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An adherence-focused case management intervention was evaluated in 84 public clinic patients in Los Angeles County, California, and included weekly contact with a paraprofessional case manager development of an individualized highly-active antiretroviral therapy (HAART) adherence support plan, and referrals to ancillary services. Participants were primarily Latino (65%) or African American (25%); male (74%); monolingual Spanish-speakers (57%) with annual incomes under $10,000 (65%). Participants were in the intervention for a median of 26 weeks; attended 67% of appointments; participated in an average of 9 hours of case management; and each visit averaged 23 minutes. Seventy-two percent of the goals established at baseline were achieved and 74% of referrals were completed. The most common goals were related to adherence (16%), housing (12%), or nutrition (12%). Self-reported adherence to HAART was no different for intervention participants compared to those in standard case management at 6 months. These data suggest that an adherence-focused case management program was effective in achieving established goals and referrals. In addition, the existing provider and standard case management adherence support appears sufficient to sustain adherence in this public clinic population. [ABSTRACT FROM AUTHOR]

Supervised dosing is a cornerstone of tuberculosis treatment. HIV treatment strategies that use directly administered antiretroviral therapy (DAART) are increasingly being assessed. In a prospective single-arm clinical trial, we enrolled methadone-maintained, HIV-infected participants to receive supervised doses of antiretroviral therapy (ART) on days when they received methadone. Other ART doses were self-administered. In this analysis we examined factors associated with retention to DAART, adherence to supervised doses, and virologic failure. Factors associated with retention to DAART were assessed with the Kaplan-Meier method and Cox proportional hazards models. Factors associated with nonadherence with supervised dosing and with virologic failure were assessed by logistic regression and techniques for longitudinal data analysis. A total of 16,453 supervised doses were administered to 88 participants over a median follow-up of 9.4 months. The median participant adherence with supervised dosing was 83%. Active drug use, determined by urine drug screens, was associated twofold increased risks of both intervention dropout and nonadherence with supervised doses. Adherence with supervised doses was strongly associated with virologic failure. Because DAART was administered only on methadone dosing days, fewer than half of the total ART doses were scheduled to be supervised in most participants. The percent of doses that was scheduled to be supervised was not associated with either adherence or with virologic failure. Given that a relatively small proportion of the total ART doses were supervised in many patients, future studies should assess how DAART affects adherence with nonsupervised doses and retention to ART. [ABSTRACT FROM AUTHOR]

Coadministration of didanosine (ddI) and tenofovir (TDF) results in increased ddI serum concentrations, which may lead to increased risk of ddI-associated toxicities. To evaluate the safety and tolerability of ddI/TDF, we performed a retrospective cohort analysis of patients seen in the HIV Outpatient Study, an ongoing dynamic cohort study of HIV-infected persons in clinical care. Study subjects were those who received at least 14 days of combined ddI/TDF before October 2003. Of 260 subjects who received ddI/TDF-based antiretroviral therapy, 155 (60%) received high-dose ddI (400 mg daily dose) and 105 (40%) received low-dose ddI (100-250 mg daily). Forty-two of the high-dose ddI recipients were later switched to low-dose ddI. The median time of observation for those on high-dose ddI only was 5 months, high-dose ddI switched to low-dose ddI was 16 months, and low-dose ddI only was 5 months (p < 0.05). Discontinuations because of toxicity were more frequent on high-dose ddI regimens (34/155, 22%) than on low-dose ddI regimens (9/105, 9%) (unadjusted odds ratio [OR(unadj)] 3.0, 95% confidence interval [95% CI] 1.30-7.09; p = 0.007). Among subjects without preexisting peripheral neuropathy, 12 (12%) of 101 subjects ever on high-dose ddI regimens had treatment-emergent peripheral neuropathy compared to 2 (4%) of 55 subjects on low-dose ddI regimens (OR(unadj) 3.57; 95% CI, 0.72-24.1; p = 0.14). Among patients without a history of pancreatitis, 6 (4%) of 153 subjects developed pancreatitis after starting high-dose ddI regimens, compared to none of the 103 subjects on low-dose ddI regimens (OR(adj) and 95% CIs undefined; p = 0.08). Severe laboratory abnormalities of creatinine, phosphorous, and bicarbonate were not different between the groups. A summary variable for any event--discontinuation for toxicity, treatment- emergent adverse event or abnormal laboratory values--indicated that 44 (28%) of 155 of those on high-dose ddI versus 13 (12%) of 105 on low-dose ddI developed any event (OR(unadj) 2.81; 95% CI, 1.36-5.86; p = 0.004). In conclusion, high-dose ddI/TDF-based therapy was more frequently associated with drug-related toxicity, adverse events, and treatment discontinuation than low-dose ddI/TDF regimens; low-dose ddI with TDF was generally well tolerated in these HIV-infected persons. [ABSTRACT FROM AUTHOR]

The study was performed to compare the efficacy and side effects of azathioprine (AZA) and mycophenolate mofetil (MMF) in conjunction with cyclosporine or tacrolimus and steroids for the prevention of acute pancreas rejection during the first 6 months of pancreas transplantation. In this case-controlled study, MMF is compared with historical controls of AZA in the prevention of acute pancreas rejection. The primary measures of treatment efficacy were patient and pancreas survival rate at 6 months after transplantation. Secondary efficacy measures were the occurrence of biopsy-proven pancreas rejections and the use of antilymphocyte preparations for rejection treatment. A total of 111 pancreas transplant patients (57 in the AZA group and 54 in the MMF group) were evaluated. The 6-month patient survival rate was 96% in the AZA group versus 97% in the MMF group (p = 0.57). The 6-month pancreas graft survival rate was 88% in the AZA group versus 91% in the MMF group (p = 0.29). However, biopsy-proven rejection episodes during the first 6 months of transplantation were significantly lower with MMF (46%) than with AZA (69%) (p = 0.01). In addition, patients in the AZA group received a greater number of full courses of antilymphocyte therapy as a rejection treatment (p = 0.004). Overall, the frequency of adverse events was similar, although the MMF group experienced higher incidences of gastrointestinal adverse events. In conclusion, compared with AZA, MMF significantly reduces the rate of biopsy-proven pancreas rejection during the first 6 months of transplantation and is well tolerated, except for gastrointestinal adverse events. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV)-associated immunosuppression may increase the risk of hospitalization with mpox. Among persons diagnosed with mpox in the state of Georgia, we characterized the association between hospitalization with mpox and HIV status. People with HIV and a CD4 count <350 cells/mm3 or who were not engaged in HIV care had an increased risk of hospitalization., Competing Interests: Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)

Since May 2022, mpox has been identified in 108 countries without endemic disease; most cases have been in gay, bisexual, or other men who have sex with men. To determine number of missed cases, we conducted 2 studies during June-September 2022: a prospective serologic survey detecting orthopoxvirus antibodies among men who have sex with men in San Francisco, California, and a retrospective monkeypox virus PCR testing of swab specimens submitted for other infectious disease testing among all patients across the United States. The serosurvey of 225 participants (median age 34 years) detected 18 (8.0%) who were orthopoxvirus IgG positive and 3 (1.3%) who were also orthopoxvirus IgM positive. The retrospective PCR study of 1,196 patients (median age 30 years; 54.8% male) detected 67 (5.6%) specimens positive for monkeypox virus. There are likely few undiagnosed cases of mpox in regions where sexual healthcare is accessible and patient and clinician awareness about mpox is increased.

