HIV Sexual Risk and Syndemics among Women in Three Urban Areas in the United States: Analysis from HVTN 906.

Limited data are available on the longitudinal occurrence of syndemic factors among women at risk for HIV infection in the USA and how these factors relate to sexual risk over time. HVTN 906 was a longitudinal study enrolling 799 HIV-uninfected women in three cities. Assessments were done at baseline, 6, 12, and 18 months to assess syndemic factors (low education, low income, unemployment, lack of health insurance, housing instability, substance use, heavy alcohol use, partner violence, incarceration) and sexual risk outcomes. For each sexual risk outcome, a GEE model was fit with syndemic factors or syndemic score (defined as sum of binary syndemics, ranging from 0 to 9), visit, study site, age and race/ethnicity as predictors to examine the multivariable association between syndemic factors and outcomes over time. Odds of unprotected sex while drunk or high were significantly higher when women reported lack of health insurance, substance and heavy alcohol use and partner violence. Housing instability, substance and heavy alcohol use, partner violence and recent incarceration were associated with higher odds of having multiple sexual partners. Odds of sex exchange were significantly higher in the presence of unemployment, housing instability, low education, lack of health insurance, substance and heavy alcohol use, partner violence and incarceration. Housing instability, substance and heavy alcohol use, and partner violence were significantly associated with higher odds of unprotected anal sex. Odds of having a recent STI were significantly higher when women reported housing instability and partner violence. There were significantly higher odds of the reporting of any risk outcomes during follow-up with higher syndemic score. This study highlights a group of women experiencing multiple poor social and health outcomes who need to be the focus of comprehensive interventions.

Cost analysis of enhancing linkages to HIV care following jail: a cost-effective intervention.

We are not aware of published cost-effectiveness studies addressing community transitional programs for HIV-infected jail detainees. To address this gap, data from 9 sites of EnhanceLink, a project that enrolled HIV-infected releasees from jails across the US, were examined. Figures on the number of clients served, cost of linkage services, number of linkages and 6-month sustained linkages to community HIV care, and number of clients achieving viral suppression were assessed for subjects released in the first quarter of 2010 (n = 543). The cost analysis included all costs that participating service agencies incurred. A cost-effectiveness analysis was conducted to estimate the new HIV cases averted by EnhanceLink and the cost per quality-adjusted life year saved by the program. The mean cost per linked client was $4,219; the mean cost per 6-month sustained linkage was $4,670; and the mean cost per client achieving viral suppression was $8,432. Compared to standard care, the cost per additional quality-adjusted life year saved was $72,285, suggesting that the EnhanceLink interventions were cost-effective from the societal perspective.

Validation data-based adjustments for outcome misclassification in logistic regression: an illustration.

Misclassification of binary outcome variables is a known source of potentially serious bias when estimating adjusted odds ratios. Although researchers have described frequentist and Bayesian methods for dealing with the problem, these methods have seldom fully bridged the gap between statistical research and epidemiologic practice. In particular, there have been few real-world applications of readily grasped and computationally accessible methods that make direct use of internal validation data to adjust for differential outcome misclassification in logistic regression. In this paper, we illustrate likelihood-based methods for this purpose that can be implemented using standard statistical software. Using main study and internal validation data from the HIV Epidemiology Research Study, we demonstrate how misclassification rates can depend on the values of subject-specific covariates, and we illustrate the importance of accounting for this dependence. Simulation studies confirm the effectiveness of the maximum likelihood approach. We emphasize clear exposition of the likelihood function itself, to permit the reader to easily assimilate appended computer code that facilitates sensitivity analyses as well as the efficient handling of main/external and main/internal validation-study data. These methods are readily applicable under random cross-sectional sampling, and we discuss the extent to which the main/internal analysis remains appropriate under outcome-dependent (case-control) sampling.

A Comparison of Sequential Glaucoma Drainage Device Implantation Versus Cyclophotocoagulation Following Failure of a Primary Drainage Device.

PURPOSE: To compare sequential glaucoma drainage device (GDD) implantation with transscleral diode cyclophotocoagulation (CPC) following failure of a primary GDD. MATERIALS AND METHODS: A retrospective review of all patients who underwent GDD implantation at a single institution over 10 years. Patients who required an additional GDD and/or CPC were analyzed. Success was defined as absence of loss of light perception, reoperation for glaucoma, and intraocular pressure (IOP) >21 or <6 at 2 consecutive visits after an initial 3-month period. RESULTS: Thirty-two patients received sequential GDD. Twenty-one underwent CPC. Cohorts were statistically similar in regards to age, sex, race, and number of previous surgeries. Preoperatively, the GDD cohort had a lower IOP and better visual acuity. The mean length of follow-up was 37.9 months for the GDD group and 46.3 months for CPC. Both procedures significantly reduced IOP; however, CPC led to a greater reduction (P=0.0172). Survival analysis found the 5-year probability of surgical success to be 65.3% for sequential GDD and 58.0% for CPC (P=0.8678). No cases of phthisis occurred in either group. There were 2 cases of endophthalmitis (6.3%) in the GDD group, and none in the CPC group. In eyes without preexisting corneal edema, estimated corneal decompensation probability at 3 years was 31.6% for GDD and 6.7% for CPC (P=0.0828). CONCLUSIONS: Sequential GDD and CPC are both effective at reducing IOP following the failure of a primary GDD. CPC after GDD failure warrants further investigation as it led to a greater reduction in IOP with fewer serious adverse events.

