Conectar
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.
Patient-reported outcome measures (PROMs) are required for patient-centred care. There are limited PROMs with good psychometric properties, and limitations to any language-based scale are often constrained by the written words or numerals used. Therefore, we developed the Functional Activity Scoring Tool (FAST), a self-reporting pictorial scale. FAST measures the impact of knee osteoarthritis on essential activities of daily living (ADL) and the significant changes in the self-perceived functional status over time.
This study aims to (1) develop FAST with adaptation from the Wong-Baker FACES pain rating scale, (2) validate FAST against the Patient-Specific Functional Scale (PSFS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and (3) establish the reliability, validity and responsiveness of FAST in individuals with knee osteoarthritis.
The prospective study protocol investigates the validity, responsiveness and reliability of FAST. The PSFS and KOOS will be gold standard comparisons. Participant recruitment will occur at four public polyclinics that offer physiotherapy outpatient services in Singapore. Onsite physiotherapists familiar with the study eligibilities will refer potential participants to the investigators after the routine physiotherapy assessment. After providing written consent, eligible participants will complete outcome measurements with FAST, the PSFS and KOOS during baseline and follow-up assessments. The Global Rating of Change (GROC) scale will determine how the participant’s knee status was changed compared with the beginning of the physiotherapy intervention.
SingHealth Centralised Institutional Review Board approved the study (CIRB reference number: 2022/2602). The final results will be published via scientific publication. FAST will benefit the evaluation and management of those who suffer knee osteoarthritis regardless of English proficiency or language barriers.
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