Persistent organic pollutants may negatively impact cognition; however, associations between persistent organic pollutants and changes in cognition among United States Hispanic/Latino adults have not been investigated. Herein, we examined the associations between 33 persistent organic pollutants and cognitive changes among 1837 Hispanic/Latino adults. At baseline (2008-2011; Visit 1), participants provided biospecimens in which we measured levels of 5 persistent pesticides or pesticide metabolites, 4 polybrominated diphenyl ethers and 2,2',4,4',5,5'-hexabromobiphenyl, and 24 polychlorinated biphenyls. At Visit 1 and again at Visit 2 (2015-2018), a battery of neurocognitive tests was administered which included the Brief-Spanish English Verbal Learning Test, Word Fluency Test, and Digit Symbol Substitution Test. To estimate the adjusted associations between changes in cognition and each POP, we used linear regression for survey data. Each doubling in plasma levels of polychlorinated biphenyls 146, 178, 194, 199/206, and 209 was associated with steeper declines in global cognition (βs range:-0.053 to -0.061) with stronger associations for the Brief-Spanish English Verbal Learning Test. Persistent organic pollutants, in particular polychlorinated biphenyls, were associated with declines in cognition over 7 years and may be a concern for Hispanic/Latino adults.

BACKGROUND: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of combination injectable contraceptives. SELECTION CRITERIA: Randomized controlled trials reported in any language were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives. DATA COLLECTION AND ANALYSIS: The primary reviewer evaluated all titles and abstracts from the literature searches to determine their eligibility. Two reviewers independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan 4.2. MAIN RESULTS: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These combination injectable contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems, but had higher rates of discontinuation due to other reasons than the progestin-only comparison contraceptives. Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall early discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials making this comparison. The NET-EN plus E(2)V group also had more cyclical (regular) bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation rates are dependent on many other factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinical sites, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

BACKGROUND: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of combination injectable contraceptives. SELECTION CRITERIA: Randomized controlled trials were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives. DATA COLLECTION AND ANALYSIS: One author evaluated all titles and abstracts from the literature searches to determine their eligibility. Two authors independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan. MAIN RESULTS: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons. Acceptability results favored the combination injectable in one study and the progestin-only in another.Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials. The NET-EN plus E(2)V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

BACKGROUND & AIMS: Nonalcoholic steatohepatitis (NASH) is the leading indication for liver transplant (LT) in women and the elderly. Granular details into factors impacting survival in this population are needed to optimize management and improve outcomes. METHODS: Patients receiving LT for NASH cirrhosis from 1997 to 2017 across 7 transplant centers (NailNASH consortium) were analyzed. The primary outcome was all-cause mortality, and causes of death were enumerated. All outcomes were cross referenced with United Network for Organ Sharing and adjudicated at each individual center. Cox regression models were constructed to elucidate clinical factors impacting mortality. RESULTS: Nine hundred thirty-eight patients with a median follow-up of 3.8 years (interquartile range, 1.60-7.05 years) were included. The 1-, 3-, 5-, 10-, and 15-year survival of the cohort was 93%, 88%, 83%, 69%, and 46%, respectively. Of 195 deaths in the cohort, the most common causes were infection (19%), cardiovascular disease (18%), cancer (17%), and liver-related (11%). Inferior survival was noted in patients >65 years. On multivariable analysis, age >65 (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.04-2.77; P = .04), end-stage renal disease (HR, 1.55; 95% CI, 1.04-2.31; P = .03), black race (HR, 5.25; 95% CI, 2.12-12.96; P = .0003), and non-calcineurin inhibitors-based regimens (HR, 2.05; 95% CI, 1.19-3.51; P = .009) were associated with increased mortality. Statin use after LT favorably impacted survival (HR, 0.38; 95% CI, 0.19-0.75; P = .005). CONCLUSIONS: Despite excellent long-term survival, patients transplanted for NASH at >65 years or with type 2 diabetes mellitus at transplant had higher mortality. Statin use after transplant attenuated risk and was associated with improved survival across all subgroups, suggesting that careful patient selection and implementation of protocol-based management of metabolic comorbidities may further improve clinical outcomes.