We assessed mpox virus prevalence in blood, pharyngeal, and rectal specimens among persons without characteristic rash presenting for JYNNEOS vaccine. Our data indicate that the utility of risk-based screening for mpox in persons without skin lesions or rash via pharyngeal swabs, rectal swabs, and/or blood is likely limited., Competing Interests: Potential conflicts of interest . The authors received no specific funding for this work. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)

Objectives. To examine the potential impact of contact tracing to identify contacts and prevent mpox transmission among gay, bisexual, and other men who have sex with men (MSM) as the outbreak expanded. Methods. We assessed contact tracing outcomes from 10 US jurisdictions before and after access to the mpox vaccine was expanded from postexposure prophylaxis for persons with known exposure to include persons at high risk for acquisition (May 17-June 30, 2022, and July 1-31, 2022, respectively). Results. Overall, 1986 mpox cases were reported in MSM from included jurisdictions (240 before expanded vaccine access; 1746 after expanded vaccine access). Most MSM with mpox were interviewed (95.0% before vaccine expansion and 97.0% after vaccine expansion); the proportion who named at least 1 contact decreased during the 2 time periods (74.6% to 38.9%). Conclusions. During the period when mpox cases among MSM increased and vaccine access expanded, contact tracing became less efficient at identifying exposed contacts. Public Health Implications. Contact tracing was more effective at identifying persons exposed to mpox in MSM sexual and social networks when case numbers were low, and it could be used to facilitate vaccine access. ( Am J Public Health . 2023;113(7):815-818. https://doi.org/10.2105/AJPH.2023.307301).

Background: A collaborative, data-to-care strategy to identify persons with HIV (PWH) newly out-of-care, combined with an active public health intervention, significantly increases the proportion of PWH re-engaged in HIV care. We assessed this strategy's impact on durable viral suppression (DVS)., Methods: A multisite, prospective randomized controlled trial for out-of-care individuals using a data-to-care strategy and comparing public health field services to locate, contact, and facilitate access to care versus the standard of care. DVS was defined as the last viral load, the viral load at least 3 months before, and any viral load between the 2 were all <200 copies/mL during the 18-month postrandomization. Alternative definitions of DVS were also analyzed., Results: Between August 1, 2016-July 31, 2018, 1893 participants were randomized from Connecticut (n = 654), Massachusetts (n = 630), and Philadelphia (n = 609). Rates of achieving DVS were similar in the intervention and standard-of-care arms in all jurisdictions (all sites: 43.4% vs 42.4%, P = 0.67; Connecticut: 46.7% vs 45.0%, P = 0.67; Massachusetts: 40.7 vs 44.4%, P = 0.35; Philadelphia: 42.4% vs 37.3%, P = 0.20). There was no association between DVS and the intervention (RR: 1.01, CI: 0.91-1.12; P = 0.85) adjusting for site, age categories, race/ethnicity, birth sex, CD4 categories, and exposure categories., Conclusion: A collaborative, data-to-care strategy, and active public health intervention did not increase the proportion of PWH achieving DVS, suggesting additional support to promote retention in care and antiretroviral adherence may be needed. Initial linkage and engagement services, through data-to-care or other means, are likely necessary but insufficient for achieving DVS for all PWH., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Monkeypox (mpox) cases in the 2022 outbreak have primarily occurred among adult gay, bisexual, and other men who have sex with men (MSM); however, other populations have also been affected (1). To date, data on mpox in cisgender women and pregnant persons have been limited. Understanding transmission in these populations is critical for mpox prevention. In addition, among pregnant persons, Monkeypox virus can be transmitted to the fetus during pregnancy or to the neonate through close contact during or after birth (2-5). Adverse pregnancy outcomes, including spontaneous abortion and stillbirth, have been reported in previous mpox outbreaks (3). During May 11-November 7, 2022, CDC and U.S. jurisdictional health departments identified mpox in 769 cisgender women aged ≥15 years, representing 2.7% of all reported mpox cases. † Among cases with available data, 44% occurred in cisgender women who were non-Hispanic Black or African American (Black), 25% who were non-Hispanic White (White), and 23% who were Hispanic or Latino (Hispanic). Among cisgender women with available data, 73% reported sexual activity or close intimate contact as the likely route of exposure, with mpox lesions most frequently reported on the legs, arms, and genitals. Twenty-three mpox cases were reported in persons who were pregnant or recently pregnant § ; all identified as cisgender women based on the mpox case report form. ¶ Four pregnant persons required hospitalization for mpox. Eleven pregnant persons received tecovirimat, and no adverse reactions were reported. Continued studies on mpox transmission risks in populations less commonly affected during the outbreak, including cisgender women and pregnant persons, are important to assess and understand the impact of mpox on sexual, reproductive, and overall health., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

