Effect of Cryotherapy vs Loop Electrosurgical Excision Procedure on Cervical Disease Recurrence Among Women With HIV and High-Grade Cervical Lesions in Kenya: A Randomized Clinical Trial.

Importance: The World Health Organization recommends cryotherapy or loop electrosurgical excision procedure (LEEP) for histologically confirmed cervical intraepithelial neoplasia (CIN) grade 2 or higher regardless of HIV status. Cryotherapy is more feasible in resource-limited settings but may be less effective for women living with HIV. Objective: To evaluate whether cryotherapy or LEEP is a more effective treatment for high-grade cervical lesions among women with HIV. Design, Setting, and Participants: Single-center randomized trial conducted among women with HIV and CIN grade 2 or 3. From June 2011 to September 2016, women with HIV in Kenya underwent cervical screening with Papanicolaou testing and confirmatory biopsy. The final date on which a study procedure was administered was September 7, 2016. Interventions: Women with HIV infection and CIN grade 2 or 3 were randomized 1:1 to receive cryotherapy (n = 200) or LEEP (n = 200) and were followed up every 6 months for 24 months with a Papanicolaou test and confirmatory biopsy. Main Outcome and Measures: The primary outcome was disease recurrence, defined as CIN grade 2 or higher on cervical biopsy, during the 24-month follow-up period. Results: Among 400 women who were randomized (median age, 37.4 [interquartile range, 31.9-43.8] years), 339 (85%) completed the trial. Over 2 years, 60 women (30%) randomized to cryotherapy had recurrent CIN grade 2 or higher vs 37 (19%) in the LEEP group (relative risk, 1.71 [95% CI, 1.12-2.65]; risk difference, 7.9% [95% CI, 1.9%-14.0%]; P = .01). Adverse events occurred in 40 women (45 events, including change in pathology and death due to other causes) in the cryotherapy group and in 30 women (38 events, including change in pathology and unrelated gynecological complications) in the LEEP group. Conclusions and Relevance: In this single-center study of women with HIV infection and CIN grade 2 or 3, treatment with LEEP compared with cryotherapy resulted in a significantly lower rate of cervical neoplasia recurrence over 24 months. Cost-effectiveness analysis is necessary to determine whether the additional benefit of LEEP represents an efficient use of the additional resources that would be required. Trial Registration: ClinicalTrials.gov Identifier: NCT01298596.

Increased Cervical Human Immunodeficiency Virus (HIV) RNA Shedding Among HIV-Infected Women Randomized to Loop Electrosurgical Excision Procedure Compared to Cryotherapy for Cervical Intraepithelial Neoplasia 2/3.

Background: Treatment of human immunodeficiency virus (HIV)-infected women to prevent cervical cancer may stimulate HIV RNA cervical shedding and risk HIV transmission. Methods: From 2011 to 2014, 400 HIV-infected women diagnosed with cervical intraepithelial neoplasia 2/3 in Kenya were randomized to loop electrosurgical excision procedure (LEEP) or cryotherapy. Cervical samples were collected at baseline and 3 weekly intervals. Samples were tested for HIV RNA using the Gen-Probe Aptima HIV assay with a minimum detection level of 60 copies/swab and analyzed using generalized estimating equations. Results: Women who received LEEP had significantly higher cervical HIV RNA levels than those who received cryotherapy at weeks 2 (adjusted incident rate ratio [aIRR], 1.07; P = .038) and 3 (aIRR, 1.08; P = .046). Within LEEP, significantly higher cervical shedding was found at weeks 2 (2.03 log10 copies/swab; P < .001) and 3 (2.04 log10 copies/swab; P < .001) compared to baseline (1.80 log10 copies/swab). Cervical HIV RNA was significantly higher following LEEP for up to 3 weeks among women on antiretroviral treatment (ART) (0.18 log10 copies/swab increase; P = .003) and in ART-naive women (1.13 log10 copies/swab increase; P < .001) compared to baseline. Within cryotherapy, cervical shedding increased in ART-naive women (0.72 log10 copies/swab increase; P = 0.004) but did not increase in women on ART. Conclusions: Women randomized to LEEP had a larger increase in post-procedural cervical HIV shedding than cryotherapy. Benefits of cervical cancer prevention outweigh the risk of HIV sexual transmission; our findings underscore the importance of risk-reduction counseling. Clinical Trials Registration: NCT01298596.

