Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol.

INTRODUCTION: 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+). METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT04415424.

Associations between intravaginal practices and incidence of sexually transmitted infections and bacterial vaginosis among women enrolled in the dapivirine vaginal ring trial (The Ring Study) in southwestern Uganda: a retrospective secondary analysis.

OBJECTIVES: We assessed associations between intravaginal practices (IVPs) and the incidence of sexually transmitted infections (STIs) and bacterial vaginosis (BV) among women using the dapivirine vaginal ring (DVR) or placebo vaginal ring in southwestern Uganda. METHODS: This was a retrospective secondary analysis of data collected from women at risk of HIV infection recruited into the Ring Study. The latter evaluated the safety and efficacy of the DVR between 2013 and 2016. At baseline, a behavioural questionnaire was administered to obtain information on sexual activity and IVP (exposure) defined as; insertion inside the vagina of any items aimed at cleaning the vagina for any reason before, during or after sex other than practices to manage menses. Each participant self-inserted the DVR/placebo and replaced it every 4 weeks for 2 years. Outcomes were diagnosis of STIs, that is, Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis (TV), HIV and BV. The incidence rate of STI/BV was estimated, overall, by IVP and trial arm in single-event-per-participant and multiple-event-per-participant analyses. RESULTS: Of the 197 women enrolled, 66 (33.5%) were <25 years of age. Overall, 93 (47.2%) practised at least one form of IVP. During the follow-up, 172 (87.3%) women were diagnosed with an STI/BV at least once. The majority had TV (73.6%, n=145). Overall rate of STI/BV was 51.9/100 person-years, 95% CI 44.7 to 60.3 (IVP: yes, 51.0 (40.8-63.8) vs no, 52.6 (43.0-64.4)). IVPs were not statistically significantly associated with rate of individual STIs/BV. Similar results were observed when the analyses were conducted separately for each trial arm. CONCLUSIONS: IVP was not associated with risk of STIs/BV in the Ring Study. TRIAL REGISTRATION NUMBER: NCT01539226.

Dyadic Adjustment of Couples and State Anxiety in Patients Tested for Sexually Transmitted Infections.

Background: While existing literature addresses the psychological impact of HIV, there is a notable gap in data regarding other sexually transmitted infections (STIs). This study aims to fill this gap by evaluating the association between STIs, the psychological profile of patients as measured by anxiety levels, and the impact on couple adaptability. Methods: A prospective investigation was conducted in Romania, from November 2021, including individuals with high suspicion of STI and healthy controls. Data collection comprised a questionnaire, the Dyadic Adjustment Scale (DAS), and State-Trait Anxiety Inventory (STAI Y-1). Statistical methods, including multivariate logistic and linear regressions, were used to carry out the analyses. Results: The participant cohort consisted of 441 individuals. STI participants exhibited consistently lower DAS scores, notably in dyadic adaptability (DA) (p = 0.031), dyadic satisfaction (DS) (p = 0.006), and affectional expression (AE) (p = 0.016). Multivariate logistic regression with adjustment for confounders confirmed a significant association between STIs and atypical DAS responses (2.56-fold increase). STAI T scores were significantly higher in the STI suspected group (p < 0.01), remaining robust after adjusting for confounders in a multiple linear regression model. Conclusions: Our prospectively designed study highlights the mental health repercussions associated with STIs. This is evident through the diminished DAS scores and heightened STAI Y-1 scores observed in individuals with suspected STIs.

A systematic review and meta-analysis of sexually transmitted infections and blood-borne viruses in travellers.

