Showing papers in "Journal of Acquired Immune Deficiency Syndromes in 2017"

Estimated HIV Incidence in the United States, 2003-2010.

Abstract: Objective To estimate HIV incidence in the United States using a newly developed method. Methods The analysis period (2002-2011) was broken down into 3-year periods with overlaps, and HIV incidence was estimated based on the relationship between number of new diagnoses and HIV incidence in each of these 3-year periods, by assuming that all HIV infections would eventually be diagnosed and within each 3-year period HIV incidence and case finding were stable. Results The estimated HIV incidence in the United States decreased from 52,721 (range: 47,449-57,993) in 2003 to 39,651 (range: 35,686-43,617) in 2010, among males from 38,164 (range: 35,051-42,840) to 33,035 (range: 29,088-35,553), and among females from 13,557 (range: 12,133-14,830) to 6616 (range: 5825 to 7120). Conclusions Using a simple and novel method based on the number of new HIV diagnoses, we were able to estimate HIV incidence and report a declining trend in HIV incidence in the United States since 2003.

An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM.

Abstract: P REVENTION S CIENCE An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM Sybil G. Hosek, PhD,* Bret Rudy, MD,† Raphael Landovitz, MD,‡ Bill Kapogiannis, MD,§ George Siberry, MD,§ Brandy Rutledge, PhD,k Nancy Liu, MPH,k Jennifer Brothers, MPH,* Kathleen Mulligan, PhD,¶ Gregory Zimet, PhD,# Michelle Lally, MD,** Kenneth H. Mayer, MD,†† Peter Anderson, PharmD,‡‡ Jennifer Kiser, PharmD,‡‡ James F. Rooney, MD,§§ and Craig M. Wilson, MD,kk the Adolescent Trials Network (ATN) for HIV/AIDS Interventions Background: Young men who have sex with men (YMSM) are a key population for implementation of preexposure prophylaxis (PrEP) interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 US cities. Methods: Eligible participants were 18- to 22-year-old HIV- uninfected MSM who reported HIV transmission risk behavior in the previous 6 months. Participants were provided daily tenofovir disoproxil fumarate/emtricitabine (Truvada). Study visits occurred at baseline, monthly through week 12, and then quarterly through week 48. Dried blood spots were serially collected for the quantification of tenofovir diphosphate (TFV-DP). Results: Between March and September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age = 20.2; 54.5% black, 26.5% Latino). Diagnosis of sexually transmitted infections, including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with $4 pills per week. By week 48, 34% of participants had TFV-DP levels consistent with $4 pills per week, with a noticeable drop-off occurring at week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Con- domless sex was reported by .80% of participants, and condomless anal sex with last partner was associated with higher TFV-DP levels. Conclusions: Acceptability of PrEP was high, and most partic- Received for publication February 6, 2016; accepted August 26, 2016. From the *John Stroger Hospital of Cook County, Chicago, IL; †New York University Medical Center, New York, NY; ‡University of California Los Angeles, Los Angeles, CA; §NICHD/MPIDB, Bethesda, MD; kWestat, Rockville, MD; ¶University of California San Francisco, San Francisco, CA; #Indiana University, Indianapolis, IN; **Alpert Medical School of Brown University and Lifespan Hospital System, Providence, RI; ††Fenway Health, Boston, MA; ‡‡University of Colorado, Denver, CO; §§Gilead Sciences, Foster City, CA; and kkUniversity of Alabama at Birmingham, Birmingham, AL. This study was funded under cooperative agreements U01 HD040533 and U01 HD040474 from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Devel- opment with supplemental funding from the National Institute on Drug Abuse and National Institute of Mental Health. Study drug was donated by Gilead Sciences, Inc., along with supplemental funds for a portion of the dried blood spot testing. Supported by The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) from the National Institutes of Health (U01 HD 040533 and U01 HD 040474) through the National Institute of Child Health and Human Development (B.K. and S. Lee), with supplemental funding from the National Institutes on Drug Abuse (K. Davenny and S. Kahana) and Mental Health (P. Brouwers, S. Allison). Study drug was donated by Gilead Sciences. K.M. has received unrestricted research grants from Gilead Sciences and ViiV. P.A. receives donated study drug and contract work from Gilead. J. F.R. is employed by Gilead Sciences, the maker of the study drug. The remaining authors have no funding or conflicts of interest to disclose. The comments and views of the authors do not necessarily represent the views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Correspondence to: Sybil G. Hosek, PhD, Department of Psychiatry, John Stroger Hospital of Cook County, 1900 W Polk Street, room 854, Chicago, IL 60612 (e-mail: shosek@cookcountyhhs.org). Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. ipants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the United States may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules. Key Words: preexposure prophylaxis, youth, men who have sex with men (J Acquir Immune Defic Syndr 2017;74:21–29) INTRODUCTION Young men who have sex with men (YMSM), particu- larly black and Latino YMSM, are the group most affected by HIV in the United States, 1 making them a key domestic population for implementation of HIV preexposure prophylaxis (PrEP) interventions. Based on evidence from multiple clinical trials of PrEP, 2–4 the US Food and Drug Administration approved daily use of tenofovir disoproxil fumarate/emtricita- bine (TDF/FTC) for the prevention of sexually acquired HIV in July 2012. In anticipation of this new drug indication, several open-label demonstration projects were launched to evaluate PrEP safety and adherence outside of a placebo-controlled trial setting; effective PrEP implementation strategies for specific at- risk populations are also being evaluated. Although not placebo controlled, the more recent PROUD study used an open-label randomized controlled design of either immediate or delayed PrEP to pilot test the implementation of PrEP in the public health system of the J Acquir Immune Defic Syndr Volume 74, Number 1, January 1, 2017 www.jaids.com | Copyright O 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