Emergency department utilization among recently released prisoners: a retrospective cohort study.

BACKGROUND: The population of ex-prisoners returning to their communities is large. Morbidity and mortality is increased during the period following release. Understanding utilization of emergency services by this population may inform interventions to reduce adverse outcomes. We examined Emergency Department utilization among a cohort of recently released prisoners. METHODS: We linked Rhode Island Department of Corrections records with electronic health record data from a large hospital system from 2007 to 2009 to analyze emergency department utilization for mental health disorders, substance use disorders and ambulatory care sensitive conditions by ex-prisoners in the year after release from prison in comparison to the general population, controlling for patient- and community-level factors. RESULTS: There were 333,369 total ED visits with 5,145 visits by a cohort of 1,434 ex-prisoners. In this group, 455 ex-prisoners had 3 or more visits within 1 year of release and 354 had a first ED visit within 1 month of release. ED visits by ex-prisoners were more likely to be made by men (85% vs. 48%, p < 0.001) and by blacks (26% vs. 16%, p < 0.001) compared to the Rhode Island general population. Ex-prisoners were more likely to have an ED visit for a mental health disorder (6% vs. 4%, p < 0.001) or substance use disorder (16%vs. 4%, p < 0.001). After controlling for patient- and community-level factors, ex-prisoner visits were significantly more likely to be for mental health disorders (OR 1.43; 95% CI 1.27-1.61), substance use disorders (OR 1.93; 95% CI 1.77-2.11) and ambulatory care sensitive conditions (OR 1.09; 95% CI 1.00-1.18). CONCLUSIONS: ED visits by ex-prisoners were significantly more likely due to three conditions optimally managed in outpatient settings. Future work should determine whether greater access to outpatient services after release from prison reduces ex-prisoners' utilization of emergency services.

Community-associated methicillin-resistant Staphylococcus aureus skin and soft-tissue infection in HIV-infected patients.

BACKGROUND: Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) has emerged as the most common cause of skin and soft tissue infections (SSTIs). METHODS: Retrospective chart review of 43 adult HIV-infected patients with CA-MRSA SSTI was conducted. RESULTS: Antibiotic susceptibility was as follows: vancomycin (100%), rifampin (100%), gentamicin (97.7%), tetracycline (96.5%), trimethoprim-sulfamethoxazole (95.2%), clindamycin (89.5%), levofloxacin (66.7%), and erythromycin (6.9%). At SSTI presentation, 58.5% of patients had CD4 counts greater than 200 cells/uL, 82.9% had a viral load (VL) below 100 000 log copies/mL, 6 of whom had undetectable VL. All 43 patients received empiric antibiotic therapy. Additionally, 34 patients underwent incision and drainage (I&D). For the 37 patients with follow-up data available at 4 weeks, 30 of the infections were resolved/resolving and 7 had no improvement or worsened. CONCLUSION: A majority of our patients with CA-MRSA SSTI did not have immunological/virological markers consistent with severe HIV/AIDS disease at time of presentation.

Partner Disclosure and Early CD4 Response among HIV-Infected Adults Initiating Antiretroviral Treatment in Nairobi Kenya.