BACKGROUND: Sexually transmitted infections (STIs) and blood-borne viruses (BBVs) impose a global health and economic burden. International travellers facilitate the spread of infectious diseases, including STIs. Hence, this review assessed the prevalence/proportionate morbidity of travellers with STIs and sexually transmitted BBVs, and factors associated with the infection in this population. METHODS: PubMed, Scopus, Web of Science, CINHAL, Embase, and Cochrane Library were searched from inception of the databases until November 2022. Published analytical observational studies reporting the prevalence/proportionate morbidity of travellers with STIs and factors associated with STIs by type of traveller (i.e. tourists, business travellers, students, visiting friends or relatives [VFRs], international truck drivers, backpackers, expatriates, and men who have sex with men [MSM]) were included. The selection of articles, data extraction, and risk of bias assessment were conducted by two independent reviewers. Meta-analyses were conducted for each STI by clinical presentation and type of traveller. RESULTS: Thirty-two studies (n = 387 731 travellers) were included, 19 evaluated the proportionate morbidity of STIs among symptomatic travellers, while 13 examined the prevalence of STIs in asymptomatic travellers. The highest proportionate morbidity was found among VFRs (syphilis, 1.67%; 95%CI:1.03-2.81%), backpackers (chlamydia trachomatis, 6.58%; 95%CI: 5.96-7.25%), and MSM (HIV [2.50%;95%CI:0.44-12.88%], gonorrhoea [4.17%;95%CI:1.1.5-13.98%], lymphogranuloma venereum [4.17%;95%CI:1.1.5-13.98%], and HAV [20.0%; 95% CI: 14.99-26.17%]). The highest prevalence of STIs among asymptomatic were found in MSM (HIV [25.94%;95%CI:22.21-30.05%] and HBV [24.90%; 95%CI:21.23-28.96%]) and backpackers (chlamydia trachomatis, 3.92%;95% CI:2.72-5.32%). Short duration of the trip (<1 month), not having pre-travel consultation, travelling to Southeast Asia, and being unvaccinated for HBV were identified as risk factors for STIs. CONCLUSION: Strategies to prevent STIs and sexually transmitted BBVs should be discussed at pretravel consultations and recommendations should be prioritized in high-risk groups of travellers, such as backpackers, VFRs, and MSMs. Additionally, healthcare providers should tailor recommendations for safe sex practices to individual travellers' unique needs.

Prevalence and determinants of not testing for HIV among young adult women in Papua New Guinea: findings from the Demographic and Health Survey, 2016-2018.

OBJECTIVE: The aim of this study was to assess the prevalence of not testing for HIV and its determinants among young adult women aged 15-29 years in Papua New Guinea (PNG). DESIGN AND SETTING: The study used secondary data from the 2016 to 2018 PNG Demographic and Health Survey (PNGDHS), a nationally representative cross-sectional survey that used a two-stage stratified sampling. PARTICIPANTS: A total weighed sample of 5164 young adult women aged 15-29 years were included in the analysis. PRIMARY OUTCOME MEASURE: Ever been tested for HIV was the primary outcome of the study. All analyses were adjusted using survey weights to account for unequal sampling probabilities. RESULTS: The prevalence of not testing for HIV was 58.8% (95% CI: 57.4% to 60.1%). The mean age was 21.65 years (SD = 4.23). Of the women who were not tested for HIV, the majority were never married (79.4%), without formal education (63%), not working (60.2%), and from rural areas (62.9%). In the multivariable analysis, those who were never married (adjusted OR (AOR) 4.9, 95% CI 3.6 to 6.6), had poor wealth index (AOR 1.8, 95% CI 1.3 to 2.5), were from rural areas (AOR 2.0, 95% CI 1.5 to 2.6), were from the Momase region (AOR 1.3, 95% CI 1.0 to 1.7), did not read newspapers or magazines (AOR 1.7, 95% CI 1.3 to 2.1), did not listen to the radio (AOR 1.5, 95% CI 1.1 to 2.0), experienced early sexual debut (AOR 1.5, 95% CI 1.1 to 1.9), had one sexual partner (AOR 1.5, 95% CI 1.2 to 2.0) and reported no sexually transmitted infection (STI) in the past 12 months (AOR 1.8, 95% CI 1.1 to 3.1) had higher odds of not testing for HIV. CONCLUSIONS: Our study found a very high unmet need for HIV testing among young adult women in PNG. Health promotion programmes should be designed to increase HIV knowledge and access to testing services, particularly targeting young women who are disadvantaged and from rural areas.

Laboratory Data Timeliness and Completeness Improves Following Implementation of an Electronic Laboratory Information System in Côte d'Ivoire: Quasi-Experimental Study on 21 Clinical Laboratories From 2014 to 2020.