OBJECTIVES: Diabetes may delay milk letdown, and perceiving milk production as insufficient can lead to breastfeeding cessation. We evaluated whether prepregnancy or gestational diabetes is associated with cessation of breastfeeding by 1 week postpartum. METHODS: We analyzed 2016-2018 data from 42 sites in the Pregnancy Risk Assessment Monitoring System, a population-based survey of women with a recent live birth. Participants were surveyed 2-6 months after childbirth. We used logistic regression models to evaluate the relationship between prepregnancy or gestational diabetes only and breastfeeding <1 week postpartum among women who had initiated breastfeeding. RESULTS: Among 82 050 women who initiated breastfeeding, 4.5% reported breastfeeding <1 week postpartum. Overall, 11.7% of women reported any history of diabetes in the 3 months before becoming pregnant; 3.3% reported prepregnancy diabetes, and 8.4% reported gestational diabetes only. In both unadjusted and adjusted models, the prevalence of breastfeeding <1 week postpartum did not differ significantly among women with prepregnancy diabetes or gestational diabetes only compared with women without any history of diabetes. The prevalence of breastfeeding <1 week postpartum was 4.4% among women without any history of diabetes, 5.6% among women with prepregnancy diabetes (adjusted prevalence ratio [aPR] = 1.15; 95% CI, 0.91-1.46), and 4.5% among women with gestational diabetes only (aPR = 1.01; 95% CI, 0.84-1.20). CONCLUSIONS: We found no association between a history of diabetes prepregnancy or gestational diabetes only and breastfeeding <1 week postpartum in a large, population-based survey of postpartum women who initiated breastfeeding. Regardless of their diabetes status, women who want to breastfeed might benefit from interventions that support their ability to continue breastfeeding.

Due to the large number of patients with severe coronavirus disease 2019 (COVID-19), many were treated outside the traditional walls of the intensive care unit (ICU), and in many cases, by personnel who were not trained in critical care. The clinical characteristics and the relative impact of caring for severe COVID-19 patients outside the ICU is unknown. This was a multinational, multicentre, prospective cohort study embedded in the International Severe Acute Respiratory and Emerging Infection Consortium World Health Organization COVID-19 platform. Severe COVID-19 patients were identified as those admitted to an ICU and/or those treated with one of the following treatments: invasive or noninvasive mechanical ventilation, high-flow nasal cannula, inotropes or vasopressors. A logistic generalised additive model was used to compare clinical outcomes among patients admitted or not to the ICU. A total of 40440 patients from 43 countries and six continents were included in this analysis. Severe COVID-19 patients were frequently male (62.9%), older adults (median (interquartile range (IQR), 67 (55-78) years), and with at least one comorbidity (63.2%). The overall median (IQR) length of hospital stay was 10 (5-19)days and was longer in patients admitted to an ICU than in those who were cared for outside the ICU (12 (6-23) days versus 8 (4-15) days, p<0.0001). The 28-day fatality ratio was lower in ICU-admitted patients (30.7% (5797 out of 18831) versus 39.0% (7532 out of 19295), p<0.0001). Patients admitted to an ICU had a significantly lower probability of death than those who were not (adjusted OR 0.70, 95% CI 0.65-0.75; p<0.0001). Patients with severe COVID-19 admitted to an ICU had significantly lower 28-day fatality ratio than those cared for outside an ICU.