BACKGROUND: Disclosure of HIV serostatus can have significant benefits for people living with HIV/AIDS. However, there is limited data on whether partner disclosure influences ART treatment response. METHODS: We conducted a retrospective cohort study of newly diagnosed, ART-naïve HIV-infected adults (>18 years) who enrolled at the Coptic Hope Center in Nairobi, Kenya between January 1st 2009 and July 1st 2011 and initiated ART within 3 months. Analysis was restricted to adults who reported to have either disclosed or not disclosed their HIV status to their partner. Analysis of CD4 response at 6 and 12 months post-ART was stratified by age group. RESULTS: Among 615 adults newly initiating ART with partner disclosure data and 12 month follow-up, mean age was 38 years and 52% were male; 76% reported that they had disclosed their HIV-status to their partner. Those who disclosed were significantly younger and more likely to be married/cohabitating than non-disclosers. At baseline, median CD4 counts were similar between disclosure groups. Among younger adults (< 38 years) those who disclosed had higher CD4 recovery than those who did not at 6 months post- ART (mean difference = 31, 95% CI 3 to 58 p = 0.03) but not at 12 months (mean difference = 17, 95% CI -19 to 52, p = 0.4). Among older adults (≥ 38years) there was no observed difference in CD4 recovery at 6 or 12 months between disclosure groups. CONCLUSION: Among younger adults, disclosure of HIV status to partners may be associated with CD4 recovery following ART.

HIV Suppression among Patients on Treatment in Vietnam: A Review of HIV Viral Load Testing in a Public Urban Clinic in Ho Chi Minh City.

Background. There are few reports of HIV viral load (VL) testing among patients on ART in Vietnam. Methods. From a public clinic in Ho Chi Minh City (HCMC), we reviewed cases of VL measurements from adults on ART. Results. We identified 228 cases. Median age was 30 years (27-34), 85% were male, and 77% had a history of IDU. The mean ART duration was 26 months (95% CI 25-27); d4T/3TC/NVP was the most common regimen. Viral suppression was seen in 160/228 (70%). Viremia (>1000 copies/mL) was associated with prior ART exposure (OR 5.68, P < .0001) and immunologic failure (OR 4.69, P = .0001). Targeted testing accounted for 13% of cases, only half of which yielded viremia. Conclusion. We demonstrate a high HIV suppression rate among patients on ART in HCMC, Vietnam. In this setting, routine testing detects viremia missed by targeted testing.

Peripheral venous catheter-related Staphylococcus aureus bacteremia.

OBJECTIVE: Better understand the incidence, risk factors, and outcomes of peripheral venous catheter (PVC)-related Staphylococcus aureus bacteremia. DESIGN: Retrospective study of PVC-related S. aureus bacteremias in adult patients from July 2005 through March 2008. A point-prevalence survey was performed January 9, 2008, on adult inpatients to determine PVC utilization; patients with a PVC served as a cohort to assess risk factors for PVC-related S. aureus bacteremia. SETTING: Tertiary care teaching hospital. RESULTS: Twenty-four (18 definite and 6 probable) PVC-related S. aureus bacteremias were identified (estimated incidence density, 0.07 per 1,000 catheter-days), with a median duration of catheterization of 3 days (interquartile range, 2-6). Patients with PVC-related S. aureus bacteremia were significantly more likely to have a PVC in the antecubital fossa (odds ratio [OR], 6.5), a PVC placed in the emergency department (OR, 6.0), or a PVC placed at an outside hospital (P = .005), with a longer duration of catheterization (P < .001). These PVCs were significantly less likely to have been inserted in the hand (OR, 0.23) or placed on an inpatient medical unit (OR, 0.17). Mean duration of antibiotic treatment was 19 days (95% confidence interval, 15-23 days); 42% (10/24) of cases encountered complications. We estimate that there may be as many as 10,028 PVC-related S. aureus bacteremias yearly in US adult hospitalized inpatients. CONCLUSION: PVC-related S. aureus bacteremia is an underrecognized complication. PVCs inserted in the emergency department or at outside institutions, PVCs placed in the antecubital fossa, and those with prolonged dwell times are associated with such infections.