BACKGROUND: The Ministry of Health in Côte d'Ivoire and the International Training and Education Center for Health at the University of Washington, funded by the United States President's Emergency Plan for AIDS Relief, have been collaborating to develop and implement the Open-Source Enterprise-Level Laboratory Information System (OpenELIS). The system is designed to improve HIV-related laboratory data management and strengthen quality management and capacity at clinical laboratories across the nation. OBJECTIVE: This evaluation aimed to quantify the effects of implementing OpenELIS on data quality for laboratory tests related to HIV care and treatment. METHODS: This evaluation used a quasi-experimental design to perform an interrupted time-series analysis to estimate the changes in the level and slope of 3 data quality indicators (timeliness, completeness, and validity) after OpenELIS implementation. We collected paper and electronic records on clusters of differentiation 4 (CD4) testing for 48 weeks before OpenELIS adoption until 72 weeks after. Data collection took place at 21 laboratories in 13 health regions that started using OpenELIS between 2014 and 2020. We analyzed the data at the laboratory level. We estimated odds ratios (ORs) by comparing the observed outcomes with modeled counterfactual ones when the laboratories did not adopt OpenELIS. RESULTS: There was an immediate 5-fold increase in timeliness (OR 5.27, 95% CI 4.33-6.41; P<.001) and an immediate 3.6-fold increase in completeness (OR 3.59, 95% CI 2.40-5.37; P<.001). These immediate improvements were observed starting after OpenELIS installation and then maintained until 72 weeks after OpenELIS adoption. The weekly improvement in the postimplementation trend of completeness was significant (OR 1.03, 95% CI 1.02-1.05; P<.001). The improvement in validity was not statistically significant (OR 1.34, 95% CI 0.69-2.60; P=.38), but validity did not fall below pre-OpenELIS levels. CONCLUSIONS: These results demonstrate the value of electronic laboratory information systems in improving laboratory data quality and supporting evidence-based decision-making in health care. These findings highlight the importance of OpenELIS in Côte d'Ivoire and the potential for adoption in other low- and middle-income countries with similar health systems.

Estimation of the Population Size of Street- and Venue-Based Female Sex Workers and Sexually Exploited Minors in Rwanda in 2022: 3-Source Capture-Recapture.

BACKGROUND: HIV surveillance among key populations is a priority in all epidemic settings. Female sex workers (FSWs) globally as well as in Rwanda are disproportionately affected by the HIV epidemic; hence, the Rwanda HIV and AIDS National Strategic Plan (2018-2024) has adopted regular surveillance of population size estimation (PSE) of FSWs every 2-3 years. OBJECTIVE: We aimed at estimating, for the fourth time, the population size of street- and venue-based FSWs and sexually exploited minors aged ≥15 years in Rwanda. METHODS: In August 2022, the 3-source capture-recapture method was used to estimate the population size of FSWs and sexually exploited minors in Rwanda. The field work took 3 weeks to complete, with each capture occasion lasting for a week. The sample size for each capture was calculated using shinyrecap with inputs drawn from previously conducted estimation exercises. In each capture round, a stratified multistage sampling process was used, with administrative provinces as strata and FSW hotspots as the primary sampling unit. Different unique objects were distributed to FSWs in each capture round; acceptance of the unique object was marked as successful capture. Sampled FSWs for the subsequent capture occasions were asked if they had received the previously distributed unique object in order to determine recaptures. Statistical analysis was performed in R (version 4.0.5), and Bayesian Model Averaging was performed to produce the final PSE with a 95% credibility set (CS). RESULTS: We sampled 1766, 1848, and 1865 FSWs and sexually exploited minors in each capture round. There were 169 recaptures strictly between captures 1 and 2, 210 recaptures exclusively between captures 2 and 3, and 65 recaptures between captures 1 and 3 only. In all 3 captures, 61 FSWs were captured. The median PSE of street- and venue-based FSWs and sexually exploited minors in Rwanda was 37,647 (95% CS 31,873-43,354), corresponding to 1.1% (95% CI 0.9%-1.3%) of the total adult females in the general population. Relative to the adult females in the general population, the western and northern provinces ranked first and second with a higher concentration of FSWs, respectively. The cities of Kigali and eastern province ranked third and fourth, respectively. The southern province was identified as having a low concentration of FSWs. CONCLUSIONS: We provide, for the first time, both the national and provincial level population size estimate of street- and venue-based FSWs in Rwanda. Compared with the previous 2 rounds of FSW PSEs at the national level, we observed differences in the street- and venue-based FSW population size in Rwanda. Our study might not have considered FSWs who do not want anyone to know they are FSWs due to several reasons, leading to a possible underestimation of the true PSE.

Gonorrhea caused due to antimicrobial-resistant bacteria Neisseria gonorrhoeae treated using probiotic peptide.

