BACKGROUND: The Women's Health Needs Study (WHNS) collected information on the health characteristics, needs, and experiences, including female genital mutilation (FGM) experiences, attitudes, and beliefs, of women aged 18 to 49 years who were born, or whose mothers were born, in a country where FGM is prevalent living in the US. The purpose of this paper is to describe the WHNS design, methods, strengths and limitations, as well as select demographic and health-related characteristics of participants. METHODS: We conducted a cross-sectional survey from November 2020 -June 2021 in four US metropolitan areas, using a hybrid venue-based sampling (VBS) and respondent-driven sampling (RDS) approach to identify women for recruitment. RESULTS: Of 1,132 participants, 395 were recruited via VBS and 737 RDS. Most were born, or their mothers were born, in either a West African country (Burkina Faso, Guinea, Mali, Mauritania, Sierra Leone, The Gambia) (39.0%) or Ethiopia (30.7%). More than a third were aged 30-39 years (37.5%) with a majority who immigrated at ages ≥13 years (86.6%) and had lived in the United States for ≥5 years (68.9%). Medicaid was the top health insurer (52.5%), followed by private health insurance (30.5%); 17% of participants had no insurance. Nearly half of women reported 1-2 healthcare visits within the past 12 months (47.7%). One in seven did not get needed health care due to cost (14.8%). Over half have ever used contraception (52.1%) to delay or avoid pregnancy and 76.9% had their last pelvic and/or Papanicolaou (pap) exam within the past 3 years. More than half experienced FGM (55.0%). Nearly all women believed that FGM should be stopped (92.0%). CONCLUSION: The VBS/RDS approach enabled recruitment of a diverse study population. WHNS advances research related to the health characteristics, needs, and experiences of women living in the US from countries where FGM is prevalent.

Associations between antenatal SARS-CoV-2 infection and pregnancy outcomes have been conflicting and the role of the immune system is currently unclear. This prospective cohort study investigated the interaction of antenatal SARS-CoV-2 infection, changes in cytokine and HS-CRP levels, birthweight and gestational age at birth. 2352 pregnant participants from New York City (2020-2022) were included. Plasma levels of interleukin (IL)-1β, IL-6, IL-17A and high-sensitivity C-reactive protein (HS-CRP) were quantified in blood specimens obtained across pregnancy. Quantile and linear regression models were conducted to 1) assess the impact of antenatal SARS-CoV-2 infection, overall and by timing of detection of SARS-CoV-2 positivity (< 20 weeks versus ≥ 20 weeks), on birthweight and gestational age at delivery; 2) examine the relationship between SARS-CoV-2 infection and maternal immune changes during pregnancy. All models were adjusted for maternal demographic and obstetric factors and pandemic timing. Birthweight models were additionally adjusted for gestational age at delivery and fetal sex. Immune marker models were also adjusted for gestational age at specimen collection and multiplex assay batch. 371 (15.8%) participants were infected with SARS-CoV-2 during pregnancy, of which 98 (26.4%) were infected at < 20 weeks gestation. Neither SARS-CoV-2 infection in general nor in early or late pregnancy was associated with lower birthweight nor earlier gestational age at delivery. Further, we did not observe cytokine or HS-CRP changes in response to SARS-CoV-2 infection and thus found no evidence to support a potential association between immune dysregulation and the diversity in pregnancy outcomes following infection.

Pregnant, postpartum, and lactating people, and infants have unique needs during public health emergencies, including nuclear and radiological incidents. This report provides information on the CDC Division of Reproductive Health's emergency preparedness and response activities to address the needs of women of reproductive age (aged 15-49 years), people who are pregnant, postpartum, or lactating, and infants during a radiation emergency. Highlighted preparedness activities include: (1) development of a quick reference guide to inform key questions about pregnant, postpartum, and lactating people, and infants during radiation emergencies; and (2) exercising the role of reproductive health experts during nuclear and radiological incident preparedness activities.

BACKGROUND: Antenatal care provides unique opportunities to assess severe acute respiratory syndrome coronavirus 2 seroprevalence and antibody response duration after natural infection detected during pregnancy; transplacental antibody transfer may inform peripartum and neonatal protection. We estimated seroprevalence and durability of antibodies from natural infection (anti-nucleocapsid immunoglobulin G) among pregnant people, and evaluated transplacental transfer efficiency. OBJECTIVE AND DESIGN: We conducted a cross-sectional study to measure severe acute respiratory syndrome coronavirus 2 seroprevalence, and a prospective cohort study to longitudinally measure anti-nucleocapsid immunoglobulin G responses and transplacental transfer of maternally derived anti-nucleocapsid antibodies. METHODS: We screened pregnant people for the seroprevalence study between 9 December 2020 and 19 June 2021 for anti-nucleocapsid immunoglobulin G in Seattle, Washington. We enrolled anti-nucleocapsid immunoglobulin G positive people from the seroprevalence study or identified through medical records with positive reverse transcription polymerase chain reaction or antigen positive results in a prospective cohort between 9 December 2020 and 9 August 2022. RESULTS: In the cross-sectional study (N = 1284), 5% (N = 65) tested severe acute respiratory syndrome coronavirus 2 anti-nucleocapsid immunoglobulin G positive, including 39 (60%) without prior positive reverse transcription polymerase chain reaction results and 42 (65%) without symptoms. In the prospective cohort study (N = 107 total; N = 65 from the seroprevalence study), 86 (N = 80%) had anti-nucleocapsid immunoglobulin G positive results during pregnancy. Among 63 participants with delivery samples and prior anti-nucleocapsid positive results, 29 (46%) were anti-nucleocapsid immunoglobulin G negative by delivery. Of 34 remaining anti-nucleocapsid immunoglobulin G positive at delivery with paired cord blood, 19 (56%) had efficient transplacental anti-nucleocapsid immunoglobulin G antibody transfer. Median time from first anti-nucleocapsid immunoglobulin G positive to below positive antibody threshold was 19 weeks and did not differ by prior positive reverse transcription polymerase chain reaction status. CONCLUSIONS: Maternally derived severe acute respiratory syndrome coronavirus 2 antibodies to natural infection may wane before delivery. Vaccines are recommended for pregnant persons to reduce severe illness and confer protection to infants.