Introduction: Data-to-care programmes utilize surveillance data to identify persons who are out of HIV care, re-engage them in care and improve HIV care outcomes. We assess the costs and cost-effectiveness of re-engagement in an HIV care intervention in the United States., Methods: The Cooperative Re-engagement Control Trial (CoRECT) employed a data-to-care collaborative model between health departments and HIV care providers, August 2016-July 2018. The health departments in Connecticut (CT), Massachusetts (MA) and Philadelphia (PHL) collaborated with HIV clinics to identify newly out-of-care patients and randomize them to receive usual linkage and engagement in care services (standard-of-care control arm) or health department-initiated active re-engagement services (intervention arm). We used a microcosting approach to identify the activities and resources involved in the CoRECT intervention, separate from the standard-of-care, and quantified the costs. The cost data were collected at the start-up and recurrent phases of the trial to incorporate potential variation in the intervention costs. The costs were estimated from the healthcare provider perspective., Results: The CoRECT trial in CT, MA and PHL randomly assigned on average 327, 316 and 305 participants per year either to the intervention arm (n = 166, 159 and 155) or the standard-of-care arm (n = 161, 157 and 150), respectively. Of those randomized, the number of participants re-engaged in care within 90 days in the intervention and standard-of-care arms was 85 and 70 in CT, 84 and 70 in MA, and 98 and 67 in PHL. The additional number of participants re-engaged in care in the intervention arm compared with those in the standard-of-care arm was 15 (CT), 14 (MA) and 31 (PHL). We estimated the annual total cost of the CoRECT intervention at $490,040 in CT, $473,297 in MA and $439,237 in PHL. The average cost per participant enrolled was $2952, $2977 and $2834 and the average cost per participant re-engaged in care was $5765, $5634 and $4482. We estimated an incremental cost per participant re-engaged in care at $32,669 (CT), $33,807 (MA) and $14,169 (PHL)., Conclusions: The costs of the CoRECT intervention that identified newly out-of-care patients and re-engaged them in HIV care are comparable with other similar interventions, suggesting a potential for its cost-effectiveness in the US context., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: Pharmacy-based HIV and hepatitis C virus (HCV) screening services developed in conjunction with state and local health departments can improve public health through increased access to testing and a linkage-to-care strategy. The objective of this study was to evaluate the impact of implementing HIV and HCV screening in community pharmacies., Methods: This prospective, multicenter implementation project was conducted from July 2015 through August 2018. Sixty-one pharmacies participated in 3 US regions. We assessed the effectiveness of point-of-care testing, counseling, and disease education for populations at increased risk for HIV and HCV infection through screening programs offered in community pharmacies. Pharmacy customers were offered screening with point-of-care HIV and/or HCV tests. Reactive test results were reported to state or local health departments for disease surveillance., Results: A total of 1,164 patients were screened for HIV, HCV, or both at the 61 participating pharmacies; the average number of patients screened per pharmacy was 19. Pharmacists conducted 1,479 HIV or HCV tests among the 1,164 patients. Five of 612 (0.8%) HIV tests yielded a reactive result, and 181 of 867 (20.9%) of HCV tests yielded a reactive result., Conclusion: Patients at increased risk of HIV or HCV can benefit from screening for infection at community pharmacies. Ease of accessibility to testing coupled with a strategy for linkage to care designed for the local community can improve patient care and improve the course of treatment for HIV and HCV.

Upon request from tribal nations, and as part of the Centers for Disease Control and Prevention's (CDC's) emergency response, CDC staff provided both remote and on-site assistance to tribes to plan, prepare, and respond to the COVID-19 pandemic. From April 2, 2020, through June 11, 2021, CDC deployed a total of 275 staff to assist 29 tribal nations. CDC staff typically collaborated in multiple work areas including epidemiology and surveillance (86%), contact tracing (76%), infection prevention control (72%), community mitigation (72%), health communication (66%), incident command structure (55%), emergency preparedness (38%), and worker safety (31%). We describe the activities of CDC staff in collaboration with 4 tribal nations, Northern Cheyenne, Hoopa Valley, Shoshone-Bannock, and Oglala Sioux Tribe, to combat COVID-19 and lessons learned from the engagement.

The Centers for Disease Control and Prevention (CDC) and state, territorial, and local health departments have expanded efforts to detect and respond to HIV clusters and outbreaks in the United States. In July 2017, CDC created the HIV Outbreak Coordination Unit (OCU) to ensure consistent and collaborative assessment of requests from health departments for consultation or support on possible HIV clusters and outbreaks of elevated concern. The HIV OCU is a multidisciplinary, cross-organization functional unit within CDC's Division of HIV/AIDS Prevention. HIV OCU members have expertise in areas such as outbreak detection and investigation, prevention, laboratory services, surveillance and epidemiology, policy, communication, and operations. HIV OCU discussions facilitate problem solving, coordination, and situational awareness. Between HIV OCU meetings, designated CDC staff members communicate regularly with health departments to provide support and assessment. During July 2017-December 2019, the HIV OCU reviewed 31 possible HIV clusters and outbreaks (ie, events) in 22 states that were detected by CDC, health departments, or local partners; 17 events involved HIV transmission associated with injection drug use, and other events typically involved sexual transmission or overall increases in HIV diagnoses. CDC supported health departments remotely or on site with planning and prioritization; data collection, management, and analysis; communications; laboratory support; multistate coordination; and expansion of HIV prevention services. The HIV OCU has augmented CDC's support of HIV cluster and outbreak assessment and response at health departments and had important internal organizational benefits. Health departments may benefit from developing or strengthening similar units to coordinate detection and response efforts within and across public health agencies and advance the national Ending the HIV Epidemic initiative.

Objectives: Retention in care is a critical component of effective HIV treatment, and adolescents and young adults are at higher risk of inadequate retention than older adults. The objective of our study was to examine the patterns of retention in care among adolescents and young adults with HIV infection by analyzing Medicaid and commercial health insurance claims data., Methods: We evaluated retention in care for HIV-diagnosed adolescents and young adults aged 13-24 using the 2010-2014 MarketScan Medicaid and MarketScan Commercial Claims health insurance databases. The study period extended 36 months from the date of the first claim with a code for HIV or AIDS. We determined the unweighted proportion retained in care for the Medicaid and Commercial Claims cohorts for months 0-24 and 25-36. We assessed associations between demographic characteristics and retention in care using logistic regression., Results: A total of 378 adolescents and young adults were in the Medicaid cohort and 1028 in the Commercial Claims cohort. In the Medicaid and Commercial Claims cohorts, respectively, 186 (49%) and 591 (57%) adolescents and young adults were retained in care during months 0-24. In the Medicaid cohort, 113 (73%) people retained in care and 69 (45%) people not retained in care during months 0-24 were retained in care during months 25-36. In the Commercial Claims cohort, 313 (77%) and 94 (31%) retained and not retained people, respectively, were found to be in care during months 25-36., Conclusions: Notable proportions of HIV-diagnosed adolescents and young adults are not adequately retained in care; public health interventions tailored to this population are needed.

Background: Persons with HIV (PWH), aware of their HIV infection but not in care account for an estimated 42.6% of HIV transmissions in the United States. Health departments and clinics implemented a collaborative data-to-care strategy to identify persons newly out-of-care with the objective of increasing re-engagement, retention in medical care, and viral load suppression., Methods: A multi-site, prospective randomised trial was conducted to identify newly out-of-care PWH using surveillance and clinic data in Connecticut (CT), Massachusetts (MA) and Philadelphia (PHL). All out-of-care participants were randomised to receive standard of care or an active public health intervention. Re-engagement in care was defined as having a documented CD4 count and/or HIV viral load within 90 days of randomization. Retention was defined as having at least two CD4 count and/or HIV viral load results ≥ 3 months apart within 12 months of randomization, and viral load suppression as having a viral load < 200 copies/ml within 12 months of randomization., Findings: Between August 2016 and July 2018, 1893 out-of-care participants were randomised from CT ( N  = 654), MA ( N  = 630), and PHL ( N  = 609). Participants were male (69.5%), non-Hispanic Black (48.3%) and men who have sex with men (38.8%). Re -engagement within 90 days was significantly higher for the intervention group overall and in all three jurisdictions (All sites: 54.9% vs 42.1%, p  < 0.0001; CT: 51.2% vs 41.9%, p  = 0.02; MA: 52.7% vs 44.1%, p  = 0.03; PHL 61.2% vs 40.3%, p  < 0.0001). Retention in care over 12 months improved overall ( p  = 0.04). Median time to viral suppression was reduced overall ( p  = 0.0006); CT ( p  = 0.32), MA ( p  = 0.02) and PHL ( p  < 0.0001)., Interpretation: This trial showed that a collaborative, data-to-care strategy, and active public health intervention led by health departments significantly increases the proportion of PWH re-engaged in HIV care and may improve retention in care and decrease time to viral suppression., Competing Interests: As an academic principal investigator on several funded projects, Dr. Altice receives support from Merck Sharp & Dohme, Gilead, National Institutes of Health, National Institute on Drug Abuse, Fogarty International Center, Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration.