Neisseria gonorrhea is a sexually transmitted disease from gonorrhea that lacks treatment; despite the urgency, the absence of adequate drugs, lack of human correlates of protection, and inadequate animal models of infection have delayed progress toward the prevention of gonococcal infection. Lactobacillus crispatus is a lactic acid bacterium typically found in the human vaginal microbiota. Peptides from L. crispatus have shown a potential therapeutic option for targetting N. gonorrhea. Bioinformatics analysis is important for speeding up drug target acquisition, screening refinement, and evaluating adverse effects and drug resistance prediction. Therefore, this study identified an antimicrobial peptide from the bacteriocin immunity protein (BIP) of L. crispatus using the bioinformatics tool and Collection of Antimicrobial Peptide (CAMPR3). Based on the AMP score and highest ADMET properties, the peptide SM20 was chosen for docking analysis. SM20 was docked against multiple proteins from the genome of the AMR bacterium N. gonorrhea using an online tool; protein-peptide interactions were established and visualized using the PyMol visualizing tool. Molecular docking was carried out using the CABSdock tool, and multiple conformations were obtained against the membrane proteins of N. gonorrhoea. The peptide SM20 exhibited higher docking scores and ADMET properties. Therefore, SM20 could be further encapsulated with cellulose; it can be applied topically to the genital tract to target N. gonorrhea infection. The controlled release of the antimicrobial peptide from the gel can provide sustained delivery of the treatment, increasing its efficacy and reducing the risk of resistance development.

Intranasal delivery of Salmonella OMVs decorated with Chlamydia trachomatis antigens induces specific local and systemic immune responses.

Chlamydia trachomatis is an obligate intracellular pathogen responsible for the most prevalent bacterial sexually transmitted disease globally. The high prevalence of chlamydial infections underscores the urgent need for licensed and effective vaccines to prevent transmission in populations. Bacterial outer membrane vesicles (OMVs) have emerged as promising mucosal vaccine carriers due to their inherent adjuvant properties and the ability to display heterologous antigens. In this proof-of-concept study, we evaluated the immunogenicity of Salmonella OMVs decorated with C. trachomatis MOMP-derived CTH522 or HtrA antigens in mice. Following a prime-boost intranasal vaccination approach, two OMV-based C. trachomatis vaccines elicited significant humoral responses specific to the antigens in both systemic and vaginal compartments. Furthermore, we demonstrated strong antigen-specific IFN-γ and IL17a responses in splenocytes and cervical lymph node cells of vaccinated mice, indicating CD4+ Th1 and Th17 biased immune responses. Notably, the OMV-CTH522 vaccine also induced the production of spleen-derived CD8+ T cells expressing IFN-γ. In conclusion, these results highlight the potential of OMV-based C. trachomatis vaccines for successful use in future challenge studies and demonstrate the suitability of our modular OMV platform for intranasal vaccine applications.

Using Social Listening for Digital Public Health Surveillance of Human Papillomavirus Vaccine Misinformation Online: Exploratory Study.

Despite challenges related to the data quality, representativeness, and accuracy of artificial intelligence-driven tools, commercially available social listening platforms have many of the attributes needed to be used for digital public health surveillance of human papillomavirus vaccination misinformation in the online ecosystem.

Exploring young people's attitudes to HIV prevention medication (PrEP) in England: a qualitative study.

INTRODUCTION: Young people aged 18-24 years old are a key demographic target for eliminating HIV transmission globally. Pre-exposure prophylaxis (PrEP), a prevention medication, reduces HIV transmission. Despite good uptake by gay and bisexual men who have sex with men, hesitancy to use PrEP has been observed in other groups, such as young people and people from ethnic minority backgrounds. The aim of this study was to explore young people's perceptions and attitudes to using PrEP. DESIGN: A qualitative transcendental phenomenological design was used. PARTICIPANTS AND SETTING: A convenience sample of 24 young people aged between 18 and 24 years was recruited from England. METHODS: Semistructured interviews and graphical elicitation were used to collect data including questions about current experiences of HIV care, awareness of using PrEP and decision-making about accessing PrEP. Thematic and visual analyses were used to identify findings. RESULTS: Young people had good levels of knowledge about HIV but poor understanding of using PrEP. In this information vacuum, negative stigma and stereotypes about HIV and homosexuality were transferred to using PrEP, which were reinforced by cultural norms portrayed on social media, television and film-such as an association between using PrEP and being a promiscuous, white, gay male. In addition, young people from ethnic minority communities appeared to have negative attitudes to PrEP use, compared with ethnic majority counterparts. This meant these young people in our study were unable to make decisions about when and how to use PrEP. CONCLUSION: Findings indicate an information vacuum for young people regarding PrEP. A strength of the study is that theoretical data saturation was reached. A limitation of the study is participants were largely from Northern England, which has low prevalence of HIV. Further work is required to explore the information needs of young people in relation to PrEP.

