S. cohort study completed 44-item self-report questionnaires assessing knowledge of cervical cancer prevention, HPV, and HPV vaccination. Results across time were assessed for individuals, and three study enrollment cohorts were compared. Knowledge scores were correlated with demographic variables, measures of education and attention, and medical factors. Associations were assessed in multivariable models. Results In all, 974 women completed three serial questionnaires; most were minority, low income, and current or former smokers. The group included 652 (67%) HIV infected and 322 (33%) uninfected. Summary knowledge scores (possible range 0–24) increased from 2007 (12.8, S.D. 5.8) to 2008–9 (13.9, S.D. 5.3, P, Highlights • Women at high risk for cervical cancer have substantial knowledge gaps about prevention. • Knowledge gaps improved after an intervention, but little additional improvement followed. • Poor and less educated women have lower knowledge scores despite higher cancer risk.

Objective The purpose of this study was to compare alpha-fetoprotein, human chorionic gonadotropin, and unconjugated estriol levels in women who take protease inhibitors and those women who do not. Study design This retrospective review from August 2000 to May 2003 was performed for maternal serum screen results, medication use, pregnancy, and perinatal outcomes. Results Thirty-nine women met study criteria. Sixteen women were treated with protease inhibitors, and 23 women were not treated with protease inhibitors. There was no difference in initial viral load or initial CD4 count between the groups. No difference was found for human chorionic gonadotropin and estriol levels; significantly lower alpha-fetoprotein multiples of the median were found for the women who were treated with protease inhibitors compared with the women who were not (0.97 ± 0.32 [SD] MoM vs 1.2 ± 0.4 MoM, respectively; P = .04). Six of 39 women (15%) had positive maternal serum screens. All the babies were normal at birth, and there were no cases of perinatal transmission of human immunodeficiency virus. Conclusion Protease inhibitors are associated with lower alpha-fetoprotein levels in women who are infected with human immunodeficiency virus.

The objective of the study was to estimate the impact of human immunodeficiency virus (HIV) infection on the incidence of high-grade cervical intraepithelial neoplasia (CIN).HIV-seropositive and comparison seronegative women enrolled in a prospective US cohort study were followed up with semiannual Papanicolaou testing, with colposcopy for any abnormality. Histology results were retrieved to identify CIN3+ (CIN3, adenocarcinoma in situ, and cancer) and CIN2+ (CIN2 and CIN3+). Annual detection rates were calculated and risks compared using a Cox analysis. Median follow-up (interquartile range) was 11.0 (5.4-17.2) years for HIV-seronegative and 9.9 (2.5-16.0) for HIV-seropositive women.CIN3+ was diagnosed in 139 HIV-seropositive (5%) and 19 HIV-seronegative women (2%) (P.0001), with CIN2+ in 316 (12%) and 34 (4%) (P.0001). The annual CIN3+ detection rate was 0.6 per 100 person-years in HIV-seropositive women and 0.2 per 100 person-years in seronegative women (P.0001). The CIN3+ detection rate fell after the first 2 years of study, from 0.9 per 100 person-years among HIV-seropositive women to 0.4 per 100 person-years during subsequent follow-up (P.0001). CIN2+ incidence among these women fell similarly with time, from 2.5 per 100 person-years during the first 2 years after enrollment to 0.9 per 100 person-years subsequently (P.0001). In Cox analyses controlling for age, the hazard ratio for HIV-seropositive women with CD4 counts less than 200/cmm compared with HIV-seronegative women was 8.1 (95% confidence interval, 4.8-13.8) for CIN3+ and 9.3 (95% confidence interval, 6.3-13.7) for CIN2+ (P.0001).Although HIV-seropositive women have more CIN3+ than HIV-seronegative women, CIN3+ is uncommon and becomes even less frequent after the initiation of regular cervical screening.

Objective The aim of this study is to compare colposcopic findings and the accuracy of colposcopic impression in HIV seropositive and seronegative women with abnormal Pap tests. Methods HIV seropositive and seronegative women in a national cohort study had Pap tests collected every six months, with colposcopy for any abnormal result. Prospectively collected colposcopy and histology findings were analyzed retrospectively using Pearson Chi-square, t -test and Wilcoxon two-sample tests, logistic regression models, and Kappa coefficients. Results After adjusting for age and Pap result, 1618 eligible HIV seropositive women were more likely than 406 seronegative women to have inadequate colposcopic examinations, abnormal colposcopic findings, and large cervical lesions. However, among those with abnormal colposcopy, colposcopic characteristics and lesion size and number did not differ by HIV serostatus. Agreement between colposcopists' impressions and highest grade biopsy diagnoses was fair (kappa coefficient 0.35, 95% C.I. 0.31, 0.38). Agreement did not differ by HIV serostatus and did not improve with multiple biopsies (weighted kappa coefficient 0.35, 95% C.I. 0.32, 0.39) or after including all histology results over two years following colposcopy. Conclusion Although HIV seropositive women with abnormal cytology are more likely to have colposcopic abnormality, the performance of colposcopy appears to be similar to that in HIV seronegative women. Biopsy is required to confirm colposcopic impression.

