Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+).

This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm³), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies.

Ethical approval was obtained from the St Vincent’s Hospital Human Research Ethics Committee, St Vincent’s Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences.

NCT04415424.

The COVID-19 pandemic has had drastic effects on worldwide mental health and laid bare health disparities and inequities among marginalised groups and racial/ethnic minoritised communities in the USA. This is especially the case among Hispanic/Latino/a immigrants who face numerous structural and socioeconomic barriers to well-being. The increased mental health burden on Hispanic/Latino/a immigrants may have far reaching effects if left unaddressed. Thus, by understanding further Hispanic/Latino/a immigrant mental health during the pandemic, communities and health providers may be able to better address this growing issue. This scoping review aims to assess and outline the current literature on the pandemic’s effects on Hispanic/Latino/a immigrant mental health in the USA, identify research gaps and areas of urgent concern, and inform future research and public health interventions and guidelines.

A scoping review following the Joanna Briggs Institute methodology will be conducted. The PsycINFO, PubMed, Scopus and Web of Science: Core Collection databases and five grey literature sources will be searched for articles published in English from 1 January 2020 to 31 December 2022. Two independent reviewers will screen the search results at title and abstract and then full text using Covidence with conflicts resolved by a third reviewer. Data collection will also be performed in duplicate using Microsoft Excel with discrepancies resolved by a third reviewer and consensus discussion.

Ethics approval is not required for this scoping review. Results will be published in a peer-reviewed journal as well as presented at local and national conferences and meetings relevant to our field. Furthermore, to make our findings accessible to non-scientific audiences, we will use various mediums, such as graphical abstracts, policy briefs and fact sheets to share the results in both English and Spanish on different platforms.