Scoping review of HIV-related intersectional stigma among sexual and gender minorities in sub-Saharan Africa.

OBJECTIVES: Sexual and gender minority (SGM) populations in sub-Saharan Africa (SSA) are disproportionately impacted by HIV and often face multiple HIV-related stigmas. Addressing these stigmas could reduce SGM HIV vulnerability but little is known about how the stigmas operate and intersect. Intersectional stigma offers a lens for understanding the experiences of stigmatised populations and refers to the synergistic negative health effects of various systems of oppression on individuals with multiple stigmatised identities, behaviours or conditions. This review aims to (1) assess how often and in what ways an intersectional lens is applied in HIV-related stigma research on SGM populations in SSA and (2) understand how intersectional stigma impacts HIV risk in these populations. DESIGN: Scoping review following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews. DATA SOURCES: Public health and regional databases were searched in 2020 and 2022. ELIGIBILITY CRITERIA: Articles in French and English on HIV-related stigma and HIV outcomes among men who have sex with men, women who have sex with women and/or transgender individuals in SSA. DATA EXTRACTION AND SYNTHESIS: Articles were screened and extracted twice and categorised by use of an intersectional approach. Study designs and stigma types were described quantitatively and findings on intersectional stigma were thematically analysed. RESULTS: Of 173 articles on HIV-related stigma among SGM in SSA included in this review, 21 articles (12%) applied an intersectional lens. The most common intersectional stigmas investigated were HIV and same-sex attraction/behaviour stigma and HIV, same-sex attraction/behaviour and gender non-conformity stigma. Intersectional stigma drivers, facilitators and manifestations were identified across individual, interpersonal, institutional and societal socioecological levels. Intersectional stigma impacts HIV vulnerability by reducing HIV prevention and treatment service uptake, worsening mental health and increasing exposure to HIV risk factors. CONCLUSION: Intersectional approaches are gaining traction in stigma research among SGM in SSA. Future research should prioritise quantitative and mixed methods investigations, diverse populations and intervention evaluation.

Impact of human papillomavirus age-related prevalence and vaccination levels on interpretation of cervical screening modalities: a modelling study.

OBJECTIVE: Cervical screening is a life-saving intervention, which reduces the incidence of and mortality from cervical cancer in the population. Human papillomavirus (HPV) based screening modalities hold unique promise in improving screening accuracy. HPV prevalence varies markedly by age, as does resultant cervical intraepithelial neoplasia (CIN), with higher rates recorded in younger women. With the advent of effective vaccination for HPV drastically reducing prevalence of both HPV and CIN, it is critical to model how the accuracy of different screening approaches varies with age cohort and vaccination status. This work establishes a model for the age-specific prevalence of HPV factoring in vaccine coverage and predicts how the accuracy of common screening modalities is affected by age profile and vaccine uptake. DESIGN: Modelling study of HPV infection rates by age, ascertained from European cohorts prior to the introduction of vaccination. Reductions in HPV due to vaccination were estimated from the bounds predicted from multiple modelling studies, yielding a model for age-varying HPV and CIN grades 2 and above (CIN2+) prevalence. SETTING: Performance of both conventional liquid-based cytology (LBC) screening and HPV screening with LBC reflex (HPV reflex) was estimated under different simulated age cohorts and vaccination levels. PARTICIPANTS: Simulated populations of varying age and vaccination status. RESULTS: HPV-reflex modalities consistently result in much lower incidence of false positives than LBC testing, with an accuracy that improves even as HPV and CIN2+ rates decline. CONCLUSIONS: HPV-reflex tests outperform LBC tests across all age profiles, resulting in greater test accuracy. This improvement is especially pronounced as HPV infection rates fall and suggests HPV-reflex modalities are robust to future changes in the epidemiology of HPV.

Cohort profile: PRESTIGIO, an Italian prospective registry-based cohort of people with HIV-1 resistant to reverse transcriptase, protease and integrase inhibitors.