Importance: Antenatal care provides unique opportunities to assess SARS-CoV-2 seroprevalence and antibody response duration after natural infection detected during pregnancy; transplacental antibody transfer may inform peripartum and neonatal protection. Objective(s): Estimate seroprevalence and durability of antibodies from natural infection (anti-nucleocapsid (anti-N) IgG) among pregnant people, and evaluate transplacental transfer efficiency. Design(s): Seroprevalence study: cross-sectional SARS-CoV-2 antibody screening among pregnant people December 9, 2020-June 19, 2021. Cohort study: Pregnant people screened anti-N IgG+ by Abbott Architect chemiluminescent immunoassay in seroprevalence study or identified through medical records with RT-PCR+ or antigen positive results enrolled in a prospective cohort December 9, 2020-June 30, 2022 to longitudinally measure anti-N IgG responses. We collected cord blood and assessed transplacental transfer of maternally-derived anti-N antibodies. Setting(s): Three hospitals and 14 affiliated clinics providing antenatal and delivery care, Seattle, Washington metropolitan area. Participant(s): Seroprevalence study: pregnant people were screened for SAR-CoV-2 anti-N IgG during routine care. Cohort study: Pregnant people with evidence of prior SARS-CoV-2 infection (screened anti-N IgG+ from seroprevalence study or identified with a RT-PCR+ or antigen positive result from medical records) were enrolled in a cohort study to longitudinally measure anti-N IgG responses. Exposure(s) (for observational studies): COVID-19 diagnosis, symptoms, and disease severity. Main Outcome(s) and Measure(s): Presence and durability of SARS-CoV-2 anti-N IgG, transplacental transfer of maternally-derived anti-N IgG. Result(s): Of 1289 pregnant people screened in the seroprevalence study, 5% (65) tested SARS-CoV-2 anti-N IgG+, including 39 (60%) without prior RT-PCR+ or antigen positive results and 53 (82%) without symptoms. Among 89 participants enrolled in the cohort study, 73 (82%) had anti-N IgG+ results during pregnancy. Among 49 participants with delivery samples 33 (67%) were anti-N IgG negative by delivery. Of 24 remaining anti-N IgG+ at delivery with paired cord blood samples, 12 (50%) had efficient transplacental anti-N IgG antibody transfer. Median time from first anti-N IgG to below positive antibody threshold was 17 weeks and did not differ by prior RT-PCR+ or antigen positive status. Conclusions and Relevance: Maternally-derived SARS-CoV-2 antibodies to natural infection may wane before delivery. Vaccines are recommended for pregnant persons to reduce severe illness and confer protection to infants. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license.

Objective: Dysregulation of the immune system during pregnancy is associated with adverse pregnancy outcomes. Recent studies report cytokine changes during the acute phase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We examine whether there is a lasting association between SARS-CoV-2 infection during pregnancy and peripheral blood cytokine levels. Study design: We conducted a case-control study at the Mount Sinai health system in NYC including 100 SARS-CoV-2 IgG antibody positive people matched to 100 SARS-CoV-2 IgG antibody negative people on age, race/ethnicity, parity, and insurance status. Blood samples were collected at a median gestational age of 34 weeks. Levels of 14 cytokines were measured. Result(s): Individual cytokine levels and cytokine cluster Eigenvalues did not differ significantly between groups, indicating no persisting maternal cytokine changes after SARS-CoV-2 infection during pregnancy. Conclusion(s): Our findings suggest that the acute inflammatory response after SARS-CoV-2 infection may be restored to normal values during pregnancy. Copyright The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

OBJECTIVES: The American Academy of Pediatrics National Registry for the Surveillance and Epidemiology of Perinatal coronavirus disease 2019 (COVID-19) (NPC-19) was developed to provide information on the effects of perinatal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. METHODS: National Registry for the Surveillance and Epidemiology of Perinatal COVID-19 participating centers entered maternal and newborn data for pregnant persons who tested positive for SARS-CoV-2 infection between 14 days before and 10 days after delivery. Incidence of and morbidities associated with maternal and newborn SARS-CoV-2 infection were assessed. RESULTS: From April 6, 2020 to March 19, 2021, 242 centers in the United States centers reported data for 7524 pregnant persons; at the time of delivery, 78.1% of these persons were asymptomatic, 18.2% were symptomatic but not hospitalized specifically for COVID-19, 3.4% were hospitalized for COVID-19 treatment, and 18 (0.2%) died in the hospital of COVID-related complications. Among 7648 newborns, 6486 (84.8%) were tested for SARS-CoV-2, and 144 (2.2%) were positive; the highest rate of newborn infection was observed when mothers first tested positive in the immediate postpartum period (17 of 125, 13.6%). No newborn deaths were attributable to SARS-CoV-2 infection. Overall, 15.6% of newborns were preterm: among tested newborns, 30.1% of polymerase chain reaction-positive and 16.2% of polymerase chain reaction-negative were born preterm (P < .001). Need for mechanical ventilation did not differ by newborn SARS-CoV-2 test result, but those with positive tests were more likely to be admitted to a NICU. CONCLUSIONS: Early in the pandemic, SARS-CoV-2 infection was acquired by newborns at variable rates and without apparent short-term effects. During a period that preceded widespread availability of vaccines, we observed higher than expected numbers of preterm births and maternal in-hospital deaths.

