INTRODUCTION:The imbalance between those impacted by HIV and the HIV healthcare workforce may be one of the drivers of racial health disparities in the epidemic. To address this, the Academy Council for Racial Equity (ACRE), a committee of the American Academy of HIV Medicine, developed a program of engagement and informal mentorship for underrepresented racial, ethnic and gender minority (UREGM) students and trainees of the health professions. This pilot program was designed to increase interest in HIV related careers among these trainees. METHODS:The program was developed as a career pathways and development workshop with a specific focus on UREGM trainees and students and named the Minority Student Open (MSO). Breakout sessions were included within the workshop to provide skills and potential solutions to workplace challenges these trainees may face. RESULTS:One hundred and thirty-one trainees registered for the MSO. Only (47) 35.8 % of registered students attended the MSO. Among registered students 42 (89 %) provided adequate evaluable information at registration. Post event, one student and faculty mentor provided detailed feedback with recommendations. All received feedback was reviewed based on potential impact and feasibility. Key recommendation was to continue similar events with engagement of a broader diversity of faculty. To improve attendance the team could embed events within student targeted meetings CONCLUSION: Based on the response from student attendees, committee members, and other stakeholders, student engagement events would be continued. The team will continually evaluate and adapt students centered events in response to engagement and feedback.

INTRODUCTION:There are persistent race- and ethnicity-based disparities in HIV incidence among gay and bisexual men who have sex with men (GBMSM) in the United States, partially driven by inequities in distribution of pre-exposure prophylaxis (PrEP). We assessed how additional modalities of PrEP beyond daily oral might affect the uptake of PrEP and ongoing disparities in HIV incidence in the United States. METHODS:In an online survey of GBMSM in the United States, we presented participants with descriptions of each PrEP modality. Among GBMSM not willing to use daily oral PrEP, we assessed willingness to use on-demand or long-acting injectable (LA) PrEP. Among GBMSM using daily oral PrEP, we assessed willingness to switch to on-demand or LA PrEP. RESULTS:Among GBMSM who were not willing to use daily oral PrEP, most were also not willing to use either on-demand or LA PrEP. In adjusted analyses, Hispanic/Latino, non-Hispanic/Latino Black, and non-Hispanic/Latino GBMSM of other races were more willing to use LA PrEP than non-Hispanic/Latino White GBMSM; none of the adjusted prevalence ratios was statistically significant. Most GBMSM currently taking daily oral PrEP reported a preference for staying on that regimen. Among those interested in switching, most were interested in on-demand PrEP. CONCLUSIONS:Most GBMSM not willing to use daily oral PrEP are also not willing to use other modalities of PrEP; most GBMSM who are currently using daily oral PrEP prefer to continue using that dosing strategy. Our results suggest that differential preferences in modalities of PrEP will not exacerbate existing disparities in PrEP distribution or HIV incidence.

BACKGROUND:Long-acting (LA) injectable preexposure prophylaxis (PrEP) and on-demand PrEP may improve overall PrEP uptake among men who have sex with men (MSM), but little is understood about the PrEP option preferences of MSM in practical scenarios where they may choose between various PrEP options. OBJECTIVE:This study aims to examine the preferences for starting various PrEP options among a US nationwide online convenience sample of MSM from September 2021 to February 2022. METHODS:Participants reporting no prior HIV diagnosis were provided brief descriptions of each PrEP option and were asked, "If [PrEP option] were available from your local doctor and you could access it for free, would you go to your doctor in the next month to start [PrEP option]?" Those who said "yes" to multiple options were asked to rank them in order of preference. MSM currently taking daily oral (DO) PrEP were asked whether they would switch to on-demand or LA PrEP options. Log binomial models were created to examine the association between willingness to start or switch to on-demand and LA PrEP with various sociodemographic and behavioral factors. RESULTS:In the analytic sample (N=7760), among the participants who did not use any PrEP in the past 12 months (n=5108, 66%), 54% (n=2445) reported willingness to start at least 1 PrEP option and 41% (n=1845) of participants showed interest in starting multiple PrEP options. Overall, the highest willingness was reported for on-demand PrEP (n=2235, 44%), followed by DO PrEP (n=2174, 43%) and LA PrEP (n=1482, 29%). LA PrEP was ranked first among those interested in multiple options. Characteristics associated with ranking LA PrEP as a first option to start PrEP versus DO or on-demand PrEP were region of residence (residing in the West vs Northeast), report of sexually transmitted infection diagnosis in the past year, report of illicit drug use other than marijuana in the past year, and prior awareness of LA PrEP. Among current DO PrEP users (n=2379, 31%), 58% (n=1386) were willing to switch to on-demand or LA PrEP, and LA PrEP was ranked first among participants who were open to switching to both options. Willingness to switch to LA PrEP was higher among those who used illicit drugs other than marijuana in the past year, who heard of LA PrEP prior to the survey, and those who took 15 or less doses of oral PrEP in the last 30 days. CONCLUSIONS:LA PrEP was the highest-ranked option among most MSM who were willing to try multiple options or switch from DO PrEP. These findings highlight that LA PrEP might fill coverage gaps among MSM who use illicit drugs, have had a recent sexually transmitted infection diagnosis, and have less than optimal DO PrEP adherence.