PURPOSE: The PRESTIGIO Registry was established in 2017 to collect clinical, virological and immunological monitoring data from people living with HIV (PLWH) with documented four-class drug resistance (4DR). Key research purposes include the evaluation of residual susceptibility to specific antiretrovirals and the validation of treatment and monitoring strategies in this population. PARTICIPANTS: The PRESTIGIO Registry collects annual plasma and peripheral blood mononuclear cell samples and demographic, clinical, virological, treatment and laboratory data from PLWH followed at 39 Italian clinical centres and characterised by intermediate-to-high genotypic resistance to ≥1 nucleoside reverse transcriptase inhibitors, ≥1 non-nucleoside reverse transcriptase inhibitors, ≥1 protease inhibitors, plus either intermediate-to-high genotypic resistance to ≥1 integrase strand transfer inhibitors (INSTIs) or history of virological failure to an INSTI-containing regimen. To date, 229 people have been recorded in the cohort. Most of the data are collected from the date of the first evidence of 4DR (baseline), with some prebaseline information obtained retrospectively. Samples are collected from the date of enrollment in the registry. FINDINGS TO DATE: The open-ended cohort has been used to assess (1) prognosis in terms of survival or development of AIDS-related or non-AIDS-related clinical events; (2) long-term efficacy and safety of different antiretroviral regimens and (3) virological and immunological factors predictive of clinical outcome and treatment efficacy, especially through analysis of plasma and cell samples. FUTURE PLANS: The registry can provide new knowledge on how to implement an integrated approach to study PLWH with documented resistance to the four main antiretroviral classes, a population with a limited number of individuals characterised by a high degree of frailty and complexity in therapeutic management. Given the scheduled annual updates of PLWH data, the researchers who collaborate in the registry can send study proposals at any time to the steering committee of the registry, which evaluates every 3 months whether the research studies can be conducted on data and biosamples from the registry and whether they are aimed at a better understanding of a specific health condition, the emergence of comorbidities or the effect of potential treatments or experimental drugs that may have an impact on disease progression and quality of life. Finally, the research studies should aim to be inclusive, innovative and in touch with the communities and society as a whole. TRIAL REGISTRATION NUMBER: NCT04098315.

Temporal Trends in Syphilis Incidence among Men with HIV in Busan, Korea, 2005-2022: A Retrospective Cohort Study.

We aimed to assess the temporal trends of incident syphilis and its associated risk factors among men with HIV (Human Immunodeficiency Virus) in Korea during the COVID-19 pandemic. We conducted a retrospective cohort study of men with HIV attending an HIV clinic in Korea between 2005 and 2022. Of 767 men with HIV, 499 were included and contributed 3220 person-years (PY) of the observation period. Eighty-two patients were diagnosed with incident syphilis, with an overall incidence of 2.55/100 PY (95% confidence interval [CI] 20.56-31.53). The incidence of syphilis per 100 PY gradually decreased from 2.43 (0.79-7.42) in 2005-2007 to 1.85 (1.08-3.17) in 2014-2016; however, it increased to 3.0 (1.99-4.53) in 2017-2019, and further to 3.33 (2.26-4.89) in 2020-2022. A multivariate analysis identified young age (≤30 years versus >50, adjusted HR 6.27, 95% CI 2.38-16.56, p < 0.001), treponemal test positive at baseline (2.33, 1.48-3.67, p < 0.001), men who have sex with men (2.36, 1.34-4.16, p = 0.003), and history of incarceration (2.62, 1.21-5.67, p = 0.015) as risk factors for incident syphilis. Recently, syphilis incidence in men with HIV has increased in Korea, especially in young patients and at-risk groups, highlighting the need for enhanced regular screening and targeted behavioral interventions among these populations.

Analytical and clinical validation of a multiplex PCR assay for detection of Neisseria gonorrhoeae and Chlamydia trachomatis including simultaneous LGV serotyping on an automated high-throughput PCR system.

