Implementing pathogen reduction technology while discontinuing blood donor deferral criteria for sexual risk behaviors: A simulation study.

BACKGROUND: Combining pathogen reduction technology (PRT) with blood screening may alleviate concerns over the risk of transfusion-transmitted infections (TTI) and support changes in blood donor selection to potentially increase blood availability. This study aimed to estimate the residual risk of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) transfusion-transmission in Canada after implementing PRT, while eliminating deferrals for sexual risk behaviors. STUDY DESIGN AND METHODS: A probabilistic approach that combined Bayesian networks with Monte Carlo simulations was used to estimate the risk of transfusing HIV-, HBV-, or HCV-contaminated blood components. Different scenarios were considered to compare the current residual risk after PRT implementation, with and without donor deferral criteria for sexual risk behaviors. Donor profiles and blood component outcomes were simulated based on a literature review including the prevalence and incidence of HIV, HBV, and HCV in the Canadian blood donor population; the use of current blood screening assays; and HIV, HBV, and HCV blood donor viral loads. RESULTS: In the universal PRT scenario (i.e., with PRT/without deferral criteria), the estimated risks of HIV, HBV, and HCV transmission were significantly lower than those in the currently observed scenario (i.e., without PRT/with deferral criteria). CONCLUSIONS: This risk model suggests that PRT for platelets and plasma (and eventually for RBCs when available) significantly reduces the residual risks of HIV, HBV and HCV transfusion-transmission and could enable the removal of blood donor deferral criteria for sexual risk behaviors.

Predictors of PrEP Retention and Attrition in an Urban Publicly Funded Safety-net Specialty Clinic.

Pre-exposure prophylaxis (PrEP) is an effective tool for human immunodeficiency virus (HIV) prevention. The purpose of this study is to identify correlates of PrEP retention using patient data from an urban, publicly funded safety-net clinic in Washington, DC. Cox proportional hazards regression, logistical regression, and survival curves were used to assess the association of age, gender, race/ethnicity, insurance, number of partners, and sexually transmitted infection (STI) diagnosis at PrEP initiation with time on PrEP. From August 2016-December 2020, 1,126 people were prescribed PrEP - patients were mostly Black (44.8%) or Latinx (30.4%) and identified as cisgender men (84.6%). Half had no insurance (49.1%), with the remaining patients reporting private (28.9%) or public (21.5%) insurance. Age at PrEP prescription ranged from 15 to 66 with 80% being 20 to 39 years. For the 87.7% (n = 987) of patients who discontinued PrEP, mean PrEP time was 158 days and median was 28 days. The highest rates of discontinuation were observed within the first month with 44.3% discontinuing by day 30, 52.3% by 3 months, and 73.2% by 1 year. Cisgender women, transgender persons, and those younger than 30 years were more likely to discontinue PrEP. Latinx and patients with less than 3 male partners in the last 90 days were less likely to discontinue PrEP. We demonstrated a high level of PrEP uptake among populations disproportionally affected by HIV. Future analyses are needed to examine ways of reducing barriers to PrEP initiation and improving PrEP adherence.

Latent Class Analysis of Online Platforms for Partner-Seeking and Sexual Behaviors Among Men Who Have Sex with Men from Central Kentucky.

Little is known whether engagement in sexual behaviors associated with potential HIV risks differs by subgroups of men who have sex with men (MSM), who are distinct regarding patterns of use of online tools for partner-seeking. Using latent class analysis, we revealed four classes of app-using MSM (n = 181, 18-34 y.o., 82.4% identified as White and non-Hispanic) residing in Central Kentucky: the Grindr/Tinder class; the Poly App Use class of MSM-oriented apps; the General Social Media class, and the Bumble class. Unadjusted penalized logistic regressions showed associations of the Poly App Use class with increased numbers of receptive anal sex partners and reporting condomless receptive anal sex. Adjusting for other covariates, poly app users versus others were more likely to be older (25-34 vs. 18-24, AOR = 3.81, 95%CI = 1.70-9.03), to report past six-month illicit drug use (AOR = 2.93, 95%CI = 1.25-7.43) and to have ever used pre-exposure prophylaxis (AOR = 2.79, 95%CI = 1.10-7.12). Poly app users had behavior profiles associated with an elevated HIV risk and also reported HIV-related protective behaviors likely indicating increased risk awareness among this class. Our findings warrant differentiation of behavior profiles by patterns of app use and suggest not to generalize sexual behaviors associated with potential HIV risks to all app-using MSM.

