Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons.

Background: Twice-yearly subcutaneous lenacapavir has been shown to be efficacious for prevention of HIV infection in cisgender women. The efficacy of lenacapavir for preexposure prophylaxis (PrEP) in cisgender men, transgender women, transgender men, and gender-nonbinary persons is unclear.

Methods: In this phase 3, double-blind, randomized, active-controlled trial, we randomly assigned participants in a 2:1 ratio to receive subcutaneous lenacapavir every 26 weeks or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF).

Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases.

Primary vaccination with mRNA-1273 (100-µg) was safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the previously reported, blinded Part A of the phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial in adults (≥18 years) across 99 U.S. sites.

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.

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.

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.

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.

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.

"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.

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.

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.

"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.

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.

Integrated Infectious Disease and Substance Use Disorder Care for the Treatment of Injection Drug Use-Associated Infections: A Prospective Cohort Study With Historical Control.

Background: To address the infectious disease (ID) and substance use disorder (SUD) syndemic, we developed an integrated ID/SUD clinical team rooted in harm reduction at a county hospital in Miami, Florida. The Severe Injection-Related Infection (SIRI) team treats people who inject drugs (PWID) and provides medical care, SUD treatment, and patient navigation during hospitalization and after hospital discharge. We assessed the impact of the SIRI team on ID and SUD treatment and healthcare utilization outcomes.

"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.

Refining an Implementation Strategy to Enhance the Reach of HIV-Prevention and Behavioral Health Treatments to Latino Men Who Have Sex with Men.

Background: Latino men who have sex with men (LMSM) experience HIV and behavioral health disparities. Yet, evidence-based interventions, such as pre-exposure prophylaxis (PrEP) and behavioral health treatments, have not been equitably scaled up to meet LMSM needs. To address quality of life and the public health importance of HIV prevention, implementation strategies to equitably scale up these interventions to LMSM need to be developed.

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.

Feasibility and Acceptability of HIV Self-Test Kit Distribution Through PrEP Clients' Social and Sexual Networks to Increase HIV Testing and PrEP Information.

Objective: To determine the feasibility, acceptability, and implementation of a HIV self-test (HIVST) program through PrEP clients' social and sexual networks.

Background: HIV testing is critical for treatment and prevention engagement. HIVST kits can overcome barriers to testing.

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.

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.