To identify research and gaps in literature about FGM/C-related attitudes and experiences among individuals from FGM/C-practicing countries living in the United States,we conducted a scoping review guided by Arksey and O'Malley's framework. We searched Medline (OVID), Embase (OVID), PubMed, and SCOPUS and conducted a grey literature search for studies assessing attitudes or experiences related to FGM/C with data collected directly from individuals from FGM/C-practicing countries living in the United States. The search yielded 417 studies, and 40 met the inclusion criteria. Findings suggest that women and men from FGM/C-practicing countries living in the United States generally oppose FGM/C, and that women with FGM/C have significant physical and mental health needs and have found US healthcare providers to lack understanding of FGM/C. Future research can improve measurement of FGM/C by taking into account the sociocultural influences on FGM/C-related attitudes and experiences.

OBJECTIVES: Zika virus (ZIKV) can be sexually transmitted, and ZIKV infection during pregnancy can cause birth defects. Contraception is a medical countermeasure to reduce unintended pregnancy and ZIKV-associated birth defects. We estimated the prevalence of condom use and associated factors among women at risk for unintended pregnancy in Puerto Rico during the 2016 ZIKV outbreak. DESIGN: Secondary analysis of a cross-sectional, population-based, cell-phone survey. SETTING AND PARTICIPANTS: Women, 18-49 years, living in Puerto Rico during July-November 2016. We limited our analytical sample (n=1840) to women at risk for unintended pregnancy, defined as those who were sexually active with a man in the last 3 months and did not report menopause, hysterectomy, current pregnancy or desiring pregnancy. OUTCOME MEASURES: We estimated the weighted prevalence of any condom use among women at risk for unintended pregnancy. We calculated crude and adjusted prevalence ratios (aPRs) to examine the association between condom use and ZIKV-related factors, stratified by use of more effective versus less effective or no contraception. RESULTS: Overall, 32.7% (95% CI: 30.2% to 35.1%) of women reported any condom use in the last 3 months. Among women using more effective contraception, condom use was higher for women who received ZIKV counselling (aPR: 1.61, 95% CI: 1.15 to 2.25) and those worried about having a child with a ZIKV-associated birth defect (aPR: 1.47, 95% CI: 1.03 to 2.10). Among women using less effective or no contraception, condom use was associated with being worried (aPR: 1.20, 95% CI: 1.01 to 1.43) compared with those not worried about ZIKV infection or with a previous known infection. CONCLUSIONS: During the 2016 ZIKV outbreak, one in three women at risk for unintended pregnancy reported any condom use. Counselling to promote consistent and correct condom use may address concerns regarding ZIKV among women of reproductive age, which may differ by use of effective contraception.

BACKGROUND: The prevalence and severity of disasters triggered by natural hazards has increased over the last 20 years. Women of reproductive age may encounter unique reproductive health challenges following a disaster. In this scoping review we identify gaps in literature to inform future research and search for potential associations between disasters by natural hazards and post-disaster fertility and contraception among women of reproductive age. METHODS: Medline (OVID), Embase (OVID), PsycInfo (OVID), CINAHL (Ebsco), Scopus, Environmental Science Collection (ProQuest Central), and Sociological Abstracts (ProQuest Central) were searched for articles published from 1980 through March 3, 2022 in English or Spanish language. Search terms were related to fertility, contraception, and disasters. We included original research that described a discrete natural hazard exposure, a population of women of reproductive age (15-49 years), and outcomes of fertility or contraception use or access, with pre- and post-disaster measures. RESULTS: Among 9788 citations, after initial exclusion 5121 remained for title and abstract review. One hundred and eighteen citations underwent full-text review and 26 articles met the inclusion criteria. Following critical appraisal, 20 articles were included in this review. Eighteen articles described outcomes related to fertility, five articles described contraception access, and three articles described contraception use. CONCLUSIONS: Clearly defined exposure measures, robust analyses, and methodical post-disaster assessment periods, may address the current gaps within disaster research on fertility and contraception among women of reproductive age. Consistent patterns in fertility following a disaster triggered by natural hazards were not identified between or within disaster types. Studies that assessed contraception found no change in use, while some studies found a decrease in contraceptive access overall.