To estimate the long term cumulative risk for cervical intraepithelial neoplasia grade 3 or worse (CIN3+ after an abnormal cervical Pap test and to assess the effect of HIV infection on that risk. Participants in the Women’s Interagency HIV Study were followed semiannually for up to 10 years. Pap tests were categorized according to the 1991 Bethesda system. Colposcopy was prescribed within six months of any abnormality. Risk for biopsy-confirmed CIN3 or worse after abnormal cytology and at least 12 months follow-up was assessed using Kaplan-Meier curves and compared using log-rank tests. Risk for CIN2 or worse was also assessed, since CIN2 is the threshold for treatment. After a median of 3 years of observation, 1,947 (85%) women subsequently presented for colposcopy (1571 [81%] HIV seropositive, 376 [19%] seronegative). CIN2 or worse was found in 329 (21%) of HIV seropositive and 42 (11%) seronegative women. CIN3 or worse was found in 141 (9%) of seropositive and 22 (6%) seronegative women. In multivariable analysis, after controlling for cytology grade HIV seropositive women had an increased risk for CIN2 or worse (H.R. 1.66, 95% C.I 1.15, 2.45) but higher risk for CIN3 or worse did not reach significance (H.R. 1.33, 95% C.I. 0.79, 2.34).HIV seropositive women with abnormal Paps face a marginally increased and long-term risk for cervical disease compared to HIV seronegative women, but most women with ASCUS and LSIL Pap results do not develop CIN2 or worse despite years of observation.

OBJECTIVE: To estimate the accuracy of Pap testing for women who are human immunodeficiency virus (HIV)–seropositive, with a focus on negative predictive value. METHODS: Participants in the Women's Interagency HIV Study were monitored with conventional Pap tests every 6 months. After excluding those with abnormal Pap test results before study, cervical disease, or hysterectomy, women with negative enrollment Pap test results were monitored for development of precancer within 15 or 39 months, defined as a Pap test result read as high-grade squamous intraepithelial lesion, atypical glandular cells favor neoplasia, or adenocarcinoma in situ, or a cervical biopsy read as cervical intraepithelial neoplasia 2 or worse. Correlations between one or more consecutive negative Pap test results and subsequent precancer were assessed using Cox proportional hazards models. RESULTS: Among 942 HIV-infected women with negative baseline Pap test results, eight (1%) developed precancer within 15 months and 40 (4%) within 39 months. After three consecutive negative Pap test results, precancer was rare, with no cases within 15 months and 10 of 539 (2%) within 39 months. No women developed precancer or cancer within 39 months after 10 consecutive negative Pap test results. Risks for precancer within 15 months after negative Pap test result included current smoking (adjusted hazard ratio [HR] 1.5, 95% confidence interval [CI] 1.2–2.0 compared with nonsmokers), younger age (adjusted HR 1.5, 95% CI 1.1–2.1 for women aged younger than 31 years compared with older than 45 years), and lower CD4 count (adjusted HR 11.8, 95% CI 1.3–2.3 for CD4 200–500/microliter, adjusted HR 2.2, 95% CI 1.6–2.9 for CD4 less than 200/microliter, compared with CD4 more than 500/microliter). CONCLUSION: Annual Pap testing appears safe for women infected with HIV; for those with serial negative tests, longer intervals are appropriate. LEVEL OF EVIDENCE: II

To describe the natural history of genital warts and vulvar intraepithelial neoplasia (VIN) in women with human immunodeficiency virus (HIV).A cohort of 2,791 HIV-infected and 953 uninfected women followed for up to 13 years had genital examinations at 6-month intervals with biopsy for lesions suspicious for VIN.The prevalence of warts was 4.4% (5.3% for HIV-seropositive women and 1.9% for HIV-seronegative women, P.001). The cumulative incidence of warts was 33% (95% confidence interval [CI] 30-36%) in HIV-seropositive and 9% (95% CI 6-12%) in HIV-seronegative women (P.001). In multivariable analysis, lower CD4 lymphocyte count, younger age, and current smoking were strongly associated with risk for incident warts. Among 501 HIV-seropositive and 43 HIV-seronegative women, warts regressed in 410 (82%) seropositive and 41 (95%) seronegative women (P=.02), most in the first year after diagnosis. In multivariable analysis, regression was negatively associated with HIV status and lower CD4 count as well as older age. Incident VIN of any grade occurred more frequently among HIV-seropositive than HIV-seronegative women: 0.42 (0.33-0.53) compared with 0.07 (0.02-0.18) per 100 person-years (P.001). Positivity for VIN 2 was found in 58 women (55 with and three without HIV, P.001). Two women with HIV developed stage IB squamous cell vulvar cancers.Although genital warts and VIN are more common among HIV-seropositive than HIV-seronegative women, wart regression is common even in women with HIV, and cancers are infrequent.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00000797.II.