Reactive astrocytes are astrocytes undergoing morphological, molecular, and functional remodeling in response to injury, disease, or infection of the CNS. Although this remodeling was first described over a century ago, uncertainties and controversies remain regarding the contribution of reactive astrocytes to CNS diseases, repair, and aging. It is also unclear whether fixed categories of reactive astrocytes exist and, if so, how to identify them. We point out the shortcomings of binary divisions of reactive astrocytes into good-vs-bad, neurotoxic-vs-neuroprotective or A1-vs-A2. We advocate, instead, that research on reactive astrocytes include assessment of multiple molecular and functional parameters-preferably in vivo-plus multivariate statistics and determination of impact on pathological hallmarks in relevant models. These guidelines may spur the discovery of astrocyte-based biomarkers as well as astrocyte-targeting therapies that abrogate detrimental actions of reactive astrocytes, potentiate their neuro- and glioprotective actions, and restore or augment their homeostatic, modulatory, and defensive functions.

By June 2020, Marshallese and Hispanic or Latino (Hispanic) persons in Benton and Washington counties of Arkansas had received a disproportionately high number of diagnoses of coronavirus disease 2019 (COVID-19). Despite representing approximately 19% of these counties' populations (1), Marshallese and Hispanic persons accounted for 64% of COVID-19 cases and 57% of COVID-19-associated deaths. Analyses of surveillance data, focus group discussions, and key-informant interviews were conducted to identify challenges and propose strategies for interrupting transmission of SARS-CoV-2, the virus that causes COVID-19. Challenges included limited native-language health messaging, high household occupancy, high employment rate in the poultry processing industry, mistrust of the medical system, and changing COVID-19 guidance. Reducing the COVID-19 incidence among communities that suffer disproportionately from COVID-19 requires strengthening the coordination of public health, health care, and community stakeholders to provide culturally and linguistically tailored public health education, community-based prevention activities, case management, care navigation, and service linkage.

The first patients with laboratory-confirmed cases of Zika virus disease in American Samoa had symptom onset in January 2016. In response, the American Samoa Department of Health (ASDoH) implemented mosquito control measures, strategies to protect pregnant women, syndromic surveillance based on electronic health record (EHR) reports, Zika virus testing of persons with one or more signs or symptoms of Zika virus disease (fever, rash, arthralgia, or conjunctivitis), and routine testing of all asymptomatic pregnant women in accordance with CDC guidance. All collected blood and urine specimens were shipped to the Hawaii Department of Health Laboratory for Zika virus testing and to CDC for confirmatory testing. Early in the response, collection and testing of specimens from pregnant women was prioritized over the collection from symptomatic nonpregnant patients because of limited testing and shipping capacity. The weekly numbers of suspected Zika virus disease cases declined from an average of six per week in January-February 2016 to one per week in May 2016. By August, the EHR-based syndromic surveillance indicated a return to pre-outbreak levels. The last Zika virus disease case detected by real-time, reverse transcription-polymerase chain reaction (rRT-PCR) occurred in a patient who had symptom onset on June 19, 2016. In August 2016, ASDoH requested CDC support in assessing whether local transmission had been reduced or interrupted and in proposing a timeline for discontinuation of routine testing of asymptomatic pregnant women. An end date (October 15, 2016) was determined for active mosquito-borne transmission of Zika virus and a timeline was developed for discontinuation of routine screening of asymptomatic pregnant women in American Samoa (conception after December 10, 2016, with permissive testing for asymptomatic women who conceive through April 15, 2017).

Women's power in sexual relationships is thought to be an important predictor of condom use. However, research on correlates of condom use often relies on participant reporting of behavior, which has questionable validity. We evaluated the association between scores from the modified Sexual Relationship Power Scale (SRPS-M) and biological detection of semen exposure in a prospective study of adult women attending a sexually transmitted infection clinic in Kingston, Jamaica with cervicitis or abnormal vaginal discharge in 2010-2011. At enrollment, women were counseled to avoid sex while on treatment and were asked to return in 6 days for a follow-up visit. At both study visits, women were administered a questionnaire and had vaginal swabs collected to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure. We found no significant association at enrollment or follow-up between SRPS-M scores and semen exposure, as measured with either self-reported data or PSA positivity. Semen biomarkers could be used to develop and validate new scales on relationship power and self-efficacy related to condom use.

