HIV and hepatitis C virus (HCV) infection rates among persons, who use drugs, have risen during the US overdose crisis. We elicited patient perspectives about these interconnected infections to identify the areas of misinformation that might prevent appropriate management. We used in-depth interviews and thematic analysis of coded data collected from patients (N = 24) at detox and from key informants (N = 10). Seventy-one per cent reported injecting drugs. We found that patient narratives included misinformation about HIV and HCV transmission, natural history and treatment. Some participants thought that activities such as sharing drinkware or food with persons with HIV could lead to infection, while others believed that mainly men who have sex with men were at risk. Despite significant improvements in treatment, some participants still believed that HIV was a fatal condition, while others noted that treatment was only necessary at later stages. Some participants thought that HCV was a common, mild infection that might not need immediate attention, and others stated that individuals who were actively using drugs were ineligible for treatment. The current study exposes a considerable level of misinformation about HIV prevention and about the importance and benefits of HCV therapy. Educational interventions are necessary to counter misinformation identified.

Men who have sex with men (MSM) are vulnerable to HIV infection. Although daily oral pre-exposure prophylaxis (PrEP) prevents HIV among MSM, its usage remains low. We conducted virtual in-depth interviews (IDIs) and focus groups (FGs) with Black, Hispanic/Latino, and White MSM consisting of current PrEP users and those aware of but not currently using PrEP. We delved into their preferences regarding six emerging PrEP products: a weekly oral pill, event-driven oral pills, anal douche/enema, anal suppository, long-acting injection, and a skin implant. Our mixed methods analysis involved inductive content analysis of transcripts for thematic identification and calculations of preferences. Among the sample (n = 98), the weekly oral pill emerged as the favored option among both PrEP Users and PrEP Aware IDI participants. Ranking exercises during FGs also corroborated this preference, with the weekly oral pill being most preferred. However, PrEP Users in FGs leaned toward the long-acting injectable. Conversely, the anal suppository and douche/enema were the least preferred products. Overall, participants were open to emerging PrEP products and valued flexibility but expressed concerns about limited protection for products designed solely for receptive sex. Public health practitioners should tailor recommendations based on individuals\' current sexual behaviors and long-term vulnerability to infection.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) represent a high-risk group for HIV transmission in Romania, yet they possess few resources for prevention. Despite having no formal access to pre-exposure prophylaxis (PrEP) through the health system, GBMSM in Romania demonstrate a high need for and interest in this medication. In anticipation of a national rollout of PrEP, this study tests the efficacy of a novel strategy, Prepare Romania, that combines two evidence-based PrEP promotion interventions for GBMSM living in Romania.
METHODS: This study uses a randomized controlled trial design to examine whether GBMSM living in Romania receiving Prepare Romania, a culturally adapted counseling and mobile health intervention (expected n = 60), demonstrate greater PrEP adherence and persistence than those assigned to a PrEP education control arm (expected n = 60). Participants from two main cities in Romania are prescribed PrEP and followed-up at 3 and 6 months post-randomization. PrEP adherence data are obtained through weekly self-report surveys and dried blood spot testing at follow-up visits. Potential mediators (e.g., PrEP use motivation) of intervention efficacy are also assessed. Furthermore, Prepare Romania\'s implementation (e.g., proportion of enrolled participants attending medical visits, intervention experience) will be examined through interviews with participants, study implementers, and healthcare officials.
CONCLUSIONS: The knowledge gained from this study will be utilized for further refinement and scale-up of Prepare Romania for a future multi-city effectiveness trial. By studying the efficacy of tools to support PrEP adherence and persistence, this research has the potential to lay the groundwork for PrEP rollout in Romania and similar contexts. Trial registration This study was registered on ClinicalTrials.gov, identifier NCT05323123 , on March 25, 2022.