Uptake of HIV Pre-Exposure Prophylaxis (PrEP) in a National Cohort of Gay and Bisexual Men in the United States

Abstract: Objectives The HIV care cascade provides milestones to track the progress of HIV-positive people from seroconversion through viral suppression. We propose a Motivational pre-exposure prophylaxis (PrEP) Cascade involving 5 stages based on the Transtheoretical Model of Change. Methods We analyzed data from 995 men in One Thousand Strong, a longitudinal study of a national panel of HIV-negative gay and bisexual men in the United States. Results Nearly all (89%) participants were sexually active in the past 3 months and 65% met Centers for Disease Control criteria for PrEP candidacy. Of those identified as appropriate candidates, 53% were Precontemplative (stage 1; unwilling to take or believing they were inappropriate candidates for PrEP) and 23% were in Contemplation (stage 2; willing and self-identified as appropriate candidates). Only 11% were in PrEParation (stage 3; seeing PrEP as accessible and planning to initiate PrEP) and 4% were in PrEP Action (stage 4; prescribed PrEP). Although few of those who were identified as appropriate candidates were on PrEP, nearly all PrEP users (98%) reported adhering to 4 or more doses per week and most (72%) were returning for recommended quarterly medical visits, resulting in 9% of PrEP candidates reaching Maintenance and Adherence (stage 5). Conclusions The large majority of participants were appropriate candidates for PrEP, yet fewer than 1 in 10 were using and adherent to PrEP. These findings highlight the need for interventions tailored to address the unique barriers men face at each stage of the cascade, particularly at the earliest stages where the most dramatic losses were identified.

Brief Report: Weight Gain in Persons With HIV Switched From Efavirenz-Based to Integrase Strand Transfer Inhibitor-Based Regimens.

Abstract: Background:With the introduction of integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy, persons living with HIV have a potent new treatment option. Recently, providers at our large treatment clinic noted weight gain in several patients who switched from efavirenz/tenofovir diso

Confronting Challenges in Monitoring and Evaluation: Innovation in the Context of the Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive.

Abstract: The Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive (Global Plan), which was launched in 2011, set a series of ambitious targets, including a reduction of new HIV infections among children by 90% by 2015 (from a baseline year of 2009) and AIDS-related maternal mortality by 50% by 2015. To reach these targets, the Global Plan called for unprecedented investments in the prevention of mother-to-child transmission of HIV (PMTCT), innovative new approaches to service delivery, immense collective effort on the programmatic and policy fronts, and importantly, a renewed focus on data collection and use. We provide an overview of major achievements in monitoring and evaluation across Global Plan countries and highlight key challenges and innovative country-driven solutions using PMTCT program data. Specifically, we describe the following: (1) Uganda's development and use of a weekly reporting system for PMTCT using short message service technology that facilitates real-time monitoring and programmatic adjustments throughout the transition to a "treat all" approach for pregnant and breastfeeding women living with HIV (Option B+); (2) Uganda's work to eliminate parallel reporting systems while strengthening the national electronic district health information system; and (3) how routine PMTCT program data in Nigeria can be used to estimate HIV prevalence at the local level and address a critical gap in local descriptive epidemiologic data to better target limited resources. We also identify several ongoing challenges in data collection, analysis, and use, and we suggest potential solutions.

Retention in HIV Care During Pregnancy and the Postpartum Period in the Option B+ Era: Systematic Review and Meta-Analysis of Studies in Africa.