RESUMEN: Poco se sabe si la participación en comportamientos sexuales asociados con riesgos potenciales de VIH difiere según distintos subgrupos de hombres que tienen sexo con hombres (HSH) en base a patrones en el uso de herramientas online para la búsqueda de pareja. Mediante el análisis de clases latentes, identificamos cuatro clases de HSH que usan aplicaciones (n = 181, 18­34 años, 82.4% identificados como Blancos y no-Hispanos) y residen en Kentucky Central: la clase Grindr/Tinder, la clase Poly App Use de aplicaciones orientadas a HSH, la clase General Social Media y la clase Bumble. Las regresiones logísticas penalizadas no ajustadas mostraron asociaciones de la clase Poly App Use con un alza en el número de parejas receptivas en relaciones sexuales anales y con reportes de sexo anal receptivo sin condón. Al ajustar por otras covariables, los miembros de la clase Poly App Use, con respecto a las otras clases, tuvieron más probabilidades de ser mayores (25­34 vs. 18­24, ORA = 3,81; IC95%=1,70 − 9,03), de informar el uso de drogas ilícitas en los últimos 6 meses (ORA = 2,93; IC95%=1,25 − 7,43) y haber utilizado alguna vez profilaxis-preexposición (ORA = 2,79; IC95%=1,10 − 7,12). Así mismo, los miembros de esta clase tuvieron perfiles de comportamiento asociado con el riesgo elevado de VIH y también informaron comportamientos de protección relacionados con el VIH que probablemente indican una mayor conciencia del riesgo entre ellos. Nuestros hallazgos justifican la diferenciación de perfiles de comportamiento en base a patrones de uso de aplicaciones y sugieren no generalizar los comportamientos sexuales asociados con riesgos potenciales de VIH a todos los HSH que las usan.

Barriers and facilitators to pre-exposure prophylaxis (PrEP) uptake and adherence among men who have sex with men (MSM) in Thailand: a qualitative study.

Young MSM (YMSM), aged 15-24, account for nearly half of new HIV infections in Thailand. Pre-exposure prophylaxis (PrEP) is an effective prevention medicine for populations at substantial HIV risk, yet YMSM frequently have suboptimal uptake of and adherence to PrEP. We conducted 35 in-depth interviews with YMSM to explore barriers and facilitators of both PrEP initiation and adherence. Interviews also elicited the perceptions and experiences of healthcare providers (HCPs) working with YMSM at three clinics in Bangkok. Primary barriers to PrEP initiation were limited accessibility, insufficient knowledge, and efficacy concerns; HCPs identified no-to-low self-perception of HIV risk, pre-existing health problems, fears of side effects, and living in distant provinces as barriers to PrEP initiation. YMSM primarily reported PrEP information and self-perceptions of elevated HIV risk as facilitators to PrEP initiation. Additionally, forgetfulness and low HIV risk awareness were common barriers to PrEP adherence. Reminders were a prominent facilitator of PrEP adherence alongside disclosure to close relationships, the routinization of regimens, and convenient facilities. HCPs regarded counseling as the leading facilitator of PrEP adherence. By understanding the barriers/facilitators of PrEP use, the current study seeks to help develop evidence-informed PrEP intervention programs among YMSM while considering cultural sensitivity.

Intersectional Microaggressions, Sexual Identity Concealment, and Mental Health of Young Black Sexual Minority Men and Transgender Women.

Previous research has demonstrated associations between experiences of microaggressions and negative mental and physical health outcomes, and national organizations such as the Centers for Disease Control and Prevention have acknowledged racism as a public health issue. Individuals with multiple marginalized identities, such as young Black men who have sex with men and transgender women, are commonly affected by discrimination and stigma, contributing to health disparities. One possible path by which microaggressions are linked to negative health outcomes for these groups is their impact on individuals' decisions to conceal their sexual identity, in some cases leading to increased stress and use of maladaptive coping strategies. We surveyed 280 young Black male (86%) and transgender or non-binary (14%) individuals between the ages of 16-25 years old (M = 21.68, SD = 2.73) who reported being recently sexually active with men about their experiences with intersectional microaggressions, concealment of their sexual identity, psychological distress, and substance use before and during sexual activity. Structural equation modeling revealed that experiences of microaggressions were associated with greater sexual identity concealment, and concealment partially mediated the relationship between microaggressions and psychological distress. While microaggressions were associated with greater substance use, sexual identity concealment did not mediate this relationship. Findings have implications for addressing health disparities among this population.