Glaucoma drainage devices: risk of exposure and infection.

PURPOSE: To identify risk factors for device exposure and intraocular infection following implantation of a glaucoma drainage device. DESIGN: Retrospective case series. METHODS: The medical records of adult patients undergoing glaucoma drainage device implantation at an academic medical center between 2000 and 2010 were reviewed. Main outcome measures included device exposure and intraocular infection. RESULTS: Seven hundred and sixty-three cases were identified. These included 702 primary implants (ie, the first drainage device implanted into an eye) and 61 sequential implants. Among 702 primary implants, there were 41 cases of exposure (5.8%). None of the potential risk factors were statistically significant. Implant location was found to be a marginally significant risk factor. The exposure rates for inferior and superior implants were 12.8% (5 of 39) and 5.4% (36 of 663), respectively (P = .056). The highest rate of exposure for primary implants occurred in the inferior-nasal quadrant (17.2%, 5 of 29). The rate of exposure for sequential devices was 13.1% (8 of 61), with the highest rate also found in the inferior-nasal quadrant (20%, 5 of 25). Of 49 total exposures, 8 were associated with intraocular infection (16.3%). Exposures over inferior implants were more likely to be associated with infection than exposures over superior implants (41.7% vs 8.1%; P = .0151). CONCLUSION: Implant location approached, but did not reach, statistical significance as a risk factor for exposure. Exposures over inferior implants place patients at a higher risk of infection than superior exposures. More studies are needed to identify modifiable risk factors for device exposure.

Behavioral, clinical and pathological effects of multiple daily intraperitoneal injections on female mice.

Pharmacological agents are commonly administered to mice through multiple intraperitoneal (i.p.) injections. The i.p. route of administration is usually considered safe, but questions of animal welfare arise when protocols require that multiple injections be given to the same animal. IACUCs must consider the potential risks associated with multiple i.p. injections in order to determine the maximum number of injections an animal can receive within a study protocol, but there are no published studies of such potential risks. The authors investigated the effects of 30 daily i.p. saline injections on the behavior, body condition, weight, fecal corticosterone levels, hematology and pathology of female adult mice. Results indicate that multiple i.p. injections do not cause any ill effects in mice.

Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial.

BACKGROUND: Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking. METHODS: We conducted a double-blind, placebo-controlled, crossover, Phase II randomized pilot clinical trial to estimate the effects of melatonin supplementation on MetS components and the overall prevalence of MetS. We randomized 39 subjects with MetS to receive 8.0 mg oral melatonin or matching placebo nightly for 10 weeks. After a 6-week washout, subjects received the other treatment for 10 more weeks. We measured waist circumference, triglycerides, HDL cholesterol, fasting glucose, and blood pressure (BP) in each subject at the beginning and end of both 10-week treatment periods. The primary outcome was the mean 10-week change in each MetS component, and a secondary outcome was the proportion of subjects free from MetS, after melatonin versus placebo. RESULTS: The mean 10-week change for most MetS components favored melatonin over placebo (except fasting glucose): waist circumference -0.9 vs. +1.0 cm (p = 0.15); triglycerides -66.3 vs. -4.2 mg/dL (p = 0.17); HDL cholesterol -0.2 vs. -1.1 mg/dL (p = 0.59); fasting glucose +0.3 vs. -3.1 mg/dL (p = 0.29); systolic BP -2.7 vs. +4.7 mmHg (p = 0.013); and diastolic BP -1.1 vs. +1.1 mmHg (p = 0.24). Freedom from MetS tended to be more common following melatonin versus placebo treatment (after the first 10 weeks, 35.3% vs. 15.0%, p = 0.25; after the second 10 weeks, 45.0% vs. 23.5%, p = 0.30). Melatonin was well-tolerated. CONCLUSIONS: Melatonin supplementation modestly improved most individual MetS components compared with placebo, and tended to increase the proportion of subjects free from MetS after treatment. TRIAL REGISTRATION: NCT01038921, clinicaltrials.gov.

Long-term risk of glaucoma after congenital cataract surgery.

PURPOSE: To report the long-term risk of glaucoma development in children following congenital cataract surgery. DESIGN: Retrospective interventional consecutive case series. METHODS: We retrospectively reviewed the records of 62 eyes of 37 children who underwent congenital cataract surgery when <7 months of age by the same surgeon using a limbal approach. The Kaplan-Meier method was used to calculate the probability of an eye's developing glaucoma and/or becoming a glaucoma suspect over time. RESULTS: The median age of surgery was 2.0 months and the median follow-up after cataract surgery was 7.9 years (range, 3.2-23.5 years). Nine eyes (14.5%) developed glaucoma a median of 4.3 months after cataract surgery and an additional 16 eyes (25.8%) were diagnosed as glaucoma suspects a median of 8.0 years after cataract surgery. The probability of an eye's developing glaucoma was estimated to be 19.5% (95% CI: 10.0%-36.1%) by 10 years after congenital cataract surgery. When the probability of glaucoma and glaucoma suspect were combined, the risk increased to 63.0% (95% CI: 43.6%-82.3%). CONCLUSIONS: Long-term monitoring of eyes after congenital cataract surgery is important because we estimate that nearly two thirds of these eyes will develop glaucoma or become glaucoma suspects by 10 years after cataract surgery.