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 .)
Role-based sexual identities structure male same-sex partnerships and influence HIV/STI epidemiology among MSM in Latin America. We explored shifting relationships between sexual roles, identities and practices among MSM in Lima, Peru, and implications for HIV/STI prevention. Patterns of HIV/STI epidemiology reflected differential risks for transmission within role-based partnerships with relatively low prevalences of HIV, syphilis, and HSV-2 but higher prevalences of urethral gonorrhea/chlamydia among activo MSM compared with moderno and pasivo participants. Qualitative analysis of how MSM in Peru integrate sexual identities, roles, and practices identified four key themes: pasivo role as a gay approximation of cultural femininity; activo role as a heterosexual consolidation of masculinity; moderno role as a masculine reconceptualization of gay identity; and role-based identities as social determinants of partnership, network, and community formation. The concept of role-based sexual identities provides a framework for HIV prevention for Latin American MSM that integrates sexual identities, practices, partnerships, and networks.
Introduction Diet-related disease is disproportionally concentrated in low-income communities where fruit and vegetable consumption is far below guidelines. To address financial barriers, Double Up Food Bucks (DUFB)—a statewide healthy food incentive—matches Supplemental Nutrition Assistance Program (SNAP) funds spent at farmers markets. However, incentive use is limited. This study examined the impact of a brief waiting room–based intervention about DUFB on program utilization and produce consumption. Study design Longitudinal, repeated measures, quasi-experimental trial. Setting/participants SNAP—enrolled adults at a health center in a low-income, racially and ethnically diverse area of Southeast Michigan. Intervention Participants received a brief explanation of DUFB, written program materials, a map highlighting market locations and hours, and an initial $10 market voucher. DUFB use and produce consumption were measured through four surveys over 5 months (August 2014–January 2015). Main outcome measures Outcome measures included DUFB use and fruit and vegetable consumption (analyses conducted in 2015–2016). Results A total of 302 eligible adults were identified, and 177 (59%) enrolled. One hundred twenty-seven (72%) completed all surveys. At baseline, 57% of participants reported shopping at a farmers market within the last year; 18% had previously used DUFB. By the end of the DUFB season, participants were significantly more likely to report DUFB use than at baseline (AOR=19.2, 95% CI=10.3, 35.5, p<0.001), with 69% of participants reporting use of DUFB at least once, and 34% reporting use of DUFB three or more times. Adjusted fruit and vegetable consumption increased from baseline by 0.65 servings/day (95% CI=0.37, 0.93, p<0.001) at 3 months, and remained 0.62 servings/day (95% CI=0.32, 0.92, p<0.001) higher than baseline 2 months post-DUFB season. Conclusions A brief clinic-based intervention was associated with a nearly fourfold increase in uptake of a SNAP incentive, as well as clinically significant increases in produce consumption. Results suggested sustained behavior change even once the financial incentive was no longer available. Providing information about healthy food incentives is a low-cost, easily implemented intervention that may increase produce consumption among low-income patients.
Introduction: In Peru, transgender women (TW) experience unique vulnerabilities for HIV infection due to factors that limit access to, and quality of, HIV prevention, treatment and care services. Yet, despite recent advances in understanding factors associated with HIV vulnerability among TW globally, limited scholarship has examined how Peruvian TW cope with this reality and how existing community-level resilience strategies are enacted despite pervasive social and economic exclusion facing the community. Addressing this need, our study applies the understanding of social capital as a social determinant of health and examines its relationship to HIV vulnerabilities to TW in Peru. Methods: Using qualitative methodology to provide an in-depth portrait, we assessed (1) intersections between social marginalization, social capital and HIV vulnerabilities; and (2) community-level resilience strategies employed by TW to buffer against social marginalization and to link to needed HIV-related services in Peru. Between January and February 2015, 48 TW participated (mean age = 29, range = 18–44) in this study that included focus group discussions and demographic surveys. Analyses were guided by an immersion crystallization approach and all coding was conducted using Dedoose Version 6.1.18. Results: Themes associated with HIV vulnerability included experiences of multilevel stigma and limited occupational opportunities that placed TW at risk for, and limited their engagement with, existing HIV services. Emergent resiliency-based strategies included peer-to-peer and intergenerational knowledge sharing, supportive clinical services (e.g. group-based clinic attendance) and emotional support through social cohesion (i.e. feeling part of a community). Conclusion: This study highlights the importance of TW communities as support structures that create and deploy social resiliency-based strategies aimed at deterring and mitigating the impact of social vulnerabilities to discrimination, marginalization and HIV risk for individual TW in Peru. Public health strategies seeking to provide HIV prevention, treatment and care for this population will benefit from recognizing existing social capital within TW communities and incorporating its strengths within HIV prevention interventions. At the intersection of HIV vulnerabilities and collective agency, dimensions of bridging and bonding social capital emerged as resiliency strategies used by TW to access needed healthcare services in Peru. Fostering TW solidarity and peer support are key components to ensure acceptability and sustainability of HIV prevention and promotion efforts.
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