Awareness and Uptake of Pre-Exposure Prophylaxis (PrEP) for HIV Prevention Among Men who have Sex with Men in Nepal.

Pre-exposure prophylaxis (PrEP) is a highly effective biomedical prevention strategy that remarkably reduces HIV transmission risk. Although PrEP has been available in Nepal since 2019, very little is known about PrEP use among MSM in Nepal. This study aimed to examine PrEP awareness and its use among Nepali MSM and the factors influencing its adoption. A cross-sectional survey was conducted among MSM in Nepal between October and December 2022 (N = 250). Bivariate analysis and logistic regression were performed to determine factors associated with awareness and use of PrEP. In the study population, 59.6% of participants were aware of PrEP, however, only 30.4% of them had utilized it. The odds of PrEP awareness were higher among participants who had completed high school or above (aOR = 4.1; 95% CI = 1.8-9.6), those with health insurance coverage (aOR = 6.9; 95% CI = 2.1-22.3) and had tested for HIV (aOR = 21.2; 95% CI = 8.3-53.9). Similarly, participants who identified as gay (aOR = 3.4; 95% CI = 1.4-8.4), had visited a doctor within the past 6 months (aOR = 2.9; 95% CI = 1.2-6.5), had previously tested for HIV (aOR = 12.3; 95% CI = 3.4-44.7), and had been diagnosed with sexually transmitted infections (aOR = 7.0; 95% CI = 2.5-19.5) were more likely to have used PrEP. Our results highlight the critical importance of healthcare providers engaging in providing care for MSM, including facilitating as well as discussions about PrEP. In addition, there is a pressing need for innovative strategies (e.g., peer educators, social media, online facilitating technologies) to disseminate PrEP knowledge and reduce stigma surrounding PrEP.

Asymptomatic lymphogranuloma venereum is commonly found among men who have sex with men in Austria.

BACKGROUND AND OBJECTIVES: Serovar L1-L3 of Chlamydia trachomatis (CT) causes lymphogranuloma venereum (LGV). A surge in LGV-cases has been observed among HIV-positive men who have sex with men (MSM). Discrimination between LGV and non-LGV is pivotal since it has major treatment implications. Here, we aimed to determine the prevalence and characteristics of LGV among CT-infections. PATIENTS AND METHODS: All CT-positive results from 04/2014-12/2021 at the four largest Austrian HIV and STI clinics were evaluated. Disease characteristics and patient demographics were analyzed. RESULTS: Overall, n  =  2,083 infections of CT were documented in n  =  1,479 individual patients: median age was 31.4 years, 81% were male, 59% MSM, 44% HIV-positive, 13% on HIV pre-exposure-prophylaxis. Available serovar analyses (61% [1,258/2,083]) showed L1-L3 in 15% (192/1,258). Considering only MSM with rectal CT-infection, LGV accounted for 23% (101/439). Cases of LGV vs. other CT-infections were primarily MSM (92% [177/192] vs. 62% [1,179/1,891], p < 0.001), more often HIV-positive (64% [116/180] vs. 46% [631/1,376]; p < 0.001) and had frequently concomitant syphilis infection (18% [32/180] vs. 7% [52/749]; p < 0.001). LGV commonly manifested as proctitis (38% [72/192]) whereas 45% (87/192) were asymptomatic. CONCLUSIONS: Lymphogranuloma venereum accounted for 23% of rectal CT-infections in MSM. Furthermore, 45% of all LGV-cases were asymptomatic. In the absence of CT-serovar analysis, a high LGV prevalence should be considered in risk-populations and guide empiric treatment selection.

Monkeypox awareness and low vaccination hesitancy among men who have sex with men in China.

