Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study.

BACKGROUND: People who inject drugs (PWID) are at high risk for opioid overdose and infectious diseases including HIV. We piloted PARTNER UP, a telemedicine-based program to provide PWID with medication for opioid use disorder (MOUD) with buprenorphine/naloxone (bup/nx) and oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine through two syringe services programs (SSP) in North Carolina. We present overall results from this project, including participant retention rates and self-reported medication adherence. METHODS: Study participants met with a provider for an initial in-person visit at the SSP, followed by weekly telemedicine visits in month 1 and then monthly until program end at month 6. Participants were asked to start both MOUD and PrEP at initiation but could choose to discontinue either at any point during the study. Demographics and health history including substance use, sexual behaviors, and prior use of MOUD/PrEP were collected at baseline. Follow-up surveys were conducted at 3- and 6-months to assess attitudes towards MOUD and PrEP, change in opioid use and sexual behaviors, and for self-reported medication adherence. Participant retention was measured by completion of visits; provider notes were used to assess whether the participant reported continuation of medication. RESULTS: Overall, 17 persons were enrolled and started on both bup/nx and PrEP; the majority self-identified as white and male. At 3 months, 13 (76%) remained on study; 10 (77%) reported continuing with both MOUD and PrEP, 2 (15%) with bup/nx only, and 1 (8%) with PrEP only. At 6 months, 12 (71%) remained on study; 8 (67%) reported taking both bup/nx and PrEP, and 4 (33%) bup/nx only. Among survey participants, opioid use and HIV risk behaviors decreased. Nearly all reported taking bup/nx daily; however, self-reported daily adherence to PrEP was lower and declined over time. The most common reason for not continuing PrEP was feeling not at risk for acquiring HIV. CONCLUSIONS: Our study results show that MOUD and PrEP can be successfully administered via telemedicine in SSPs. PrEP appears to be a lower priority for participants with decreased continuation and adherence. Low perception of HIV risk was a reason for not continuing PrEP, possibly mitigated by MOUD use. Future studies including helping identify PWID at highest need for PrEP are needed. TRIAL REGISTRATION: Providing Suboxone and PrEP Using Telemedicine, NCT04521920. Registered 18 August 2020. https://clinicaltrials.gov/study/NCT04521920?term=mehri%20mckellar&rank=2 .

Cardiometabolic Parameters 3 Years After Switch to Dolutegravir/Lamivudine vs Maintenance of Tenofovir Alafenamide-Based Regimens.

Background: Cardiometabolic outcomes were investigated 3 years after switching to the 2-drug regimen dolutegravir/lamivudine (DTG/3TC) vs continuing 3-/4-drug tenofovir alafenamide (TAF)-based regimens in a multicenter phase 3 noninferiority study based on an open-label randomized design. Method: Adults with virologically suppressed HIV-1 switched to once-daily DTG/3TC (n = 369) or continued TAF-based regimens (n = 372). Cardiometabolic health parameters were assessed through week 144 via mixed-model repeated measures or logistic regression analyses, adjusting for baseline variables. Results: At week 144, 13% (42/316) of the DTG/3TC group and 12% (37/303) of the TAF-based regimen group had ≥10% weight gain from baseline (adjusted odds ratio, 1.11; 95% CI, .68-1.80). Adjusted change from baseline in serum leptin, a surrogate marker of adiposity, was similar between groups (treatment ratio, 1.00; 95% CI, .89-1.13). The lipid profile generally favored DTG/3TC in the baseline boosted subgroup. Adjusted odds revealed no clinically meaningful differences between groups: homeostatic model assessment of insulin resistance ≥2 (adjusted odds ratio, 0.79; 95% CI, .50-1.26), metabolic syndrome (International Diabetes Federation criteria, 0.99; .59-1.68), hepatic fibrosis (fibrosis-4 index score ≥1.45, 1.39; .63-3.06), and coronary artery disease risk (Framingham risk score ≥10%, 0.92; .56-1.49). Baseline variables and characteristics associated with odds of each cardiometabolic parameter outcome were consistent with known risk factors, including age, sex, race, and some disease characteristics. Conclusions: Cardiometabolic health 3 years after switching to DTG/3TC was comparable to that for individuals continuing TAF-based regimens, further supporting DTG/3TC as a robust switch option with a stable metabolic profile. Trial registration: ClinicalTrials.gov NCT03446573.