The Patient-centered HIV Care Model (PCHCM) integrated community-based pharmacists with medical providers and required sharing of patient clinical information and collaborative therapy-related action planning. We determined the proportions of participants with HIV and mental health conditions who were retained in care and the proportion virally suppressed, pre- and post-implementation. Overall, we found a relative 13% improvement in both retention [60% to 68% (p = 0.009)] and viral suppression [79% to 90% (p < 0.001)]. Notable improvements were seen among persons triply diagnosed with HIV, mental illness and substance use [+ 36% (50% to 68%, p = 0.036) and + 32% (66% to 86%, p = 0.001) in retention and viral suppression, respectively]. There were no differences in the proportions of persons adherent to psychiatric medications, pre- to post-implementation, nor were there differences in the proportions of persons retained in care or virally suppressed by psychiatric medication adherence, post-implementation. PCHCM demonstrated that collaborations between community-based pharmacists and medical providers can improve HIV care continuum outcomes among persons with mental health conditions.

In 2019, President Trump announced a new initiative, Ending the HIV Epidemic: A Plan for America (EHE). EHE will use 3 key strategies-diagnose, treat, and prevent-to reduce new HIV infections at least 90% by 2030, as well as new laboratory methods and epidemiological techniques to respond quickly to potential outbreaks. Partnerships are an important component in the initiative's success. Pharmacists and pharmacies can play important roles in EHE, including dispensing antiretroviral therapy and providing HIV screening, adherence counseling, medication therapy management, preexposure prophylaxis, and nonprescription syringe sales. The objective of this report is to discuss potential roles that pharmacists and pharmacies can play under the key strategies of EHE.

Objectives: Hepatitis C virus (HCV) and HIV transmission in the United States may increase as a result of increasing rates of opioid use disorder (OUD) and associated injection drug use (IDU). Epidemiologic trends among American Indian/Alaska Native (AI/AN) persons are not well known., Methods: We analyzed 2010-2014 Indian Health Service data on health care encounters to assess regional and temporal trends in IDU indicators among adults aged ≥18 years. IDU indicators included acute or chronic HCV infection (only among adults aged 18-35 years), arm cellulitis and abscess, OUD, and opioid-related overdose. We calculated rates per 10 000 AI/AN adults for each IDU indicator overall and stratified by sex, age group, and region and evaluated rate ratios and trends by using Poisson regression analysis., Results: Rates of HCV infection among adults aged 18-35 increased 9.4% per year, and rates of OUD among all adults increased 13.3% per year from 2010 to 2014. The rate of HCV infection among young women was approximately 1.3 times that among young men. Rates of opioid-related overdose among adults aged <50 years were approximately 1.4 times the rates among adults aged ≥50 years. Among young adults with HCV infection, 25.6% had concurrent OUD. Among all adults with arm cellulitis and abscess, 5.6% had concurrent OUD., Conclusions: Rates of HCV infection and OUD increased significantly in the AI/AN population. Strengthened public health efforts could ensure that AI/AN communities can address increasing needs for culturally appropriate interventions, including comprehensive syringe services programs, medication-assisted treatment, and opioid-related overdose prevention and can meet the growing need for treatment of HCV infection.

Background: Human immunodeficiency virus (HIV) viral suppression (VS) decreases morbidity, mortality, and transmission risk., Methods: The Patient-centered HIV Care Model integrated community-based pharmacists with HIV medical providers and required them to share patient clinical information, identify therapy-related problems, and develop therapy-related action plans.Proportions adherent to antiretroviral therapy (proportion of days covered [PDC] ≥90%) and virally suppressed (HIV RNA <200 copies/mL), before and after model implementation, were compared. Factors associated with postimplementation VS were determined using multivariable logistic regression; participant demographics, baseline viral load, and PDC were explanatory variables. PDC was modified to account for time to last viral load in the year postimplementation, and stratified as <50%, 50% to <80%, 80% to <90%, and ≥90%., Results: The 765 enrolled participants were 43% non-Hispanic black, 73% male, with a median age of 48 years; 421 and 649 were included in the adherence and VS analyses, respectively. Overall, proportions adherent to therapy remained unchanged. However, VS improved a relative 15% (75% to 86%, P < .001). Higher PDC (adjusted odds ratio [AOR], 1.74 per 1-level increase in PDC category [95% confidence interval {CI}, 1.30-2.34]) and baseline VS (AOR, 7.69 [95% CI, 3.96-15.7]) were associated with postimplementation VS. Although non-Hispanic black persons (AOR, 0.29 [95% CI, .12-.62]) had lower odds of suppression, VS improved a relative 23% (63% to 78%, P < .001)., Conclusions: Integrated care models between community-based pharmacists and primary medical providers may identify and address HIV therapy-related problems and improve VS among persons with HIV., (Published by Oxford University Press for the Infectious Diseases Society of America 2019.)

A syringe services program (SSP) was established following the Indiana HIV outbreak among persons who inject drugs (PWID) in Scott County. Among Indiana-based PWID, we examined injection behaviors associated with HIV status, SSP use after its establishment, and changes in injection behaviors after the outbreak response. During 2016, we interviewed 200 PWID and assessed injection behaviors before the response by HIV status. We reported injection behaviors prior to the response and used Fisher's exact Chi square tests (P < 0.05) to assess differences by HIV status. Next, among persons who injected both before (July-December 2014) and after (past 30 days) the response, we (1) reported the proportion of persons who used the SSP to obtain sterile syringes, and assessed differences in SSP use by HIV status using Fisher's exact Chi square tests; and (2) compared distributive and receptive sharing of injection equipment and disposal of syringes before and after the outbreak response, and assessed statistical differences using McNemar's test. We also compared injection behaviors before and after the response by HIV status. Injecting extended release oxymorphone (Opana® ER); receptive sharing of syringes and cookers; and distributive sharing of cookers, filters, or water before the response were associated with HIV infection. SSP use was high (86%), particularly among HIV-positive compared with HIV-negative persons (98% vs. 84%). Injection equipment sharing decreased and safe disposal of used syringes increased after the response, especially among HIV-positive persons. Injection equipment sharing contributed to the outbreak. High SSP use following the response, particularly among HIV-positive persons, contributed to decreased high-risk injection practices.