Men who have sex with men (MSM) have been recommended for targeted monkeypox vaccination. We aimed to investigate monkeypox awareness and explore the correlates of monkeypox vaccination hesitancy among MSM in China. We conducted a cross-sectional survey from August 10 to September 9, 2022. Awareness related to monkeypox and attitude toward monkeypox vaccination among MSM aged ≥18 years were collected. Multivariable logistic regression was applied to evaluate correlates of vaccination hesitancy. The discrepancy in awareness between subgroups regarding HIV status was assessed. A total of 1090 MSM were included (age: median 30 years, interquartile range [IQR], 25-35; HIV-infected: 53.12%). Only 13.85% of respondents expressed high monkeypox vaccination hesitancy. Hesitancy was associated with no fixed income (adjuster odds ratio [aOR], 2.46, 95% confidence interval [CI], 1.48-4.11), infrequent information following (sometimes, 3.01, 1.55-5.83; seldom or never, 5.66, 2.58-12.45), and lack of worries about monkeypox endemic (1.78, 1.11-2.87). Participants who believed that HIV-infected cases accounted for a smaller proportion (1.62, 1.01-2.60), disagreed that monkeypox virus could be detected in semen (2.21, 1.26-3.88), and considered either replication-competent (1.84, 1.14-2.96) or replication-deficient (4.80, 2.26-10.21) monkeypox vaccine unsuitable for HIV-infected people were generally more hesitant. Compared with HIV-uninfected MSM, HIV-infected MSM supported more for vaccination promotion. MSM in China had low hesitancy toward monkeypox vaccination. Safety and affordability of vaccine and availability of information were essential aspects to reduce hesitancy. Education on vaccination benefits should be encouraged to promote future vaccination plans.

Changes in HPV prevalence, incidence, and clearance following the use of HIV pre-exposure prophylaxis (PrEP) among MSM in Xinjiang, China: An observational cohort study.

The association between HIV pre-exposure prophylaxis (PrEP) and the natural history of human papillomavirus (HPV) has not been well documented. Our objective was to evaluate the impact of PrEP on the prevalence, incidence, and clearance of anal HPV among men who have sex with men (MSM). Sexually active, HIV-negative MSM aged 18 years and older in Xinjiang, China since September 1, 2016, were enrolled in an ongoing observational cohort study of HPV. At baseline and every 6 months, an anal swab was taken to test for HPV and a questionnaire on sociodemographic characteristics and sexual behaviors was collected. Those who consented to receive PrEP were enrolled in an open-label PrEP intervention study from November 1, 2019, to June 30, 2021. This study analyzed data from participants present in the HPV cohort between November 1, 2019, and June 30, 2021. We compared the prevalence, incidence, and clearance of anal HPV between men who received PrEP (PrEP users) and those who did not (non-PrEP users), and compared men before and after initiating PrEP. We calculated prevalence ratios (PRs), incidence rate ratios (IRRs), and clearance rate ratios (CRRs) for both comparisons. Of the 870 participants present in the HPV cohort during the period between November 1, 2019, and June 30, 2021, 859 had adequate ß-globin for HPV genotype testing and were included in our study. Among them, 429 were PrEP users, while 430 were non-PrEP users. Median age was 32 years (interquartile range [IQR]: 26-38). Among PrEP users, 217 were tested for anal HPV before PrEP initiation. PrEP users had lower prevalence of HPV 45, 51, and 54 (PRs: 0.27 [95% CI: 0.09-0.80], 0.42 [0.21-0.85], and 0.41 [0.17-0.99], respectively) and lower clearance of HPV 16 (CRR: 0.31 [0.10-0.91]) compared with non-PrEP users. PrEP users exhibited lower prevalence of HPV 51 (PR: 0.31 [0.12-0.84]), lower incidence of HPV 6, 11, 16, 39 and 61 (IRRs: 0.34 [0.13-0.90], 0.26 [0.08-0.87], 0.44 [0.21-0.91], 0.21 [0.05-0.93], and 0.19 [0.04-0.82], respectively), as well as higher clearance of HPV 52 (CRR: 2.17 [1.08-4.35]) after PrEP initiation. PrEP use may lower the risk of HPV infection among MSM in Xinjiang, China. Our findings further extend the knowledge of the impact of PrEP on sexually transmitted infections.

Serological responses to smallpox A33 antigen and monkeypox A35 antigen in healthy people and people living with HIV-1 from Guangzhou, China.

