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Background: Pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate is efficacious in reducing HIV acquisition. For some gay, bisexual, and other men who have sex with men (MSM), daily ongoing PrEP may be unsuitable for use as a long-term prevention strategy because of episodic risk, cost issues, or concerns about the biological consequences of medication. Setting: This study evaluated the feasibility of short-term, fixed-interval episodic PrEP (Epi-PrEP) for use among vacationing MSM. We describe the feasibility of implementing a clinic-based Epi-PrEP pilot program for 48 MSM who reported occasional condomless sex and anticipated a defined high-risk time. Methods: This was a nonrandomized naturalistic study of an observational clinical intervention. The primary outcome assessed was adherence, as measured by self-report and plasma tenofovir levels. Results: Of 54 MSM who enrolled in the study, 48 completed the 3-month visit. The majority (93.7%) had tenofovir concentrations consistent with daily use on returning from vacation. Almost 3/4 reported condomless sex during vacation, and about 1/3 reported recreational drug use. During the 3-month follow-up, 1 participant had become HIV-infected because of a lapse in continued access to the PrEP after study. Although adverse events were common, none were serious. More than 70% of participants indicated an interest in daily ongoing PrEP use. Conclusions: Epi-PrEP was well tolerated by at risk MSM in this study, with high levels of medication adherence. Many participants felt the experience of initiating PrEP while on vacation could be a means for transition to long-term PrEP use. [ABSTRACT FROM AUTHOR]

Research has shown that buprenorphine/naloxone (bup/nx) is a safe and effective treatment for opioid dependence. Few reports, however, describe the patient perspective on bup/nx treatment and its integration into HIV care settings.We conducted qualitative interviews with 33 patients to further investigate patient satisfaction and experience with bup/nx treatment and integrated care. Interviews focused on drug use/cessation history; attitudes toward and satisfaction with bup/nx treatment; and perspectives on integrated bup/nx treatment and HIV care.Patients were overwhelmingly satisfied with the pharmacologic effects and treatment outcomes of bup/nx, including effectiveness in blocking cravings and controlling opioid use; decreased fear of withdrawal and/or missing doses; and an overall improvement in quality of life. Patients also described being more engaged with both their substance abuse treatment and HIV care, including greater ability to manage their own treatment, keep, appointments, and adhere to antiretroviral medication regimes. Counseling was seen by some patients as an important component of bup/nx treatment. Nearly all were positive about their experience with integrated care, appreciative of an improved drug treatment environment, convenience, and quality of care.Findings suggest that patients report bup/nx to be a viable treatment and many prefer it to other opioid replacement therapies. [ABSTRACT FROM AUTHOR]

Substance abuse is associated with poor medical and quality-of-life outcomes among HIV-infected individuals. Although drug treatment may reduce these negative consequences, for many patients, options are limited. Buprenorphine/naloxone, an opioid agonist treatment that can be prescribed in the United States in office-based settings, can be used to expand treatment capacity and integrate substance abuse services into HIV care. Recognizing this potential, the US Health Resources and Services Administration funded the development and implementation of demonstration projects that integrated HIV care and buprenorphine/naloxone treatment at 10 sites across the country. An Evaluation and Technical Assistance Center provided programmatic and clinical support as well as oversight for an evaluation that examined the processes for and outcomes of integrated care. The evaluation included patient-level self-report and chart abstractions as well as provider and site level data collected through surveys and in-depth interviews. Although multisite demonstrations pose implementation and evaluation challenges, our experience demonstrates that these can, in part, be addressed through ongoing communication and technical assistance as well as a comprehensive evaluation design that incorporates multiple research methods and data sources. Although limitations to evaluation findings persist, they may be balanced by the scope and “real-world” context of the initiative. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The impact of prenatal screening for Down syndrome has largely been assessed under the assumption that screening protocols and policies are fully used. To measure the overall effectiveness in actual clinical practice, we analyzed the tests performed by a single cytogenetics laboratory. METHODS: We reviewed all amniotic fluid and chorionic villus samples (CVS) processed by the University of Connecticut Health Center's cytogenetics laboratory for the years 1991 to 2002. We evaluated trends in the use of prenatal testing, referral indications, and the numbers of cytogenetic abnormalities identified. RESULTS: The number of women receiving amniocentesis or CVS declined more than 50% from 1,988 in 1091 to 933 in 2002 (P < .001), despite an increase in the number of women of advanced maternal age in the population served. There was a 68% decline in the number of women who underwent invasive prenatal testing solely on the basis of their age (1,314 in 1991 to 423 in 2002, P < .001). The number of Down syndrome fetuses detected prenatally increased from 20 to 31 (P = .08), representing approximately one half of the affected pregnancies present in the population served. Between 1991 and 2002, the proportion of antenatal cytogenetic tests with a significant chromosomal abnormality increased from 1 in 43 (2.3%) to 1 in 14 (7.0%; P < .001). CONCLUSION: Advances in maternal serum screening and second-trimester ultrasonography have resulted in more judicious use of amniocentesis and chorionic villus sampling. [ABSTRACT FROM AUTHOR]

