Prevalence of SARS-CoV-2 Infection among Children and Adults in 15 US Communities, 2021

During January-August 2021, the Community Prevalence of SARS-CoV-2 Study used time/location sampling to recruit a cross-sectional, population-based cohort to estimate SARS-CoV-2 seroprevalence and nasal swab sample PCR positivity across 15 US communities. Survey-weighted estimates of SARS-CoV-2 infection and vaccine willingness among participants at each site were compared within demographic groups by using linear regression models with inverse variance weighting. Among 22,284 persons >2 months of age and older, median prevalence of infection (prior, active, or both) was 12.9% across sites and similar across age groups. Within each site, average prevalence of infection was 3 percentage points higher for Black than White persons and average vaccine willingness was 10 percentage points lower for Black than White persons and 7 percentage points lower for Black persons than for persons in other racial groups. The higher prevalence of SARS-CoV-2 infection among groups with lower vaccine willingness highlights the disparate effect of COVID-19 and its complications.

Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase.

BACKGROUND: At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported. METHODS: We enrolled volunteers who were at high risk for Covid-19 or its complications; participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 µg) or placebo, 28 days apart, at 99 centers across the United States. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The data cutoff date was March 26, 2021. RESULTS: The trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. More than 96% of participants received both injections, 2.3% had evidence of SARS-CoV-2 infection at baseline, and the median follow-up was 5.3 months in the blinded phase. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval [CI], 91.0 to 94.8), with 55 confirmed cases in the mRNA-1273 group (9.6 per 1000 person-years; 95% CI, 7.2 to 12.5) and 744 in the placebo group (136.6 per 1000 person-years; 95% CI, 127.0 to 146.8). The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified. CONCLUSIONS: The mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).

A Rapid Environmental Scan of South Florida HIV Organizations' Mpox Messaging During the August 2022 Peak of the U.S. Outbreak.

The 2022 outbreak of mpox disproportionately impacted men who have sex with men and people living with HIV. As such, HIV organizations were uniquely situated to reach populations affected by mpox. However, the extent to which these organizations pivoted to address mpox, and what form mpox messaging took, is unknown. We conducted a rapid environmental scan of 29 HIV or sexual health organizations to assess the frequency and content of mpox messaging in August 2022, the peak of the mpox outbreak in Miami, FL. Approximately half of the organizations provided mpox messaging, most of which was accurate. Only 5% of the messages were in Spanish and 4% in Spanish and Haitian Creole. Our findings suggest HIV organizations' pivot to mpox messaging may have been delayed overall and in reaching Spanish- and Haitian Creole-speaking communities. Results could inform modifications to mpox messaging campaigns and future outbreaks that disproportionately affect minoritized communities.

RESUMEN: El brote de la viruela del mono en 2022 afectó desproporcionadamente a hombres que tienen relaciones sexuales con hombres y personas que viven con el VIH. Como tal, las organizaciones dedicadas al VIH estaban en una posición única para llegar a las poblaciones afectadas por la viruela del mono. Sin embargo, no se sabe en qué medida estas organizaciones cambiaron su enfoque para abordar la viruela del mono y qué forma tomó la mensajería sobre a la viruela del mono. Realizamos un escaneo ambiental rápido de 29 organizaciones de VIH o salud sexual para evaluar la frecuencia y el contenido de la mensajería sobre la viruela del mono en agosto de 2022, en el pico del brote de la viruela del mono en Miami, Florida. Aproximadamente la mitad de las organizaciones proporcionaron mensajería sobre la viruela del mono, la mayoría de la cual era precisa. Solo el 5% de los mensajes estaban en español y el 4% en español y criollo haitiano. Nuestros hallazgos sugieren que el cambio de enfoque de las organizaciones de VIH hacia la mensajería sobre la viruela del mono puede haber sido en general demorado y que no llegó adecuadamente a las comunidades de habla hispana y criollo haitiano. Los resultados podrían informar modificaciones en las campañas de mensajería sobre la viruela del mono y en futuros brotes que afecten desproporcionadamente a comunidades minorizadas.

Addressing disparities in Pre-exposure Prophylaxis (PrEP) access: implementing a community-centered mobile PrEP program in South Florida.