People are expected to have been previously vaccinated with a Vaccinia-based vaccine, as until 1980 smallpox vaccination was a standard protocol in China. It is unclear whether people with smallpox vaccine still have antibody against vaccinia virus (VACV) and cross-antibody against monkeypox virus (MPXV). Herein, we assessed the binding antibodies with antigen of VACV-A33 and MPXV-A35 in the general population and HIV-1 infected patients. Firstly, we detected VACV antibody with A33 protein to evaluate the efficiency of smallpox vaccination. The result show that 29% (23 of 79) of hospital staff (age ≥ 42 years) and 63% (60 of 95) of HIV-positive patients (age ≥ 42 years) from Guangzhou Eighth People's Hospital were able to bind A33. However, among the subjects below 42 years of age, 1.5% (3/198) of the hospital volunteer samples and 1% (1/104) of the samples from HIV patients were positive for antibodies against A33 antigen. Then, we assessed the specific cross-reactive antibodies against MPXV A35 protein. 24% (19 of 79) hospital staff (age〉 = 42 years) and 44% (42 of 95) of HIV-positive patients (age〉 = 42 years) were positive. 98% (194/198) of the hospital staff and 99% (103/104) of the HIV patients had no A35-binding antibodies. Further, we found significant sex differences for the reactivity to A35 antigen were observed in HIV population, but no significant sex differences in hospital staff. Further, we analyzed the positivity rate of anti-A35 antibody of men who have sex with men (MSM) and non-MSM in HIV patients (age〉 = 42years). We found that 47% of no-MSM population and 40% of MSM population were positive for A35 antigen, with no significant difference. Lastly, we found only 59 samples were positive for anti-A33 IgG and anti-A35 IgG in all participants. Together, we demonstrated A33 and A35 antigens binding antibodies were detected in HIV patients and general population who were older than 42 years, and cohort studies only provided data of serological detection to support early response to monkeypox outbreak.

Randomized Controlled Trial of Automated Directly Observed Therapy for Measurement and Support of PrEP Adherence Among Young Men Who have Sex with Men.

Measurement of adherence to oral pre-exposure prophylaxis (PrEP) in real-time has been challenging. We developed DOT Diary, a smartphone application that combines automated directly observed therapy with a PrEP adherence visualization toolkit, and tested its ability to measure PrEP adherence and to increase adherence among a diverse cohort of young men who have sex with men (MSM). We enrolled 100 MSM in San Francisco and Atlanta and randomly assigned them 2:1 to DOT Diary versus standard of care. Concordance between DOT Diary measurement and drug levels in dried blood spots was substantial, with 91.0% and 85.3% concordance between DOT Diary and emtricitabine-triphosphate and tenofovir-diphosphate, respectively. There was no significant difference in the proportion of participants with detectable PrEP drug levels at 24 weeks between study arms. These results suggest DOT Diary is substantially better than self-reported measures of adherence, but additional interventions are needed to improve PrEP adherence over time.

RESUMEN: La medición de la adherencia a la profilaxis oral previa a la exposición (PrEP) en tiempo real ha constituido un desafío. Hemos desarrollado DOT Diary, una aplicación para teléfonos inteligentes que combina la terapia automatizada observada de forma directa con un kit de herramientas para visualizar la adherencia a la PrEP, y testeamos su capacidad para medir la adherencia a la PrEP, así como para aumentar la adherencia entre una cohorte variada de hombres jóvenes que tienen sexo con hombres (HSH). Reclutamos a 100 HSH en San Francisco y Atlanta y los asignamos aleatoriamente 2:1 a DOT Diary con respecto a la asistencia estándar. La concordancia entre la medición del DOT Diary y los niveles de fármacos en gotas de sangre seca fue sustancial, con un 91,0% y un 85,3% de concordancia entre el uso del DOT Diary y el de emtricitabina-trifosfato y tenofovir-difosfato, respectivamente. No hubo diferencias significativas en la proporción de participantes con niveles detectables del fármaco de la PrEP a las 24 semanas entre los brazos del estudio. Estos resultados sugieren que DOT Diary es sustancialmente superior a las medidas de adherencia que se notifican de forma personal, aunque hacen falta intervenciones adicionales para mejorar la adherencia a la PrEP a largo plazo.

Rapid point of care testing for four bacterial sexually transmitted infections using the portable isothermal loop-mediated nucleic acid amplification eazyplex platform.

PURPOSE: To analyze sensitivity and specificity of the rapid point-of-care (POC) eazyplex testing platform for bacterial sexually transmitted infections (STI) among men who have sex with men (MSM). METHODS: 272 anal, urethral, and pharyngeal swabs collected from 153 MSM were tested by both the eazyplex platform and an in-house PCR or culture in the university microbiology reference laboratory. RESULTS: Compared to the reference diagnostic method, the overall sensitivity/specificity of eazyplex was 88%/98% for N. gonorrhoeae, 82%/100% for C. trachomatis, 70%/ > 99% for U. urealyticum, and 85%/98% for M. hominis, respectively. Sensitivity for N. gonorrhoeae and U. urealyticum in urethral samples was 100%. CONCLUSION: With good to very good sensitivity depending on the sampling site and pathogen as well as very good specificity overall the eazyplex platform is a useful rapid diagnostic method for POC bacterial STI-testing especially for N. gonorrhoeae and C. trachomatis, allowing for almost immediate treatment initiation.