For effective infection control measures for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), a reliable tool for screening and diagnosis is essential. Here, we aimed to establish and validate a multiplex PCR assay on an automated system using a dual-target approach for the detection of CT/NG and differentiation between lymphogranuloma venereum (LGV) and non-LGV from genital and extra-genital specimens. Published primer/probe sets (CT: pmpH, cryptic plasmid; NG: porA, opa) were modified for the cobas 5800/6800/8800. Standards quantified by digital PCR were used to determine linearity and lower limit of detection (LLoD; eSwab, urine). For clinical validation, prospective samples (n = 319) were compared with a CE-marked in vitro diagnostics (CE-IVD) assay. LLoDs ranged from 21.8 to 244 digital copies (dcp)/mL and 10.8 to 277 dcp/mL in swab and urine, respectively. A simple linear regression analysis yielded slopes ranging from -4.338 to -2.834 and Pearson correlation coefficients from 0.956 to 0.994. Inter- and intra-run variability was <0.5 and <1 cycle threshold (ct), respectively. No cross-reactivity was observed (n = 42). Clinical validation showed a sensitivity of 94.74% (95% confidence interval (CI): 87.23%-97.93%) and 95.51% (95% CI: 89.01%-98.24%), a specificity of 99.59% (95% CI: 97.71%-99.98%) and 99.57% (95% CI: 97.58%-99.98%), positive predictive values of 89.91% (estimated prevalence: 3.7%; 95% CI: 80.91%-95.6%) and 88.61% (estimated prevalence: 3.4%; 95% CI: 80.18%-94.34%), and negative predictive values of 99.81% (95% CI: 98.14%-100%) and 99.85% (95% CI: 98.14%-100%) for the detection of CT and NG, respectively. In conclusion, we established a dual-target, internally controlled PCR on an automated system for the detectiwon of CT/NG from genital and extra-genital specimens. Depending on local regulations, the assay can be used as a screening or a confirmatory/typing assay.IMPORTANCEChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) represent a major global health burden, with the World Health Organization estimating that >128 million and >82 million people, respectively, were newly infected in 2020. For effective infection control measures, a reliable tool for sensitive diagnosis and screening of CT/NG is essential. We established a multiplex PCR assay for the detection of CT/NG and simultaneous discrimination between lymphogranuloma venereum (LGV) and non-LGV strains, which has been validated for genital and extra-genital specimens on a fully automated system. To increase assay sensitivity, a dual-target approach has been chosen for both pathogens. This strategy reduces false-positive results in oropharyngeal swabs due to the detection of commensal N. species that may harbor NG DNA fragments targeted in the PCR due to horizontal gene transmission following previous infection. In sum, the established assay provides a powerful tool for use as either a screening/diagnostic or a typing/confirmatory assay.

Risk factors for human papillomavirus infection and disease: A targeted literature summary.

Adolescents are the primary cohort for routine human papillomavirus (HPV) vaccination, but unvaccinated adults may also benefit. A lack of consensus on which adults to target and the presence of reimbursement barriers likely contribute to the lag in adult vaccinations, highlighting missed prevention opportunities. Understanding factors contributing to risk of HPV infection and disease could help in decision making on vaccination. This review summarizes existing literature on risk factors for HPV infection and disease and includes 153 studies reporting relative risks or odds ratios for factors associated with HPV infection or disease in adults, published between 2009 and 2020. Despite inconsistent design and reporting of risk factors across studies, this review confirmed several risk factors associated with adult infection, including human immunodeficiency virus positivity, number of sex partners, and smoking. These findings can support policymaking, guideline development, and clinical decision making for HPV vaccination and screening of high-risk adult groups.

Research on the barriers to accessing sexual healthcare for sexually diverse Muslim men: protocol for a scoping review.

INTRODUCTION: Sexually diverse Muslim men are seen to be at a higher risk for HIV and other sexually transmitted infections due to their limited access to sexual healthcare services. We outline a protocol to conduct a scoping review of research on the barriers that may impede these men's access to sexual healthcare. METHODS AND ANALYSIS: To conduct this scoping review, we will follow the methodological framework developed by Arksey and O'Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses' extension for scoping reviews. To classify the barriers to sexual healthcare, we will employ Bronfenbrenner's socioecological model as a conceptual framework. We will conduct a literature search via Medline, Embase and Global Health (OVID); Scopus; CINAHL on EBSCOhost along with several other EBSCOhost databases (Academic Search Complete, Canadian Reference Centre, Alternative Press Index, Family & Society Studies Worldwide, Social Work Abstracts) and Google Scholar, published until November 2023. Journal articles, published in the English language, describing quantitative and qualitative research on sexual healthcare access barriers for sexually diverse Muslim men will be included in the review. Commentaries and correspondences, along with grey literature including research reports and conference abstracts, as well as studies that do not include men with the Muslim faith, will be considered ineligible. Following screening of titles and abstracts, we will conduct a full-text screening to determine the final number of studies to be included in the review. A Microsoft Excel spreadsheet will be used to extract study characteristics, and information on sexual healthcare access barriers will be classified according to the socioecological model's core concepts. ETHICS AND DISSEMINATION: Our review does not require ethics approval. We will disseminate the review findings through peer-reviewed academic journals, seminars and conference presentations.