BACKGROUND: Pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but disparities in PrEP access remain considerable, particularly among Black and Latino men who have sex with men (MSM). To address this, the University of Miami Mobile PrEP Program was created, offering mobile HIV prevention/PrEP services in areas throughout South Florida where HIV incidence is high and PrEP access is geographically limited. Using a community-centered participatory approach, the program strategized and executed expansion into the Liberty City neighborhood of Miami. This study qualitatively assessed factors affecting Mobile PrEP implementation as perceived by community stakeholders, clients, and program staff. METHODS: Forty-one in-depth interviews were conducted with 21 Mobile PrEP clients, 10 key informants from local health organizations, and 10 program staff. Interview questions queried perceived organizational and positional barriers and facilitators to mobile clinic implementation. Service satisfaction, setting preferences, social factors, and likelihood of recommending Mobile PrEP were also assessed. A thematic content analysis was performed using the Consolidated Framework for Implementation Research (CFIR) taxonomy as the guiding constructs for the analysis. RESULTS: Participant statements indicated that providing no-cost services, convenient location, program-covered rideshares, individualized patient navigation, and a community-centric approach to patient care, which included staff members with shared lived experiences to increase positive interactions and renewed trust among poorly served communities, were facilitators of PrEP access and intervention uptake. The importance of program familiarization with the community before implementation, particularly for Black and African American communities, who may experience unique barriers to accessing sexual healthcare was strongly emphasized by participants. CONCLUSIONS: The Mobile PrEP intervention was found to be an acceptable and accessible mode of HIV/STI preventive care. The importance of pre-implementation community engagement and preparation is emphasized. Future research is needed to refine understanding of the intervention's components and evaluate implementation determinants in other highly impacted neighborhoods.

"The familiar taste of poison": a qualitative study of multi-level motivations for stimulant use in sexual minority men living in South Florida.

BACKGROUND: In the US, stimulant use is associated with a 3-6 times greater rate of HIV seroconversion in sexual minority men (SMM) than in those who do not use stimulants. Annually, 1 in 3 SMM who HIV seroconvert will be persistent methamphetamine (meth) users. The primary objective of this qualitative study was to explore experiences of stimulant use in SMM living in South Florida, a high priority region for the Ending the HIV Epidemic initiative. METHODS: The sample included 25 SMM who use stimulants, recruited via targeted ads on social networking apps. Participants completed one-on-one semi-structured qualitative interviews, conducted from July 2019 through February 2020. A general inductive approach was used to identify themes relating to experiences, motivations, and overall relationship with stimulant use. RESULTS: Mean age of participants was 38.8, ranging from 20 to 61 years old. Participants were 44% White, 36% Latino, 16% Black and 4% Asian. Most participants were born in the US, self-identified as gay, and preferred meth as their stimulant of choice. Themes included: (1) stimulants as cognitive enhancements for focus or task completion, including transitioning to meth after first using prescription psychostimulants; (2) unique South Florida environment where participants could be open regarding their sexual minority status while also being influential on their stimulant use; (3) stimulant use as both stigmatizing and a coping mechanism for stigma. Participants anticipated stigma by family and potential sexual partners due to their stimulant use. They also reported using stimulants to cope with feelings of stigma due to their minoritized identities. CONCLUSION: This study is among the first to characterize motivations for stimulant use in SMM living in South Florida. Results highlight both the risk and protective factors of the South Florida environment, psychostimulant misuse as a risk for meth initiation, and the role of anticipated stigma on stimulant use in SMM. Understanding stimulant use motivations can help to shape intervention development. This includes developing interventions that address individual, interpersonal, and cultural factors that drive stimulant use and increase risk of HIV acquisition. Trial registration NCT04205487.

The association between egocentric sexual networks and sexual meeting venues with PrEP conversation and encouragement for use among Latinx men who have sex with men.

Despite the increasing availability of pre-exposure prophylaxis (PrEP), Latinx men who have sex with men (LMSM) are not receiving PrEP-related information. To understand the influence of LMSM sexual networks on PrEP-related conversations and encouragement to use PrEP, this cross-sectional egocentric network study characterized the PrEP-related communication of 130 LMSM egos with 507 sexual partners (alters). Participants were recruited using respondent-driven sampling methods from a Miami-Dade County community-health organization. Egocentric-level data were collected from 2018-2019 and analyzed using multilevel modeling. Of egos, 30% reported using PrEP. Closeness between participants and sexual partners played a role in PrEP conversation and encouragement. Participants believed they would have less success convincing sexual partners to use PrEP if partners were older. Participants perceived higher likelihood to talk about PrEP or success in encouraging alters to use PrEP if, relative to meeting sexual partners on Grindr, they met at a friend's party, gay-centric community event, or school/work. Given that increased closeness and in-person sexual partner meeting venues are associated with PrEP information dissemination and encouragement, social network-based interventions can capitalize on PrEP navigators who run network visualizations, and with this information develop a longitudinal plan to increase PrEP conversation and encouragement as needed for each network.