BACKGROUND: Structural racism and pandemic-related stress from the COVID-19 pandemic may increase risk of adverse birth outcomes. OBJECTIVE: Our objective was to examine associations between neighborhood measures of structural racism and pandemic stress with three outcomes: SARS-CoV-2 infection, preterm birth (PTB) and delivering a newborn small-for-gestational-age (SGA). Our secondary objective was to investigate the joint associations of SARS-CoV-2 infection during pregnancy and neighborhood measures on PTB and SGA. STUDY DESIGN: We analyzed data for 967 patients from a prospective cohort of pregnant persons in New York City, comprised of 367 White persons (38%), 169 Black persons (17%), 293 Latina persons (30%), 87 Asian persons (9%), 41 persons of unknown race-ethnicity (4%), and 10 of unknown race-ethnicity (1%). We evaluated structural racism (social/built structural disadvantage, racial-economic segregation) and pandemic-related stress (community COVID-19 mortality, community unemployment rate increase) in quartiles by zip code. SARS-CoV-2 serologic enzyme-linked immunosorbent assay was performed on blood samples from pregnant persons. We ascertained preterm birth (PTB) and small-for-gestational age (SGA) from an electronic medical record database. We used log-binomial regression with robust standard error for clustering by zip code to estimate associations of each neighborhood measure separately with three outcomes: SARS-CoV-2 infection, PTB, and SGA. Covariates included maternal age, parity, insurance status, and BMI. Models with PTB and SGA as the dependent variables additionally adjusted for SARS-CoV-2 infection. RESULTS: 193 (20%) persons were SARS-CoV-2 seropositive, and the overall risk of PTB and SGA were 8.4% and 9.8%, respectively. Among birthing persons in neighborhoods in the highest quartile of structural disadvantage (n=190), 94% were non-White, 50% had public insurance, 41% were obese, 32% were seropositive, 11% delivered preterm, and 12% delivered an infant SGA. Among birthing persons in neighborhoods in the lowest quartile of structural disadvantage (n=360), 39% were non-White, 17% had public insurance, 15% were obese, 9% were seropositive, 6% delivered preterm, and 10% delivered an infant SGA. In adjusted analyses structural racism measures and community unemployment were associated with both SARS-CoV-2 infection and PTB, but not SGA. High vs. low structural disadvantage was associated with an adjusted relative risk (aRR) of 2.6 for infection (95% Confidence Interval (CI)=1.7, 3.9) and 1.7 for PTB (95%CI=1.0, 2.9); high vs. low racial-economic segregation was associated with aRR of 1.9 (95% CI=1.3, 2.8) for infection and 2.0 (95%CI=1.3, 3.2) for PTB; high vs. low community unemployment increase was associated with aRR of 1.7 (95% CI=1.2, 1.5) for infection and 1.6 (95%CI=1.0, 2.8) for PTB. COVID-19 mortality rate was associated with SARS-CoV-2 infection, but not PTB or SGA. SARS-CoV-2 infection was not independently associated with birth outcomes. We found no interaction between SARS-CoV-2 infection and neighborhood measures on PTB or SGA. CONCLUSIONS: Neighborhood measures of structural racism were associated with both SARS-CoV-2 infection and PTB, but these associations were independent and did not have a synergistic effect. Community unemployment rate increases were also associated with an increased risk of PTB independently of SARS-CoV-2 infection. Mitigating these factors might reduce the impact of the pandemic on pregnant people.

This report provides historical context and rationale for coordinated, systematic, and evidence-based public health emergency preparedness and response (EPR) activities to address the needs of women of reproductive age. Needs of pregnant and postpartum women, and infants-before, during, and after public health emergencies-are highlighted. Four focus areas and related activities are described: (1) public health science; (2) clinical guidance; (3) partnerships, communication, and outreach; and (4) workforce development. Finally, the report summarizes major activities of the Division of Reproductive Health's EPR Team at the Centers for Disease Control and Prevention.

Background: Among adolescents, racial disparities in reproductive health outcomes persist. The question of whether reproductive coercion (RC) influences these outcomes has received increased attention. Little is known about whether RC is independently associated with contraceptive use and having a sexually transmitted disease (STD) among African American female adolescents. Materials and Methods: Survey data for self-identified African American young women 14-19 years of age (n = 735) who accessed services at a publicly funded clinic were used to assess the extent of RC, the association between RC and other forms of intimate partner violence (IPV), and whether RC was independently associated with contraceptive use and an STD diagnosis. Results: Approximately 20% of participants had experienced RC; there was a statistically significant bivariate association between RC and other forms of IPV. In multivariate analyses, experiencing two or more forms of RC (vs. not experiencing any RC) was associated with reduced odds of contraceptive use in the past 3 months (adjusted odds ratio [aOR] = 0.46; 95% confidence interval [CI] = 0.24-0.76) and with increased odds of having an STD (aOR = 2.43; 95% CI = 2.35-4.37). Experiencing only one type of RC and experiencing other forms of IPV were not associated with the outcomes. Although ease of partner communication (aOR = 0.94; 95% CI = 0.80-0.98) was associated with having an STD, few other psychosocial variables were associated with the outcomes. Conclusions: RC is associated with reduced contraceptive use and increased STDs among African American adolescent women. Interventions to prevent and respond to RC that engage adolescent women and men are needed.

OBJECTIVE: To inform the current coronavirus disease 2019 (COVID-19) outbreak, we conducted a systematic literature review of case reports of Middle East respiratory syndrome coronavirus (MERS-CoV), severe acute respiratory syndrome coronavirus (SARS-CoV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, during pregnancy and summarized clinical presentation, course of illness, and pregnancy and neonatal outcomes. DATA SOURCES: We searched MEDLINE and ClinicalTrials.gov from inception to April 23, 2020. METHODS OF STUDY SELECTION: We included articles reporting case-level data on MERS-CoV, SARS-CoV, and SARS-CoV-2 infection in pregnant women. Course of illness, indicators of severe illness, maternal health outcomes, and pregnancy outcomes were abstracted from included articles. TABULATION, INTEGRATION, AND RESULTS: We identified 1,328 unique articles, and 1,253 articles were excluded by title and abstract review. We completed full-text review on 75, and 29 articles were excluded by full-text review. Among 46 publications reporting case-level data, eight described 12 cases of MERS-CoV infection, seven described 17 cases of SARS-CoV infection, and 31 described 98 cases of SARS-CoV-2 infection. Clinical presentation and course of illness ranged from asymptomatic to severe fatal disease, similar to the general population of patients. Severe morbidity and mortality among women with MERS-CoV, SARS-CoV, or SARS-CoV-2 infection in pregnancy and adverse pregnancy outcomes, including pregnancy loss, preterm delivery, and laboratory evidence of vertical transmission, were reported. CONCLUSION: Understanding whether pregnant women may be at risk for adverse maternal and neonatal outcomes from severe coronavirus infections is imperative. Data from case reports of SARS-CoV, MERS-CoV, and SAR-CoV-2 infections during pregnancy are limited, but they may guide early public health actions and clinical decision-making for COVID-19 until more rigorous and systematically collected data are available. The capture of critical data is needed to better define how this infection affects pregnant women and neonates. This review was not registered with PROSPERO.

