Background Sexual partners of persons with newly diagnosed HIV infection require HIV counseling, testing and, if necessary, evaluation for therapy. However, many African countries do not have a standardized protocol for partner notification and the effectiveness of partner notification has not been evaluated in developing countries. Methods Individuals with newly diagnosed HIV infection presenting to STI clinics in Lilongwe, Malawi were randomized to one of three methods of partner notification: passive referral, contract referral, or provider referral. The passive referral group was responsible for notifying their partners themselves. The contract referral group was given seven days to notify their partners, after which a health care provider contacted partners who had not reported for counseling and testing. In the provider referral group, a health care provider notified partners directly. Results 240 index patients named 302 sexual partners and provided locator information for 252. Among locatable partners, 107 returned for HIV counseling and testing; 20/82 (24%; 95% CI 15 – 34%) partners returned in the passive referral arm, 45/88 (51%; 95% CI 41 – 62%) in the contract referral arm, and 42/82 (51%; 95% CI 40 – 62%) in the provider referral arm (p<0·001). Among returning partners (n=107), 67 (64%) of were HIV-infected with 54 (81%) newly diagnosed. Discussion This study provides the first evidence of the effectiveness of partner notification in sub-Saharan Africa. Active partner notification was feasible, acceptable, and effective among STI clinic patients. Partner notification will increase early referral to care and facilitate risk reduction among high-risk uninfected partners.

Importance Long-acting injectable (LAI) antipsychotics are used to reduce medication non-adherence and subsequent relapse in schizophrenia-spectrum disorders. The relative effectiveness of LAI versions of second-generation (atypical) and older antipsychotics has not been assessed. Objective To compare the effectiveness of the second-generation LAI antipsychotic paliperidone palmitate (PP) to the older LAI antipsychotic haloperidol decanoate (HD). Design, Setting, and Participants Multisite, double-blind, randomized clinical trial conducted at 22 clinical research sites in the U.S. The 311 randomized patients (PP=157, HD=154) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a LAI antipsychotic. Interventions Intramuscular injections of HD 25–200 mg or PP 39–234 mg every month for up to 24 months. Main Outcome Measures Efficacy failure, which reflected inadequate control of psychopathology by the study medication, as determined by a blinded adjudication committee. Key secondary outcomes were common adverse effects of antipsychotic medications. Results There was no statistically significant difference in the rate of efficacy failure for PP compared to HD (adjusted hazard ratio 0.98, 95% confidence interval [CI] 0.65–1.47). On average, patients on PP gained and those on HD lost weight; after six months the least squares mean weight change on PP was +2.17 kg (1.25 to 3.09) and on HD was −0.96 kg (−1.88 to −0.04). Patients taking PP had significantly greater increases in serum prolactin (men 34.56 µg/L (29.75 to 39.37) vs. 15.41 (10.73 to 20.08), p<0.001; women 75.19 (63.03 to 87.36) vs. 26.84 (13.29 to 40.40), p<0.001). Patients taking HD had significantly larger increases in global ratings of akathisia (0.73 [0.59 to 0.87] vs. 0.45 [0.31 to 0.59], p=0.006). Conclusions and Relevance Among adults with schizophrenia or schizoaffective disorder, treatment with paliperidone palmitate compared with haloperidol decanoate did not result in a statistically significant difference in efficacy failure, but was associated with more weight gain and greater increases in serum prolactin, whereas haloperidol was associated with more akathisia. However, based on the 95% confidence limits, a clinically meaningful difference in efficacy failure between treatments cannot be ruled out. Trial Registration clinicaltrials.gov identifier NCT01136772