The Association Between Homophily on Illicit Drug Use and PrEP Conversations Among Latino Men Who Have Sex with Men Friends: A Dyadic Network and Spatially Explicit Study.

Despite the wide availability of PrEP, Latino men who have sex with men (LMSM) continue to experience access barriers. Novel HIV prevention research strategies to increase PrEP uptake and adherence among the high incidence populations, such as LMSM who misuse drugs, include social network analyses. This study identified the associations of drug use homophily within LMSM friendship networks and PrEP promotion conversations and described the physical overlap between geographic drug risk areas with conversations of PrEP promotion. Respondent-driven sampling was used to recruit 10 sociocentric networks. Quadratic assignment procedure (QAP) correlations and multiple regression QAPs were used to identify influences of drug use homophily, and geocoding and visualizations to describe drug use polygons and PrEP conversations. Friendship relationships in which both friends used cocaine or marijuana were more likely to report PrEP-related conversations in the past six months. The likelihood of talking about PrEP in the next six months was higher among dyads with cocaine use homophily and ecstasy use homophily, while lower among dyads with marijuana use homophily. Participants reported using marijuana and cocaine throughout Miami-Dade County while ecstasy polygons were mostly in urban areas. The majority of drug polygons associated with PrEP conversations were located in north and central Miami. Future interventions can consider enrolling entire sociocentric friendship groups, configuring friendship networks to connect those without PrEP information to those with information, and incorporating peer leaders.

"We want everything in a one-stop shop": acceptability and feasibility of PrEP and buprenorphine implementation with mobile syringe services for Black people who inject drugs.

INTRODUCTION: A recent surge in HIV outbreaks, driven by the opioid and stimulant use crises, has destabilized our progress toward targets set forth by Ending the HIV Epidemic: A Plan for America for the high-priority community of people who inject drugs (PWID), particularly Black PWID. METHODS: In order to ascertain the acceptability and feasibility of using a mobile syringe services program (SSP) for comprehensive HIV prevention via PrEP and medications for opioid use disorder (MOUD), our mixed methods approach included a quantitative assessment and semi-structured qualitative interviews with Black PWID (n = 30) in Miami-Dade County who were actively engaged in mobile syringe services. RESULTS: Participants felt that delivery of MOUD and PrEP at a mobile SSP would be both feasible and acceptable, helping to address transportation, cost, and stigma barriers common within traditional healthcare settings. Participants preferred staff who are compassionate and nonjudgmental and have lived experience. CONCLUSIONS: A mobile harm reduction setting could be an effective venue for delivering comprehensive HIV prevention services to Black PWID, a community that experiences significant barriers to care via marginalization and racism in a fragmented healthcare system.

PrEP Use and PrEP Use Disclosure are Associated with Condom Use During Sex: A Multilevel Analysis of Latino MSM Egocentric Sexual Networks.

Pre-exposure prophylaxis (PrEP) is integral to HIV prevention; however, the influence of PrEP use and PrEP use disclosure on condom use is unclear among Latinx men who have sex with men (LMSM). This study explored associations of LMSM PrEP use and use disclosure on consistent dyadic condom use in the past 6 months. Participants were 130 HIV-negative PrEP and non-PrEP using LMSM ages 20-39 years. Two-level logistic regression models assessing individual- and dyadic-level predictors on condom use were fitted using R. Participants reported a mean of four sexual partners (n = 507 dyads). Participants who reported using PrEP or having more sexual partners were more likely to use condoms; however, participants who reported disclosing PrEP use were less likely to use condoms. Future longitudinal studies should characterize approaches to increase informed personal health choices and conversations about PrEP, condom use, and other HIV risk-reduction strategies using network methodologies.