A survey of South Carolina pharmacists' readiness to prescribe human immunodeficiency virus pre-exposure prophylaxis.

Introduction: HIV pre-exposure prophylaxis (PrEP) is largely underutilized in the Southern United States. Given their community presence, pharmacists are well positioned to provide PrEP within rural, Southern regions. However, pharmacists' readiness to prescribe PrEP in these communities remains unknown. Objective: To determine the perceived feasibility and acceptability of prescribing PrEP by pharmacists in South Carolina (SC). Methods: We distributed a 43-question online descriptive survey through the University of SC Kennedy Pharmacy Innovation Center's listerv of licensed SC pharmacists. We assessed pharmacists' comfort, knowledge, and readiness to provide PrEP. Results: A total of 150 pharmacists responded to the survey. The majority were White (73%, n=110), female (62%, n=93), and non-Hispanic (83%, n=125). Pharmacists practiced in retail (25%, n=37), hospital (22%, n=33), independent (17%, n=25), community (13%, n=19), specialty (6%, n=9), and academic settings (3%, n=4); 11% (n=17) practiced in rural locales. Pharmacists viewed PrEP as both effective (97%, n=122/125) and beneficial (74% n=97/131) for their clients. Many pharmacists reported being ready (60% n=79/130) and willing (86% n=111/129) to prescribe PrEP, although over half (62% n=73/118) cited lack of PrEP knowledge as a barrier. Pharmacists described pharmacies as an appropriate location to prescribe PrEP (72% n=97/134). Conclusions: Most SC pharmacists surveyed considered PrEP to be effective and beneficial for individuals who frequent their pharmacy and are willing to prescribe this therapy if statewide statutes allow. Many felt that pharmacies are an appropriate location to prescribe PrEP but lack a complete understanding of required protocols to manage these patients. Further investigation into facilitators and barriers of pharmacy-driven PrEP are needed to enhance utilization within communities.

Impact of Policy Change on Access to Medication for Opioid Use Disorder in Primary Care.

OBJECTIVES: The opioid overdose epidemic is escalating. Increasing access to medications for opioid use disorder in primary care is crucial. The impact of the US Department of Health and Human Services' policy change removing the buprenorphine waiver training requirement on primary care buprenorphine prescribing remains unclear. We aimed to investigate the impact of the policy change on primary care providers' likelihood of applying for a waiver and the current attitudes, practices, and barriers to buprenorphine prescribing in primary care. METHODS: We used a cross-sectional survey with embedded educational resources disseminated to primary care providers in a southern US academic health system. We used descriptive statistics to aggregate survey data, logistic regression models to evaluate whether buprenorphine interest and familiarity correlate with clinical characteristics, and a χ2 test to evaluate the effect of the educational intervention on screening. RESULTS: Of the 54 respondents, 70.4% reported seeing patients with opioid use disorder, but only 11.1% had a waiver to prescribe buprenorphine. Few nonwaivered providers were interested in prescribing, but perceiving buprenorphine to be beneficial to the patient population was associated with interest (adjusted odds ratio 34.7, P < 0.001). Two-thirds of nonwaivered respondents reported the policy change having no impact on their decision to obtain a waiver; however, among interested providers, it increased their likelihood of obtaining a waiver. Barriers to buprenorphine prescribing included lack of clinical experience, clinical capacity, and referral resources. Screening for opioid use disorder did not increase significantly after the survey. CONCLUSIONS: Although most primary care providers reported seeing patients with opioid use disorder, interest in prescribing buprenorphine was low and structural barriers remained the dominant obstacles. Providers with a preexisting interest in buprenorphine prescribing reported that removing the training requirement was helpful.

Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs: a qualitative descriptive evaluation.

BACKGROUND: People who inject drugs (PWID) are at risk for HIV and opioid overdose. We piloted PARTNER UP, a telemedicine-based program to provide PWID with access to both oral pre-exposure prophylaxis (PrEP) for HIV prevention and medication for opioid use disorder (MOUD) through two syringe services programs (SSPs) in North Carolina. We conducted a qualitative evaluation to assess the acceptability and feasibility of PARTNER UP from the participant perspective. METHODS: PARTNER UP participants met with a provider for an initial in-person visit at the SSP, followed by weekly telemedicine visits in month 1 and then monthly telemedicine visits until program end at month 6. Using a qualitative descriptive study design, we conducted in-depth interviews with a subsample of PARTNER UP participants at 1 month and 4 months. Informed by the technology acceptance model, we assessed participant perceptions of the usefulness and ease of use of PARTNER UP, as well as their intent to continue to use the program's components. We audio-recorded all interviews with participants' permission and used applied thematic analysis to analyze the verbatim transcripts. RESULTS: We interviewed 11 of 17 people who participated in PARTNER UP-10 in the month 1 interview and 8 in the month 4 interview. Nearly all participants were motivated to join for consistent and easy access to buprenorphine/naloxone (i.e., MOUD); only a few joined to access PrEP. Most were comfortable accessing healthcare at the SSP because of their relationship with and trust toward SSP staff, and accessing services at the SSP was preferred compared with other healthcare centers. Some participants described that telemedicine allowed them to be honest and share more information because the visits were not in-person and they chose the location, although the initial in-person meeting was helpful to build provider trust and rapport. Most participants found the visit schedule to be feasible, although half described needing to reschedule at least once. Nearly all participants who were interviewed intended to continue with MOUD after the program ended, whereas none were interested in continuing with PrEP. CONCLUSIONS: Participant narratives suggest that the PARTNER UP telemedicine program was acceptable and feasible. Future studies should continue to explore the benefits of embedding both PrEP and MOUD into SSPs with larger numbers of participants. Trial registration Clinicaltrials.gov Identifier: NCT04521920.

Perceptions on HIV Pre-Exposure Prophylaxis Among Urgent Care Clinicians in the Southern United States.

BACKGROUND: Underutilization of HIV pre-exposure prophylaxis (PrEP) in the Southern United States (US) is well-documented. Urgent care (UC) centers are positioned as communityfacing access points to PrEP, but the feasibility of integrating PrEP services into this setting is unclear. We conducted a survey of UC clinicians in the Southern US to better understand their perceptions of the feasibility of providing PrEP in their practice setting. OBJECTIVE: The study aims to determine the feasibility and acceptability of providing PrEP services in the UC setting through a cross-sectional survey of UC clinicians. METHODS: We conducted a 48-item cross-sectional survey of UC clinicians in the Southern US, between July and September 2020. The survey was distributed through the Urgent Care Association (UCA) and American Academy of Urgent Care Medicine (AAUCM) professional listservs as well as directly to publicly listed e-mail addresses. RESULTS: Eighty-two clinicians responded to the survey. Most clinicians had familiarity with PrEP (97%). All respondents rated PrEP as an effective way to prevent HIV. However, less than half felt UC facilities were an appropriate place to prescribe PrEP. Few respondents (8%) expressed doubts that expansion of PrEP access would decrease the incidence of HIV in their community. CONCLUSION: These findings show UC clinicians are familiar with PrEP, and many believe it would benefit their patients; however, provider opinions on the appropriateness of providing PrEP in the UC setting differ. Further studies on PrEP implementation in UC centers are needed.

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM.