Purpose In 2021 the NIH acknowledged the role of structural racism in research, including the systematic exclusion of diseaseaffected individuals in favor of cohorts that resemble the “census” population. To address future racial exclusion, understanding the attitudes towards research among current Underrepresented in Medicine (URiM) trainees is essential. Methods An ad-hoc survey of trainees (pre-medical students, medical students, and residents) was conducted at the 2024 Student National Medical Association (SNMA) Annual Medical Education Conference (AMEC). Demographic data was collected, and participants were surveyed on their experiences as research subjects. The anonymous survey was conducted via Microsoft Forms; deidentified data was stored securely on SNMA servers. Results Out of approximately 3500 attendees, 158 (4.5%) completed surveys. Most were current medical students (76.6%), and identified as Black (93.7%), and as female/women (65.8%). Most respondents (71.5%) had never been a research subject and 64.6% had never been invited. Non-participation was mainly due to scheduling conflicts (35.4%), ineligibility (21.5%), and being unaware of opportunities (12%). Only 8% of respondents cited historical mistrust or friend/family concerns. Conclusion This pilot survey of AMEC attendees suggests URiM trainees have infrequently been asked to participate in research as subjects, despite possible interest. Contrary to popular narratives, most respondents indicated that logistical concerns, not concerns of historical mistrust, drive underrepresentation in research studies, even among medical trainees. Future directions include surveying trainees’ experiences joining research teams, and further analyses by geographics, age, and levels of training.

We investigated men who have sex with men's (MSM) location preferences for long-acting injectable pre-exposure prophylaxis (LA-PrEP). MSM ( n = 1076) who completed the 2021 American Men's Internet Survey, were currently prescribed oral PrEP, and expressed LA-PrEP interest reported location preferences for receiving LA-PrEP: healthcare provider (HCP) setting, pharmacy, or at-home. HCP settings were preferred by 60% of participants; 26% preferred home and 14% preferred pharmacy. In adjusted models, high healthcare stigma was associated with preferring pharmacy and at-home versus HCP, while high friends/family stigma was associated with preferring HCP settings versus pharmacy. Healthcare access history was associated with preference for HCP setting versus home. Being 25 to 29 or 30 to 29 years old versus 40+ was associated with preferring HCP versus home. Private insurance was associated with location preferences. Findings support the need for multiple LA-PrEP service locations to best reach MSM and highlight multiple complex factors that influence such preferences.

Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA PrEP) is efficacious, with a good safety profile, and was approved by the US Food and Drug Administration in December 2021. Understanding variations in potential user preferences for LA PrEP may inform implementation and subsequently improve uptake and community-level effectiveness. HIV-negative, sexually active men who have sex with men (MSM) aged ≥15 years were recruited online for the 2019 American Men's Internet Survey, before LA PrEP approval. Respondents completed a discrete-choice experiment (DCE) with hypothetical LA PrEP attributes (out-of-pocket cost, perceived side effects, injection frequency, perceived stigma, service location). Latent class analysis segmented respondents into groups based on their preferences for the attributes presented, and relative importance of preference weights and willingness-to-pay were calculated. While the majority had never used daily oral PrEP, 73% of the 2489 respondents were very or somewhat likely to use LA PrEP. Three latent classes were identified from 2241 respondents in the DCE. The "side effects-averse" class was the largest group (64% of respondents) and placed 61% relative importance on side effects. The "ambivalent" class (20% of respondents) placed higher importance on stigma (17% of relative importance) than other classes. The "cost-conscious" class (16% of respondents) placed higher relative importance (62%) on cost compared with other attributes and classes. Perceived side effects were an important hypothetical barrier for LA PrEP uptake among a large proportion of potential MSM users. Minimizing out-of-pocket costs is likely to increase uptake and may be important to equitable access. Tailored communication strategies are recommended for the different groups of potential LA PrEP users.