OBJECTIVE: To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy. STUDY DESIGN: We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/penile misdirection) study and women in the contraceptive efficacy study completed condom self-reports and collected pre and postcoital vaginal samples for up to four uses of the WC. Both studies used nearly identical self-report questions and the same self-sampling procedures and laboratory for prostatic specific antigen (PSA), a well-studied semen biomarker. We compared condom failure and semen exposure proportions using generalized estimating equations methods accounting for within-couple correlation. RESULTS: Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC. Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p-value=0.030). Of the 207 WC efficacy uses with evaluable post-coital PSA levels, 14.5% (30 uses) resulted in semen exposure compared to 14.2% (184 uses) of the 1293 evaluable WC functionality study uses. CONCLUSIONS: When evaluating the ability of an experimental condom to prevent semen exposure, the rate of clinical condom failure reported by participants risking pregnancy in an efficacy substudy was significantly higher than the rate reported by participants not risking pregnancy in a functionality study. The rate of semen exposure, assessed by an objective biomarker was nearly identical for the two studies. IMPLICATIONS: Our results suggest that an objective marker of semen exposure in functionality studies could provide a reasonable alternative to contraceptive efficacy studies in evaluating risk of unintended pregnancy and inferring protection from sexually transmitted infection than condom failure rates based on self-report.

OBJECTIVES: To assess potentially missed sexually transmitted infections (STIs), we compared clinically diagnosed STIs to laboratory-confirmed diagnoses of gonorrhoea (GC), chlamydia (CT) and trichomonas (Tvag). DESIGN: Secondary analysis of a randomised controlled trial. SETTING: We used data and specimens previously collected for the Sino-Implant Study in Kingston, Jamaica. PARTICIPANTS: The Sino-Implant Study randomised 414 women to receive a levonorgestrel implant at either baseline or 3 months post-enrolment to evaluate unprotected sex after implant initiation. This analysis used 254 available vaginal swab samples. OUTCOME MEASURES: Clinically diagnosed STIs were determined from medical records by assessing clinical impressions and prescriptions. Laboratory-confirmed STIs included GC, CT and Tvag tested by Aptima Combo 2 for CT/GC and Aptima Tvag assays (Hologic, San Diego, California, USA). Log-binomial regression models fit with generalised estimating equations were used to estimate associations of clinically diagnosed STIs with laboratory-confirmed diagnoses and demographic and behavioural characteristics. RESULTS: Overall, 195 (76.8%) women had laboratory-confirmed STI (CT, GC or Tvag) while only 65 (25.6%) women had clinically diagnosed cervicitis and/or vaginitis during the study period. Clinical diagnosis missed 79.7% of laboratory-confirmed STIs: 85% of GC (n=17/20), 78.8% of CT (n=141/179) and 80.0% of Tvag (n=180/225). Hormonal contraceptive use in the month prior to the study visit was significantly associated with clinical diagnosis at any time point (prevalence ratio (PR): 1.65, 95% CI 1.07 to 2.54). As age increased, clinically missed infections significantly decreased (PR: 0.98 per year increase, 95% CI 0.97 to 1.00). CONCLUSIONS: The prevalence of laboratory-confirmed STIs was much higher than what was captured by clinical diagnosis. GC, CT and Tvag were not accurately detected without lab confirmation. Missed diagnoses decreased with older age. Increased laboratory capacity and refinement of the syndromic approach are needed to protect the health of sexually active Jamaican women. TRIAL REGISTRATION NUMBER: NCT01684358.

OBJECTIVE: Prostate-specific antigen (PSA) is the best established biomarker of semen exposure. PSA in vaginal fluid returns to pre-exposure concentrations within 24-48 h, but the speed of decay during the first ten hours is unknown. We sought to determine how fast PSA concentrations decline during the first ten hours after exposure to semen. STUDY DESIGN: Women in the 50 enrolled couples were intravaginally inoculated with 10, 20, 100, and 200mul of their partner's semen and then collected vaginal swabs immediately after, 30min, 4 and 10h after exposure. Forty-seven sets of samples were tested for PSA. Mixed linear models for repeated measures examined the association between log-transformed PSA values and sampling time and semen exposure volume. Sensitivity analyses excluded data from non-abstainers. Fixed effect estimates from the statistical models were graphed. RESULTS: PSA values were highest at 200mul inoculation volumes and at earlier post-exposure timepoints, then decline steadily. The lowest inoculation volume (10mul) corresponded to the smallest concentration of PSA throughout the post-inoculation timepoints. Average PSA levels return to clinically non-detectable levels within 10h only at the lowest semen exposures. The PSA decay curve assumes a very similar profile across all timepoints and semen amounts. CONCLUSIONS: The PSA decay curve is similar for varying semen exposure volumes, with average PSA concentrations remaining above clinical thresholds 10h after exposure at all except the very smallest semen exposure levels. PSA is an objective marker of recent exposure to semen, permitting such detection with high accuracy. IMPLICATIONS: This study clarifies how PSA values vary at different semen exposure levels and timepoints during the first 10h post-exposure. Future contraceptive studies that use PSA as a semen biomarker will be better informed about PSA concentrations at different sampling times and exposure amounts.