RESUMEN: La pastilla PrEP es un nuevo método profiláctico para prevenir el contagio del VIH. Aun no se ha determinado la manera en que el consumo de PrEP y las conversaciones sobre el uso de PrEP puedan influenciar en el uso de condones entre los hombres Latinos que tienen relaciones sexuales con otros hombres (HLSH). Este estudio exploró las asociaciones entre el uso y la divulgación del uso de PrEP con el uso de condones durante las relaciones sexuales que los HLSH tuvieron en los últimos 6 meses. En este estudio participaron un total 130 HLSH que eran VIH-negativos usuarios. Los participantes podían ser usuarios o no usuarios de PrEP, pero todos debían tener entre 20 y 39 años. Estimamos modelos de regresión logística de dos niveles, utilizando el programa R, para identificar factores individuales y diádicos asociados con el uso de condones. Los participantes reportaron un promedio de cuatro parejas sexuales (n = 507 diadas). Encontramos que los participantes que reportaron usar PrEP o tenían un promedio mayor de parejas sexuales tenían una mayor probabilidad de haber usando condones. Sin embargo, la probabilidad de haber usados condones se redujo en los participantes que comunicaron a sus parejas sexuales que usaban PrEP. Es necesario implementar otros estudios longitudinales para entender como diseñar estrategias basadas en redes sociales que promuevan conversaciones sobre PrEP y el uso de condones.

In Vitro Exposure of Leukocytes to HIV Preexposure Prophylaxis Decreases Mitochondrial Function and Alters Gene Expression Profiles.

The use of antiretroviral therapy (ART) as preexposure prophylaxis (PrEP) is an effective strategy for preventing HIV acquisition. The cellular consequences of PrEP exposure, however, have not been sufficiently explored to determine potential effects on health in individuals without HIV. In this study, peripheral blood mononuclear cells (PBMCs) from people without HIV were exposed to tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC) overnight. Mitochondrial mass and function were measured by flow cytometry and an Agilent XFp analyzer. Monocyte-derived macrophages (MDMs) were differentiated in 20% autologous serum for 5 days in the presence or absence of TDF or FTC, and surface markers, lipid uptake, and efferocytosis were measured by flow cytometry. MDM gene expression was measured using transcriptome sequencing (RNA-seq). Plasma lipids were measured using mass spectrometry. PBMCs exposed to TDF or FTC had decreased maximal oxygen consumption rate (OCR) and reduced mitochondrial mass. Exposure to PrEP also increased reactive oxygen species (ROS) production from monocyte subsets. Compared to MDMs cultured in medium alone, cells differentiated in the presence of TDF (829 genes) or FTC (888 genes) had significant changes in gene expression. Further, PrEP-exposed MDMs had decreased mitochondrial mass and displayed increased lipid uptake and reduced efferocytosis. Plasma biomarkers and lipid levels were also altered in vivo in individuals receiving a PrEP regimen. In conclusion, exposure of leukocytes to TDF or FTC resulted in decreased mitochondrial function and altered functional and transcriptional profiles. These findings may have important implications for the metabolic and immunologic consequences of PrEP in populations at risk for HIV acquisition.

Knowledge, attitudes, and practices of Florida physicians regarding dengue before and after an educational intervention.

BACKGROUND: Failure to recognize and appropriately manage dengue early in the clinical course may result in late initiation of supportive treatment for severe disease. In Florida, travel-related and autochthonous dengue occur and are likely under-recognized. The objective of this study was to evaluate physician knowledge of dengue and its management before and after an educational intervention in Florida. METHODS: From 2012-13 we conducted 14 grand-rounds style lectures on dengue clinical management attended by 413 physicians, and analyzed data from the pre- and post-tests. RESULTS: Of those attending, 231 and 220 completed the pre-and post-tests, respectively. Overall, the mean pre-test score for knowledge-based questions was 74.3 and average post-test score was 94.2%, indicating a mean increase of 19.9% (P < 0.0001, 95% CI 17.7-22.4). Reported confidence in dengue recognition and management also increased. Non-US trained physicians and those who had treated more than ten dengue cases performed significantly better in the pre-test. Post-test scores did not differ by subgroup. CONCLUSIONS: The train-the-trainer approach with grand-rounds style presentations appear to be an effective intervention to improve knowledge of dengue among physicians.

Preventing HIV infection: pre-exposure and postexposure prophylaxis.

Data supporting the use of pre-exposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) in the prevention of HIV infection after a sexual encounter continue to grow. In this review, we describe some of the research driving the various recommendations for use of antiretrovirals in prevention. In addition, current research is described regarding the establishment of viral reservoirs that argues for rethinking the timing for nPEP treatment. We discuss the variables that impact on the choice of prevention antiretrovirals, including drug distribution, drug transporters, and potential impact of race and ethnicity on these variables.

Adapting mHealth Interventions (PrEPmate and DOT Diary) to Support PrEP Retention in Care and Adherence Among English and Spanish-Speaking Men Who Have Sex With Men and Transgender Women in the United States: Formative Work and Pilot Randomized Trial.