Dyspareunia, signs of epithelial disruption, sexual abstinence, and HIV status in female sex workers in Nairobi: a cross-sectional study.

BACKGROUND: Epithelial trauma is a risk factor of HIV infection in men who have sex with men (MSM) and female sex workers (FSWs). Painful intercourse may be indicative of epithelial tissue disruption. Previous studies on a cohort of Kenyan FSWs established an association between prolonged sexual abstinence and late HIV seroconversion. Our research objective was to establish whether there is a relationship between HIV serostatus and signs of epithelial disruption and between HIV serostatus and sexual abstinence behaviour. METHODS: Participants were selected from a Nairobi health facility. A structured questionnaire was administered to 322 FSWs, who provided data on HIV status, sexual behaviour, abstinence intervals and the level of sexual dysfunction. Sexual dysfunction scores were created using parts of the Female Sexual Function Index (FSFI-19). Additional questions addressed epithelial trauma signs. Descriptive data analysis, bivariate and multivariate logistic regression were used to describe the study population and determine factors associated with living with HIV. Potential factors influencing sexual dysfunction were assessed by FSWs via self-rating. RESULTS: 36% of FSWs reported discomfort or pain during vaginal penetration half the time. 44% noticed genital bleeding half the time. Vaginal tenderness was experienced by 70.6% half the time during or after intercourse. Variables predictive of living with HIV on multivariate analysis included a medium and high score of discomfort or pain during and following vaginal penetration (medium: AOR 2.288, p-value 0.032, 95% CI 1.075-4.871; high: AOR 3.044, p-value 0.031, 95% CI 1.110-8.348). No significant association of HIV status with past abstinence durations as reported by participants could be established in the multivariate analysis. A majority of FSWs agreed that steady partnerships (81% agreement), regularity of intercourse (74%), foreplay (72%) and lubricants (65%) alleviated dyspareunia. CONCLUSIONS: Recurrent exposure to blood during sex was highly prevalent in FSWs, as was sexual dysfunction. Complaint levels were associated with living with HIV, providing evidence that reducing sexual dysfunctions may prevent HIV transmission. Preventive initiatives may be created that address sexual dysfunction in key populations and general populations with a high HIV prevalence. Subjective assessments indicate that prevention may include the promotion of sexual intercourse regularity, foreplay, and lubricant use.

Perspectives of Young Men Who Have Sex with Men on PrEP Adherence and Peer Navigation: A Qualitative Study.

HIV incidence is disproportionately high among young cisgender men who have sex with men (YMSM), but YMSM are less likely than adults to use HIV pre-exposure prophylaxis (PrEP). Among YMSM living with HIV, peer navigation programs have been effective in linkage to care and increasing medication adherence; such programs may aid HIV-uninfected YMSM in overcoming barriers to engagement in PrEP care. We conducted 32 semi-structured qualitative interviews at a community health center in Massachusetts, USA, specializing in sexual and gender minority health with four sub-groups of YMSM who: (1) had never discussed PrEP with a medical provider, (2) had discussed PrEP with a medical provider but declined a prescription, (3) were prescribed PrEP and have sub-optimal adherence (taking fewer than 4 pills per week), and (4) were prescribed PrEP and were optimally adherent. Domains addressed in the interviews included knowledge of PrEP and HIV prevention, barriers and facilitators to PrEP adherence, and attitudes toward peer navigation for PrEP. Interviews were transcribed and coded using thematic analysis methodology. Multiple themes emerged from the interviews, including finding that perceived costs, anticipated stigma, sexual activity, and relationship status influence PrEP uptake and adherence; establishing pill-taking routines is an important adherence facilitator; and peer navigators could offer benefits for PrEP adherence.

Optimizing Peer Distribution of Syphilis Self-Testing Among Men Who Have Sex with Men in China: A Multi-City Pragmatic Randomized Controlled Trial.

