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Annually, Shigella spp. cause ≈188 million cases of diarrheal disease globally, including 500,000 cases in the United States; rates of antimicrobial resistance are increasing. To determine antimicrobial resistance and risk factors in San Diego, California, USA, we retrospectively reviewed cases of diarrheal disease caused by Shigella flexneri and S. sonnei diagnosed during 2017-2020. Of 128 evaluable cases, S. flexneri was slightly more common than S. sonnei; most cases were in persons who were gay or bisexual cisgender men, were living with HIV, were unhoused, or used methamphetamines. Overall, rates of resistance to azithromycin, fluoroquinolones, ampicillin, and trimethoprim/sulfamethoxazole (TMP/SMX) were comparable to the most recent national data reported from the Centers for Disease Control and Prevention; 55% of isolates were resistant to azithromycin, 23% to fluoroquinolones, 70% to ampicillin, and 83% to TMP/SMX. The rates that we found for TMP/SMX were slightly higher than those in national data.

Black and Hispanic/Latinx cisgender men who have sex with men (MSM), transgender women, transgender men, and gender nonbinary (TGNB) individuals have been historically underrepresented in HIV pre-exposure prophylaxis (PrEP) clinical trials. There is an urgent need for ongoing engagement with communities that have been the most impacted by HIV and diverse representation in clinical trials. Here we describe strategic approaches undertaken in the PURPOSE 2 trial to optimize engagement of underrepresented individuals. PURPOSE 2 is an ongoing Phase 3 trial evaluating the safety and efficacy of lenacapavir as PrEP in cisgender MSM and TGNB individuals. In PURPOSE 2, we used a multipronged approach aimed at enriching participation of underrepresented individuals. We conducted a review to identify evidence-informed recommendations from literature, engaged with stakeholders, and established the Global Community Advisory and Accountability Group (GCAG) to represent the needs of the community. Insights from stakeholders and GCAG members resulted in an expansion of the study population to include transgender men, gender nonbinary persons, and adolescents, and evaluation of population-specific outcomes. Feedback from stakeholders and GCAG members also informed investigator and site selection; these were selected based on prior experience working with persons from diverse racial, ethnic and gender identities, and estimates of local HIV incidence. Site selection was also expanded to include community-based clinics with services tailored towards Black, Hispanic/Latinx, and TGNB populations. We established a study-wide recruitment goal of 50% Black MSM and 20% Hispanic/Latinx MSM in US sites and 20% transgender women globally. Site-specific recruitment goals were also developed based on local demographics and HIV incidence. Mandatory trainings included Good Participatory Practice guidelines, gender inclusivity, and antiracism. While further work is needed to achieve equitable representation, the strategies we describe may serve as a framework for future clinical trials. Clinical Trial Number: NCT04925752.

Pulmonary Tuberculosis (PTB) is a major health problem in prisons. Multiple studies of TB in regional Ethiopian prisons have assessed prevalence and risk factors but have not examined recently implemented screening programs for TB in prisons. This study compares bacteriologically-confirmed PTB (BC-PTB) prevalence in prison entrants versus residents and identifies risk factors for PTB in Kality prison, a large federal Ethiopian prison located in Addis Ababa, through a study of an enhanced TB screening program. Participating prisoners (n = 13,803) consisted of 8,228 entrants screened continuously and 5,575 residents screened in two cross-sectional waves for PTB symptoms, demographics, TB risk factors, and medical history. Participants reporting at least one symptom of PTB were asked to produce sputum which was examined by microscopy for acid-fast bacilli, Xpert MTB/RIF assay and MGIT liquid culture. Prevalence of BC-PTB, defined as evidence of Mycobacterium tuberculosis (MTB) in sputum by the above methods, was compared in entrants and residents for the study. Descriptive analysis of prevalence was followed by bivariate and multivariate analyses of risk factors. Prisoners were mainly male (86%), young (median age 26 years) and literate (89%). Prevalence of TB symptoms by screening was 17% (2,334/13,803) with rates in residents >5-fold higher than entrants. Prevalence of BC-PTB detected by screening in participating prisoners was 0.16% (22/13,803). Prevalence in residents increased in the second resident screening compared to the first (R1 = 0.10% and R2 = 0.39%, p = 0.027), but remained higher than in entrants (4.3-fold higher during R1 and 3.1-fold higher during R2). Drug resistance (DR) was found in 38% (5/13) of culture-isolated MTB. Risk factors including being ever diagnosed with TB, history of TB contact and low Body Mass Index (BMI) (<18.5) were significantly associated with BC-PTB (p<0.05). BC-PTB prevalence was strikingly lower than previously reported from other Ethiopian prisons. PTB appears to be transmitted within this prison based on its higher prevalence in residents than in entrants. Whether a sustained program of PTB screening of entrants and/or residents reduces prevalence of PTB in prisons is not clear from this study, but our findings suggest that resources should be prioritized to resident, rather than entrant, screening due to higher BC-PTB prevalence. Detection of multi- and mono-DR TB in both entrant and resident prisoners warrants regular screening for active TB and adoption of methods to detect drug resistance.