OBJECTIVE: To evaluate initiation of a two-rod, 150-mg levonorgestrel contraceptive implant on women's perceived and observed body weight. METHODS: We conducted a secondary analysis of data from an open, randomized controlled trial of adult, nonpregnant, human immunodeficiency virus-negative women attending a public clinic in Kingston, Jamaica, who were assigned to initiate implant use either immediately or after a 3-month delay. The primary objective of the parent study was to assess the effect of initiation of the implant on the frequency of condom use. We compared study arms during follow-up using one-sided chi tests for differences in perceived weight gain and loss, one-sided Wilcoxon-Mann-Whitney tests for median gain in measured weight, and logistic regression with generalized estimating equations for risk of gaining greater than 2 kg. RESULTS: From 2012 to 2014, women were assigned to the implant (n=208) or delay arm (n=206). At 3 months, more women in the implant arm (15.3%) reported perceived weight gain than in the control arm (4.3%) (P=.01). Despite differences in perception, the implant and control arms did not differ significantly in median weight gain at 1-month (0.0 kg and 0.0 kg, respectively; P=.44) and 3-month visits (0.5 kg and 0.0 kg, respectively; P=.27). Study arms did not differ in risk of gaining greater than 2 kg (odds ratio 0.9, 95% confidence interval 0.6-1.3). CONCLUSION: We found no evidence of weight gain from short-term implant use. Through the power of the nocebo effect, the practice of counseling women to expect possible weight gain from initiating implant use could lead them to perceive weight gain even in its absence and contribute to the early discontinuation of this highly effective contraceptive method.

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.

BACKGROUND: Few studies have assessed patients' sexual behaviours during the period immediately following a new diagnosis of a curable sexually transmitted infection (STI). METHODS: Data were analysed from a behavioural study nested within the Safe in the City trial, which evaluated a video-based STI/HIV prevention intervention in three urban STI clinics. We studied 450 patients who reported having received a new STI diagnosis, or STI treatment, 3 months earlier. Participants reported on whether they seriously considered, attempted and succeeded in adopting seven sex-related behaviours in the interval following the diagnostic visit. We used multivariable logistic regression to identify, among men, correlates of two behaviours related to immediately reducing reinfection risk and preventing further STI transmission: sexual abstinence until participants were adequately treated and abstinence until their partners were tested for STIs. RESULTS: Most participants reported successfully abstaining from sex until they were adequately treated for their baseline infection (89%-90%) and from sex with potentially exposed partners until their partners were tested for HIV and other STIs (66%-70%). Among men who intended to be abstinent until they were adequately treated, those who did not discuss the risks with a partner who was possibly exposed were more likely not to be abstinent (OR, 3.7; 95% CI 1.5 to 9.0) than those who had this discussion. Similarly, among men who intended to abstain from sex with any potentially exposed partner until the partner was tested for HIV and other STIs, those who reported not discussing the risks of infecting each other with HIV/STIs were more likely to be sexually active during this period (OR, 3.5; 95% CI 1.6 to 8.1) than were those who reported this communication. CONCLUSIONS: Improved partner communication could facilitate an important role in the adoption of protective behaviours in the interval immediately after receiving a new STI diagnosis. TRIAL REGISTRATION NUMBER: NCT00137670.

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.

We used data from a prospective study of 300 women attending a sexually transmitted infection clinic in Kingston, Jamaica, to compare participant self-report of recent semen exposure to actual semen exposure measured by prostate-specific antigen in vaginal swabs. Underreporting of semen exposure was significantly more frequent at follow-up than baseline, suggesting that the accuracy of reports of sexual behavior may vary over time.