Background: A benchmark of near-perfect adherence (≥95%) to antiretroviral therapy (ART) is often cited as necessary for HIV viral suppression. However, given newer, more effective ART medications, the threshold for viral suppression may be lower. We estimated the minimum ART adherence level necessary to achieve viral suppression., Settings: The Patient-centered HIV Care Model demonstration project., Methods: Adherence to ART was calculated using the proportion of days covered measure for the 365-day period before each viral load test result, and grouped into 5 categories (<50%, 50% to <80%, 80% to <85%, 85% to <90%, and ≥90%). Binomial regression analyses were conducted to determine factors associated with viral suppression (HIV RNA <200 copies/mL); demographics, proportion of days covered category, and ART regimen type were explanatory variables. Generalized estimating equations with an exchangeable working correlation matrix accounted for correlation within subjects. In addition, probit regression models were used to estimate adherence levels required to achieve viral suppression in 90% of HIV viral load tests., Results: The adjusted odds of viral suppression did not differ between persons with an adherence level of 80% to <85% or 85% to <90% and those with an adherence level of ≥90%. In addition, the overall estimated adherence level necessary to achieve viral suppression in 90% of viral load tests was 82% and varied by regimen type; integrase inhibitor- and nonnucleoside reverse transcriptase inhibitor-based regimens achieved 90% viral suppression with adherence levels of 75% and 78%, respectively., Conclusions: The ART adherence level necessary to reach HIV viral suppression may be lower than previously thought and may be regimen-dependent.

Background: Data to Care (D2C) is a strategy for using health departments' HIV surveillance data (HIV viral load and CD4 laboratory reports) to identify and re-engage not-in-care persons with HIV. In the current D2C model, there is a delay in the identification of persons not in care due to the time interval between recommended monitoring tests (ie, every 3-6 months) and the subsequent reporting of these tests to the health department., Methods: Pharmacy claims and fulfillment data can be used to identify persons with HIV who have stopped filling antiretroviral therapy and are at risk of falling out of care. Because most antiretrovirals (ARVs) are prescribed as a 30-day supply of medication, these data can be used to identify persons who are not filling their medications on a monthly basis. The use of pharmacy claims data to identify persons not filling ARV prescriptions is an example of how "big data" can be used to conduct a modified D2C model., Results: Although a D2C strategy using pharmacy data has not been broadly implemented, a few health departments are implementing demonstration projects using this strategy. As the projects progress, processes and outcomes can be evaluated., Conclusions: Tracking ARV refill data can be a more real-time indicator of poor adherence and can help identify HIV-infected persons at risk of falling out of HIV medical care.

Poor retention in HIV care is associated with higher morbidity and mortality and greater risk of HIV transmission. The Patient-Centered HIV Care Model (PCHCM) integrated community-based pharmacists with medical providers. The model required sharing of patient clinical information and collaborative therapy-related action planning. The proportion of persons retained in care (≥1 medical visit in each 6-month period of a 12-month measurement period with ≥60 days between visits), pre- and post-PCHCM implementation, was modeled using log binomial regression. Factors associated with post-implementation retention were determined using multi-variable regression. Of 765 enrolled persons, the plurality were male (n = 555) and non-Hispanic black (n = 331), with a median age of 48 years (interquartile range = 38-55); 680 and 625 persons were included in the pre- and post-implementation analyses, respectively. Overall, retention improved 12.9% (60.7-68.5%, p = 0.002). The largest improvement was seen among non-Hispanic black persons, 22.6% increase (59.7-73.2%, p < 0.001). Persons who were non-Hispanic black [adjusted risk ratio (ARR) 1.27, 95% confidence interval (CI) 1.08-1.48] received one or more pharmacist-clinic developed action plan (ARR 1.51, 95% CI 1.18-1.93), had three or more pharmacist encounters (ARR 1.17, 95% CI 1.05-1.30), were more likely to be retained post-implementation. In the final multi-variable models, only race/ethnicity [non-Hispanic black (ARR 1.27, 95% CI 1.09-1.48) and "other or unknown" race/ethnicity (ARR 1.36, 95% CI 1.14-1.63)] showed an association with post-implementation retention. PCHCM demonstrated how collaborations between community-based pharmacists and primary medical providers can improve retention in HIV care. This care model may be particularly useful for non-Hispanic black persons who often are less likely to be retained in care.

Background: Increased access to sterile syringes has been shown to reduce HIV risk among people who inject drugs (PWID). Where syringe services programs (SSPs) are limited, pharmacies are an important sterile syringe source. We assessed factors associated with using pharmacies as the primary source of syringes among PWID from 20 US cities., Methods: PWID ages ≥18 years were recruited for the 2015 National HIV Behavioral Surveillance using respondent-driven sampling. Using generalized estimating equation (GEE) models, we assessed demographic characteristics independently associated with participant-reported primary syringe source: pharmacies vs. SSPs. We calculated associations between primary syringe source and various behavioural outcomes, adjusted for participant characteristics., Results: PWID who were <30 years old, female, white, and less frequent injectors were more likely have used pharmacies as their primary syringe source. Accessing syringes primarily from pharmacies, as compared to SSPs, was associated with receptive syringe sharing and unsafe syringe disposal; using sterile syringes, recent HIV testing and participation in an HIV behavioural intervention were negatively associated with primary pharmacy use., Conclusions: Pharmacies can play an important role in comprehensive HIV prevention among PWID. Linkage to HIV interventions and syringe disposal services at pharmacies could strengthen prevention efforts for PWID who cannot access or choose not to utilize SSPs., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Competing Interests: Nivedha Panneer reports stock ownership in Gilead Sciences, outside the current work. No other conflicts of interest were reported.

Background: An incidence of perinatally acquired HIV infection less than 1:100,000 live births is one of the Centers for Disease Control and Prevention (CDC) goals of the United States. Such an estimate has only been possible in recent years because regular nationwide data were lacking., Method: Using previously published CDC estimates of the number of infants born with HIV infection in the United States (interpolating for years for which there was no published estimate), and census data on the annual number of live-born infants, estimated incidence was calculated for 1978-2013. Exact 95% confidence intervals (CIs) were calculated using the Poisson distribution., Results: Estimated incidence of perinatally acquired HIV infection peaked at 43.1 (95% CI: 41.1 to 45.1) in 1992 and declined rapidly after the use of zidovudine prophylaxis was recommended in 1994. In 2013, estimated incidence of perinatally acquired HIV infection in the United States was 1.8 (95% CI: 1.4 to 2.2), a 96% decline since the peak., Conclusion: Estimated incidence of perinatally acquired HIV infection in the United States in 2013 was 1.8/100,000 live births.