Abstract: Background:Under Option B+ guidelines for prevention of mother-to-child transmission of HIV, pregnant and breastfeeding women initiate antiretroviral therapy for lifelong use. The objectives of this study were: (1) to synthesize data on retention in care over time in option B+ programs in Africa, an

The Effect of Same-Day Observed Initiation of Antiretroviral Therapy on HIV Viral Load and Treatment Outcomes in a US Public Health Setting

Abstract: Background Antiretroviral therapy (ART) is typically begun weeks after HIV diagnosis. We assessed the acceptability, feasibility, safety, and efficacy of initiating ART on the same day as diagnosis. Methods We studied a clinic-based cohort consisting of consecutive patients who were referred with new HIV diagnosis between June 2013 and December 2014. A subset of patients with acute or recent infection ( Results Among 86 patients, 39 were eligible and managed on the RAPID protocol. Thirty-seven (94.9%) of 39 in RAPID began ART within 24 hours. Minor toxicity with the initial regimen occurred in 2 (5.1%) of intervention patients versus none in the nonintervention group. Loss to follow-up was similar in intervention (10.3%) and nonintervention patients (14.9%) during the study. Time to virologic suppression ( Conclusions Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of ART. Same-day ART may shorten the time to virologic suppression.

Brief Report: PrEP Uptake, Adherence, and Discontinuation Among California YMSM Using Geosocial Networking Applications.

Abstract: We investigated pre-exposure prophylaxis (PrEP) uptake, adherence, and discontinuation among young app-using men who have sex with men in California (N = 761). Approximately, 9.7% of participants had ever used PrEP; 87% of those deemed good candidates for screening (indicated by a Centers for Disease Control and Prevention risk index score ≥10) were not current or past users. PrEP use was associated with higher income [adjusted odds ratio (aOR): 4.13; confidence interval (CI): 1.87 to 9.12], receptive condomless anal sex (aOR: 3.41; CI: 1.71 to 6.78), HIV-positive sex partners (aOR: 2.87; CI: 1.53 to 5.38), popper use (aOR: 3.47; CI: 1.96 to 6.13), and recent sexually transmitted infection diagnosis (aOR: 2.90; CI: 1.64 to 5.13). Some users (41.5%) wanted help remembering to take PrEP. The top reason for discontinuation was concern about long-term side effects (33.0%). Young men who have sex with men app users are prime candidates for PrEP, despite low uptake. Apps may be useful tools for PrEP information dissemination, adherence monitoring, and support.

Challenges in Translating PrEP Interest Into Uptake in an Observational Study of Young Black MSM

Abstract: Background HIV incidence among US young, black men who have sex with men (YBMSM) is high, and structural barriers (eg lack of health insurance) may limit access to Pre-exposure prophylaxis (PrEP). Research studies conducted with YBMSM must ensure access to the best available HIV prevention methods, including PrEP. Methods We implemented an optional, nonincentivized PrEP program in addition to the standard HIV prevention services in a prospective, observational cohort of HIV-negative YBMSM in Atlanta, GA. Provider visits and laboratory costs were covered; participant insurance plans and/or the manufacturer assistance program were used to obtain drugs. Factors associated with PrEP initiation were assessed with prevalence ratios and time to PrEP initiation with Kaplan-Meier methods. Results Of 192 enrolled YBMSM, 4% were taking PrEP at study entry. Of 184 eligible men, 63% indicated interest in initiating PrEP, 10% reported no PrEP interest, and 27% wanted to discuss PrEP again at a future study visit. Of 116 interested men, 46% have not attended a PrEP initiation appointment. Sixty-three men (63/184; 34%) initiated PrEP; 11/63 (17%) subsequently discontinued PrEP. The only factor associated with PrEP initiation was reported sexually transmitted infection in the previous year (prevalence ratio 1.50, 95% confidence interval: 1.002 to 2.25). Among interested men, median time to PrEP initiation was 16 weeks (95% confidence interval: 7 to 36). Conclusions Despite high levels of interest, PrEP uptake may be suboptimal among YBMSM in our cohort even with amelioration of structural barriers that can limit use. PrEP implementation as the standard of HIV prevention care in observational studies is feasible; however, further research is needed to optimize uptake for YBMSM.

Increased Risk of Myocardial Infarction in HIV-Infected Individuals in North America Compared With the General Population.