Abstract Background Cisgender women account for approximately 20% of incident HIV diagnoses in the US. However, only 10% of women who could benefit from HIV pre-exposure prophylaxis (PrEP) have been prescribed PrEP. US women face several challenges that may affect their seeking HIV prevention services, such as lack of PrEP awareness. Understanding these challenges may improve PrEP uptake, especially as innovative PrEP options, such as long-acting (LA) injectable PrEP, become available. This study explored interest in using LA-PrEP by factors that may increase risk of HIV acquisition. Methods Cisgender women were recruited between November 2021 – March 2022 though targeted social media ads on Facebook, Instagram, and Tinder to complete an online, self-administered survey. Eligible participants were cisgender women who were: 18+ years, current US residents, reported penetrative sex in the past six months, and reported an unknown or negative HIV status. The survey included questions on demographics, sexual health and behavior, LA-PrEP awareness, and LA-PrEP interest. Descriptive statistics were calculated using SAS v9.4. Results 1,834 eligible women completed the survey (median age: 28 years (IQR: 25, 33); Geography: South – 65%, West – 21%, Northeast – 7.3%, Midwest – 6.8%; Race: Black, non-Hispanic – 34%, White, non-Hispanic – 25%, Hispanic – 27%, Another race – 14%). Women were more likely to have heard of LA-PrEP if they had reported injection drug use in the past year (71%), had an STI diagnosis (70%) or HIV test (66%) in the past two years, and were currently using contraception (65%). Interest in using LA-PrEP was consistently high; the difference between LA-PrEP awareness and interest was greatest among women with non-private health insurance and those with perceived likelihood of future HIV acquisition. Conclusion Although interest in using LA-PrEP is high among US women, these results demonstrate the large gap between LA-PrEP awareness and interest in using it. Disclosures Tonia Poteat, PhD, MPH, PAC, Viiv Healthcare: Advisor/Consultant Supriya Sarkar, PhD, MPH, GlaxoSmithKline: Stocks/Bonds|Viiv Healthcare: Employee Leigh Ragone, MS, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Danielle Bogan, BSN, MPH,DrPH, ViiV Healthcare: Contract worker Keith Rawlings, MD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Alex R. Rinehart, PhD, ViiV Healthcare: Employee Vani Vannappagari, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee

Abstract Background In HIV clinical trials, proportions of Black and female participants achieving virologic suppression (VS) are often lower compared with White and male participants. As the antiretroviral therapy (ART) landscape continues to evolve, addressing existing challenges in clinical trial diversity will be critical to effectively translate results into clinical practice. Here, we pooled data to evaluate the efficacy and safety of dolutegravir (DTG)-containing regimens by race, sex, and regional subgroups. Methods Three pooled analyses were conducted using 48-week results from phase 3/3b trials: DTG 3-drug vs non-DTG-containing 3- or 4-drug regimens in ART-naive participants (ARIA, FLAMINGO, SINGLE, SPRING-2), DTG-containing 2-drug vs 3-drug regimens in ART-naive participants (GEMINI-1, GEMINI-2), and DTG 3-drug vs non-DTG-containing 3- or 4-drug regimens in ART-experienced participants (SAILING, DAWNING). Proportions of participants with VS, safety, and change from baseline in CD4+ cell count were analyzed. Results Proportions of participants achieving VS were high among those receiving DTG vs comparator regimens. Proportions of participants achieving VS were generally lower in Black (vs non-Black), female (vs male), and US (vs non-US) subgroups. No new safety signals emerged from any subgroup in pooled analyses. Conclusions These analyses confirm that, across subgroups, DTG has robust efficacy and a good safety profile at week 48 relative to comparator regimens. Achieving VS may vary by participant characteristics, highlighting the urgent need for enrollment to reflect the demographics of global HIV populations more accurately. Future studies should strive to support participants throughout the trial to ensure optimal representation, inclusion, and retention.