perinatally infected with human immunodeficiency virus Maria Miraz, Omar Duenas-Garcia, Daniella Fonseca, Priya Prasad, Maria Timoney, Rodney Wright Bronx Lebanon Hospital Center, Obstetrics and Gynecology, Bronx, NY, Montefiore Medical Center/Albert Einstein College of Medicine, Obstetrics & Gynecology and Women’s Health, Bronx, NY OBJECTIVE: To describe the pregnancy outcomes of women with perinatally acquired HIV (PAH) compared to those with non perinatally acquired HIV (NPAH), and to determine if factors such as ethnicity and income affect the pregnancy outcomes in these patients. STUDY DESIGN: We performed a retrospective case control study of HIV infected women who delivered in a large South Bronx NY hospital between January 2005 and December 2011. Cases were PAH patients and NPAH patients served as controls. The Student’s t-test was used for continuous variables and Chi square for categorical variables. Bivariate analyses were performed to determine the associations between birth outcome and pregnancy outcome with factors such as viral load, CD4 count and method of contracting HIV using both linear and logistic regression. RESULTS: 13 pregnancies were identified in the PAH group and 170 NPAH pregnancies. PAH patients were younger (mean age 21) compared to NPAH (mean age 31). 69% of PAH patients were Hispanic compared to 34% of NPAH (p 0.02). 23% of PAH and 27% of NPAH had some form of mental health problem (p ns). The median BMI for PAH patients was 26 where the mean BMI for NPAH was 31 (p 0.01). 37% of all patients reported some form of domestic or family violence (p ns). Preterm delivery and low birthweight were significantly higher in PAH (p 0.001). Median age at delivery for PAH was 35.4 weeks. Only 31% of PAH had an undetectable viral load at delivery compared to 78% of NPAH (p 0.001). PAH were 7.8x less likely to have an undetectable viral load at delivery but there were no mother to child HIV transmissions in the PAH group. There were two HIV infected infants born in the NPAH group to mothers with limited prenatal care (p 0.001). CONCLUSION: In a very high risk HIV infected patient population, numerous psychosocial factors may play a role in determining birth outcome. Careful attention to all of these factors may be key to eliminating mother to child transmission of HIV and improving birth outcomes.

ON SECOND TRIMESTER ULTRASOUND BRIAN WAGNER, RODNEY WRIGHT, JOHN ILAGAN, PETER S. BERNSTEIN, Albert Einstein College of Medicine/ Montefiore Medical Center, Obstetrics & Gynecology and Women’s Health, Bronx, New York OBJECTIVE: Placenta previa is commonly diagnosed on second trimester ultrasounds causing patient and provider anxiety. Our objective was to determine factors associated with the persistence of placenta previa diagnosed on prenatal ultrasound in order to guide patient counseling. STUDY DESIGN: A retrospective cohort review was performed on all patients diagnosed with placenta previa and marginal placenta previa on ultrasound from 2003 to 2005. Using the AS-OBGYN computerized patient record, those patients with the terms ‘‘placenta previa’’ or ‘‘marginal placenta previa,’’ within the ultrasound reports were identified. A medical records review was then undertaken to identify those factors that are related to the resolution or continuance of the previa. Information including type of previa, gestational age at diagnosis, maternal age, parity, previous uterine surgery including cesarean delivery, curettage and myomectomy, race and smoking history were recorded. RESULTS: 532 patients were identified and after exclusion for incomplete data collection, 511 records were available for this analysis. In univariate analysis, later mean gestational age at diagnosis (22.5G5.52 v. 19.1G3.79 weeks, p!0.04), smoking (OR 8.14; 95% CI 4.18,15.92), complete previa (OR 16.98; 95% CI 9.36, 30.95), multiparty (OR 3.81; 95% CI 2.02-7.28), previous uterine curettage (OR 1.62; 95% CI 1.01, 2.62) and previous cesarean delivery (OR 16.98; 95% CI 7.93, 24.15) were all independent risk factors for persistence of placenta previa to delivery. In a multivariate analysis, only later gestational age at diagnosis, complete previa and previous cesarean delivery remained risk factors for persistence until delivery. CONCLUSION: Type of placentation, history of prior cesarean delivery, and gestational age at diagnosis are all important factors that modify the risk that a previa will persist to delivery. Using these risk factors providers may be able to individualize patient counseling on the risk of persistence of placenta previa diagnosed during second trimester ultrasounds.