OBJECTIVE: Tixagevimab/cilgavimab is a cocktail of two long-acting monoclonal antibodies approved for pre-exposure prophylaxis (PrEP) of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (cause of coronavirus disease 2019 [COVID-19]) in immunocompromised (IC) or high-risk patients. We investigated the patient characteristics and clinical outcomes of IC patients administered tixagevimab/cilgavimab for PrEP in real-world use in Japan.
METHODS: This observational study used anonymous secondary data from Real-World Data Co., Ltd. for IC patients aged ≥12 years administered tixagevimab/cilgavimab between September 2022 and September 2023. We analyzed the baseline characteristics and event-rates of COVID-19-related clinical outcomes within 6 months of administration.
RESULTS: Data were analyzed for 397 IC patients. About half (53.4%) were male and the median age was 71.0 (interquartile range 61.0, 77.0) years. Malignancy (97.2%), cardiovascular disease (71.3%), and diabetes (66.5%) were frequent comorbidities. Systemic corticosteroids and immunosuppressants were prescribed to 87.4% and 24.9%, respectively. The two most common target clinical conditions were active therapy for hematologic malignancies (88.2%) and treatment with B cell-depleting therapies (57.4%). The event-rates per 100 person-months (95% confidence interval; number) for medically attended COVID-19, COVID-19 hospitalization, in-hospital mortality due to COVID-19, and all-cause death were 4.14 (3.06-5.48; n=49), 1.74 (1.09-2.64; n=22), 0.07 (0.00-0.42; n=1), and 0.60 (0.26-1.17; n=8), respectively.
CONCLUSIONS: This is the first report using a multicenter database to describe the clinical characteristics and COVID-19-related outcomes of IC patients administered with tixagevimab/cilgavimab in real-world settings in Japan. This cohort of IC patients who received tixagevimab/cilgavimab included many elderly patients with comorbidities.

BACKGROUND: Clinical risk score tools require validation in diverse settings and populations before they are widely implemented. We aimed to externally validate an HIV risk assessment tool for predicting HIV acquisition among pregnant and postpartum women. In the context of prevention of mother-to-child transmission programs, risk score tools could be used to prioritize retesting efforts and delivery of pre-exposure prophylaxis (PrEP) to pregnant and postpartum women most at risk for HIV acquisition while minimizing unnecessary perinatal exposure.
METHODS: Data from women enrolled in a cross-sectional study of programmatic HIV retesting and/or receiving maternal and child health care services at five facilities in Western Kenya were used to validate the predictive ability of a simplified risk score previously developed for pregnant/postpartum women. Incident HIV infections were defined as new HIV diagnoses following confirmed negative or unknown status during pregnancy. Predictive performance was assessed using the area under the receiver operating characteristic curve (AUC) and Brier score.
RESULTS: Among 1266 women with 35 incident HIV infections, we found an AUC for predicting HIV acquisition of 0.60 (95% CI, 0.51, 0.69), with a Brier score of 0.27. A risk score >6 was associated with a 2.9-fold increase in the odds of HIV acquisition (95% CI, 1.48, 5.70; p = 0.002) vs scores ≤6. Women with risk scores >6 were 27% (346/1266) of the population but accounted for 52% of HIV acquisitions. Syphilis, age at sexual debut, and unknown partner HIV status were significantly associated with increased risk of HIV in this cohort.
CONCLUSIONS: The simplified risk score performed moderately at predicting risk of HIV acquisition in this population of pregnant and postpartum women and may be useful to guide PrEP use or counseling.