Abstract: Author(s): Drozd, Daniel R; Kitahata, Mari M; Althoff, Keri N; Zhang, Jinbing; Gange, Stephen J; Napravnik, Sonia; Burkholder, Greer A; Mathews, William C; Silverberg, Michael J; Sterling, Timothy R; Heckbert, Susan R; Budoff, Matthew J; Van Rompaey, Stephen; Delaney, Joseph AC; Wong, Cherise; Tong, Weiqun; Palella, Frank J; Elion, Richard A; Martin, Jeffrey N; Brooks, John T; Jacobson, Lisa P; Eron, Joseph J; Justice, Amy C; Freiberg, Matthew S; Klein, Daniel B; Post, Wendy S; Saag, Michael S; Moore, Richard D; Crane, Heidi M | Abstract: BackgroundPrevious studies of cardiovascular disease (CVD) among HIV-infected individuals have been limited by the inability to validate and differentiate atherosclerotic type 1 myocardial infarctions (T1MIs) from other events. We sought to define the incidence of T1MIs and risk attributable to traditional and HIV-specific factors among participants in the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) and compare adjusted incidence rates (IRs) to the general population Atherosclerosis Risk in Communities (ARIC) cohort.MethodsWe ascertained and adjudicated incident MIs among individuals enrolled in 7 NA-ACCORD cohorts between 1995 and 2014. We calculated IRs, adjusted incidence rate ratios (aIRRs), and 95% confidence intervals of risk factors for T1MI using Poisson regression. We compared aIRRs of T1MIs in NA-ACCORD with those from ARIC.ResultsAmong 29,169 HIV-infected individuals, the IR for T1MIs was 2.57 (2.30 to 2.86) per 1000 person-years, and the aIRR was significantly higher compared with participants in ARIC [1.30 (1.09 to 1.56)]. In multivariable analysis restricted to HIV-infected individuals and including traditional CVD risk factors, the rate of T1MI increased with decreasing CD4 count [≥500 cells/μL: ref; 350-499 cells/μL: aIRR = 1.32 (0.98 to 1.77); 200-349 cells/μL: aIRR = 1.37 (1.01 to 1.86); 100-199 cells/μL: aIRR = 1.60 (1.09 to 2.34); l100 cells/μL: aIRR = 2.19 (1.44 to 3.33)]. Risk associated with detectable HIV RNA [l400 copies/mL: ref; ≥400 copies/mL: aIRR = 1.36 (1.06 to 1.75)] was significantly increased only when CD4 was excluded.ConclusionsThe higher incidence of T1MI in HIV-infected individuals and increased risk associated with lower CD4 count and detectable HIV RNA suggest that early suppressive antiretroviral treatment and aggressive management of traditional CVD risk factors are necessary to maximally reduce MI risk.

Evolving Models and Ongoing Challenges for HIV Preexposure Prophylaxis Implementation in the United States.

Abstract: Background:The use of preexposure prophylaxis (PrEP) for HIV prevention was approved by the Food and Drug Administration in 2012, but delivery to at-risk persons has lagged. This critical review analyzes the current state of PrEP implementation in the United States, by reviewing barriers and innovat

High Acceptability and Increased HIV-Testing Frequency After Introduction of HIV Self-Testing and Network Distribution Among South African MSM.

Abstract: BACKGROUND South African men who have sex with men (MSM) have a high burden of undiagnosed HIV infection and HIV-testing rates incommensurate with their risk. HIV self-testing (HIVST) may increase testing uptake, frequency, and earlier HIV detection and treatment. SETTING Gert Sibande and Ehlanzeni districts, Mpumalanga Province, South Africa. METHODS We conducted a longitudinal HIVST study among MSM between June 2015 and May 2017. Overall 127 HIV-negative MSM were provided with up to 9 test kits of their choice-oral fluid or blood fingerstick-to use themselves and distribute to their networks. Surveys conducted 3- and 6-month post-enrollment elicited information on HIVST experiences, preferences, acceptability, utilization, and distribution. We used generalized estimating equations to assess changes in testing frequency. RESULTS Ninety-one percent of participants self-tested. All participants who self-tested reported being likely to self-test again, with over 80% preferring HIVST to clinic-based testing. Fingerstick was preferred to oral fluid tests by approximately 2:1. Returning participants distributed 728 tests to sexual partners (18.5% of kits), friends (51.6%), and family (29.8%). Six participants seroconverted during the study, and 40 new diagnoses were reported among test recipients. Frequent (semi-annual) testing increased from 37.8% before the study to 84.5% at follow-up (P < 0.001), and participants reported anticipated frequent testing of 100% if HIVST were available compared with 84% if only clinic-testing were available in the coming year (P < 0.01). CONCLUSIONS HIVST use and network distribution is acceptable and feasible for MSM in South Africa and can increase testing uptake and frequency, potentially improving early detection among MSM and their networks.

Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomized, Open-Label, Clinical Trial.