Syphilis testing uptake is low among men who have sex with men (MSM) around the world. Syphilis self-testing (SST) may complement facility-based testing; the distribution model is yet to be explored. This study aimed to investigate the effectiveness of peer distribution of syphilis self-testing on promoting syphilis testing. We conducted a three-arm, unblinded, parallel individually randomized controlled trial among MSM in three cities in Guangdong, China. Inclusion criteria were: men who were born biologically male, aged 18 or above, have ever had sex with a man, will refer the interventions to peers, and will take the three-month follow-up survey. Enrolled indexes were randomly assigned in a 1:1:1 ratio into standard-of-care arm (SOC arm), standard SST delivery arm (S-SST arm), and a web-based referral link SST delivery arm (RL-SST arm). The primary outcome was the number of returned photograph-verified syphilis testing results per index. A total number of 300 indexes were enrolled, with 100 indexes in each arm. The number of verified syphilis tests per index conducted by alters was 0.05 in the control arm, 0.51 in the S-SST arm, and 0.31 in the RL-SST arm. The cost per alter tested was $760.60 for SOC, $83.78 for S-SST, and $93.10 for RL-SST. Minimal adverse event was reported among both indexes and alters during the study. This study showed that peer distribution of SST could improve syphilis testing uptake among MSM in China compared to facility-based testing. This approach warrants further consideration as part of expanding syphilis self-testing.

Perspectives on long-acting formulations of pre-exposure prophylaxis (PrEP) among men who have sex with men who are non-adherent to daily oral PrEP in the United States.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) persistence among men who have sex with men (MSM) in real world clinical settings for HIV prevention is suboptimal. New longer-acting formulations of PrEP are becoming available, including injectables, subdermal implants, and other oral medications. These longer-acting formulations have the potential to improve retention among those who have challenges remaining adherent to daily oral PrEP. METHODS: We interviewed 49 MSM who had initiated but discontinued oral PrEP at three diverse clinics across the United States. We examined participants' perspectives about long-acting PrEP formulations and how long-acting options could affect PrEP use using thematic analysis. RESULTS: Participants were not very knowledgeable about long-acting formulations of PrEP but were open to learning about them and considering use. Participants were concerned about safety and efficacy of products given that they were still newer and/or in development. Finally, participants had clear preferences for oral pills, injectables, and then subdermal implants and were most interested in options that reduced the number of visits to the clinic. CONCLUSION: Long-acting formulations of PrEP are acceptable to MSM with suboptimal PrEP persistence and have the potential to improve PrEP persistence. However, many felt they needed more information on safety, efficacy, and use to consider these options. As these long-acting formulations are implemented, public health campaigns and clinical interventions to encourage may maximize uptake particularly among those who are not currently adherent to daily oral PrEP.

An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study protocol.

BACKGROUND: Gonorrhoea is an ongoing public health concern due to its rising incidence and the emergence of antibiotic resistance. There are an estimated 82 million new Neisseria gonorrhoeae infections each year, with several populations at higher risk for gonococcal infection, including gay and bisexual men (GBM). If left untreated, infection can lead to serious morbidity including infertility, sepsis and increased risk of HIV acquisition. Development of a gonorrhoea vaccine has been challenging, however there is observational evidence that serogroup B meningococcal vaccines, used to protect against the closely related bacteria Neisseria meningitidis, could provide cross-protection against N. gonorrhoeae. METHODS: The MenGO (Meningococcal vaccine efficacy against Gonorrhoea) study is a phase III open-label randomised control trial in GBM to evaluate the efficacy of the four-component meningococcal serogroup B vaccine, 4CMenB, against gonorrhoea. A total of 130 GBM will be recruited at the Gold Coast Sexual Health Clinic, Australia, and randomised to either receive 2 doses of 4CMenB or no intervention. Participants will be followed up for 24 months with testing for N. gonorrhoeae and other sexually transmissible infections every three months. Demographics, sexual behaviour risk, antibiotic use, and blood samples for analysis of N. gonorrhoeae-specific immune responses, will be collected during the study. The primary outcome is the number of N. gonorrhoeae infections in participants over 2 years measured by nucleic acid amplification test (NAAT). Secondary outcomes are vaccine-induced N. gonorrhoeae-specific immune responses, and adverse events in trial participants. DISCUSSION: This trial will determine if the 4CMenB vaccine is able to reduce N. gonorrhoeae infection. If shown to be effective, 4CMenB could be used in gonococcal prevention. Analysis of 4CMenB-induced immune responses will increase understanding of the type of immune response needed to prevent N. gonorrhoeae, which may enable identification of a potential correlate of protection to aid future gonorrhoea vaccine development. TRIAL REGISTRATION: The trial has been registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12619001478101) on 25 October 2019.

High Interest in Long-acting Injectable Pre-exposure Prophylaxis (LAI-PrEP) for HIV Prevention Among Men Who Have Sex With Men (MSM): Result From A Nationwide Survey in Malaysia.