Abstract Background Use of daily oral HIV pre-exposure prophylaxis (DO PrEP) has increased steadily in the past several years, but patterns of racial disparities have emerged in PrEP uptake. Although Black and Hispanic people are disproportionately affected by HIV in the US, they constitute a minority among those accessing DO PrEP. Newly available prevention options, such as long-acting injectable (LA) PrEP may help close the gap in unmet need for PrEP; however, interest in LA PrEP has not been evaluated specifically among racial/ethnic minority groups. Awareness, willingness, and usage of PrEP as well as HIV prevention preferences were assessed among sexually active adult men in the US. Methods Participants were recruited through a geographically targeted social media campaign and completed a self-administered, cross-sectional, online survey on demographics, sexual health and behavior, healthcare access, PrEP awareness and usage, and PrEP intention and preferences. Eligible participants met the following criteria: cisgender men, self-identified Black race and/or Hispanic ethnicity, 18 years or older, reporting unknown or HIV-negative status, currently residing in the US, and reporting anal or vaginal sex in the past six months. Descriptive statistics were calculated using SAS v9.4. Results From November to December 2021, 1365 men completed the survey (median age: 29.0 years; Black non-Hispanic: 43.1%, Black Hispanic: 40.3%, White Hispanic: 10.2%, Other Hispanic: 6.4%). A majority had heard of DO PrEP (66.6%) and LA PrEP (47.5%) as a way to prevent HIV; however, a smaller proportion had spoken to a healthcare provider (HCP) about PrEP (42.1%), had ever used PrEP (24.7%), or were currently taking PrEP (16.3%) (Figure 1). A large majority (74.0%) reported interest in using LA PrEP. When asked about their preferred PrEP option, 60.2% chose LA PrEP and 7.4% chose DO PrEP, while 27.5% stated that they preferred neither PrEP option. Figure 1.PrEP Awareness, Discussion with HCP, and Usage Among US Black and Hispanic Men, Overall and by Race/Ethnicity Conclusion Most participants demonstrated high awareness of PrEP and a strong interest in LA PrEP. The availability of and interest in LA PrEP may serve as an opportunity to help increase overall PrEP uptake among Black and Hispanic men in the US. Disclosures TONIA POTEAT, PhD, MPH, PA-C, ViiV Healthcare: Advisor/Consultant Supriya Sarkar, PhD, MPH, ViiV Healthcare: Salary|ViiV Healthcare: Stocks/Bonds Leigh Ragone, MS, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Keith Rawlings, MD, ViiV Healthcare: Employee Alex R. Rinehart, PhD, ViiV Healthcare: Stocks/Bonds Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: I am full time employee of ViiV Healthcare and receive GlaxoSmithKline stock as part of my compensation package|ViiV Healthcare: Stocks/Bonds.

Abstract Background Daily oral (DO) HIV pre-exposure prophylaxis (PrEP) effectively prevents HIV acquisition, but few men who have sex with men (MSM) currently use it. Newer options, such as on-demand (OD) oral and long-acting injectable (LA) PrEP may improve uptake, but little is understood about relative preferences among these options in practical start scenarios. Preferences for starting various PrEP options were examined among a US nationwide online convenience sample of MSM age 15+ collected September 2021 to February 2022. Methods Participants reporting no prior HIV diagnosis were given brief descripitions of each PrEP option and were asked “If [PrEP option] were available from your local doctor and you could access it for free, would you go to your doctor in the next month to start [PrEP option]?” Those who said yes to multiple options were asked to rank them in order of preference. MSM currently taking DO PrEP were asked whether they would switch to OD or LA. Willingness to start LA was examined by age, race/ethnicity, insurance, and prior awareness of LA. Results Of 5585 MSM not currently using DO PrEP, 50% (n=2805) would start at least one option with greatest preference for OD (Figure 1). Among this group, 73% (n=2060) were willing to start more than one option, with LA the most preferred option. Among the 27% (n=745) who would start only one, OD was the most preferred. Overall, 58% of DO PrEP users (n=1342/2332) would switch to either OD or LA, with LA being most preferred (Figure 2). Hispanic MSM who were not DO PrEP users were more likely to start LA compared to white MSM, and those with other/multiple health insurance were less likely to start LA compared to those on private health insurance (Table 1). Regardless of current DO PrEP use, MSM aware of LA were more likely to start it. Conclusion There is substantial interest in new PrEP options. Current DO PrEP users appear to be more aware of and interested in LA than PrEP naïve. Although OD PrEP may be favored by those who are PrEP-naïve, most selected multiple options and preferred LA PrEP. Increasing awareness of LA PrEP may bolster interest in its use. These findings highlight the potential role that newer PrEP options will play in community uptake of PrEP and can also inform patient-provider decisions about which PrEP options to consider. Disclosures Travis Sanchez, DVM, MPH, ViiV Healthcare: Grant/Research Support S. Wilson Beckham, PhD, MPH, MA, Viiv Healthcare: Advisor/Consultant Keith Rawlings, MD, ViiV Healthcare: Employee Alex R. Rinehart, PhD, ViiV Healthcare: Stocks/Bonds Supriya Sarkar, PhD, MPH, ViiV Healthcare: Salary|ViiV Healthcare: Stocks/Bonds Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: I am full time employee of ViiV Healthcare and receive GlaxoSmithKline stock as part of my compensation package|ViiV Healthcare: Stocks/Bonds.