OBJECTIVE: To better understand preferences and practices regarding partner notification of sexually transmitted infection (STI) among female, African-American adolescents. METHODS: Participants completed a questionnaire and STI testing at baseline. Those diagnosed with Chlamydia or gonorrhea were recruited for a follow-up study, involving another questionnaire and repeat STI testing after three months. RESULTS: At baseline, most participants (85.1%) preferred to tell their partner about an STI diagnosis themselves instead of having a health care provider inform him, and 71.0% preferred to bring their partner for clinic treatment instead of giving him pills or a prescription. Two-thirds of participants were classified as having high self-efficacy for partner notification of a positive STI diagnosis. In the multivariable analysis, older participants and those with fewer lifetime sexual partners were more likely to have high self-efficacy. Ninety-three participants (26.6%) had Chlamydia or gonorrhea and, of this subset, 55 participated in the follow-up study. Most adolescents in the follow-up study (76.4%) notified their partner about their infection. CONCLUSION: Although participants were willing to use most methods of partner notification, most preferred to tell partners themselves and few preferred expedited partner therapy. Traditional methods for partner notification and treatment may not be adequate for all adolescents in this population.

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.

Molecular data are now widely used in epidemiological studies to investigate the transmission, distribution, biology, and diversity of pathogens. Our objective was to establish recommendations to support good scientific reporting of molecular epidemiological studies to encourage authors to consider specific threats to valid inference. The statement Strengthening the Reporting of Molecular Epidemiology for Infectious Diseases (STROME-ID) builds upon the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative. The STROME-ID statement was developed by a working group of epidemiologists, statisticians, bioinformaticians, virologists, and microbiologists with expertise in control of infection and communicable diseases. The statement focuses on issues relating to the reporting of epidemiological studies of infectious diseases using molecular data that were not addressed by STROBE. STROME-ID addresses terminology, measures of genetic diversity within pathogen populations, laboratory methods, sample collection, use of molecular markers, molecular clocks, timeframe, multiple-strain infections, non-independence of infectious-disease data, missing data, ascertainment bias, consistency between molecular and epidemiological data, and ethical considerations with respect to infectious-disease research. In total, 20 items were added to the 22 item STROBE checklist. When used, the STROME-ID recommendations should advance the quality and transparency of scientific reporting, with clear benefits for evidence reviews and health-policy decision making.

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.

BACKGROUND: The advent of fertility treatments has led to an increase in the rate of multiple births in the United States. However, the trends in and magnitude of the contribution of fertility treatments to the increase are uncertain. METHODS: We derived the rates of multiple births after natural conception from data on distributions of all births from 1962 through 1966 (before fertility treatments were available). Publicly available data on births from 1971 through 2011 were used to determine national multiple birth rates, and data on in vitro fertilization (IVF) from 1997 through 2011 were used to estimate the annual proportion of multiple births that were attributable to IVF and to non-IVF fertility treatments, after adjustment for maternal age. Trends in multiple births were examined starting from 1998, the year when clinical practice guidelines for IVF were developed with an aim toward reducing the incidence of multiple births. RESULTS: We estimated that by 2011, a total of 36% of twin births and 77% of triplet and higher-order births resulted from conception assisted by fertility treatments. The observed incidence of twin births increased by a factor of 1.9 from 1971 to 2009. The incidence of triplet and higher-order births increased by a factor of 6.7 from 1971 to 1998 and decreased by 29% from 1998 to 2011. This decrease coincided with a 70% reduction in the transfer of three or more embryos during IVF (P<0.001) and a 33% decrease in the proportion of triplet and higher-order births attributable to IVF (P<0.001). CONCLUSIONS: Over the past four decades, the increased use of fertility treatments in the United States has been associated with a substantial rise in the rate of multiple births. The rate of triplet and higher-order births has declined over the past decade in the context of a reduction in the transfer of three or more embryos during IVF.