BACKGROUND: A growing number of mobile health (mHealth) technologies are being developed to support HIV preexposure prophylaxis (PrEP) adherence and persistence; however, most tools have focused on men who have sex with men (MSM), and few are available in Spanish. To maximize the potential impact of these tools in reducing gender and racial/ethnic disparities and promoting health equity, mHealth tools tailored to Spanish-speaking people and transgender women are critically needed. OBJECTIVE: The aim of this study is to adapt and tailor 2 mHealth technologies, PrEPmate and DOT Diary, to support daily PrEP adherence and persistence among Spanish-speaking MSM and English- and Spanish-speaking transgender women and to evaluate the feasibility and acceptability of these tools. METHODS: PrEPmate, an interactive, bidirectional, text messaging intervention that promotes personalized communication between PrEP users and providers, and DOT Diary, a mobile app that promotes self-management of PrEP use and sexual health through an integrated electronic pill-taking and sexual activity diary, were previously developed for English-speaking MSM. We conducted 3 focus groups with 15 English- and Spanish-speaking transgender women and MSM in San Francisco and Miami to culturally tailor these tools for these priority populations. We then conducted a 1-month technical pilot among 21 participants to assess the usability and acceptability of the adapted interventions and optimize the functionality of these tools. RESULTS: Participants in focus groups liked the "human touch" of text messages in PrEPmate and thought it would be helpful for scheduling appointments and asking questions. They liked the daily reminder messages, especially the fun facts, gender affirmations, and transgender history topics. Participants recommended changes to tailor the language and messages for Spanish-speaking and transgender populations. For DOT Diary, participants liked the adherence tracking and protection level feedback and thought the calendar functions were easy to use. Based on participant recommendations, we tailored language within the app for Spanish-speaking MSM and transgender women, simplified the sexual diary, and added motivational badges. In the technical pilot of the refined tools, mean System Usability Scale scores were 81.2/100 for PrEPmate and 76.4/100 for DOT Diary (P=.48), falling in the "good" to "excellent" range, and mean Client Satisfaction Questionnaire scores were 28.6 and 28.3 for PrEPmate and DOT Diary, respectively (maximum possible score=32). Use of both tools was high over the 1-month pilot (average of 10.5 messages received from each participant for PrEPmate; average of 17.6 times accessing the DOT Diary app), indicating good feasibility for both tools. CONCLUSIONS: Using a user-centered design approach, we culturally tailored PrEPmate and DOT Diary to support daily PrEP use among Spanish-speaking MSM and English- and Spanish-speaking transgender women. Our positive findings in a technical pilot support further testing of these mHealth interventions in an upcoming comparative effectiveness trial.

Estimating the potential value of MSM-focused evidence-based implementation interventions in three Ending the HIV Epidemic jurisdictions in the United States: a model-based analysis.

INTRODUCTION: Improving the delivery of existing evidence-based interventions to prevent and diagnose HIV is key to Ending the HIV Epidemic in the United States. Structural barriers in the access and delivery of related health services require municipal or state-level policy changes; however, suboptimal implementation can be addressed directly through interventions designed to improve the reach, effectiveness, adoption or maintenance of available interventions. Our objective was to estimate the cost-effectiveness and potential epidemiological impact of six real-world implementation interventions designed to address these barriers and increase the scale of delivery of interventions for HIV testing and pre-exposure prophylaxis (PrEP) in three US metropolitan areas. METHODS: We used a dynamic HIV transmission model calibrated to replicate HIV microepidemics in Atlanta, Los Angeles (LA) and Miami. We identified six implementation interventions designed to improve HIV testing uptake ("Academic detailing for HIV testing," "CyBER/testing," "All About Me") and PrEP uptake/persistence ("Project SLIP," "PrEPmate," "PrEP patient navigation"). Our comparator scenario reflected a scale-up of interventions with no additional efforts to mitigate implementation and structural barriers. We accounted for potential heterogeneity in population-level effectiveness across jurisdictions. We sustained implementation interventions over a 10-year period and evaluated HIV acquisitions averted, costs, quality-adjusted life years and incremental cost-effectiveness ratios over a 20-year time horizon (2023-2042). RESULTS: Across jurisdictions, implementation interventions to improve the scale of HIV testing were most cost-effective in Atlanta and LA (CyBER/testing cost-saving and All About Me cost-effective), while interventions for PrEP were most cost-effective in Miami (two of three were cost-saving). We estimated that the most impactful HIV testing intervention, CyBER/testing, was projected to avert 111 (95% credible interval: 110-111), 230 (228-233) and 101 (101-103) acquisitions over 20 years in Atlanta, LA and Miami, respectively. The most impactful implementation intervention to improve PrEP engagement, PrEPmate, averted an estimated 936 (929-943), 860 (853-867) and 2152 (2127-2178) acquisitions over 20 years, in Atlanta, LA and Miami, respectively. CONCLUSIONS: Our results highlight the potential impact of interventions to enhance the implementation of existing evidence-based interventions for the prevention and diagnosis of HIV.