Replication of effective practices requires detailed descriptions of implementation processes, barriers and facilitators, and lessons learned. The experiences of physicians leading the Buprenorphine HIV Evaluation and Support initiative provides valuable information for other HIV providers seeking to integrate medication-assisted treatment services into HIV clinical care.Evaluation staff conduced site visits to the 10 funded Buprenorphine HIV Evaluation and Support programs to better understand buprenorphine/naloxone (bup/nx) integration practices; services offered; staffing; provider experiences with and perceptions of bup/nx; perceived barriers, facilitators, and sustainability; and recommendations regarding replication of integrated care program components. Interviews with site principal investigators conducted during the last year of program implementation were transcribed, coded, and analyzed according to both pre-identified and emerging themes.Integrated bup/nx and HIV treatment was successfully introduced to community and hospital-based clinics under the direction of infectious disease, psychiatry, and general internal medicine physicians. All but 1 of the principal investigators interviewed were highly satisfied with integrated HIV and bup/nx treatment, and all anticipated continued provision of the service. Multiple prescribers were necessary to ensure sufficient coverage and a bup/nx coordinator (eg, nurse, counselor) was seen as essential to the provision of quality care. Ongoing challenges included multisubstance use and mental health issues among patients; limited adoption of bup/nx treatment among colleagues; and the necessity of incorporating new procedures, including urine toxicology testing into established practice.Findings suggest that integrated bup/nx treatment and HIV care is acceptable to providers and feasible in a variety of practice settings. [ABSTRACT FROM AUTHOR]

: ObjectiveTo evaluate the efficacy of the second-trimester quadruple test (maternal serum alpha-fetoprotein, unconjugated estriol, human chorionic gonadotropin, and inhibin-A) in prenatal screening for Down syndrome.: MethodsAll quadruple tests performed on singleton pregnancies over a 32-month period were reviewed. The sensitivity and false-positive rates were compared with the theoretic rates predicted by the screening model when applied to a population of women with the same maternal age distribution.: ResultsTwenty-three thousand seven hundred four women with unaffected pregnancies and 45 women with Down syndrome–affected pregnancies received the quadruple test. Mean analyte values for both unaffected and affected pregnancies were similar to those expected. The sensitivity of the quadruple test, which was based on ascertainment of all viable affected pregnancies in the screened population, was 85.8%. This sensitivity did not significantly differ from an expected 83.8% (P = .8). The initial false-positive rate, 9.0%, was significantly below that expected (9.9%) (P = .002) and was further reduced to 8.2% after correction for major gestational age errors. The positive predictive value of the quadruple test was one in 51. Women with an affected pregnancy and a positive test result (true positives) generally had very high risks (median 1:22) relative to women with false-positive results (median risk 1:111).: ConclusionThe quadruple test meets or exceeds performance expectations and appears to represent an improvement over the widely used triple test. [Copyright &y& Elsevier]

Introduction: Pre-exposure prophylaxis (PrEP), taken as a single daily coformulated pill containing tenofovir -emtricitabine, is a promising intervention to reduce the likelihood of HIV acquisition in at-risk individuals, including men who have sex with men. Little is known about the acceptability of less than daily, intermittent PrEP regimens. Methods: We conducted an online survey of North American men who have sex with men to characterize their sexual frequency and planning behaviors and correlate these with PrEP dosing preferences. Results: Of the 3217 respondents who completed the survey, 46% reported engaging in unplanned condomless anal intercourse (CAI) at least once in previous 3 months and 8% reported engaging in CAImore than once per week. In multivariable analysis, reporting unplanned CAI was associated with lower educational level, identifying as homosexual/ gay as compared with bisexual, being in a monogamous relationship, having a higher self-perceived risk of HIV acquisition, reporting higher income, engaging in CAI more than five times in the last 3 months, and not having visited a health care provider in the previous year. Frequent CAI (.1 time per week) was associated with being younger, identifying as homosexual/gay as compared with bisexual, being in a monogamous relationship, and having a higher self-perceived risk of HIV. Having only planned sex over the last 3 months was associated with a preference for event-based PrEP, whereas having frequent or unplanned CAI was associated with a preference for daily or time-driven PrEP regimens, respectively. Conclusion: Our findings suggest that preferences for different PrEP regimens are associated with the sexual frequency and planning behaviors of potential users. [ABSTRACT FROM AUTHOR]