Adherence to prescribed medications is associated with improved clinical outcomes for chronic disease management and reduced mortality from chronic conditions (1). Conversely, nonadherence is associated with higher rates of hospital admissions, suboptimal health outcomes, increased morbidity and mortality, and increased health care costs (2). In the United States, 3.8 billion prescriptions are written annually (3). Approximately one in five new prescriptions are never filled, and among those filled, approximately 50% are taken incorrectly, particularly with regard to timing, dosage, frequency, and duration (4). Whereas rates of nonadherence across the United States have remained relatively stable, direct health care costs associated with nonadherence have grown to approximately $100-$300 billion of U.S. health care dollars spent annually (5,6). Improving medication adherence is a public health priority and could reduce the economic and health burdens of many diseases and chronic conditions (7).

In 2014, an estimated 2,477 children aged <13 years were living with diagnosed human immunodeficiency virus (HIV) infection in the United States (1). Nationally, little is known about how well children with a diagnosis of HIV infection are retained in medical care. CDC analyzed insurance claims data to evaluate retention in medical care for children in the United States with a diagnosis of HIV infection. Data sources were the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases. Children aged <13 years with a diagnosis of HIV infection in 2010 were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnostic billing codes for HIV or acquired immunodeficiency syndrome (AIDS), resulting in Medicaid and commercial claims cohorts of 163 and 129 children, respectively. Data for each child were evaluated during a 36-month study period, counted from the date of the first claim containing an ICD-9-CM code for HIV or AIDS. Each child's consistency of medical care was assessed by evaluating the frequency of medical visits during the first 24 months of the study period to see if the frequency of visits met the definition of retention in care. Frequency of medical visits was then assessed during an additional 12-month follow-up period to evaluate differences in medical care consistency between children who were retained or not retained in care during the initial 24-month period. During months 0-24, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care, among whom 93% (Medicaid) and 85% (commercial claims) were in care during months 25-36. To identify areas for additional public health action, further evaluation of the objectives for national medical care for children with diagnosed HIV infection is indicated.

Importance: Perinatal transmission of human immunodeficiency virus (HIV) can be reduced through services including antiretroviral treatment and prophylaxis. Data on the national incidence of perinatal HIV transmission and missed prevention opportunities are needed to monitor progress toward elimination of mother-to-child HIV transmission., Objective: To estimate the number of perinatal HIV cases among infants born in the United States., Design, Setting, and Participants: Data were obtained from the National HIV Surveillance System on infants with HIV born in the United States (including the District of Columbia) and their mothers between 2002 and 2013 (reported through December 31, 2015). Estimates were adjusted for delay in diagnosis and reporting by weighting each reported case based on a model incorporating time from birth to diagnosis and report. Analysis was performed from April 1 to August 15, 2016., Exposures: Maternal HIV infection and antiretroviral medication, including maternal receipt prenatally or during labor/delivery and infant receipt postnatally., Main Outcomes and Measures: Diagnosis of perinatally acquired HIV infection in infants born in the United States. Infant and maternal characteristics, including receipt of perinatal HIV testing, treatment, and prophylaxis., Results: The estimated annual number of perinatally infected infants born in the United States decreased from 216 (95% CI, 206-230) in 2002 to 69 (95% CI, 60-83) in 2013. Among perinatally HIV-infected children born in 2002-2013, 836 (63.0%) of the mothers identified as black or African American and 243 (18.3%) as Hispanic or Latino. A total of 236 (37.5%) of the mothers had HIV infection diagnosed before pregnancy in 2002-2005 compared with 120 (51.5%) in 2010-2013; the proportion of mother-infant pairs receiving all 3 recommended arms of antiretroviral prophylaxis or treatment (prenatal, intrapartum, and postnatal) was 22.4% in 2002-2005 and 31.8% in 2010-2013, with approximately 179 (28.4%) (2002-2005) and 94 (40.3%) (2010-2013) receiving antiretroviral prophylaxis or treatment during pregnancy. Five Southern states (Florida, Texas, Georgia, Louisiana, and Maryland) accounted for 687 (38.0%) of infants born with HIV infection in the United States during the overall period. According to national data for live births, the incidence of perinatal HIV infection among infants born in the United States in 2013 was 1.75 per 100 000 live births., Conclusions and Relevance: Despite reduced perinatal HIV infection in the United States, missed opportunities for prevention were common among infected infants and their mothers in recent years. As of 2013, the incidence of perinatal HIV infection remained 1.75 times the proposed Centers for Disease Control and Prevention elimination of mother-to-child HIV transmission goal of 1 per 100 000 live births.

Objectives: Using published, nationally-representative estimates, we calculated the total number of perinatally HIV-exposed and HIV-infected infants born during 1978-2010, the number of perinatal HIV cases prevented by interventions designed for the prevention of mother-to-child transmission (PMTCT), and the number of infants exposed to antiretroviral (ARV) drugs during the prenatal and intrapartum periods., Design: We calculated the number of infants exposed to ARV drugs since 1994, and the number of cases of mother-to-child HIV transmission prevented from 1994 to 2010 using published data. We generated confidence limits for our estimates by performing a simulation study., Methods: Data were obtained from published, nationally-representative estimates from the Centers for Disease Control and Prevention. Model parameters included the annual numbers of HIV-infected pregnant women, the annual numbers of perinatally infected infants, the annual proportions of infants exposed to ARV drugs during the prenatal and intrapartum period and the estimated MTCT rate in the absence of preventive interventions. For the simulation study, model parameters were assigned distributions and we performed 1,000,000 repetitions., Results: Between 1978 and 2010, an estimated 186,157 [95% confidence interval (CI): 185,312-187,003] HIV-exposed infants and approximately 21,003 (95% CI: 20,179-21,288) HIV-infected infants were born in the United States. Between 1994 and 2010, an estimated 124,342 (95% CI: 123,651-125,034) HIV-exposed infants were born in the US, and approximately 6083 (95% CI: 5931-6236) infants were perinatally infected with HIV. During this same period, about 100,207 (95% CI: 99,374-101,028) infants were prenatally exposed to ARV drugs. As a result of PMTCT interventions, an estimated 21,956 (95% CI: 20,191-23,759) MTCT HIV cases have been prevented in the United States since 1994., Conclusion: Although continued vigilance is needed to eliminate mother-to-child HIV transmission, PMTCT interventions have prevented nearly 22,000 cases of perinatal HIV transmission in the United States since 1994.