BACKGROUND: There is limited information on rates of STIs in Jamaica due to syndromic management and limited aetiological surveillance. We examined the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) and characteristics associated with STIs among sexually active women who participated in a randomised trial of a progestin implant initiation in Jamaica (the Sino-Implant Study (SIS)). METHODS: SIS was a randomised trial conducted in Kingston, Jamaica, from 2012 to 2014 to evaluate whether initiation of the Sino-Implant (II) led to more unprotected sex among women ages 18-44 years. Data collected included self-reported demographic, sexual behaviour information; and vaginal swabs collected at baseline, 1-month and 3-month follow-up visits for a biomarker of recent semen exposure (prostate-specific antigen (PSA)) and for STIs. We examined associations between STIs and PSA, demographics, sexual behaviour and insertion of an implant, with a repeated-measures analysis using generalised estimating equations (SAS Institute, V.9.3). RESULTS: Remnant vaginal swabs from 254 of 414 study participants were tested for STIs. At baseline, 29% of participants tested for STIs (n=247) had laboratory-confirmed CT, 5% NG, 23% TV and 45% any STI. In a repeated-measures analysis adjusted for study arm (immediate vs delayed implant insertion), those with PSA detected did not have an increased prevalence of any STI (prevalence ratio (PR)=1.04 (95% CI 0.89 to 1.21)), whereas prevalence decreased for each 1-year increase in age (PR=0.98 (95% CI 0.97 to 0.99)). Immediate implant insertion was not associated with increases in any STI in subsequent visits (PR=1.09 (95% CI 0.94 to 1.27)). CONCLUSIONS: Although the prevalence of laboratory-confirmed STIs was high, the immediate initiation of a contraceptive implant was not associated with higher STI prevalence rates over 3 months. TRIAL REGISTRATION NUMBER: NCT01684358.

BACKGROUND: Self-reported unprotected vaginal sex seems to increase risk of bacterial vaginosis (BV). However, the validity of self-reports is questionable, given their inconsistency with more objective measures of recent semen exposure such as detection of prostate-specific antigen (PSA). We examined whether recent unprotected sex, as measured both by PSA detection on vaginal swabs and by self-report, was associated with increased BV recurrence. METHODS: We analyzed randomized trial data from nonpregnant, BV-positive adult women recruited from a sexually transmitted disease clinic. Participants received BV therapy at enrollment and were scheduled to return after 4, 12, and 24 weeks. Bacterial vaginosis (by Nugent score) and PSA were measured at each visit. We used Cox proportional hazards models to examine the association between PSA positivity and recurrent BV. We also evaluated associations between self-reported unprotected sex (ever/never since the last visit and in the last 48 hours, analyzed separately) and recurrent BV. RESULTS: Prostate-specific antigen and BV results were available for 96 women who contributed 226 follow-up visits. Prostate-specific antigen positivity was associated with increased BV recurrence (adjusted hazard ratio [aHR], 2.32; 95% confidence interval [CI], 1.28-4.21). In contrast, we observed no significant increase in BV recurrence among women self-reporting unprotected sex since the last visit (aHR, 1.63; 95% CI, 0.77-3.43) or in the last 48 hours (aHR, 1.28; 95% CI, 0.70-2.36). CONCLUSIONS: Estimates from earlier studies linking self-reported unprotected sex and BV may be biased by misclassification. Biomarkers can improve measurement of unprotected sex, a critical exposure variable in sexual health research.

OBJECTIVE: To evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception (LARC), reduces condom use, as measured by a biomarker of recent semen exposure (prostate-specific antigen (PSA)). STUDY DESIGN: We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline ("immediate" insertion arm, N=208) or at the end ("delayed" insertion arm, N=206) of a three-month study period. Participants were tested for PSA at baseline and two follow-up study visits, and asked about their sexual activity and condom use. RESULTS: At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm (1-month: 26.1% vs. 20.2%; prevalence ratio (PR) = 1.3; (95% confidence interval (CI) = 0.9-1.9); 3-month: 25.6% vs. 23.1%; PR= 1.1; (95% CI = 0.8-1.6)). The change in PSA positivity over the 3 study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value=0.15). CONCLUSIONS: Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short-term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants. IMPLICATIONS: Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant.

BACKGROUND: Black teenagers have relatively high rates of sexually transmitted diseases (STDs), and recent research suggests the role of contextual factors, as well as risk behaviors. We explore the role of 4 categories of risk and protective factors on having a biologically confirmed STD among black, female teenagers. METHODS: Black teenage girls (14-19 years old) accessing services at a publicly funded family planning clinic provided a urine specimen for STD testing and completed an audio computer-assisted self-interview that assessed the following: risk behaviors, relationship characteristics, social factors, and psychosocial factors. We examined bivariate associations between each risk and protective factor and having gonorrhea and/or chlamydia, as well as multivariate logistic regression among 339 black female teenagers. RESULTS: More than one-fourth (26.5%) of participants had either gonorrhea and/or chlamydia. In multivariate analyses, having initiated sex before age 15 (adjusted odds ratio [aOR], 1.87) and having concurrent sex partners in the past 6 months (aOR, 1.55) were positively associated with having an STD. Living with her father (aOR, 0.44), believing that an STD is the worst thing that could happen (aOR, 0.50), and believing she would feel dirty and embarrassed about an STD (aOR, 0.44) were negatively associated with having an STD. CONCLUSIONS: Social factors and attitudes toward STDs and select risk behaviors were associated with the risk for STDs, suggesting the need for interventions that address more distal factors. Future studies should investigate how such factors influence safer sexual behaviors and the risk for STDs among black female teenagers.