The article presents a study on the disclosure and sexual behavior of HIV serodiscordant or serostatus of black men who have sex with men (MSM) in New York City. It says that black MSM who had unprotected anal intercourse (UAI) were recruited in an HIV behavioral study and factors related to sexual risk behavior were evaluated. Results show that almost half of them used alcohol before or during sex, about two-thirds disclose their HIV status, and Internet was associated in their serostatus.

Opioid dependence and HIV infection are associated with poor health-related quality of life (HRQOL). Buprenorphine/naloxone (bup/nx) provided in HIV care settings may improve HRQOL.We surveyed 289 HIV-infected opioid-dependent persons treated with clinic-based bup/nx about HRQOL using the Short Form Health Survey (SF-12) administered at baseline, 3, 6, 9, and 12 months. We used normalized SF-12 scores, which correspond to a mean HRQOL of 50 for the general US population (SD 10, possible range 0-100). We compared mean normalized mental and physical composite and component scores in quarters 1, 2, 3, and 4 with baseline scores using generalized estimating equation models. We assessed the effect of clinic-based bup/nx prescription on HRQOL composite scores using mixed effects regression with site as random effect and time as repeated effect.Baseline normalized SF-12 scores were lower than the general US population for all HRQOL domains. Average composite mental HRQOL improved from 38.3 (SE 12.5) to 43.4 (SE 13.2) [β 1.13 (95% CI: 0.72 to 1.54)] and composite physical HRQOL remained unchanged [β 0.21 (95% CI: -0.16 to 0.57)] over 12 months follow-up. Continued bup/nx treatment across all 4 quarters was associated with improvements in both physical [β 2.38 (95% CI: 0.63 to 4.12)] and mental [β 2.51 (95% CI: 0.42 to 4.60)] HRQOL after adjusting for other contributors to HRQOL.Clinic-based bup/nx maintenance therapy is potentially effective in ameliorating some of the adverse effects of opioid dependence on HRQOL for HIV-infected populations. [ABSTRACT FROM AUTHOR]

Implementing integrated HIV and buprenorphine/naloxone treatment requires cost estimates to plan and obtain funding.We identified costs incurred at HIV clinical sites participating in a cross-site evaluation of integrated care that followed patients for 1 year. Costs include labor, overhead, and urine toxicology analyses (clinic perspective), buprenorphine/naloxone (payer perspective) and patient time and transportation (patient perspective). Sites provided resource utilization quarterly, and providers estimated time required for each activity. With site as the unit of analysis, results are reported as median (range) of average site costs in 2008 US dollars.The median number of monthly provider encounters for integrated care patients was 3.2 (1.5-13.3) compared with 1.7 (1.1-4.2) for similar patients not in integrated care, but integrated care patients had fewer physician encounters. Median monthly clinic costs per integrated care patient were $136 ($67-$677) for labor and overhead and $8 ($2-$23) for toxicology analyses, $22 higher than clinic costs for patients not in integrated care. Median monthly costs for buprenorphine/naloxone were $209 ($165-$272), and monthly patient costs in integrated care were $11 ($1-$54) higher.Integrated HIV and buprenorphine/naloxone treatment requires different resources, including costs that are not third-party reimbursed. Implementing integrated care will require funding for training and for new staff such as buprenorphine coordinators, in addition to reimbursement for buprenorphine/naloxone. Further research is needed to identify potential cost offsets outside of the clinic setting. [ABSTRACT FROM AUTHOR]