Oral HIV pre-exposure prophylaxis (PrEP) is effective at preventing HIV. However, low adherence is common and undermines these protective effects. This is particularly relevant for groups with disproportionately higher rates of HIV, including Black men who have sex with men (MSM). The current study tested the feasibility, acceptability, and preliminary efficacy of a gamified mobile health contingency management intervention for PrEP adherence-called mSMART (Mobile App-Based Personalized Solutions for Medication Adherence of Rx Pill Tool). Fifteen Black MSM already prescribed PrEP in the community completed baseline and follow-up assessments separated by 8 weeks of using mSMART. Regarding feasibility, there was no study attrition, no mSMART functional difficulties that significantly interfered with use, and a mean rate of 82% daily mSMART use. Acceptability ratings were in the moderately to extremely satisfied range for factors such as willingness to recommend mSMART to others and user-friendliness, and in the low range for ratings on difficulty learning how to use mSMART. Scores on a system usability measure were in the acceptable range for 73% of the sample. Qualitative analysis of follow-up interviews identified individual components of mSMART that could be modified in future iterations to make it more engaging. PrEP composite adherence scores from biomarkers indicated an improvement from baseline to follow-up with a medium effect size, as well as a decrease in the number of perceived barriers to medication adherence. Findings indicate a future efficacy trial is needed to examine the effects of this gamified mobile health contingency management intervention on PrEP adherence.

Understanding Retention in Pre-Exposure Prophylaxis Care in the South: Insights from an Academic HIV Prevention Clinic.

HIV pre-exposure prophylaxis (PrEP) is poorly utilized in the southern United States. We examined PrEP retention in care and sexually transmitted infections (STIs) through a retrospective review of the Duke University PrEP Clinic from January 1, 2015 to October 15, 2019. We evaluated short-term (3 months), long-term (additional 8-12 months), and longitudinal retention in care in our clinic. Adjusted odds ratios (aOR) were generated to explore demographics associated with retention. Kaplan-Meier curves were generated to view retention longitudinally. STIs were examined at baseline (1 year before initial PrEP visit) and while retained in care. Of a total of 255 patients; 88% were men, 37% were black, and 73% were men who have sex with men (MSM). Short- and long-term retention in care were met by 130/237 (55%) and 80/217 (37%) patients, respectively. MSM were more likely to be retained in the short term (aOR = 5.22, 95% confidence interval [CI] = 1.57-17.32). Self-referred patients were more likely to be retained in the long term (aOR = 2.18, 95% CI = 1.12-4.23). Uninsured patients were less likely to be retained in the long term (aOR = 0.32, 95% CI = 0.11-0.91). STI diagnoses include 42 infections at baseline and 69 infections during follow-up. STI diagnosed while in PrEP care was associated with longer retention in care over time. Patients discontinue PrEP care over time and STIs were frequently encountered. Additional studies are needed to determine the best way to retain patients in HIV preventative care.

Case Report: Reversal of Integrase Inhibitor- and Tenofovir Alafenamide-Related Weight Gain After Switching Back to Efavirenz/Emtricitabine/Tenofovir DF.

We report a case of substantial weight gain in a virologically suppressed patient with HIV after changing his antiretroviral therapy from efavirenz/emtricitabine/tenofovir DF to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide with subsequent rapid weight loss upon switching back. The role of antiretrovirals in weight gain and loss and patient- and HIV-specific factors are discussed.

Perspectives of Black women in the United States on salon-based intervention to promote the uptake of pre-exposure prophylaxis (PrEP) for HIV.