HIV-1 infection kinetics, drug resistance, and long-term safety of pre-exposure prophylaxis with emtricitabine plus tenofovir alafenamide (DISCOVER): week 144 open-label extension of a randomised, controlled, phase 3 trial.

BACKGROUND: Data characterising the long-term use and safety of emtricitabine plus tenofovir disoproxil fumarate as daily oral pre-exposure prophylaxis (PrEP) are scarce and there are uncertainties regarding the value of routine HIV-1 RNA testing during oral PrEP follow-up. METHODS: The DISCOVER trial was a randomised, controlled, phase 3 trial in which cisgender men and transgender women aged 18 years and older with a high likelihood of acquiring HIV were recruited from 94 clinics in Europe and North America and randomly assigned to receive either emtricitabine plus tenofovir disoproxil fumarate (200/25 mg) tablets daily, with matched placebo tablets, or emtricitabine plus tenofovir alafenamide (200/300 mg) tablets daily, with matched placebo tablets, for at least 96 weeks. After completion of the trial, participants were offered enrolment in this 48-week open-label extension study of emtricitabine plus tenofovir alafenamide. In participants diagnosed with HIV during the randomised and open-label phases of the study, we characterised HIV-1 test results and measured HIV-1 RNA viral load retrospectively when available. Adherence based on tenofovir diphosphate concentrations in dried blood spots and genotypic resistance were assessed in participants diagnosed with HIV. Safety assessments included adverse events, laboratory parameters, and, in a subset of participants, bone mineral density. HIV-1 incidence in participants initially randomly assigned to receive emtricitabine plus tenofovir alafenamide was estimated using a Poisson distribution. Changes from baseline in safety endpoints were described in participants assigned to received emtricitabine plus tenofovir alafenamide and in those who switched from emtricitabine plus tenofovir disoproxil fumarate during the open-label phase. This trial is registered with ClinicalTrials.gov, NCT02842086, and is ongoing. FINDINGS: Between Sept 13, 2016, and June 30, 2017, 5399 participants were enrolled and randomly assigned in DISCOVER. 2699 were assigned to receive emtricitabine plus tenofovir disoproxil fumarate and 2700 were assigned to receive emtricitabine plus tenofovir alafenamide, of whom 2693 and 2694, respectively, received at least one dose of study drug. 2115 (79%) assigned to emtricitabine plus tenofovir disoproxil fumarate switched to emtricitabine plus tenofovir alafenamide in the open-label phase, and 2070 (77%) continued with emtricitabine plus tenofovir alafenamide in the open-label phase. As of data cutoff (Dec 10, 2020), after 15 817 person-years of follow-up, 27 new HIV-1 diagnoses were observed across the total study period, with three occurring during the open-label phase. In participants who were initially assigned to emtricitabine plus tenofovir alafenamide, the incidence was 0·13 per 100 person-years (95% CI 0·061-0·23; ten of 2670). Stored plasma samples were available for 23 of 27 participants, including 22 with incident infection. In four (17%) of 23 participants, retrospective testing detected HIV-1 RNA before serological HIV-1 test positivity; one was a suspected baseline infection. Of the three incident cases, all three were non-adherent to PrEP and none developed drug resistance. Among participants taking emtricitabine plus tenofovir alafenamide for up to 144 weeks, markers of glomerular filtration and proximal renal tubule dysfunction (ß2-microglobulin to creatinine ratio and retinol-binding protein to creatinine ratio) improved or remained stable at 144 weeks compared with baseline, bone mineral density in hip and lumbar spine increased or remained stable from baseline to week 144 (n=191), cholesterol and glucose concentrations remained stable, and median bodyweight increased by less than 1 kg per year. In participants who switched from emtricitabine plus tenofovir disoproxil fumarate during the open-label phase (2115 [79%] of 2693), markers of glomerular filtration and proximal renal tubule dysfunction improved or remained stable, bone mineral density increased, cholesterol concentrations increased, glucose concentrations were similar, and median bodyweight increased more compared with those who remained on emtricitabine and tenofovir alafenamide. INTERPRETATION: Routine HIV-1 RNA testing for follow-up of individuals on daily oral PrEP provides modest additional clinical benefit. Long-term use of emtricitabine and tenofovir alafenamide as daily oral PrEP is safe and well tolerated and can be an especially appropriate choice for people with bone or renal morbidities. FUNDING: Gilead Sciences.