Abstract Background Cisgender women continue to have low pre-exposure prophylaxis (PrEP) uptake in the US, despite making up almost 20% of new HIV infections. The gap between the number of women who would benefit from PrEP and those who use PrEP highlights the unmet need for HIV prevention in women. As new prevention options, such as long-acting (LA) injectable PrEP, become available, it is important to understand PrEP awareness and preferences among women to help meet this need. Awareness, willingness, and usage of PrEP as well as HIV prevention preferences were assessed among sexually active women in the US. Methods Cisgender women were recruited through a geolocation targeted social media campaign and completed a self-administered, cross-sectional, online survey on demographics, sexual health and behavior, healthcare access, PrEP awareness and history, and PrEP intention and preferences. Eligible participants were cisgender women, 18 years or older, who reported an unknown or HIV-negative status, currently resided in the US, and reported vaginal or anal sex in the past six months. Descriptive statistics were calculated using SAS v9.4. Results From November to December 2021, 961 participants completed the survey (median age: 28.0 years; Black non-Hispanic: 34.7%; Black Hispanic: 19.9%; White non-Hispanic: 21.3%; White Hispanic: 12.0%; Another race: 9.1%). A majority had heard of PrEP (70.6%) and LA PrEP (50.1%) as a way to prevent HIV; however, a smaller proportion had spoken to a healthcare provider (HCP) about PrEP (37.8%), had ever used PrEP (19.7%), or were currently on PrEP (9.3%). While PrEP awareness was high across all racial and ethnic groups, PrEP discussions with an HCP and PrEP usage was lowest among Black, non-Hispanic women (Figure 1). Most participants (78.8%) expressed intent to regularly use any HIV prevention method and 66.0% reported likelihood of using LA PrEP if it were available. Condoms were the most favored prevention option (46.7%) followed by HCP administered LA PrEP (24.3%), vaginal ring (9.0%), self-administered LA PrEP (8.8%), and oral PrEP (6.7%). Conclusion Although most women demonstrated high PrEP awareness and interest, many had never discussed PrEP with an HCP. The availability of LA PrEP may be an important opportunity for HCPs to discuss a preferred PrEP option with women. Disclosures Tonia Poteat, PhD, MPH, PAC, Merck & Co. Inc: Advisor/Consultant|Viiv Healthcare: Advisor/Consultant Supriya Sarkar, PhD, MPH, ViiV Healthcare: Salary|ViiV Healthcare: Stocks/Bonds Leigh Ragone, MS, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Keith Rawlings, MD, ViiV Healthcare: Employee Alex R. Rinehart, PhD, ViiV Healthcare: Stocks/Bonds Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: I am full time employee of ViiV Healthcare and receive GlaxoSmithKline stock as part of my compensation package|ViiV Healthcare: Stocks/Bonds.