AIMS AND OBJECTIVES: To understand Black women's perspectives on a pre-exposure prophylaxis (PrEP) education intervention in a salon setting. BACKGROUND: Black women have a significant lifetime risk of acquiring HIV. Pre-exposure prophylaxis (PrEP) is an effective prevention approach in reducing that risk. Despite this, Black women are least likely to use PrEP. DESIGN: This was a qualitative study to identify Black women's perspectives on acceptability of a PrEP education intervention in a salon setting using hair stylists. The paper adhered to the COREQ checklist in reporting. METHODS: Seven focus groups among Black women (n = 44) living in north-central North Carolina were conducted. Ethical approval was obtained. The interview guide included questions on knowledge of PrEP and barriers and facilitators to a PrEP promotion programme in a salon setting. RESULTS: Conventional content analysis considered content in relation to themes of facilitators, barriers and women's preferences for intervention delivery. Facilitators included the salon characteristics, social culture and relationship with the stylist. Women noted concerns of accuracy of content from stylists and privacy as barriers. CONCLUSIONS: Participants' trust with their stylists make a PrEP education salon-based intervention feasible. Salon-based interventions are not one-size-fits-all and researchers interested in this setting should tailor interventions to the individual salon. Interventions for PrEP in a salon setting should be culturally appropriate, confidential and consider the potential reach to the social networks of Black women in the salon. RELEVANCE TO CLINICAL PRACTICE: The insights shared by Black women can contribute to developing a PrEP uptake intervention as a way of reducing new cases of HIV.

Awareness and acceptability of HIV pre-exposure prophylaxis (PrEP) among students at two historically Black universities (HBCU): a cross-sectional survey.

BACKGROUND: Despite young African American adults (ages 18-24) being among the highest risk groups for HIV infection, little is known about their awareness of HIV pre-exposure prophylaxis (PrEP) - a once daily pill shown to be > 90% effective in preventing HIV. To explore awareness and acceptability of PrEP among college students in this demographic, we conducted a survey of attendees at two large historically Black universities (HBCU) in North Carolina. METHODS: We administered a 14-item questionnaire to students at two HBCUs in North Carolina between February and April 2018. Questions were formatted in a yes/no or multiple choice format. Questionnaire items specifically addressed PrEP awareness and acceptability. Surveys were administered to students at a campus health fair and while transiting the campus student union via iPad. Response to all questions was optional. We fit a logistic regression model to determine association of key demographic determinants with PrEP acceptability and awareness. Statistical analyses were conducted using SAS 9.4 (SAS, Cary, NC). RESULTS: Overall, 210 students participated in the survey, of which 60 completed all survey items as presented. The survey cohort was 75% female, 89% heterosexual and 39% freshmen. The mean age of respondents was 19.8 years (SD: 1.8). Fifty-two percent of survey respondents reported that they were aware of PrEP prior to the time of survey administration. Only 3% of respondents reported that they were on PrEP. The most common sources of information on PrEP were campus health services (24%) and non-social media advertising (15%). Of respondents who were aware of PrEP, 61% reported that they had heard about in the 6 months prior to survey administration, while only 19% say they were aware of it for more than a year. Regarding acceptability of PrEP, 58% of respondents reported that they would take a once a day pill for HIV if they were at risk. Our logistic regression analysis found no statistically significant associations between key demographic factors and PrEP awareness. However, persons who perceived themselves to be at risk for HIV acquisition were more likely to find once daily oral PrEP (relative risk 2.66 (95% CI 1.31-5.42)) as an acceptable prevention strategy than the rest of the survey cohort. CONCLUSIONS: African American HBCU students are becoming aware of PrEP, and generally perceive the intervention as acceptable and worth consideration.

Preexposure Prophylaxis Outcomes in an Urban Community in North Carolina: Discontinuation of Care and Sexually Transmitted Infections.