Addressing Disparities in Pre-Exposure Prophylaxis (PrEP) Access: Implementing a Community-Centered Mobile PrEP Program in South Florida.

Background: Pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but disparities in PrEP access remain considerable, particularly among Black and Latino men who have sex with men (MSM). To address this, the University of Miami Mobile PrEP Program was created, offering mobile HIV prevention/PrEP services in areas throughout South Florida where HIV incidence is high and PrEP access is geographically limited. Using a community-centered participatory approach, the program strategized and executed expansion into the Liberty City neighborhood of Miami. This study qualitatively assessed factors affecting Mobile PrEP implementation as perceived by community stakeholders, clients, and program staff. Methods: Forty-one in-depth interviews were conducted with 21 Mobile PrEP clients, 10 key informants from local health organizations, and 10 program staff. Interview questions queried perceived organizational and positional barriers and facilitators to mobile clinic implementation. Service satisfaction, setting preferences, social factors, and likelihood of recommending Mobile PrEP were also assessed. A thematic content analysis was performed using the Consolidated Framework for Implementation Research (CFIR) taxonomy as the guiding constructs for the analysis. Results: Participant statements indicated that providing no-cost services, convenient location, program-covered rideshares, individualized patient navigation, and a community-centric approach to patient care, which included staff members with shared lived experiences to increase positive interactions and renewed trust among poorly served communities, were facilitators of PrEP access and intervention uptake. The importance of program familiarization with the community before implementation, particularly for Black and African American communities, who may experience unique barriers to accessing sexual healthcare was strongly emphasized by participants. Conclusions: The Mobile PrEP intervention was found to be an acceptable and accessible mode of HIV/STI preventive care. The importance of pre-implementation community engagement and preparation is emphasized. Future research is needed to refine understanding of the intervention's components and evaluate implementation determinants in other highly impacted neighborhoods.

"Test-To-PrEP": Assessing Reach and Adoption of a New Approach to Increase HIV Testing and PrEP Knowledge Using HIV Self-Test Kit Distribution Through PrEP Clients' Social Networks.

BACKGROUND: HIV self-testing (HIVST) can increase the reach of HIV testing. Preexposure prophylaxis (PrEP) clients may be ideal distributors of HIVST kits and PrEP information within their social networks. This study uses the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to evaluate the distribution of HIVST bundled with PrEP information ("Test-to-PrEP" kits) among egocentric friendship networks of PrEP users. METHODS: The study was conducted in Miami from November 2021 to March 2022. Enrolled PrEP clients (egos; n = 100) were offered Test-to-PrEP kits for distribution. Egos and Test-to-PrEP kit users completed brief online surveys. Descriptive statistics are reported for participants, their reported network members, and users of the Test-to-PrEP kits. Logistic and Poisson regression assessed the relationship between characteristics of egos, alters, and the distribution of Test-to-PrEP kits. RESULTS: The 100 enrolled egos reported a total of 414 alters. Participants received 293 Test-to-PrEP kits for distribution with 47 of the 100 participants distributing at least 1 kit. Of those who scanned the quick-response code and responded to the survey, 16.2% reported no previous HIV test and 38.5% reported no prior knowledge of PrEP; 32.5% reported interest in distributing Test-to-PrEP kits, 3 successfully distributed kits, and 2 initiated PrEP. CONCLUSIONS: An approach using PrEP clients' social networks can disseminate HIVST bundled with PrEP information to critical populations including individuals lacking knowledge of PrEP or who have never been tested for HIV. Future studies will assess whether this use of network effects can increase reach and efficiency of HIV testing and PrEP information distribution.

Geographic Disparities in Availability of Spanish-Language PrEP Services Among Latino Sexual Minority Men in South Florida.