BACKGROUND: Although biological markers of women's exposure to semen from vaginal intercourse have been developed as surrogates for risk of infection or probability of pregnancy, data on their persistence time and clearance are limited. STUDY DESIGN: During 2006-2008, 52 couples were enrolled for three 14-day cycles of abstinence from vaginal sex during which women were exposed in the clinic to a specific quantity (10, 100 or 1000 muL) of their partner's semen. Vaginal swabs were collected before and at 1, 6, 12, 24, 48, 72 and 144 h after exposure for testing for prostate-specific antigen (PSA) and Y-chromosome DNA (Yc DNA). RESULTS: Immediately after exposure to 1000 muL of semen, the predicted sensitivity of being PSA positive was 0.96; this decreased to 0.65, 0.44, 0.21 and 0.07 at 6, 12, 24 and 48 h, respectively. Corresponding predicted sensitivity of being Yc DNA positive was 0.72 immediately postexposure; this increased to 0.76 at 1 h postexposure and then decreased to 0.60 (at 6 h), 0.63 (at 12 h), 0.49 (at 24 h), 0.21 (at 48 h), 0.17 (at 72 h) and 0.12 (at 144 h). CONCLUSIONS: Overall findings suggest that PSA may be more consistent as a marker of very recent exposure and that Yc DNA is more likely to be detected in the vagina after 12 h postexposure compared to PSA.

BACKGROUND: Madagascar recently scaled up their volunteer community health worker (CHW) program in maternal health and family planning to reach remote and underserved communities. STUDY DESIGN: We conducted a cross-sectional evaluation using a systematic sample of 100 CHWs trained to provide contraceptive counseling and short-acting contraceptive services at the community level. CHWs were interviewed on demographics, recruitment, training, supervision, commodity supply, and other measures of program functionality; tested on knowledge of injectable contraception; and observed by an expert while completing five simulated client encounters with uninstructed volunteers. We developed a CHW performance score (0-100%) based on the number of counseling activities adequately met during the client encounters and used multivariable linear regression to identify correlates of the score. RESULTS: CHWs had a mean performance score of 73.9% (95% confidence interval [CI]: 70.3-77.6%). More education, more weekly volunteer hours, and receiving a refresher training correlated with a higher performance score. We found no other associations between measures of the components previously identified as essential for effective CHW programs and performance score. CONCLUSIONS: Although areas of deficiency were identified, CHWs proved capable of providing high-quality contraception services.

Research on interventions to prevent HIV and other sexually transmitted infections (STIs) is heavily influenced by participant reporting of sexual behavior, despite uncertainty about its validity. Exclusive reliance on participant self-report often is based, overtly or by implication, on 4 assumptions: (1) no feasible alternatives exist; (2) misreporting can be minimized to levels that can be disregarded; (3) misreporting tends to underreport sensitive behaviors; and (4) misreporting tends to be nondifferential with respect to the groups being compared. The objective of this review are to evaluate these assumptions, including a review of studies using semen biomarkers to evaluate the validity of self-reported data, and to make recommendations for applying biological markers of semen exposure detectable in women to further strengthen research on HIV/STI prevention. Increasing evidence shows that semen biomarkers provide an important means of assessing and augmenting the validity of studies on HIV/STI prevention. Additional biomarkers are needed to assess male exposure to vaginal sex and both male and female exposure to anal sex. Methods and study designs that incorporate biomarkers into studies collecting self-reported behavioral data should be considered where possible.