Preventing HIV transmission is a crucial step in ending the HIV epidemic. Safe and effective pre-exposure prophylaxis (PrEP) has been available in the United States since 2012. We set out to determine if persons at greatest risk for HIV acquisition were receiving HIV PrEP. HIV-negative individuals from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort who were prescribed daily PrEP were contrasted with newly diagnosed HIV persons without PrEP use between July 16, 2012 and October 31, 2020 to determine if the PrEP prescriptions reached the populations who were seroconverting. Poisson regression was used to estimate incidence rates of seroconversion to HIV among PrEP initiators, as well as new diagnoses of sexually transmitted infections among both the PrEP group and the newly HIV+ group. Out of the 14,598 PrEP users and 3558 persons newly diagnosed with HIV in OPERA, demographics varied widely. Older individuals, those of nonblack race, men, nonintravenous (IV) drug users, and those with commercial insurance were proportionally overrepresented among those prescribed PrEP compared to persons newly diagnosed with HIV during the same time period. Over 82% of new HIV+ individuals received care in the southern United States compared to only 45% of PrEP users. Seroconversion to HIV among PrEP users was generally uncommon, although more frequent among those who identified as black individuals, especially in the 13-25 years old age range. In conclusion, providers need innovative programs to better identify, educate, and link those at greatest risk of HIV acquisition, especially young people, women, black individuals, and IV drug users, to PrEP.

Abstract Background This study evaluated differences in viral suppression by race and region among PLWH in care at 10 community practices. Methods PLWH (≥18 yrs) starting a new ART between Jan’15-Sept’19 with viral load at regimen prescription (Rx) and ≥6 months (mo) of prior history were selected from Trio Health HIV EMR database. Logistic regression [LR] estimated the association of covariates with outcome “viremic” (viral load >50 cells/ml) among those with viral load recorded 12-15 mo after baseline (BSL). Sensitivity analyses were conducted using viral loads at 9-15 mo, in patients (pts) on their BSL regimens for ≥12 mo, and pts with dispensing data. Covariates: BSL suppression, gender, race, age, payer, region (South vs non-South), BSL single vs multi-tablet regimen (STR vs MTR), and switch status from BSL regimen. Multicollinearity was not present. Results Of 20271 PLWH, 10373 (51%) were treated in South (41% not suppressed at BSL including 30% treatment-naïve [TN]) and 9898 (49%) in non-South (32% not suppressed including 26% TN). The following groups had higher suppression rates at 12-15 mo: males (83%) vs females (80%) p=0.003; white (85%) vs black (78%) and other known race (78%) p< 0.001; insured by commercial or Medicare insurance (both 85%) vs Medicaid (76%) or uninsured (71%) p< 0.001; treated in non-South (88%) vs South (77%) p< 0.001; age ≥50 (87%) vs < 50 (80%) p< 0.001, those who did not switch from BSL regimen (84%) vs switchers (82%) p< 0.001; on STR (84%) vs MTR (81%) p< 0.001. In LR, pts less likely to be suppressed at 12-15 mo were: < 50 adjusted odds ratio (aOR)=0.76 (0.67-0.88), unspecified gender vs female aOR=0.51 (0.28-0.92), black vs white aOR=0.65 (0.56-0.74), other race (Asian, etc.) vs white aOR=0.73 (0.59-0.91), insured by Medicaid vs commercially aOR=0.64 (0.50-0.82), uninsured vs commercially insured aOR=0.63 (0.53-0.75), treated in South aOR=0.43 (0.38-0.50), switched from BSL regimen aOR=0.75 (0.66-.086), on MTR vs STR aOR=0.81 (0.72-0.92), viremic at BSL aOR=0.41 (0.36-0.47). Sensitivity analyses results were similar. Conclusion Our findings highlighted higher rates of viremia among younger, black or other non-white race, pts treated in the South, on Medicaid or uninsured, on MTR, even after accounting for other characteristics. Disclosures Keith M. Rawlings, MD, ViiV Healthcare (Employee) Joseph J. Eron, MD, Gilead Sciences (Consultant, Research Grant or Support)Janssen (Consultant, Research Grant or Support)Merck (Consultant)ViiV Healthcare (Consultant, Research Grant or Support) Julie Priest, MSPH, GlaxoSmithKline (Employee, Shareholder) Janna Radtchenko, MBA, Trio Health (Employee) Joseph Mrus, MD, MSc, ViiV Healthcare (Employee) Moti Rampogal, MD, Gilead Sciences (Consultant, Research Grant or Support, Speaker’s Bureau)Janssen (Consultant, Research Grant or Support, Speaker’s Bureau)Merck (Consultant, Research Grant or Support)ViiV Healthcare (Consultant, Research Grant or Support, Speaker’s Bureau) Alan Oglesby, MPH, ViiV Healthcare (Employee) Richard A. Elion, MD, Gilead Sciences (Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)Jannssen (Speaker’s Bureau)Proteus (Research Grant or Support)Trio Health (Employee)ViiV Healthcare (Advisor or Review Panel member, Research Grant or Support)

IMPORTANCE:Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).OBJECTIVE:To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.DESIGN, SETTING, AND PARTICIPANTS:Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015.INTERVENTIONS:A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring.MAIN OUTCOMES AND MEASURES:Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition.RESULTS:Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion.CONCLUSIONS AND RELEVANCE:The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.