BACKGROUND: Few studies have examined long-term outcomes among persons who initiate preexposure prophylaxis (PrEP) in the South, including PrEP discontinuation and sexually transmitted infection (STI) rates. METHODS: Care discontinuation (>6 months without a PrEP appointment) and incident STIs were evaluated for patients at 2 PrEP clinics in Durham, NC. We tested for predictors of discontinuation as a binary variable using logistic regression. Model covariates included age, race/ethnicity, sex, known HIV-positive partner, commercial sex work, men who have sex with men (MSM) versus not MSM, type of insurance, and clinic site. A similar analysis was completed for STI incidence, controlling for days in the study. RESULTS: Among 271 patients, mean age was 33.2 years, 46.9% were Black and 11.1% were Latino, 81.2% were MSM, and 32% were uninsured. Preexposure prophylaxis was discontinued in 47%, and another 11% had intermittent care. Sexually transmitted infection incidence was 45.4/100 person-years, and 5 patients were diagnosed with HIV at baseline or in follow-up. Men who have sex with men were less likely to discontinue PrEP relative to non-MSM (odds ratio [OR], 0.26; 95% confidence interval [CI], 0.10-0.64). Baseline STI was associated with a higher likelihood of incident STI (OR, 8.19; 95% CI, 3.69-19.21), whereas care discontinuation was associated with a lower likelihood of STI (OR, 0.28; 95% CI, 0.11-0.65). CONCLUSIONS: Preexposure prophylaxis programs in the Southern United States are reaching uninsured and predominantly Black and Latino MSM, but discontinuation rates are high despite elevated rates of incident STI and HIV. Further work is required to elucidate causes of PrEP discontinuation and encourage persistence in care.

Examining the Potential of Pre-exposure Prophylaxis (PrEP) for HIV Prevention in a Community Sample of Persons Who Use Stimulants Living in the Southern United States.

Pre-exposure prophylaxis (PrEP), a highly effective HIV prevention strategy, is currently underutilized by several at-risk groups, including both persons who inject drugs and those who use drugs via other routes. Stimulant use is associated with increased HIV risk due to both sexual and injection risk behaviors. In this study, we examined PrEP awareness and acceptability in persons with biologically confirmed HIV-negative status who use stimulant drugs. We also examined HIV risk behaviors to identify how many participants met behavioral eligibility for PrEP. The sample of 352 participants was 46% female, 87% African American, and 45.69 years old on average. Over half the sample (n = 213) met criteria for PrEP candidacy, but less than 20% had heard of PrEP. Ratings for willingness to take PrEP were high. PrEP candidates reported more frequent and problematic stimulant use relative to non-candidates. Our results show that persons who use stimulants are a high-risk population that could benefit significantly from PrEP. Efforts to increase PrEP awareness among high-risk populations are critical for facilitating PrEP implementation and ensuring effective HIV prevention within these communities.

Testing for HIV infection in the emergency departments of 2 hospitals in the Southeastern United States.

BACKGROUND: In 2006, the Centers for Disease Control and Prevention (CDC) recommended non-targeted, opt-out HIV screening in all healthcare settings, including emergency departments (EDs). Multiple HIV testing programs have been implemented in EDs across the United States with varying designs and testing platforms. We report findings from a free, non-targeted, rapid HIV testing program in 2 EDs in the Southeastern United States. METHODS: From 2008 to 2012, adults ≥18 years of age were offered free rapid HIV testing using an oral swab test (OraQuick ADVANCE Rapid HIV-1/2 antibody test) in the EDs of a large academic medical center and an affiliated community hospital in Durham, North Carolina. RESULTS: In total, 5443 ED patients were offered HIV testing. The overall acceptance rate was 66.9% (3639/5443). Younger persons were significantly more likely to accept testing (78.2% for 18-29 years old vs 67.1% for ≥30 years old; P < 0.001) as were Black participants (72.6% Black vs 66.5% White; P < 0.001). Acceptance rates improved significantly after opt-out oral consent replaced written consent (71.3% vs 63.1%; P < 0.001). Seven new HIV diagnoses were confirmed during the testing program, resulting in a seropositivity rate of 0.19% (7/3639). There were 8 false-positive rapid oral HIV tests (positive predictive value = 46.7%). CONCLUSIONS: Although the number of new HIV diagnoses was low, implementation of this rapid, non-targeted ED screening program was feasible with high acceptance rates, particularly after introducing the opt-out oral consent approach.