Background: In January 2015, a total of 11 new diagnoses of human immunodeficiency virus (HIV) infection were reported in a small community in Indiana. We investigated the extent and cause of the outbreak and implemented control measures., Methods: We identified an outbreak-related case as laboratory-confirmed HIV infection newly diagnosed after October 1, 2014, in a person who either resided in Scott County, Indiana, or was named by another case patient as a syringe-sharing or sexual partner. HIV polymerase (pol) sequences from case patients were phylogenetically analyzed, and potential risk factors associated with HIV infection were ascertained., Results: From November 18, 2014, to November 1, 2015, HIV infection was diagnosed in 181 case patients. Most of these patients (87.8%) reported having injected the extended-release formulation of the prescription opioid oxymorphone, and 92.3% were coinfected with hepatitis C virus. Among 159 case patients who had an HIV type 1 pol gene sequence, 157 (98.7%) had sequences that were highly related, as determined by phylogenetic analyses. Contact tracing investigations led to the identification of 536 persons who were named as contacts of case patients; 468 of these contacts (87.3%) were located, assessed for risk, tested for HIV, and, if infected, linked to care. The number of times a contact was named as a syringe-sharing partner by a case patient was significantly associated with the risk of HIV infection (adjusted risk ratio for each time named, 1.9; P<0.001). In response to this outbreak, a public health emergency was declared on March 26, 2015, and a syringe-service program in Indiana was established for the first time., Conclusions: Injection-drug use of extended-release oxymorphone within a network of persons who inject drugs in Indiana led to the introduction and rapid transmission of HIV. (Funded by the state government of Indiana and others.).

Background: K65R is a relatively rare drug resistance mutation (DRM) selected by the NRTIs tenofovir, didanosine, abacavir and stavudine and confers cross-resistance to all NRTIs except zidovudine. Selection by other NRTIs is uncommon., Objectives: In this study we investigated the frequency of emergence of the K65R mutation and factors associated with it in HIV-1-infected infants exposed to low doses of maternal lamivudine, zidovudine and either nevirapine or nelfinavir ingested through breast milk, using specimens collected from the Kisumu Breastfeeding Study., Methods: Plasma specimens with viral load ≥1000 copies/mL collected from HIV-infected infants at 0-1, 2, 6, 14, 24 and 36 weeks of age and maternal samples at delivery were tested for HIV drug resistance using Sanger sequencing of the polymerase gene. Factors associated with K65R emergence were assessed using Fisher's exact test and the Wilcoxon rank-sum test., Results: K65R was detected in samples from 6 of the 24 infants (25%) who acquired HIV-1 infection by the age of 6 months. K65R emerged in half of the infants by 6 weeks and in the rest by 14 weeks of age. None of the mothers at delivery or the infants with a positive genotype at first time of positivity had the K65R mutation. Infants with K65R had low baseline CD4 cell counts (P = 0.014), were more likely to have DRMs earlier (≤6 weeks versus ≥14 weeks, P = 0.007) and were more likely to have multiclass drug resistance (P = 0.035). M184V was the most common mutation associated with K65R emergence. K65R had reverted by 3 months after cessation of breastfeeding., Conclusions: A high rate of K65R emergence may suggest that ingesting low doses of lamivudine via breast milk could select for this mutation. The presence of this mutation may have a negative impact on future responses to NRTI-based ART. More in vitro studies are, however, needed to establish the molecular mechanism for this selection., (Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Following 42 days since the last Ebola virus disease (Ebola) patient was discharged from a Liberian Ebola treatment unit (ETU), September 3, 2015, marks the second time in a 4-month period that the World Health Organization (WHO) has declared Liberia free of Ebola virus transmission (1). The first confirmed Ebola cases in West Africa were identified in southeastern Guinea on March 23, 2014, and within 1 week, cases were identified and confirmed in Liberia (1). Since then, Liberia has reported 5,036 confirmed and probable Ebola cases and 4,808 Ebola-related deaths. The epidemic in Liberia peaked in late summer and early fall of 2014, when more than 200 confirmed and probable cases were reported each week .

Objective: To document the cost of implementing point-of-care (POC) human immunodeficiency virus (HIV) rapid testing in busy community pharmacies and retail clinics. Providing HIV testing services in community pharmacies and retail clinics is an innovative way to expand HIV testing. The cost of implementing POC HIV rapid testing in a busy retail environment needs to be documented to provide program and policy leaders with adequate information for planning and budgeting., Design: Cost analysis from a pilot project that provided confidential POC HIV rapid testing services in community pharmacies and retail clinics., Setting: The pharmacy sites were operated under several different ownership structures (for-profit, nonprofit, sole proprietorship, corporation, public, and private) in urban and rural areas. We included data from the initial six sites that participated in the project. We collected the time spent by pharmacy and retail clinic staff for pretest and posttest counseling in an activity log for time-in-motion for each interaction., Participants: Pharmacists and retail clinic staff., Intervention: HIV rapid testing., Main Outcome Measures: The total cost was calculated to include costs of test kits, control kits, shipping, test supplies, training, reporting, program administration, and advertising., Results: The six sites trained 22 staff to implement HIV testing. A total of 939 HIV rapid tests were conducted over a median time of 12 months, of which 17 were reactive. Median pretest counseling time was 2 minutes. Median posttest counseling time was 2 minutes for clients with a nonreactive test and 10 minutes for clients with a reactive test. The average cost per person tested was an estimated $47.21. When we considered only recurrent costs, the average cost per person tested was $32.17., Conclusions: Providing POC HIV rapid testing services required a modest amount of staff time and costs that are comparable to other services offered in these settings. HIV testing in pharmacies and retail clinics can provide an additional alternative venue for increasing the availability and accessibility of HIV testing services in the United States.

Blacks/Hispanics face limited access to HIV testing. We examined in-pharmacy HIV testing among customers in pharmacies participating in a nonprescription syringe program in New York City. Participants were recruited in two pharmacies to complete a survey and receive an optional HIV test. Bivariate and multivariable analyses were performed to examine associations of demographics and risk behaviors with receiving in-pharmacy HIV testing. Most participants were male (55%), black (80%), had used hard drugs (88%), and 39.5% received in-pharmacy HIV testing. Being female (AOR=2.24; 95%CI 1.24-4.05), having multiple sex partners (AOR=1.20; 95% CI 1.06-1.35), having an HIV test more than 12 months ago (AOS=4.06; CI 1.85-8.91), injecting drugs in last 3 months (AOR=2.73; 95% CI 1.31-5.69) and having continuous care (AOR=0.32; 95% CI 0.17-0.58) were associated with receiving in-pharmacy HIV test. These data provide evidence of in-pharmacy HIV testing reaching persons at risk of HIV. HIV testing in pharmacies may complement existing strategies.