Abstract: Background:No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period.Setting:Fourteen sites in Sub-Saharan Africa and India.Met

Brief Report: The Right People, Right Places, and Right Practices: Disparities in PrEP Access Among African American Men, Women, and MSM in the Deep South.

Abstract: Disproportionate rates of HIV are observed in Black women and men, especially in the Southern United States. We observed limited uptake of preexposure prophylaxis (PrEP) services in our Southern community among these groups, particularly Black men who have sex with men relative to new HIV cases in Birmingham, AL; 18% accessed PrEP services compared with 50% of new HIV cases. Further research is needed to understand PrEP access and uptake in high-risk populations.

Using CD4 Data to Estimate HIV Incidence, Prevalence, and Percent of Undiagnosed Infections in the United States.

Abstract: Introduction The incidence and prevalence of HIV infection are important measures of HIV trends; however, they are difficult to estimate because of the long incubation period between infection and symptom development and the relative infrequency of HIV screening. A new method is introduced to estimate HIV incidence, prevalence, and the number of undiagnosed infections in the United States using data from the HIV case surveillance system and CD4 test results. Methods Persons with HIV diagnosed during 2006-2013 and their CD4 test results were used to estimate the distribution of diagnosis delay from HIV infection to diagnosis based on a well-characterized CD4 depletion model. This distribution was then used to estimate HIV incidence, prevalence, and the number of undiagnosed infections. Results Applying this method, we estimated that the annual number of new HIV infections decreased after 2007, from 48,300 (95% confidence interval [CI]: 47,300 to 49,400) to 39,000 (95% CI: 36,600 to 41,400) in 2013. Prevalence increased from 923,200 (95% CI: 914,500 to 931,800) in 2006 to 1,104,600 (95% CI: 1,084,300 to 1,124,900) in 2013, whereas the proportion of undiagnosed infections decreased from 21.0% in 2006 (95% CI: 20.2% to 21.7%) to 16.4% (95% CI: 15.7% to 17.2%) in 2013. Conclusions HIV incidence, prevalence, and undiagnosed infections can be estimated using HIV case surveillance data and information on first CD4 test result after diagnosis. Similar to earlier findings, the decreases in incidence and undiagnosed infections are encouraging but intensified efforts for HIV testing and treatment are needed to meet the goals of the National HIV/AIDS Strategy.

Pre-Exposure Prophylaxis (PrEP) Use and Condomless Anal Sex: Evidence of Risk Compensation in a Cohort of Young Men Who Have Sex with Men.

Abstract: Background:Young men who have sex with men (YMSM) are disproportionately impacted by HIV. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition. It remains unclear if PrEP use increases rates of condomless sex (ie, risk compensation), which may increase risk of infection

Prevention of HIV in adolescent girls and young women : key to an AIDS-free generation.

Abstract: The Global Plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive (Global Plan) has ensured that more infants in high-HIV burden countries survive childhood HIV-free. Although equal numbers of boy and girl children have survived to age 10, a gender divergence starts to emerge as they enter adolescence. Up to 3 times as many young women aged 15-24 years in eastern and southern Africa are living with HIV compared with their male peers. Further, more adolescent girls and young women are sick and/or dying from AIDS-related or HIV-related complications during pregnancy and in the postpartum period, underscoring the importance of strengthening HIV treatment and prevention services for this group. Failure to prevent HIV in adolescent girls and young women and keep them alive will reverse the infant HIV prevention and survival gains made under the Global Plan. The promising global declines in HIV infection in young women need to be strengthened to realize the goals of an AIDS-free generation. The DREAMS initiative of the United States President's Emergency Plan for AIDS Relief (PEPFAR), which specifically addresses adolescent girls and young women at highest risk of HIV acquisition, brings new hope for meeting the prevention and care needs of this important and vulnerable population through political commitment, leadership, financial and human resource investments, advocacy efforts, and a focus on the highest priority settings. Importantly, to achieve the goal of keeping mothers alive, we have to place more emphasis on access to sexual and reproductive health services that (1) include HIV prevention and treatment services for adolescent girls and young women; (2) increase male/paternal responsibility in mother and infant health; and (3) ensure a supportive social environment that enables young women to grow up into young adults who are free to graduate from high school and plan their pregnancies, ultimately entering adulthood safe, healthy, and free from HIV.

The Continuum of HIV Care in Rural Communities in the United States and Canada: What Is Known and Future Research Directions.

Abstract: The nature of the HIV epidemic in the United States and Canada has changed with a shift toward rural areas. Socioeconomic factors, geography, cultural context, and evolving epidemics of injection drug use are coalescing to move the epidemic into locations where populations are dispersed and health care resources are limited. Rural-urban differences along the care continuum demonstrate the implications of this sociogeographic shift. Greater attention is needed to build a more comprehensive understanding of the rural HIV epidemic in the United States and Canada, including research efforts, innovative approaches to care delivery, and greater community engagement in prevention and care.