ObjectiveThe objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.Methodology/Principal FindingsThis was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between March 2004 and February 2006 in Accra and Kumasi, Ghana. We enrolled 2142 HIV-negative women at high risk of HIV infection, and randomized them to SAVVY or placebo gel. Main outcome measures were the incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate specimens and adverse events. We accrued 790 person-years of follow-up in the SAVVY group and 772 person-years in the placebo group. No clinically significant differences in the overall frequency of adverse events, abnormal pelvic examination findings, or abnormal laboratory results were seen between treatment groups. However, more participants in the SAVVY group reported reproductive tract adverse events than in the placebo group (13.0% versus 9.4%). Seventeen HIV seroconversions occurred; eight in participants randomized to SAVVY and nine in participants receiving placebo. The Kaplan-Meier estimates of the cumulative probability of HIV infection through 12 months were 0.010 in the SAVVY group and 0.011 in the placebo group (p = 0.731), with a hazard ratio (SAVVY versus placebo) of 0.88 (95% confidence interval 0.33, 2.27). Because of a lower-than-expected HIV incidence, we were unable to achieve the required number of HIV infections (66) to obtain the desired study power.Conclusions/SignificanceSAVVY was not associated with increased adverse events overall, but was associated with higher reporting of reproductive adverse events. Our data are insufficient to conclude whether SAVVY is effective at preventing HIV infection relative to placebo.Trial RegistrationClinicalTrials.gov NCT00129532

Objective To test the accuracy of five practical depression screening strategies in older adults residing in residential care/assisted living (RC/AL). Design Cross-sectional screening study. Setting Four RC/AL communities in North Carolina. Participants 112 residents aged ≥ 65 and 27 staff members involved in their care. Measurements Direct care staff was trained in and completed the Cornell Scale for Depression in Dementia, modified for use by long-term care staff (CSDD-M-LTCS). They additionally responded to a one-item question ‘Do you believe the resident is often sad or depressed?,’ and the Minimum Data Set Depression Rating Scale (DRS). Residents responded directly to the Geriatric Depression Scale (15-item version; GDS-15) and the Personal Health Questionnaire, 2-item version (PHQ-2). A geriatric psychiatrist performed gold standard diagnostic interviews using the Structured Clinical Interview for DSM-IV. Sensitivities and specificities were calculated for all instruments at pre-determined cutpoints. Results Gold standard diagnoses yielded 14% prevalence of major or minor depression. The CSDD-M-LTCS and one-item screen completed by caregivers failed to significantly discriminate depressed cases. The DRS yielded high specificity (0.85), but low sensitivity (0.47). For the two resident reported measures, the PHQ-2 had a sensitivity of 0.80 and specificity of 0.71, and the GDS-15, 0.60 and 0.75 respectively. Conclusion Measures completed by caregivers failed to adequately detect depression. Of the measures completed directly by residents, the PHQ-2 appears to have the best mix of brevity, sensitivity, and ease of administration.

Background & Aims Endoscopic findings have been used to support a diagnosis of eosinophilic esophagitis (EoE) and to assess response to therapy, but their reliability is unknown. The aim of the study was to assess inter- and intra-observer reliability of endoscopic findings with white-light endoscopy and to assess changes in inter-observer reliability when narrow band imaging (NBI) was added to white light. Methods We collected data from 35 academic and 42 community adult gastroenterologists using 2 self-administered, online assessments of endoscopic images in patients with suspected EoE. First, gastroenterologists evaluated 35-single white light images. Next, they examined 35-paired images of the initial white-light image and its NBI counterpart. To assess intra-observer reliability, a second survey, to re-examine the single white light images, was performed ≥2 weeks later. Agreement was determined by calculating κ values for multiple observers. Results Among all gastroenterologists, inter-observer agreement was fair to good when white light was used to identify rings (κ = 0.56) and furrows (κ = 0.48). Inter-observer agreement was poor for identification of plaques (κ = 0.29) and for images with no findings (κ = 0.34). Levels of agreement did not change in an analysis stratified by practice setting or patient volume. Agreement did not improve when NBI images were added to white light images. Levels of intra-observer agreement varied greatly and in some cases were not greater than those expected by chance. Conclusions Using white-light endoscopy and NBI to analyze EoE, gastroenterologists identified rings and furrows with fair to good reliability, but did not reliably identify plaques or normal images. Intra-observer agreement varied. Endoscopic findings might not be reliable for supporting a diagnosis of EoE or for making treatment decisions.