Efficacy, pharmacokinetics and neurocognitive performance of dual, NRTI-sparing antiretroviral therapy in acute HIV-infection.

OBJECTIVES: The aim of this study was to evaluate penetration of antiretrovirals into compartments and efficacy of a dual, NRTI-sparing regimen in acute HIV infection (AHI). DESIGN: Single-arm, open-label pilot study of participants with AHI initiating ritonavir-boosted darunavir 800 mg once daily and etravirine 400 mg once daily or 200 mg twice daily within 30 days of AHI diagnosis. METHODS: Efficacy was defined as HIV RNA less than 200 copies/ml by week 24. Optional sub-studies included pharmacokinetics analysis from genital fluids (weeks 0-4, 12, 48), cerebrospinal fluid (CSF) (weeks 2-4, 24 and 48) and endoscopic biopsies (weeks 4-12 and 36-48). Neuropsychological performance was assessed at weeks 0, 24 and 48. RESULTS: Fifteen AHI participants were enrolled. Twelve (80%) participants achieved HIV RNA less than 200 copies/ml by week 24. Among 12 participants retained through week 48, nine (75%) remained suppressed to less than 50 copies/ml. The median time from ART initiation to suppression less than 200 and less than 50 copies/ml was 59 and 86 days, respectively. The penetration ratios for etravirine and darunavir in gut associated lymphoid tissue were 19.2 and 3.05, respectively. Most AHI participants achieving viral suppression experienced neurocognitive improvement. Of the three participants without overall improvement in neurocognitive functioning as measured by impairment ratings (more than two tests below 1 SD), two had virologic failure. CONCLUSION: NRTI-sparing ART started during AHI resulted in rapid viral suppression similar to NRTI-based regimens. More novel and compact two-drug treatments for AHI should be considered. Early institution of ART during AHI appears to improve overall neurocognitive function and may reduce the risk of subsequent neurocognitive impairment. CLINICALTRIALS.GOV:: NCT00855413.

Racial Differences in Change in Physical Functioning in Older Male Veterans with HIV.

Little is known about longitudinal change in physical functioning of older African American/Black and White HIV-infected persons. We examined up to 10 years of data on African American (N = 1,157) and White (N = 400) men with HIV infection and comparable HIV-negative men (n = 1,137 and 530, respectively), age 50-91 years from the Veterans Aging Cohort Study Survey sample. Physical functioning was assessed using the SF-12 (12-Item Short Form Health Survey) physical component summary (PCS) score. Mixed-effects models examined association of demographics, health conditions, health behaviors, and selected interactions with PCS score; HIV biomarkers were evaluated for HIV-infected persons. PCS scores were approximately one standard deviation below that of the general U.S. population of similar age. Across the four HIV/race groups, over time and through ages 65-75 years, PCS scores were maintained; differences were not clinically significant. PCS score was not associated with race or with interactions among age, race, and HIV status. CD4 and viral load counts of African American and White HIV-infected men were similar. Older age, low socioeconomic status, chronic health conditions and depression, lower body mass index, and smoking were associated with poorer PCS score in both groups. Exercising and, counterintuitively, being HIV infected were associated with better PCS score. Among these older African American and White male veterans, neither race nor HIV status was associated with PCS score, which remained relatively stable over time. Chronic disease, depression, and lack of exercise were associated with lower PCS score. To maintain independence in this population, attention should be paid to controlling chronic conditions, and emphasizing good health behaviors.

Public Awareness of HIV Pre-Exposure Prophylaxis in Durham, North Carolina: Results of a Community Survey.