Psychiatric Symptoms in Patients Receiving Dolutegravir.

Abstract: Introduction Psychiatric symptoms (PSs) are reported to occur frequently in people living with HIV and may be associated with specific antiretrovirals. We analyzed PSs observed with dolutegravir (DTG) and other frequently prescribed anchor drugs. Methods Selected PSs (insomnia, anxiety, depression, and suicidality) occurring in HIV-positive patients during DTG treatment across 5 randomized clinical trials (3 double-blind), in the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort, and among cases spontaneously reported to ViiV Healthcare were analyzed. Results In clinical trials, PSs were reported at low and similar rates in patients receiving DTG or comparators [atazanavir, darunavir, efavirenz, or raltegravir (RAL)]. Insomnia was most commonly reported. The highest rates were observed in SINGLE (DTG 17%, efavirenz 12%), with consistently lower rates in the other trials (DTG: 3%-8% versus comparator: 3%-7%). More efavirenz-treated patients withdrew because of PSs than patients treated with other anchor drugs. In OPERA, history of PSs at baseline was lowest in efavirenz-treated patients compared with patients treated with DTG, RAL, or darunavir. Despite baseline differences, prevalence and incidence during treatment were similar across the 4 anchor drugs. Withdrawal rates for PSs were lowest for DTG (0%-0.6%) and highest for RAL (0%-2.5%). Spontaneously reported events were similar in nature to clinical trial data. Conclusions Analysis of 3 different data sources shows that, similar to other frequently prescribed anchor drugs to treat HIV infection, PSs are also reported in DTG-treated patients. These events are reported with low frequency and rarely necessitate DTG discontinuation.

Using Clinical Notes and Natural Language Processing for Automated HIV Risk Assessment.

Abstract: Objective:Universal HIV screening programs are costly, labor intensive, and often fail to identify high-risk individuals. Automated risk assessment methods that leverage longitudinal electronic health records (EHRs) could catalyze targeted screening programs. Although social and behavioral determina

Regionally Specific Brain Volumetric and Cortical Thickness Changes in HIV-Infected Patients in the HAART Era.

Abstract: Background Cognitive impairment still occurs in a substantial subset of HIV-infected patients, despite effective viral suppression with highly active antiretroviral therapy (HAART). Structural brain changes may provide clues about the underlying pathophysiology. This study provides a detailed spatial characterization of the pattern and extent of brain volume changes associated with HIV and relates these brain measures to cognitive ability and clinical variables. Methods Multiple novel neuroimaging techniques (deformation-based morphometry, voxel-based morphometry, and cortical modeling) were used to assess regional brain volumes in 125 HIV-infected patients and 62 HIV-uninfected individuals. Ninety percent of the HIV-infected patients were on stable HAART with most of them (75%) having plasma viral suppression. Brain volumetrics and cortical thickness estimates were compared between the HIV-infected and uninfected groups, and the relationships between these measures of brain volume and indices of current and past infection severity, central nervous system penetration of HAART, and cognitive performance were assessed. Results Regionally specific patterns of reduced thalamic and brainstem volumes and reduced cortical thickness in the orbitofrontal cortex, cingulate gyrus, primary motor and sensory cortex, temporal, and frontal lobes were seen in HIV-infected patients compared to HIV-uninfected participants. Observed white matter loss and subcortical atrophy were associated with lower nadir CD4 cell counts, while reduction in cortical thickness was related to worse cognitive performance. Conclusions Our findings suggest that distinct mechanisms may underlie cortical and subcortical injury in people with HIV and argues for the potential importance of early initiation of HAART to protect long-term brain health.

Potential Impact of Integrated Stigma Mitigation Interventions in Improving HIV/AIDS Service Delivery and Uptake for Key Populations in Senegal.