The safety of buprenorphine/naloxone (bup/nx) in HIV-infected patients has not been established. Prior reports raise concern about hepatotoxicity and interactions with atazanavir.We conducted a prospective cohort study of 303 opioid-dependent HIV-infected patients initiating bup/nx treatment. We assessed changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) over time. We compared bup/nx doses in patients receiving the antiretroviral atazanavir to those not receiving atazanavir. We conducted surveillance for pharmacodynamic interactions.Median AST [37.0 vs. 37.0 units/liter (U/L) respective interquartile ranges (IQRs) 26-53 and 26-59] and ALT (33.0 vs. 33.0 U/L, respective IQRs 19-50 and 18-50) values did not change over time among 141 patients comparing pre-bup/nx exposure with post-bup/nx exposure measures. During bup/nx exposure, 207 subjects demonstrated no significant change in median AST (36.0 vs. 35.0 U/L, respective IQRs 25-57 and 25-61) and ALT (29.0 vs. 31.0 U/L, respective IQRs 19-50 and 18-50) values collected a median of 6 months apart. Analyses restricted to patients with hepatitis C and HIV co-infection yielded similar results, except a small but significant decrease in first to last AST, during treatment with bup/nx (P = 0.048). Mean bup/nx dose, ranging 16.0-17.8 mg, did not differ over time or with co-administration of atazanavir. No pharmacodynamic interactions were noted.Buprenorphine/naloxone did not produce measurable hepatic toxicity or pharmacodynamic interaction with atazanavir in HIV-infected opioid-dependent patients. [ABSTRACT FROM AUTHOR]

Pain syndromes are common in HIV-infected patients, who also are commonly affected by opioid-use disorders. Although opioids can treat pain, prescribers must consider the consequences of iatrogenic or missed addiction diagnoses.In an anonymous online survey, we asked a national sample of HIV providers about their demographics, experience, and patients, and their practices and attitudes about chronic opioid therapy, addiction, and confidence recognizing opioid analgesic abuse.One hundred six providers reported 28% of their patients had chronic pain; 21% received opioid analgesics; 37% were HIV infected by injecting drug use; and 12% were addicted to prescription opioids. Few providers followed recommended guidelines for chronic opioid therapy in nonmalignant pain. Mean provider confidence was 6.3 on a scale of 10. Higher confidence was associated with provider sex (P < 0.05), patient volume (P < 0.03), discussing substance use, (P < 0.05), urine toxicology (P < 0.01), prescribing longer acting opioids (P = 0.005), and prescribing buprenorphine (P = 0.009).HIV providers seldom follow recommended guidelines for opioid prescribing and have limited confidence in their ability to recognize opioid analgesic abuse. Clinical practices developed to reduce misuse and increase early detection and treatment of opioid dependence are associated with higher confidence. The implementation of guidelines to improve the quality of opioid prescribing in HIV clinics may aid in the diagnosis of addictive disorders and prevent their adverse outcomes. [ABSTRACT FROM AUTHOR]

Buprenorphine/naloxone allows the integration of opioid dependence and HIV treatment.We conducted a prospective study in HIV-infected opioid-dependent patients to investigate the impact of buprenorphine/naloxone treatment on drug use. Self-report and chart review assessments were conducted every 3 months (quarters 1-4) for 1 year. Outcomes were buprenorphine/naloxone treatment retention, drug use, and addiction treatment processes.Among 303 patients enrolled between July 2005 and December 2007, retention in buprenorphine/naloxone treatment was 74%, 67%, 59%, and 49% during Quarters 1, 2, 3, and 4, respectively. Past 30-day illicit opioid use decreased from 84% of patients at baseline to 42% in retained patients over the year. Patients were 52% less likely to use illicit opioids for each quarter in treatment (Odds ratio = 0.66; 95% CI: 0.61 to 0.72). Buprenorphine/naloxone doses and office visits approximated guidelines published by the United States Department of Health and Human Services. Urine toxicology monitoring was less frequent than recommended.Buprenorphine/naloxone provided in HIV treatment settings can decrease opioid use. Strategies are needed to improve retention and address ongoing drug use in this treatment population. [ABSTRACT FROM AUTHOR]

This study was part of a national, multisite demonstration project evaluating the impact of integrated buprenorphine/naloxone treatment and HIV care. The goals of this study were to describe the baseline demographic, clinical, and substance use characteristics of the participants and to explore HIV transmission risk behaviors in this group.Nine sites across the United States participated. Data obtained by interview and chart review included demographic information, medical history, substance use, and risk behaviors.We performed a descriptive analysis of patient characteristics at entry and used logistic regression to evaluate factors associated with 1) unprotected anal or vaginal sex; and 2) needle-sharing within the previous 90 days.Three hundred eighty-six individuals were included in the study: 303 (78.5%) received buprenorphine/naloxone; 41 (10.6%) received methadone; and 42 (10.9%) received another form of treatment. The analysis of risk behaviors was limited to those in the buprenorphine group (n = 303). Among those reporting vaginal or anal sex in the previous 90 days, 24% had sex without a condom. Factors significantly associated with unprotected sex were: having a partner; female gender; and alcohol use in previous 30 days. A total of 8.9% of participants shared needles in the previous 90 days. Factors significantly associated with needle-sharing were: amphetamine use; marijuana use; homelessness; and anxiety.Addressing transmission risk behaviors is an important secondary HIV prevention strategy. In addition to treatment for opioid dependence, addressing other substance use, social issues, particularly housing, and mental health may have important implications for reducing HIV transmission in HIV-infected opioid-dependent patients. [ABSTRACT FROM AUTHOR]