Latino sexual minority men (LSMM) experience barriers in accessing HIV pre-exposure prophylaxis (PrEP), such as lack of proximate culturally-appropriate PrEP navigation services. We examined associations between LSMM's immigration status and Spanish-language PrEP service availability. LSMM clinically indicated for PrEP were recruited from October 2018 to August 2019 in South Florida and completed an interviewer-administered questionnaire. PrEP service navigators in South Florida were identified using the CDC PrEP Directory. We constructed network service areas of 1-, 2-, and 5-miles from Spanish-speaking PrEP navigators. We used multilevel logistic regression to examine associations of individual (i.e., age, income, immigration status, network density) and zip code-level (i.e., population density, poverty, HIV risk) measures with availability of Spanish-language PrEP navigation services. A total of 131 participants clustered into 60 zip codes in South Florida. Latin American-born LSMM reported higher immigration and discrimination stress, and were 91% less likely to have PrEP navigation service availability, relative to LSMM born in the US. Zip code-level HIV incidence was associated with higher service availability within a 1-mile network of Spanish-speaking PrEP navigators. Spanish-language PrEP navigation services were available in high-HIV incidence zip codes; however, Latin American-born LSMM experienced reduced availability. Immigration and discrimination stress may explain lack of availability.

A community-based participatory research approach to the development, refinement, and distribution of Test-to-PrEP: A peer-to-peer distributed at-home HIV self-test and prevention information kit in Miami-Dade, Florida.

In the US, there is a need for interventions that address gaps in awareness, interest, and uptake of HIV testing and biomedical HIV prevention strategies, such as pre-exposure prophylaxis and non-occupational post-exposure prophylaxis. The Test-to-PrEP intervention; an HIV self-test bundled with prevention information that was distributed via a social network strategy, was found to be effective at bridging said gaps. This manuscript presents the development and design of Test-to-PrEP, in which a community-based participatory research approach was used. The intervention combines peer-to-peer distribution of HIV self-testing kits with tailored HIV prevention education. Key features include culturally sensitive educational materials, a strategic emphasis on the connection between intervention distributors and recipients, and rigorous training protocols. Our process led to the creation of materials that were neutral to sexual identity, highlighting the importance of inclusivity and cultural relevance. It also led to a mechanism that allows enhanced network member selection. Stakeholder guidance ensured the initiative was well-aligned with community needs, enhancing its potential acceptability and effectiveness. By centering community needs and cultural nuances, interventions like Test-to-PrEP can potentially increase their reach and efficacy. Our development process underscores the importance of community engagement, cultural relevance, and well-defined reporting.

Implementation of an integrated infectious disease and substance use disorder team for injection drug use-associated infections: a qualitative study.

BACKGROUND: Hospitalizations for severe injection drug use-related infections (SIRIs) are characterized by high costs, frequent patient-directed discharge, and high readmission rates. Beyond the health system impacts, these admissions can be traumatizing to people who inject drugs (PWID), who often receive inadequate treatment for their substance use disorders (SUD). The Jackson SIRI team was developed as an integrated infectious disease/SUD treatment intervention for patients hospitalized at a public safety-net hospital in Miami, Florida in 2020. We conducted a qualitative study to identify patient- and clinician-level perceived implementation barriers and facilitators to the SIRI team intervention. METHODS: Participants were patients with history of SIRIs (n = 7) and healthcare clinicians (n = 8) at one implementing hospital (Jackson Memorial Hospital). Semi-structured qualitative interviews were performed with a guide created using the Consolidated Framework for Implementation Research (CFIR). Interviews were transcribed, double coded, and categorized by study team members using CFIR constructs. RESULTS: Implementation barriers to the SIRI team intervention identified by participants included: (1) complexity of the SIRI team intervention; (2) lack of resources for PWID experiencing homelessness, financial insecurity, and uninsured status; (3) clinician-level stigma and lack of knowledge around addiction and medications for opioid use disorder (OUD); and (4) concerns about underinvestment in the intervention. Implementation facilitators of the intervention included: (1) a non-judgmental, harm reduction-oriented approach; (2) the team's advocacy for PWID as a means of institutional culture change; (3) provision of close post-hospital follow-up that is often inaccessible for PWID; (4) strong communication with patients and their hospital physicians; and (5) addressing diverse needs such as housing, insurance, and psychological wellbeing. CONCLUSION: Integration of infectious disease and SUD treatment is a promising approach to managing patients with SIRIs. Implementation success depends on institutional buy-in, holistic care beyond the medical domain, and an ethos rooted in harm reduction across multilevel (inner and outer) implementation contexts.