BACKGROUND Adoption of HIV pre-exposure prophylaxis (PrEP) remains limited among populations at greatest risk for HIV acquisition. This study aims to assess awareness of PrEP among individuals in Durham, North Carolina, which has one of the highest rates of HIV diagnoses in the state.METHOD In 2015-2016, we administered a survey including questions to assess PrEP awareness to individuals at multiple venues throughout Durham, North Carolina.RESULTS A total of 139 respondents were surveyed. The majority were male (66%) and black/African American (75%); 21% were Hispanic/Latino. There were an estimated 53 men who have sex with men (MSM), of which 18 (33%) were black MSM M 24 years of age. Overall, only 53/138 (38%) respondents were aware of PrEP. Awareness was reported among 33/52 (63%) MSM respondents, 29/46 (63%) black MSM, and 10/17 (59%) black MSM M 24 years of age. In multivariate analysis, non-heterosexual orientation, health-insured status, and prior HIV testing were significantly associated with PrEP awareness. Ninety-four (69%) of 137 respondents reported prior HIV testing.LIMITATIONS Limitations include non-random sampling and limited sample size. Further research needs to be done in other areas of North Carolina, and assessment of PrEP acceptability and uptake needs to be performed.CONCLUSION This study reveals low overall awareness of PrEP in Durham, North Carolina, indicating that expanded outreach is necessary to increase public awareness and encourage adoption of PrEP among all demographics at risk for HIV.

Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial.

BACKGROUND: Current treatment for HIV-infected individuals with renal failure on haemodialysis frequently requires complex regimens with multiple pills. A daily single-tablet regimen of coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is approved in Europe, the USA, and in other regions for use in HIV-1-infected individuals with mild-to-moderate chronic kidney disease (creatinine clearance 30-69 mL/min). We aimed to assess the safety, efficacy, and pharmacokinetics of this regimen in HIV-infected adults with end-stage renal disease on chronic haemodialysis. METHODS: We did an open-label, single-arm, multicentre, phase 3b trial at 26 outpatient clinics in Austria, France, Germany, and the USA. Participants were HIV-1-infected adults with end-stage renal disease (creatinine clearance <15 mL/min), on chronic haemodialysis for at least 6 months before screening. Virological suppression (ie, plasma HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen was required for at least 6 months before screening with a CD4 count of at least 200 cells per µL. We switched all participants to coformulated elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg once daily, taken after haemodialysis for up to 96 weeks. We did assessments at study visits at weeks 2, 4, 8, 12, 24, 36, and 48, and every 12 weeks thereafter up to 96 weeks. The primary endpoint was the incidence of treatment-emergent adverse events of grade 3 or higher up to week 48. All participants who received at least one dose of study drug were included in the primary analysis. This study is registered with ClinicalTrials.gov (NCT02600819) and is closed to new participants. FINDINGS: Between Feb 1, and Nov 3, 2016, 55 participants were enrolled and received at least one dose of study drug. Through week 48, 18 of 55 participants (33%, 95% CI 20-45) had an adverse event of grade 3 or higher on study treatment. Treatment-emergent grade 3 or higher adverse events that occurred in more than one participant included anaemia, osteomyelitis, prolonged electrocardiogram QT, fluid overload, hyperkalaemia, hypertension, and hypotension (all n=2). No adverse event of grade 3 or higher was considered by the site investigators to be treatment related. Three participants (5%, 95% CI 0-11) discontinued treatment because of adverse events; one of these (grade 1 allergic pruritus) was considered treatment related. Treatment-related adverse events were reported for six individuals (11%, 95% CI 3-19), the most common of which was nausea (in four individuals [7%]); all treatment-related adverse events were grade 1 or 2 in severity. INTERPRETATION: At 48 weeks, switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide was well tolerated. This regimen might provide a tolerable and convenient option for ongoing treatment of HIV-1 infection in adults with end-stage renal disease on chronic haemodialysis. FUNDING: Gilead Sciences.

Canary in the Coal Mine? Transmitted Mutations Conferring Resistance to All Integrase Strand Transfer Inhibitors in a Treatment-Naive Patient.

Transmitted drug resistance to the integrase strand transfer inhibitor (INSTI) class of antiretrovirals is very rare. We present a case of a treatment-naive female patient with human immunodeficiency virus harboring resistance to all INSTIs, including bictegravir and dolutegravir.