BACKGROUND: Combination injectable contraceptives (CICs) provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of CICs. SEARCH METHODS: In January and February 2013, we searched for randomized controlled trials (RCTs) of combination injectable contraceptives. Databases include MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS. We searched for current trials in ClinicalTrials.gov and ICTRP.Earlier searches also included AIM and IMEMR. For the initial review, we also assessed the references listed in review articles and in the eligible trial reports. SELECTION CRITERIA: RCTs were eligible if they compared a combination injectable contraceptive with any other contraceptive method (e.g., a second CIC,a progestin-only injectable contraceptive, another hormonal contraceptive or a barrier method) or a placebo. We limited the review to marketed CICs. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data on contraceptive efficacy, bleeding patterns, continuation, and side effects. We calculated the Peto odds ratio or mean difference with 95% confidence interval for dichotomous or continuous outcome, respectively. Survival analysis estimates for method discontinuation were presented where available. MAIN RESULTS: Twelve trials met the inclusion criteria. Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA)25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons.Acceptability results favored the CIC in one study and the progestin-only in another. Studies comparing two CICs found that NET-EN 50 mg plus E(2)V (5)mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials.The NET-EN plus E (2) V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward improving the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

BACKGROUND: The effectiveness of counseling messages to avoid unprotected sex during short-term treatment for curable sexually transmitted infections is unknown. METHODS: We randomized 300 female STI clinic patients 18 years or older with cervicitis and/or vaginal discharge in Kingston, Jamaica, in 2010 to 2011, to 1 of 2 counseling messages for their course of syndromic treatment: abstinence only or abstinence backed up by condom use. At a follow-up visit 6 days afterward, we collected vaginal swabs to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure, and administered a questionnaire assessing sexual behavior. RESULTS: No differences were found in the proportions of women testing positive for PSA at follow-up in the abstinence-plus-condom group (11.9%) and abstinence-only group (8.4%) (risk difference, 3.5; 95% confidence interval, -3.5 to10.5). There also was no significant difference in reporting of unprotected sex between groups. Reporting a history of condom use before enrollment significantly modified the effect of counseling arm on PSA positivity (P = 0.03). Among those reporting recent condom use, 10.3% in the abstinence-only arm and 4.8% in the abstinence-plus-condom arm tested positive for PSA. Conversely, among those not reporting recent condom use, 6.5% in the abstinence-only arm and 17.3% in the abstinence-plus-condom arm had PSA detected. CONCLUSIONS: We found no evidence to support the superiority of either counseling message. Post hoc analyses suggest that women with recent condom experience may benefit significantly more from abstinence-plus-condom messages, whereas women without such experience may benefit significantly more from abstinence-only messages. Providers should weigh individual condom use history when determining the most appropriate counseling message.

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.

BACKGROUND: Studies that evaluate condom effectiveness are affected by factors related to how the condom was used, and these factors may not be consistent between different types of condoms. Also, subjective assessments of the sexual act may be unreliable. STUDY DESIGN: We performed a secondary data analysis of a randomized crossover trial of male and female condoms among 108 couples. RESULTS: Self-reported duration and activeness of coital acts were significantly different for uses of the male condom compared to uses of the female condom. Fewer individuals reported ejaculation occurring with the female condom. Reliability of self-reports of ejaculation compared to a biological marker of semen detected inside the used male and female condoms was not strong. CONCLUSIONS: We found that sexual behaviors appear to differ by the type of condom used for the coital act. Studies should consider sexual behavior when evaluating condom effectiveness. Furthermore, studies would be strengthened by the use of a biological marker of semen to determine whether ejaculation, and therefore a true risk of exposure, occurred.

Despite a global epidemic of sexually transmissible infections and the availability and endorsement of condoms as an effective intervention, the overall use of condoms remains low. This review explores various challenges and opportunities to fully realizing the prevention potential for condoms.

The female condom remains the sole female-initiated method of dual protection against unintended pregnancy and sexually transmissible infections (STIs), including HIV. We reviewed published data on the effectiveness and acceptability of the female condom for protection against pregnancy and infection. Overall, use of the female condom is low and several barriers hinder the wider adoption of the use of the method. Research on effectiveness has focussed on pregnancy, STIs and biological markers of semen exposure. Although the data available suggest that female condoms (or a mixture of female and male condoms) may provide similar degrees of protection against pregnancy and STIs as do latex male condoms alone, this conclusion has not been demonstrated and thus comparative research is urgently needed.