Abstract: BACKGROUND Men who have sex with men (MSM) and female sex workers (FSW) are consistently shown to have a higher burden of HIV compared with other adults in Senegal. This study, HIV Prevention 2.0, evaluates the impact of the 3-tiered integrated stigma mitigation interventions (ISMIs) approach to optimizing HIV service delivery for key populations in Senegal. METHODS Baseline assessment includes a questionnaire and biological testing for HIV. A proportion of participants enrolled into a 24-month longitudinal cohort with questionnaires and biological testing every 3 months. In these preliminary analyses, ISMIs are evaluated from participants in the cohort through uptake of HIV services and implementation outcomes. RESULTS Overall, 724 MSM and 758 FSW participated in the baseline assessment. HIV prevalence is 30.2% (n = 219/724) among MSM and 5.3% (n = 40/758) among FSW. Fear of seeking health services among MSM is 17.7% (n = 128/724) at baseline, 10.5% (n = 18/172) at month 3, and 9.8% (n = 10/102) at month 6 (P < 0.004); and among FSW is 21.9% (n = 166/758) at baseline, 8.1% (n = 15/185) at month 3, and 10.7% (n = 18/168) at month 6 (P < 0.001). Overall, 63.9% (n = 62/97) of MSM and 82.5% (n = 118/143) of FSW agreed that the intervention is effective in addressing stigma; however, loss to follow-up was 41.1% among MSM and 10% among FSW. CONCLUSION Baseline data reinforce the need for stigma mitigation interventions, combined with enhanced linkage and retention to optimize HIV treatment. Preliminary results show high levels of HIV-related risk determinants and suggest the potential utility of the ISMI to decrease perceived stigma relating to engagement in HIV prevention, treatment, and care services among key populations in Senegal.

Mobility and Clinic Switching Among Postpartum Women Considered Lost to HIV Care in South Africa

Abstract: OBJECTIVE: Retention in HIV care particularly among postpartum women is a challenge to national antiretroviral therapy programs. Retention estimates may be underestimated because of unreported transfers. We explored mobility and clinic switching among patients considered lost to follow-up (LTFU). DESIGN: Observational cohort study. METHODS: Of 788 women initiating antiretroviral therapy during pregnancy at 6 public clinics in Johannesburg South Africa 300 (38.1%) were LTFU (no visit >/=3 months). We manually searched for these women in the South African National Health Laboratory Services database to assess continuity of HIV care. We used geographic information system tools to map mobility to new facilities. RESULTS: Over one-third (37.6%) of women showed evidence of continued HIV care after LTFU. Of these 67.0% continued care in the same province as the origin clinic. Compared with those who traveled outside of the province for care these same-province "clinic shoppers" stayed out-of-care longer {median 373 days [interquartile range (IQR): 175-790] vs. 175.5 days (IQR: 74-371)} and had a lower CD4 cell count on re-entry [median 327 cells/muL (IQR: 196-576) vs. 493 cells/muL (IQR: 213-557). When considering all women with additional evidence of care as engaged in care cohort LTFU dropped from 38.1% to 25.0%. CONCLUSIONS: We found evidence of continued care after LTFU and identified local and national clinic mobility among postpartum women. Laboratory records do not show all clinic visits and manual matching may have been under- or overestimated. A national health database linked to a unique identifier is necessary to improve reporting and patient care among highly mobile populations.

Association Between Internalized HIV-Related Stigma and HIV Care Visit Adherence.

Abstract: Background:Internalized HIV-related stigma acts as a barrier to antiretroviral therapy (ART) adherence, but its effects on other HIV care continuum outcomes are unclear.Methods:Among 196 HIV clinic patients in Birmingham, AL, we assessed internalized HIV-related stigma and depressive symptom severit

The HIV Care Cascade Among Female Sex Workers in Zimbabwe: Results of a Population-Based Survey From the Sisters Antiretroviral Therapy Programme for Prevention of HIV, an Integrated Response (SAPPH-IRe) Trial.

Abstract: Introduction: Female sex workers (FSW) in sub-Saharan Africa have a higher prevalence of HIV than other women of reproductive age. Social, legal, and structural barriers influence their access to care. Little is known about the HIV diagnosis and care cascade in most countries in southern Africa. We aimed to describe the HIV diagnosis and care cascade among FSW in Zimbabwe. Methods: We conducted cross-sectional respondent driven sampling (RDS) surveys of FSW in 14 sites across Zimbabwe as the baseline for a cluster-randomised controlled trial investigating a combination HIV prevention and care package. We administered a questionnaire, tested women for HIV and measured viral load. We report the mean, minimum and maximum RDS-2 weighted site values. Results: The survey included 2,722 women, approximately 200 per site. The mean HIV prevalence was 57.5% (42.8-79.2 site minimum and maximum). Of HIV positive women, 64.0% (51.6-73.7) were aware of their status, 67.7% (53.4-84.1) of these reported taking ART and 77.8% (64.4-90.8) of these had a suppressed HIV viral load (<1000 copies/ml). Among all HIV positive women, 49.5% had a viral load < 1000 copies/ml. Conclusions: While the majority of HIV positive women aware of their status are accessing ART, 36.0% of HIV positive women are unaware of their status and 29.3% of all FSW have an unsuppressed HIV viral load. Investigation and investment into models of testing, treatment and care are necessary to reach UNAIDS targets for HIV elimination.

