Background: Pre-exposure prophylaxis (PrEP) for prevention of HIV infection has demonstrated efficacy in randomized controlled trials and in demonstration projects. For PrEP implementation to result in significant reductions in HIV incidence for men who have sex with men in the United States, sufficient access to PrEP care and continued engagement outside of demonstration projects is required. Methods: We report the results of a follow-up survey of 173 former participants from the Miami and San Francisco sites of the US PrEP Demo Project, administered 4–6 months after study completion. Results: Survey respondents continued to frequently access medical care and had a high incidence of sexually transmitted infections after completion of the Demo Project, indicating ongoing sexual risk behavior. Interest in continuing PrEP was high with 70.8% indicating that they were “very interested” in continuing PrEP. Among respondents, 39.9% reported continuation of PrEP after completion of the Demo Project, largely through their primary care providers and frequently at low or no cost. Variability in access and engagement was seen, with participants from the San Francisco site, those with medical insurance, and those with a primary care provider at the end of the Demo Project more likely to successfully obtain PrEP medication. Two respondents reported HIV seroconversion in the period between study completion and the follow-up survey. Conclusions: Additional effort to increase equitable access to PrEP outside of demonstration projects is needed to realize the potential impact of this evidence-based prevention intervention.

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. The open-label (Parts B and C) primary objectives were evaluation of long-term safety and effectiveness of primary vaccination plus a 50-µg booster dose; immunogenicity was a secondary objective. Of 29,035 open-label participants, 19,609 received boosters (mRNA-1273 [n = 9647]; placebo-mRNA-1273 [n = 9952]; placebo [n = 10] groups). Booster safety was consistent with that reported for primary vaccination. Incidences of COVID-19 and severe COVID-19 were higher during the Omicron BA.1 than Delta variant waves and boosting versus non-boosting was associated with a significant, 47.0% (95% CI : 39.0-53.9%) reduction of Omicron BA.1 incidence (24.6 [23.4 − 25.8] vs 46.4 [40.6 − 52.7]/1000 person-months). In an exploratory Cox regression model adjusted for time-varying covariates, a longer median interval between primary vaccination and boosting (mRNA-1273 [13 months] vs placebo-mRNA-1273 [8 months]) was associated with significantly lower, COVID-19 risk (24.0% [16.0% − 32.0%]) during Omicron BA.1 predominance. Boosting elicited greater immune responses against SARS-CoV-2 than primary vaccination, irrespective of prior SARS-CoV-2 infection. Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.

Effective approaches to promoting pre-exposure prophylaxis (PrEP) and linkage to PrEP care among those who may benefit the most from PrEP has proven to be a major challenge. We designed and pilot tested a strengths-based case management (SBCM) intervention for PrEP linkage. Adults interested in PrEP and meeting criteria (n = 61) were randomized to passive referral (control) or active SBCM (treatment). Outcomes measured were completion of provider visit, initiation of PrEP, and time to initiation of PrEP. Overall, 34% initiated PrEP by 12 weeks: 9 (29%) in the control group and 12 (40%) in the treatment group. The mean time to PrEP initiation was 13.1 weeks (95% confidence interval, 12.0-14.2) with no difference between groups (P = .382). There was a 21% difference in achieving a provider visit between the treatment and control groups (53.3% versus 32.3%) by 12 weeks (P = .096). Participants encountered financial, logistical, social, and provider-related barriers to PrEP access. Strengths-based case management–based patient navigation is a promising strategy for assisting PrEP seekers in obtaining a medical provider visit and initiating PrEP.

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 post-hospital discharge. We assessed the impact of the SIRI team on ID and SUD treatment and healthcare utilization outcomes. We prospectively collected data on patients seen by the SIRI team. A diagnostic code algorithm confirmed by chart review was used to identify a historical control group of patients with SIRI hospitalizations in the year preceding implementation of the SIRI team. The primary outcome was death or readmission within 90 days post-hospital discharge. Secondary outcomes included initiation of medications for opioid use disorder (MOUD) and antibiotic course completion. There were 129 patients included in the study: 59 in the SIRI team intervention and 70 in the pre-SIRI team control group. SIRI team patients had a 45% risk reduction (aRR = 0.55, 95% CI: [0.32, 0.95]; 24% vs. 44%) of being readmitted in 90 days or dying compared to pre-SIRI historical controls. SIRI team patients were more likely to initiate MOUD in the hospital (93% vs. 33%, p < 0.01), complete antibiotic treatment (90% vs. 60%, p < 0.01), and less likely to have patient-directed discharge (17% vs 37%, p = 0.02). An integrated ID/SUD team was associated with improvements in healthcare utilization, MOUD initiation, and antibiotic completion for PWID with infections.

SummaryPre- and non-occupational post-exposure prophylaxis for the prevention of HIV infection are recommended for adults at substantial risk of HIV. Women experiencing homelessness have increased risk of HIV infection compared with stably-housed women. We conducted a survey of 74 sheltered women at Lotus House Women's Shelter (Lotus House) in Miami to assess risk behaviour as well as knowledge and perception of pre- and non-occupational post-exposure prophylaxis in this population. Of surveyed women, 58.1% engaged in vaginal and/or anal sex while sheltered, and of sexually-active women 55.4% reported inconsistent condom use. 83.8% of women reported no concern regarding HIV acquisition due to their behaviour. Few women surveyed (20.8%) had previously heard of pre- or non-occupational post-exposure prophylaxis. The majority (58.3%) of respondents indicated receptiveness to these prevention methods when introduced. Those indicating that they would consider pre- or non-occupational post-exposure prophylaxis were significantly younger than those indicating that they would not consider these prevention strategies (p = 0.004). Education and referral for pre- and non-occupational post-exposure prophylaxis should be considered for sheltered women at risk of HIV infection. Additional research to optimise implementation of biomedical prevention strategies in this population is needed.