Digital Triage Tools for Sexually Transmitted Infection Testing Compared With General Practitioners' Advice: Vignette-Based Qualitative Study With Interviews Among General Practitioners.

BACKGROUND: Digital triage tools for sexually transmitted infection (STI) testing can potentially be used as a substitute for the triage that general practitioners (GPs) perform to lower their work pressure. The studied tool is based on medical guidelines. The same guidelines support GPs' decision-making process. However, research has shown that GPs make decisions from a holistic perspective and, therefore, do not always adhere to those guidelines. To have a high-quality digital triage tool that results in an efficient care process, it is important to learn more about GPs' decision-making process. OBJECTIVE: The first objective was to identify whether the advice of the studied digital triage tool aligned with GPs' daily medical practice. The second objective was to learn which factors influence GPs' decisions regarding referral for diagnostic testing. In addition, this study provides insights into GPs' decision-making process. METHODS: A qualitative vignette-based study using semistructured interviews was conducted. In total, 6 vignettes representing patient cases were discussed with the participants (GPs). The participants needed to think aloud whether they would advise an STI test for the patient and why. A thematic analysis was conducted on the transcripts of the interviews. The vignette patient cases were also passed through the digital triage tool, resulting in advice to test or not for an STI. A comparison was made between the advice of the tool and that of the participants. RESULTS: In total, 10 interviews were conducted. Participants (GPs) had a mean age of 48.30 (SD 11.88) years. For 3 vignettes, the advice of the digital triage tool and of all participants was the same. In those vignettes, the patients' risk factors were sufficiently clear for the participants to advise the same as the digital tool. For 3 vignettes, the advice of the digital tool differed from that of the participants. Patient-related factors that influenced the participants' decision-making process were the patient's anxiety, young age, and willingness to be tested. Participants would test at a lower threshold than the triage tool because of those factors. Sometimes, participants wanted more information than was provided in the vignette or would like to conduct a physical examination. These elements were not part of the digital triage tool. CONCLUSIONS: The advice to conduct a diagnostic STI test differed between a digital triage tool and GPs. The digital triage tool considered only medical guidelines, whereas GPs were open to discussion reasoning from a holistic perspective. The GPs' decision-making process was influenced by patients' anxiety, willingness to be tested, and age. On the basis of these results, we believe that the digital triage tool for STI testing could support GPs and even replace consultations in the future. Further research must substantiate how this can be done safely.

Factors associated with parental Human Papillomavirus (HPV) vaccination intention of daughter: A national survey in Finland.

BACKGROUND: Human papillomavirus (HPV) vaccines are offered free of charge in Finland to 10-12-year-old children. Nationally about 80% of girls are vaccinated, with regional differences in first dose coverage varying from 62% to 82% in girls born in 2011. This study examined the factors associated with HPV vaccination intention. Furthermore, we assessed the realisation of HPV vaccination among the daughters of the participating parents. METHODS: A web-based survey was conducted for randomly selected parents of girls (N = 6 465) aged 10 to 14 years of age. Data was collected in February and March 2022 in five Finnish high and low coverage municipalities. The national vaccination register was employed to assess realisation of vaccination. RESULTS: Participation rate was 13.7% (n = 883 parents). Almost all parents were aware of the association between HPV and cervical cancer, but only one fifth was aware of other diseases associated with HPV. Adherence to the national vaccination programme, parents' mother tongue, and trusting in official information were associated with positive vaccination intention. The most often reported reason for non-vaccination was fear of adverse effects (22%). Overall, parental attitudes towards HPV vaccination were positive, with 83% of parents indicating their daughter had received or will receive the vaccination. Vaccination realisation was subsequently examined and 88% of the daughters were vaccinated. CONCLUSIONS: Despite low knowledge of HPV-related diseases overall, majority of parents held a positive intention to vaccinate their daughter. Realisation of intention was high in our study, higher than the national uptake. Foreign-origin parents had lower intention to vaccinate their daughters. As information on HPV and its vaccine is available in 11 languages, there is a need to re-think accessibility. In-depth interviews are needed to better explore the reasons behind non-vaccination.