Antiviral Activity, Safety, and Pharmacokinetics of Bictegravir as 10-Day Monotherapy in HIV-1-Infected Adults.

Abstract: Objective: To evaluate antiviral activity, safety, and pharmacokinetics of short-term monotherapy with bictegravir (BIC), a novel, potent HIV integrase strand transfer inhibitor (INSTI).

Safety of tenofovir disoproxil fumarate-based antiretroviral therapy regimens in pregnancy for HIV-infected women and their infants : a systematic review and meta-analysis

Abstract: There are limited data on adverse effects of tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART) on pregnant women and their infants. We conducted a systematic review of studies published between January 1980 and January 2017 that compared adverse outcomes in HIV-infected women receiving TDF- vs. non-TDF-based ART during pregnancy. The relative risk for associations was pooled using a fixed-effects model. Sixteen studies met study inclusion criteria. We found that the rate of preterm ( 14 days) (RR=0.65; 95%CI: 0.23-1.85), but increased neonatal mortality (age <14 days) risk (RR=5.64, 95%CI: 1.70-18.79) with TDR-based ART exposure. No differences were found for anthropomorphic parameters at birth; one study reported minor differences in z-scores for length and head circumference at age one year. TDF-based ART in pregnancy appears generally safe for women and their infants. However, data remain limited and further studies are needed, particularly to assess neonatal mortality and infant growth/bone effects.

Using mHealth for HIV/TB Treatment Support in Lesotho: Enhancing Patient-Provider Communication in the START Study.

Abstract: Background mHealth is a promising means of supporting adherence to treatment. The Start TB patients on ART and Retain on Treatment (START) study included real-time adherence support using short-text messaging service (SMS) text messaging and trained village health workers (VHWs). We describe the use and acceptability of mHealth by patients with HIV/tuberculosis and health care providers. Methods Patients and treatment supporters received automated, coded medication and appointment reminders at their preferred time and frequency, using their own phones, and $3.70 in monthly airtime. Facility-based VHWs were trained to log patient information and text message preferences into a mobile application and were given a password-protected mobile phone and airtime to communicate with community-based VHWs. The use of mHealth tools was analyzed from process data over the study course. Acceptability was evaluated during monthly follow-up interviews with all participants and during qualitative interviews with a subset of 30 patients and 30 health care providers at intervention sites. Use and acceptability were contextualized by monthly adherence data. Findings From April 2013 to August 2015, the automated SMS system successfully delivered 39,528 messages to 835 individuals, including 633 patients and 202 treatment supporters. Uptake of the SMS intervention was high, with 92.1% of 713 eligible patients choosing to receive SMS messages. Patient and provider interviews yielded insight into barriers and facilitators to mHealth utilization. The intervention improved the quality of health communication between patients, treatment supporters, and providers. HIV-related stigma and technical challenges were identified as potential barriers. Conclusions The mHealth intervention for HIV/tuberculosis treatment support in Lesotho was found to be a low-tech, user-friendly intervention, which was acceptable to patients and health care providers.

Treatment as Prevention: Characterization of Partner Infections in the HIV Prevention Trials Network 052 Trial.

Abstract: HIV Prevention Trials Network 052 demonstrated that antiretroviral therapy (ART) prevents HIV transmission in serodiscordant couples. HIV from index–partner pairs was analyzed to determine the genetic linkage status of partner infections. Forty-six infections were classified as linked, indicating that the index was the likely source of the partner’s infection. Lack of viral suppression and higher index viral load were associated with linked infection. Eight linked infections were diagnosed after the index started ART: 4 near the time of ART initiation and 4 after ART failure. Linked infections were not observed when the index participant was stably suppressed on ART.

Brief Report: Long-Term (96-Week) Efficacy and Safety After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in HIV-Infected, Virologically Suppressed Adults

Abstract: In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n = 333) vs. remain on tenofovir disoproxil fumarate (TDF; n = 330), each coformulated with emtricitabine (FTC), while continuing their third agent (boosted protease inhibitor or unboosted third agent). At week 96, 88.6% on FTC/TAF and 89.1% on FTC/TDF had HIV-1 RNA <50 copies per milliliter [adjusted difference -0.5% (95% confidence interval: -5.3 to 4.4%)]. Proteinuria, albuminuria, proximal renal tubular function, and bone mineral density improved after switching to TAF- from TDF-containing regimens. These longer-term data support FTC/TAF as a safe, well-tolerated, and durable nucleotide reverse transcriptase inhibitor backbone.