The recent approval of long-acting injectable cabotegravir (CAB-LA) as PrEP for HIV prevention could be an attractive alternative for MSM, particularly among those who face barriers to adherence using the oral pill. This study reports on the awareness of long-acting injectable PrEP (LAI-PrEP) and factors associated with interest in LAI-PrEP use among a nationwide sample of MSM in Malaysia. An online cross-sectional survey was conducted between August and September 2021 to explore perspectives on PrEP modalities among Malaysian MSM (N = 870). Convenience sampling was used to recruit participants using ads on two platforms hornet and facebook. While only 9.1% of the study participants were aware of LAI-PrEP, the majority had heard of oral PrEP (80.9%). After giving a description of it, a large majority (86.6%) expressed interest in using it if made accessible. Those who had a prior history of HIV testing (aOR = 1.9; 95% CI = 1.2-3.2) were more likely to use LAI-PrEP. Interestingly, despite the concerns related to potential high cost (aOR = 3.4; 95% CI = 2.1-5.5) and long-term side effects (aOR = 1.9; 95% CI = 1.2-3.1), the majority of the participants were interested in using LAI-PrEP. Those who were afraid of (or disliked) syringes were less interested in using it (aOR = 0.2; 95% CI; 0.1-0.4). In the recent context that LAI-PrEP was shown to be safe and effective at preventing HIV, our results indicate its potential relevance as an additional PrEP option that could accelerate the uptake and scale-up of PrEP. However, it is crucial to conduct future research urgently to improve the understanding of strategies that could enhance the accessibility, acceptability, and affordability of LAI-PrEP for MSM in low- and middle-income countries, including Malaysia.

Efficacy of Daily Text Messaging to Support Adherence to HIV Pre-Exposure Prophylaxis (PrEP) among Stimulant-Using Men Who Have Sex with Men.

Background: Men who have sex with men (MSM) who use stimulants are at increased risk for HIV infection. Adherence to pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection. We evaluated the efficacy of the individualized Texting for Adherence Building (iTAB) intervention for PrEP adherence compared to standard of care (SoC) among 119 MSM who use stimulants (cocaine, methamphetamine and/or other amphetamine) from the California Collaborative Treatment Group 595 randomized control trial.Method: Three ordered levels of PrEP adherence (non-adherence, adequate adherence, and near-perfect adherence) were compared between intervention arms across study visits (weeks 12 and 48) using ordinal logistic regressions.Results: The effect of intervention arm was not significant in the final model; however, there was a 38% decrease in odds (OR = 0.62, p=.023) of having near-perfect adherence (versus non-adherence or adequate adherence) at week 48 compared to week 12, indicating a significant effect of time. In a follow-up analysis examining week 48 only, logistic regression examining PrEP adherence showed that receiving iTAB (compared to SoC) trended toward higher odds of near-perfect adherence relative to adequate adherence (OR = 2.48, p=.061). Higher HIV knowledge resulted in higher odds (OR = 1.72, p=.020) of near-perfect adherence (versus non-adherence or adequate adherence).Conclusion: HIV knowledge may influence PrEP adherence, and most notably, the iTAB intervention may support near-perfect adherence relative to adequate adherence.

A Gonococcal Vaccine Has the Potential to Rapidly Reduce the Incidence of Neisseria gonorrhoeae Infection Among Urban Men Who Have Sex With Men.

BACKGROUND: A gonococcal vaccine is urgently needed due to increasing gonorrhea incidence and emerging multidrug-resistant gonococcal strains worldwide. Men who have sex with men (MSM) have among the highest incidences of gonorrhea and may be a key target population for vaccination when available. METHODS: An individual-based, anatomical site-specific mathematical model was used to simulate Neisseria gonorrhoeae transmission in a population of 10 000 MSM. The impact of vaccination on gonorrhea prevalence was assessed. RESULTS: With a gonococcal vaccine of 100% or 50% protective efficacy, gonorrhea prevalence could be reduced by 94% or 62%, respectively, within 2 years if 30% of MSM are vaccinated on presentation for sexually transmitted infection (STI) testing. Elimination of gonorrhea is possible within 8 years with vaccines of ≥ 50% efficacy lasting 2 years, providing a booster vaccination is available every 3 years on average. A vaccine's impact may be reduced if it is not effective at all anatomical sites. CONCLUSIONS: Our study indicates that with a vaccine of modest efficacy and an immunization strategy that targets MSM presenting for STI screening, the prevalence of gonorrhea in this population could be rapidly and substantially reduced.