UNASSIGNED: Understanding and identifying the immunological markers and clinical information linked with HIV acquisition is crucial for effectively implementing Pre-Exposure Prophylaxis (PrEP) to prevent HIV acquisition. Prior analysis on HIV incidence outcomes have predominantly employed proportional hazards (PH) models, adjusting solely for baseline covariates. Therefore, models that integrate cytokine biomarkers, particularly as time-varying covariates, are sorely needed.
UNASSIGNED: We built a simple model using the Cox PH to investigate the impact of specific cytokine profiles in predicting the overall HIV incidence. Further, Kaplan-Meier curves were used to compare HIV incidence rates between the treatment and placebo groups while assessing the overall treatment effectiveness. Utilizing stepwise regression, we developed a series of Cox PH models to analyze 48 longitudinally measured cytokine profiles. We considered three kinds of effects in the cytokine profile measurements: average, difference, and time-dependent covariate. These effects were combined with baseline covariates to explore their influence on predictors of HIV incidence.
UNASSIGNED: Comparing the predictive performance of the Cox PH models developed using the AIC metric, model 4 (Cox PH model with time-dependent cytokine) outperformed the others. The results indicated that the cytokines, interleukin (IL-2, IL-3, IL-5, IL-10, IL-16, IL-12P70, and IL-17 alpha), stem cell factor (SCF), beta nerve growth factor (B-NGF), tumor necrosis factor alpha (TNF-A), interferon (IFN) alpha-2, serum stem cell growth factor (SCG)-beta, platelet-derived growth factor (PDGF)-BB, granulocyte macrophage colony-stimulating factor (GM-CSF), tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), and cutaneous T-cell-attracting chemokine (CTACK) were significantly associated with HIV incidence. Baseline predictors significantly associated with HIV incidence when considering cytokine effects included: age of oldest sex partner, age at enrollment, salary, years with a stable partner, sex partner having any other sex partner, husband\'s income, other income source, age at debut, years lived in Durban, and sex in the last 30 days.
UNASSIGNED: Overall, the inclusion of cytokine effects enhanced the predictive performance of the models, and the PrEP group exhibited reduced HIV incidences compared to the placebo group.

Pre-exposure prophylaxis (PrEP) has the potential to prevent new HIV infections, but it is unclear how state policies governing sexual and reproductive health services (SRH) impact access for cisgender women. The objective of this review is to identify barriers to PrEP access for cisgender women in the United States. Using the CDC Atlas Program, 20 states with the highest HIV incidence among cisgender women were included in this analysis. Through a search conducted in May-July 2022 of CDC, PrEPWatch.org, and other State Department and Insurance websites, Medicaid expansion status, pharmacist PrEP prescribing laws, financial support programs, and Traditional Medicaid coverage of PrEP, HIV testing, and emergency contraception were reviewed. Of the included states, nearly half did not expand Medicaid at the state level. Emergency contraception and HIV testing was covered under Traditional Medicaid for almost all included states, but insurance stipulations and eligibility requirements remain. Although PrEP is covered under all Traditional Medicaid plans, six states require pre-authorization. Three states have HIV testing mandates, four allow pharmacists to prescribe PrEP and six have financial support programs to cover the cost of PrEP. Medicaid expansion, pre-authorization requirements for PrEP prescriptions and emergency contraception, and limitations on pharmacist prescribing abilities were identified as barriers to SRH access for cisgender women. Medicaid expansion should be prioritized as an approach to expanding access to HIV prevention services at the state level.