OBJECTIVES: Previous studies have found social cognitive theory (SCT)-framed interventions are successful for improving condom use and reducing sexually transmitted infections (STIs). We conducted a secondary analysis of behavioural data from the Safe in the City intervention trial (2003-2005) to investigate the influence of SCT constructs on study participants' self-reported use of condoms at last intercourse. METHODS: The main trial was conducted from 2003 to 2005 at three public US STI clinics. Patients (n=38 635) were either shown a 'safer sex' video in the waiting room, or received the standard waiting room experience, based on their visit date. A nested behavioural assessment was administered to a subsample of study participants following their index clinic visit and again at 3 months follow-up. We used multivariable modified Poisson regression models to examine the relationships among SCT constructs (sexual self-efficacy, self-control self-efficacy, self-efficacy with most recent partner, hedonistic outcome expectancies and partner expected outcomes) and self-reported condom use at last sex act at the 3-month follow-up study visit. RESULTS: Of 1252 participants included in analysis, 39% reported using a condom at last sex act. Male gender, homosexual orientation and single status were significant correlates of condom use. Both unadjusted and adjusted models indicate that sexual self-efficacy (adjusted relative risk (RRa)=1.50, 95% CI 1.23 to 1.84), self-control self-efficacy (RRa=1.67, 95% CI 1.37 to 2.04), self-efficacy with most recent partner (RRa=2.56, 95% CI 2.01 to 3.27), more favourable hedonistic outcome expectancies (RRa=1.83, 95% CI 1.54 to 2.17) and more favourable partner expected outcomes (RRa=9.74, 95% CI 3.21 to 29.57) were significantly associated with condom use at last sex act. CONCLUSIONS: Social cognitive skills, such as self-efficacy and partner expected outcomes, are an important aspect of condom use behaviour. TRIAL REGISTRATION NUMBER: clinicaltrials.gov (#NCT00137370).

Biomarkers of semen exposure have been used in studies investigating the safety and efficacy of barrier methods of contraception. They have been used as objective indicators of semen exposure when studying sexual behaviors and in human immunodeficiency virus/sexually transmitted infection research interventions where participants are advised to avoid unprotected sex. Semen biomarkers have also been used to assess or validate self-reported sexual behaviors or condom use in reproductive health settings. Prostate-specific antigen (PSA) and Y chromosome DNA (Yc-DNA) have each been evaluated in the past as semen biomarkers and are the most widely used in the field. While both are considered reliable for evaluating exposure to semen, each has unique characteristics. In this report, we summarize the literature and provide some considerations for reproductive health researchers who are interested in using PSA or Yc-DNA as semen biomarkers. We also synthesize our previous published work on the optimal conditions of collecting and storing specimens and assay performance in the presence of other vaginal products that may influence various assays. Semen biomarkers are innovative and promising tools to further study and better understand women's reproductive and sexual health and behavior. More research is needed to better understand the strengths, limitations, and optimal performance conditions of specific assays in vivo.

Mixed-method designs are increasingly used in sexually transmitted infection (STI) and HIV prevention research. The authors designed a mixed-method approach and applied it to estimate and evaluate a predictor of continued female condom use (6+ uses, among those who used it at least once) in a 6-month prospective cohort study. The analysis included 402 women who received an intervention promoting use of female and male condoms for STI prevention and completed monthly quantitative surveys; 33 also completed a semistructured qualitative interview. The authors identified a qualitative theme (couples' female condom enjoyment [CFCE]), applied discriminant analysis techniques to estimate CFCE for all participants, and added CFCE to a multivariable logistic regression model of continued female condom use. CFCE related to comfort, naturalness, pleasure, feeling protected, playfulness, ease of use, intimacy, and feeling in control of protection. CFCE was associated with continued female condom use (adjusted odds ratio: 2.8, 95% confidence interval: 1.4-5.6) and significantly improved model fit (p < .001). CFCE predicted continued female condom use. Mixed-method approaches for "scaling up" qualitative findings from small samples to larger numbers of participants can benefit HIV and STI prevention research.

OBJECTIVES: There is currently no information on whether products evaluated in HIV microbicide trials affect the detection of the semen biomarkers prostate-specific antigen (PSA) or Y chromosome DNA. STUDY DESIGN: We tested (in vitro) dilutions of tenofovir (TFV), UC781 and the hydroxyethylcellulose (HEC) placebo gels using the Abacus ABAcard and the quantitative (Abbott Architect total PSA) assays for PSA and Y chromosome DNA by real-time polymerase chain reaction. RESULTS: TFV gel and the HEC placebo adversely affected PSA detection using the ABAcard but not the Abbott Architect total PSA assay. UC781 adversely affected both the ABAcard and Abbott Architect total PSA assays. While there were some quantitative changes in the magnitude of the signal, none of the products affected positivity of the Y chromosome assay. CONCLUSIONS: The presence of TFV or HEC gels did not affect quantitative PSA or Y chromosome detection in vitro. Confirmation of these findings is recommended using specimens obtained following use of these gels in vivo. IMPLICATIONS: Researchers should consider the potential for specific microbicides or any products to affect the particular assay used for semen biomarker detection. The ABAcard assay for PSA detection should not be used with TFV UC781, or HEC.