Objective: To estimate the accuracy of evaluating nasal bone length, expressed as multiples of the median (MoM), for the detection of Down syndrome in second- trimester fetuses. Methods: Expected normal median nasal bone measurements were established for an initial cohort of women receiving fetal ultrasound examinations at 15-24 weeks of gestation. Nasal bone lengths were converted to MoM with adjustment for maternal race and ethnicity using whites as the referent group. Nasal bone MoM were compared in euploid and Down syndrome fetuses. The sensitivity and specificity were evaluated in this initial cohort and in a second cohort in which all ultrasound measurements were carried out prospectively. Results: For the combined data set, 10 of 21 affected pregnancies had an absence of the nasal bone (sensitivity 47.6%), but absence was noted in only 1 of 2,515 unaffected pregnancies (false-positive rate 0.04%). Using less than 0.80 MoM as a cutoff, the sensitivity was 20 of 21 (95.2%), and the false-positive rate was 185 of 2,515 (7.4%). Changing the cutoff to 0.75 MoM resulted in 18 of 21 (85.7%) sensitivity and 74 of 2,515 (2.9%) false-positive rate. Using medians derived from whites to calculate MoM for the entire population resulted in higher false-positive rates. Conclusion: Nasal bone length expressed as MoM seems to be an useful ultrasound marker for Down syndrome in second-trimester fetuses with a high sensitivity and a low false-positive rate. Level Of Evidence: III. [ABSTRACT FROM AUTHOR]

The article investigates the absence or shortening of nasal bone length in the detection of Down syndrome in second-trimester fetuses. The researchers estimate the accuracy of evaluating nasal bone length for the detection of Down syndrome. The results indicate that nasal bone length expressed as multiples of the median, seems to be a useful ultrasound marker for Down syndrome in second-trimester fetuses with high sensitivity and a low false-positive rate.

OBJECTIVE:To evaluate the efficacy of a Down syndrome screening protocol that combines second-trimester maternal serum analytes and the continuous ultrasound measures of nuchal fold thickness and proximal long bone length.METHODS:Ultrasound measurements of nuchal fold, femur length, and humerus length were reviewed for 72 second-trimester Down syndrome and 7063 unaffected fetuses. Derived statistical variables for these parameters were entered into a multivariable Gaussian model together with the statistical variables used in the “quad” test (maternal serum alpha-fetoprotein, unconjugated estriol, human chorionic gonadotropin, and inhibin A). Maternal age-specific sensitivities, false-positive rates, and positive predictive values were generated together with receiver operating characteristic curves. Overall efficacy of ultrasound screening alone, the quad test, and the combination of the ultrasound and quad test were compared using a 1:270 second-trimester risk cutoff applied to 1999 US births.RESULTS:Using ultrasound, a sensitivity of 79.9% and false-positive rate of 6.7% may be achieved (positive predictive value: 1 in 42). The quad test has a sensitivity of 81.5% and false-positive rate of 6.9% (positive predictive value: 1 in 42). The combination of the quad test with nuchal fold and long bone measurements may achieve 90% sensitivity and a 3.1% false-positive rate (positive predictive value: 1 in 18).CONCLUSION:Combining second-trimester serum testing and fetal biometry is a feasible approach to Down syndrome screening, compatible with current obstetric practice. This modality is substantially more effective than either serum screening or ultrasound alone. Efficacy may be comparable to that reported for combined first- and second-trimester (integrated) screening. [Copyright &y& Elsevier]

To examine the etiology of maternal mortality in the antepartum and intrapartum period and determine perinatal survival. Intrapartum events included 3 amniotic fluid emboli and 1 hemorrhage. The 2 neonates who survived an intrapartum event were born after an amniotic fluid emboli and hemorrhage. [Extracted from the article]