BACKGROUND: Optimizing uptake of pre-exposure prophylaxis (PrEP) for individuals at risk of HIV acquisition has been challenging despite clear scientific evidence and normative guidelines, particularly for key populations (KPs) such as men who have sex with men (MSM), female sex workers (FSWs), transgender (TG) people and persons who inject drugs (PWID). Applying an iterative Programme Science cycle, building on the effective programme coverage framework, we describe the approach used by the Centre for Infectious Disease Research in Zambia (CIDRZ) to scale up PrEP delivery and address inequities in PrEP access for KP in Lusaka, Zambia.
METHODS: In 2019, CIDRZ partnered with 10 local KP civil society organizations (CSOs) and the Ministry of Health (MOH) to offer HIV services within KP-designated community safe spaces. KP CSO partners led KP mobilization, managed safe spaces and delivered peer support; MOH organized clinicians and clinical commodities; and CIDRZ provided technical oversight. In December 2021, we introduced a community-based intervention focused on PrEP delivery in venues where KP socialize. We collected routine programme data from September 2019 to June 2023 using programme-specific tools and the national electronic health record. We estimated the before-after effects of our intervention on PrEP uptake, continuation and equity for KP using descriptive statistics and interrupted time series regression, and used mixed-effects regression to estimate marginal probabilities of PrEP continuity.
RESULTS: Most (25,658) of the 38,307 (67.0%) Key Population Investment Fund beneficiaries were reached with HIV prevention services at community-based venues. In total, 23,527 (61.4%) received HIV testing services, with 15,508 (65.9%) testing HIV negative and found PrEP eligible, and 15,241 (98.3%) initiating PrEP. Across all programme quarters and KP types, PrEP uptake was >90%. After introducing venue-based PrEP delivery, PrEP uptake (98.7% after vs. 96.5% before, p < 0.001) and the number of initiations (p = 0.014) increased significantly. The proportion of KP with ≥1 PrEP continuation visit within 6 months of initiation was unchanged post-intervention (46.7%, 95% confidence interval [CI]: 45.7%, 47.6%) versus pre-intervention (47.2%, 95% CI: 45.4%, 49.1%).
CONCLUSIONS: Applying Programme Science principles, we demonstrate how decentralizing HIV prevention services to KP venues and safe spaces in partnership with KP CSOs enabled successful community-based PrEP delivery beyond the reach of traditional facility-based services.

Chlamydia trachomatis (Ct) is the most common cause for bacterial sexually transmitted infections (STIs) worldwide with a tremendous impact on public health. With the aim to unravel novel targets of the chlamydia life cycle, we screen a compound library and identify 28 agents to significantly reduce Ct growth. The known anti-infective agent pentamidine-one of the top candidates of the screen-shows anti-chlamydia activity in low concentrations by changing the metabolism of host cells impairing chlamydia growth. Furthermore, it effectively decreases the Ct burden upon local or systemic application in mice. Pentamidine also inhibits the growth of Neisseria gonorrhea (Ng), which is a common co-infection of Ct. The conducted compound screen is powerful in exploring antimicrobial compounds against Ct in a medium-throughput format. Following thorough in vitro and in vivo assessments, pentamidine emerges as a promising agent for topical prophylaxis or treatment against Ct and possibly other bacterial STIs.

BACKGROUND: HIV Pre-Exposure Pophylaxis (PrEP) is provided free of charge by the Brazilian national health system. Though effective in preventing HIV infection, little is known about its impact on the health-related Quality of Life (QoL) of users.
OBJECTIVE: The present study aimed at assessing the impact of PrEP on the QoL of its users.
METHODS: Prospective cohort study with 114 HIV-negative participants aged 18 years or older. Participants\' QoL was assessed before starting PrEP and after 7 months of use, using the self-responsive WHOQOL-bref questionnaire. Sociodemographic and behavioral aspects were described and the Wilcoxon signed-rank test with p ≤ 0.05 was considered statistically significant.
RESULTS: Improvement was seen in QoL scores for the environment domain (p = 0.02), which addresses feeling of physical safety, access to information and health services, and participation in leisure activities. Furthermore, participants reported improved satisfaction with their sex life, when questioned about the social relationships domain. There was no statistically significant change in the global QoL score, in the global health score, in the physical and psychological domains, nor in the total score for the social relationships domain. As for their socio-demographic profile, most participants were white and highly educated young cisgender men who have sex with men. 76.3% had unprotected sex in the 3 months before starting PrEP. 60.5% had reported substance use: marijuana (42.1%), club drugs (35.1%), and poppers (20.2%).
CONCLUSIONS: This study unveiled that PrEP benefited our cohort beyond its effectiveness in preventing HIV infection, having improved environmental aspects of QoL and self-satisfaction with sex life.