Objective: The purpose of this study was to investigate whether switching HIV-infected patients stabilized on Trizivir (abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg) plus lopinavir/ritonavir 400 mg/100mg twice daily to Trizivir alone affects clinical efficacy and tolerability. Methods: This phase 4, open-label, pilot study was conducted over 96 weeks in 23 antiretroviral-naïve, HIV-infected patients. Initially, these patients received induction therapy with Trizivir plus lopinavir/ritonavir 400 mg/100mg twice daily. Patients who achieved a viral load 3. Nineteen patients completed induction; of the four who did not, three were lost to follow-up and one withdrew due to gastrointestinal adverse events. In 14 induction completers who had viral load measurements taken at week 48, intent-to-treat: observed analysis showed a week 48 viral load 3 higher than the baseline count. Twelve patients completed the subsequent 48-week Trizivir-alone maintenance phase, of whom 11 (92%) achieved viral loads of both 3 above baseline. Trizivir-only maintenance was associated with fewer adverse events than the Trizivir-lopinavir/ritonavir induction phase and with improvement in total cholesterol, LDL-cholesterol, and triglycerides. Conclusions: Trizivir-alone maintenance after Trizivir-lopinavir/ritonavir induction maintained virologic and CD4+ cell response, and was associated with an improved adverse event and lipid profile.

Purpose Renal impairment in human immunodeficiency virus (HIV)-infected patients could potentially be caused by many factors. HIV-related renal impairment risks have been little studied in African Americans and Hispanics. We investigated the impact of HIV itself, highly active antiretroviral therapy (HAART), comorbidities, and non-HIV-related drug treatment on glomerular filtration rate in a predominantly African American/Hispanic HIV-infected population who had received HAART for at least one year. This study was a retrospective electronic medical record database evaluation of renal impairment risks in a largely African American/Hispanic HIV population obtaining medical care at an HIV clinic in Dallas, Texas. Methods Proportional hazards models were used to investigate an association between an estimated glomerular filtration rate decrease >25% from baseline (ie, renal impairment) and demographics, antiretroviral/nonantiretroviral medications, comorbidities (hypertension, diabetes mellitus, hepatitis C virus [HCV] infection, hepatitis B virus [HBV] infection), CD4+ counts, viral load, and duration patients were monitored at the clinic (time on study). Results In total, 323 patients were evaluated: 82% males; 61% African American/12% Hispanic/19% Caucasian; mean age 37.9 years (standard deviation [SD] 8.5); 6% HBV-positive; 34% HCV-positive; 29% hypertensive; 3% diabetic; 52% tenofovir-treated; mean weight 75.4 kg (SD, 15.4); mean estimated glomerular filtration 114.5 mL/min/1.73 m2 (SD, 36.7) using the Modification of Diet in Renal Disease (MDRD) calculation method; mean creatinine clearance (from which estimated glomerular filtration was extrapolated) by the Cockcroft-Gault calculation method 120.6 mL/min/1.73 m2 (SD, 41.2); mean time on study 2.7 years (SD, 1.0 year). An estimated glomerular filtration rate decrease of >25% from baseline was significantly associated with time on study (P = 0.0017; hazards ratio [HR] = 0.999) and hypertension (HR = 1.706; P = 0.0158) by the MDRD method, and with age (HR = 1.039; P = 0.0077), weight (HR = 0.987; P = 0.0023), and time on study (HR = 0.999; P = 0.0043) by extrapolation of Cockcroft-Gault creatinine clearance calculation. No specific HAART agent was associated with significant renal impairment risk by the definition used in this study. Conclusion This retrospective database study showed time on study, hypertension, weight, and age to be the only significant predictors of an estimated glomerular filtration rate decrease >25% from baseline.