OBJECTIVES: Although common worldwide, intravaginal cleansing is associated with poor health outcomes. We sought to describe intravaginal cleansing among women attending a sexually transmitted infection (STI) clinic in Jamaica. METHODS: We examined intravaginal cleansing ("washing up inside the vagina", douching, and products or materials used) among 293 participants in a randomized trial of counselling messages at an STI clinic in Kingston. We focussed on information on intravaginal cleansing performed in the 30 days and three days preceding their baseline study visit. We describe reported cleansing behaviours and used logistic regression to identify correlates of intravaginal cleansing. RESULTS: Fifty-eight per cent of participants reported intravaginal cleansing in the previous 30 days, and 46% did so in the three days before baseline. Among those who cleansed in the previous 30 days, 88% reported doing so for hygiene unrelated to sex, and three-fourths reported generally doing so more than once per day. Soap (usually with water) and water alone were the most common products used for washing; commercial douches or detergents were reported infrequently. Intravaginal cleansing in the three days before the baseline visit was positively associated with having more than one sex partner in the previous three months (adjusted odds ratio [AOR], 1.9; 95% CI, 1.1, 3.2), and negatively associated with experiencing itching in the genital area at baseline (AOR, 0.6; 95% CI, 0.4, 1.0). CONCLUSIONS: A large proportion of women attending STI clinics in Jamaica engage in frequent intravaginal cleansing, indicating a need for clinicians to discuss this topic with them accordingly.

OBJECTIVES: We reviewed the literature focused on socioeconomic influences on teen childbearing and suggested directions for future research and practice related to this important indicator of teen sexual health. METHODS: We conducted an electronic search of Medline, ERIC, PsychLit, and Sociological Abstracts databases for articles published from January 1995 to November 2011. Selected articles from peer-reviewed journals included original quantitative analyses addressing socioeconomic influences on first birth among teen women in the U.S. Articles were abstracted for key information, ranked for quality according to the U.S. Preventive Services Task Force guidelines, assessed for bias, and synthesized. RESULTS: We selected articles with a range of observational study designs. Risk for bias varied across studies. All 12 studies that considered socioeconomic factors as influences on teen childbearing (vs. moderators or mediators of other effects) reported at least one statistically significant association relating low socioeconomic status, underemployment, low income, low education levels, neighborhood disadvantage, neighborhood physical disorder, or neighborhood-level income inequality to teen birth. Few reports included any associations contradicting this pattern. CONCLUSIONS: This review suggests that unfavorable socioeconomic conditions experienced at the community and family levels contribute to the high teen birth rate in the U.S. Future research into social determinants of sexual health should include multiple levels of measurement whenever possible. Root causes of teen childbearing should be evaluated in various populations and contexts. Interventions that address socioeconomic influences at multiple levels could positively affect large numbers of teens and help eliminate disparities in teen childbearing.

BACKGROUND: Prostate-specific antigen (PSA) is a biomarker of recent semen exposure. There is currently only limited information on whether topical vaginal products affect PSA assays. We investigated this question using various dilutions of several vaginal products (lubricants and spermicides) and the Abacus ABAcard for PSA detection. STUDY DESIGN: Pooled semen controls and various dilutions of nonoxynol-9 (N9), carboxymethyl cellulose (CMC), Replens, Gynol 2, K-Y jelly, Astroglide, Surgilube, combined with pooled semen dilutions, were tested for PSA using the Abacus ABAcard. RESULTS: N9 (2% with saline) and CMC did not appear to affect the results of testing with the ABAcard, but not all semen dilutions were tested. The other products (including Replens and Gynol, which is 2% N9 with propylene glycol, K-Y, Astroglide and Surgilube) at some of the dilutions tested either affected or gave invalid results with PSA testing using the ABAcard. Both Gynol 2 and K-Y at 1:10 dilution gave false-positive results. CONCLUSIONS: Some vaginal products affect PSA results obtained by using the semiquantitative ABAcard. In vivo confirmation is necessary to further optimize PSA detection when topical vaginal products are present.

BACKGROUND: Prostate-specific antigen (PSA) detected in vaginal fluid can be used in studies of HIV/sexually transmitted infection (STI) and pregnancy prevention as an alternative to relying on participant reports of exposure to semen. Optimal methods for collecting and storing specimens for this testing have not been determined. STUDY DESIGN: We conducted a controlled, in vitro experiment of 550 specimens spiked with semen to determine the effects of swab type (five types), storage conditions of the swabs (room temperature with or without desiccant or at -80 degrees C without desiccant) and time from collection to testing (seven intervals over the course of 12 months) on the identification of PSA. We performed factorial analysis of variance to identify factors influencing PSA detection. RESULTS: Concentrations of PSA detected in the swabs declined with time of storage over the 1-year experiment (p<.01). The 1-mL, rayon-tipped swab stored immediately at -80 degrees C following collection performed best. CONCLUSIONS: If immediate testing or freezer storage is not feasible, investigators should use a swab with 1-mL capacity with processing and testing as soon as possible after specimen collection.

We explored the use of qualitative interviews to discuss discrepancies between two sources of information on unprotected sex: biomarker results and self-reported survey data. The study context was a randomized trial in Kingston, Jamaica examining the effect of STI counseling messages on recent sexual behavior using prostate-specific antigen (PSA) as the primary study outcome. Twenty women were interviewed. Eleven participants were selected because they tested positive for PSA indicating recent semen exposure, yet reported no unprotected sex in a quantitative survey ("discordant"): 5 reported abstinence and 6 reported condom use. Nine participants who also tested positive for PSA but reported unprotected sex in the survey were interviewed for comparison ("concordant"). Qualitative interviews with 6 of the 11 discordant participants provided possible explanations for their PSA test results, and 5 of those were prompted by direct discussion of those results. Rapid PSA testing combined with qualitative interviews provides a novel tool for investigating and complementing self-reported sexual behavior.