On January 23, 2015, the Indiana State Department of Health (ISDH) began an ongoing investigation of an outbreak of human immunodeficiency virus (HIV) infection, after Indiana disease intervention specialists reported 11 confirmed HIV cases traced to a rural county in southeastern Indiana. Historically, fewer than five cases of HIV infection have been reported annually in this county. The majority of cases were in residents of the same community and were linked to syringe-sharing partners injecting the prescription opioid oxymorphone (a powerful oral semi-synthetic opioid analgesic). As of April 21, ISDH had diagnosed HIV infection in 135 persons (129 with confirmed HIV infection and six with preliminarily positive results from rapid HIV testing that were pending confirmatory testing) in a community of 4,200 persons.

Background: Absolute neutrophil counts (ANCs) are lower in East African adults. To assess the impact of lower ANCs, we reviewed data from HIV-infected Kenyan women receiving antiretroviral therapy antepartum and postpartum., Methods: The Kisumu Breastfeeding Study (KiBS) participants received an antiretroviral regimen from 34 weeks' gestation through 6 months postpartum. Measured ANCs and subsequent illnesses were reviewed. Adverse events (AEs) potentially attributable to neutropenia were identified, and ANCs were graded using the 2004 Division of AIDS table for Grading the Severity of AEs., Results: Among 478 women with ≥1 postpartum ANC measured, 298 (62.1%) women met criteria for an AE (<1.3 × 10(9) cells/L). Of those, 38 (12.5%) women experienced a nonlife-threatening illness potentially attributable to neutropenia., Conclusion: More than half of KiBS women met criteria for neutropenia. The mild clinical experience of most participants with low ANCs supports that these values might be typical for this population and may not result in adverse clinical sequelae., (© The Author(s) 2013.)

Objective: To test the feasibility of offering rapid point-of-care human immunodeficiency virus (HIV) testing at community pharmacies and retail clinics., Design: Pilot program to determine how to implement confidential HIV testing services in community pharmacies and retail clinics., Setting: 21 community pharmacies and retail clinics serving urban and rural patients in the United States, from August 2011 to July 2013., Participants: 106 community pharmacy and retail clinic staff members., Intervention: A model was developed to implement confidential HIV counseling and testing services using community pharmacy and retail clinic staff as certified testing providers, or through collaborations with organizations that provide HIV testing. Training materials were developed and sites selected that serve patients from urban and rural areas to pilot test the model. Each site established a relationship with its local health department for HIV testing policies, developed referral lists for confirmatory HIV testing/care, secured a CLIA Certificate of Waiver, and advertised the service. Staff were trained to perform a rapid point-of-care HIV test on oral fluid, and provide patients with confidential test results and information on HIV. Patients with a preliminary positive result were referred to a physician or health department for confirmatory testing and, if needed, HIV clinical care., Main Outcome Measures: Number of HIV tests completed and amount of time required to conduct testing., Results: The 21 participating sites administered 1,540 HIV tests, with 1,087 conducted onsite by staff during regular working hours and 453 conducted at 37 different HIV testing events (e.g., local health fairs). The median amount of time required for pretest counseling/consent, waiting for test results, and posttest counseling was 4, 23, and 3 minutes, respectively. A majority of the sites (17) said they planned to continue HIV testing after the project period ended and would seek assistance or support from the local health department, a community-based organization, or an AIDS service organization., Conclusion: This pilot project established HIV testing in several community pharmacies and retail clinics to be a feasible model for offering rapid, point-of-care HIV testing. It also demonstrated the willingness and ability of staff at community pharmacies and retail clinics to provide confidential HIV testing to patients. Expanding this model to additional sites and evaluating its feasibility and effectiveness may serve unmet needs in urban and rural settings.

Cryptococcal meningitis (CM) remains a significant HIV-associated opportunistic infection in Southeast Asia and Africa, with a high burden of disease and a high mortality rate despite the availability of antiretroviral therapy (ART). We retrospectively examined the utility of cryptococcal antigen screening to identify risk for CM among 211 Thai women initiating ART. Antigenemia prevalence was 11% (n = 9) among 84 women with a CD4 count <100 cells/mm(3). Screening identified all women who later developed CM. Cryptococcal antigen titers decreased over time with ART. Our study confirmed findings from previous studies in Thailand and South Africa and provided novel observational data regarding the course of cryptococcal antigenemia in patients initiating ART and the poor efficacy of low-dose fluconazole prophylaxis in preventing CM among patients with antigenemia., (© The Author(s) 2013.)

A systematic review was conducted to identify evidence-based interventions (EBIs) for increasing HIV medication adherence behavior or decreasing HIV viral load among persons living with HIV (PLWH). We conducted automated searches of electronic databases (i.e., MEDLINE, EMBASE, PsycINFO, CINAHL) and manual searches of journals, reference lists, and listservs. Interventions were eligible for the review if they were U.S.-based, published between 1996 and 2011, intended to improve HIV medication adherence behaviors of PLWH, evaluated the intervention using a comparison group, and reported outcome data on adherence behaviors or HIV viral load. Each intervention was evaluated on the quality of study design, implementation, analysis, and strength of findings. Of the 65 eligible interventions, 10 are EBIs. The remaining 55 interventions failed to meet the efficacy criteria primarily due to null findings, small sample sizes, or low retention rates. Research gaps and future directions for development of adherence EBIs are discussed.

High-throughput, sensitive, and cost-effective HIV drug resistance (HIVDR) detection assays are needed for large-scale monitoring of the emergence and transmission of HIVDR in resource-limited settings. Using suspension array technology, we have developed a multiplex allele-specific (MAS) assay that can simultaneously detect major HIVDR mutations at 20 loci. Forty-five allele-specific primers tagged with unique 24-base oligonucleotides at the 5' end were designed to detect wild-type and mutant alleles at the 20 loci of HIV-1 subtype C. The MAS assay was first established and optimized with three plasmid templates (C-wt, C-mut1, and C-mut2) and then evaluated using 148 plasma specimens from HIV-1 subtype C-infected individuals. All the wild-type and mutant alleles were unequivocally distinguished with plasmid templates, and the limits of detection were 1.56% for K219Q and K219E, 3.13% for L76V, 6.25% for K65R, K70R, L74V, L100I, K103N, K103R, Q151M, Y181C, and I47V, and 12.5% for M41L, K101P, K101E, V106A, V106M, Y115F, M184V, Y188L, G190A, V32I, I47A, I84V, and L90M. Analyses of 148 plasma specimens revealed that the MAS assay gave 100% concordance with conventional sequencing at eight loci and >95% (range, 95.21% to 99.32%) concordance at the remaining 12 loci. The differences observed were caused mainly by 24 additional low-abundance alleles detected by the MAS assay. Ultradeep sequencing analysis confirmed 15 of the 16 low-abundance alleles. This multiplex, sensitive, and straightforward result-reporting assay represents a new efficient genotyping tool for HIVDR surveillance and monitoring.