Background Cisgender women account for 1 in 5 new HIV infections in the United States, yet remain under-engaged in HIV prevention. Women experiencing violence face risk for HIV due to biological and behavioral mechanisms, and barriers to prevention, such as challenges to Pre-Exposure Prophylaxis for HIV Prevention (PrEP) adherence. In this analysis, we aim to characterize intimate partner violence (IPV) among cisgender heterosexual women enrolled in a PrEP demonstration project and assess the associations with PrEP adherence. Methods Adherence Enhancement Guided by Individualized Texting and Drug Levels (AEGiS) was a 48-week single-arm open-label study of PrEP adherence in HIV-negative cisgender women in Southern California ( N  = 130) offered daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). From 6/2016 to 10/2018, women completed a survey reporting HIV risk behavior and experiences of any IPV (past 90-days) and IPV sub-types (past-year, lifetime) and biological testing for HIV/STIs at baseline, and concentrations of tenofovir-diphosphate (TFV-DP) in dried blood spots at weeks 4, 12, 24, 36, and 48. Outcomes were TFV-DP concentrations consistent with ≥ 4 or ≥ 6 doses/week at one or multiple visits. Multivariable logistic regression models were conducted to examine associations. Results Past-90-day IPV was reported by 34.4% of participants, and past-year and lifetime subtypes reported by 11.5-41.5%, and 21.5-52.3%, respectively. Women who engaged in sex work and Black women were significantly more likely to report IPV than others. Lifetime physical IPV was negatively associated with adherence at ≥ 4 doses/week at ≥ 3 of 5 visits, while other relationships with any IPV and IPV sub-types were variable. Conclusion IPV is an indication for PrEP and important indicator of HIV risk; our findings suggest that physical IPV may also negatively impact long-term PrEP adherence. Clinical Trials Registration NCT02584140 (ClinicalTrials.gov), registered 15/10/2015.

Prisoners generally have a higher prevalence of HIV infection compared to the general population from which they come. Whether this higher prevalence reflects a higher HIV prevalence in those entering prisons or intramural transmission of HIV within prisons or both is unclear. Any of these possibilities would increase the prevalence found in resident prisoners above that in the general population. Moreover, comparisons of HIV prevalence in entrants and residents and in men and women in African prisons are not well documented. The purpose of this study was to estimate and compare the prevalence and risk factors for HIV infection amongst both male as well as female and entrant and resident prisoners in a large Ethiopian Federal Prison. We studied consenting prisoners cross-sectionally from August 2014 through November 2016. Prison entrants were screened continuously for HIV infection and its associated risk factors and residents were screened in two waves one year apart. HIV was diagnosed at the prison hospital laboratory based on the Ethiopian national HIV rapid antibody testing protocol. An external, internationally-accredited reference laboratory confirmed results. Agreement of results between the laboratories were assessed. A total of 10,778 participants were screened for HIV. Most participants were young (median age of 26 years, IQR: 21-33), male (84%), single (61%), literate (89%), and urban residents (91%) without prior incarceration (96%). Prevalence of HIV was 3.4% overall. Rates of HIV (p = 0.80) were similar in residents and entrants in wave 1 and in entrants in both waves, but were 1.9-fold higher (5.4% vs 2.8%) in residents than entrants in wave 2 (both p<0.001). At entrance to the prison women were more likely to be HIV+ than men (5.5% in women vs 2.5% in men, p< 0.001). In contrast resident women were less likely to be HIV+, but this difference was not statistically significant (3.2% in women vs 4.3% in men, p = 0.125). Other risk factors associated with HIV infection were increasing age (p<0.001), female gender (p<0.001), marital status (never vs other categories, p = 0.016), smaller number of rooms in their houses pre-imprisonment (p = 0.031), TB diagnosis ever (p<0.001), number of lifetime sex partners (especially having 2-10, p<0.001), and genital ulcer (p = 0.037). Prevalence of HIV in the residents at this large, central Ethiopian prison was higher than that estimated for the general population and lower than in many other studies from other smaller Ethiopian prisons. A higher prevalence in residents than in entrants were found only in our second wave of screening after one year of continuous screening and treatment, possibly representing increased willingness of residents at increased risk of HIV to participate in the second wave. Thus, this findings did not clearly support intramural transmission of HIV or the effectiveness of screening to reduce prevalence. Finally, the higher HIV prevalence in women than men requires that they be similarly screened and treated for HIV infection.

Emergency departments (ED) are critical access points for individuals at increased risk for acquiring HIV infection. Expanding ED-based HIV screening programs to provide HIV prevention services (HPS), including pre-exposure prophylaxis (PrEP), may fill an important public health gap. This was a mixed-methods, type 3 hybrid implementation effectiveness study of seven California EDs that integrated HPS for HIV negative patients between September 2021 and March 2023. A data collection instrument was used to obtain care cascade metrics. Semi-structured interviews were performed to understand the procedures for determining HPS eligibility and for making HPS referrals. All EDs had pre-existing HIV screening programs. Protocols were heterogeneous, sites used HPS navigators, and none initiated same-day PrEP. There were steep drop-offs at each cascade step. Of the 104,309 patients that tested HIV negative across all sites, 1851 (1.8 %) were eligible for a HPS referral, of which 1548 (83.6 %) received ED HPS information. After receiving ED HPS information, 988 (63.8 %) were referred to an outpatient HPS appointment. Of those who were referred and linkage data was available (N = 696), 497 (71.4 %) attended their outpatient HPS appointment. Two sites reported that 29 of the 39 patients who attended an appointment (74.4 %) were started on PrEP. We identified three models used to identify HPS eligibility (Behavioral Risk Assessment, STI-based Risk Assessment, and Automated Risk Assessment) and two models for making HPS referrals (Primary and Secondary). ED HIV screening programs can be leveraged to implement HPS. Different models for identifying and referring eligible patients to HPS allow for flexible integration. Each model has strengths and weaknesses for addressing the prevention care cascade and for informing practice. •ED HIV screening programs can be leveraged to implement HIV prevention services.•Different models of ED HIV prevention service allow for flexible integration.•There are steep drop-offs at each step of the ED HIV prevention care cascade.•Relatively few ED patients adhere to outpatient HIV prevention appointments.•Patients with STIs are best suited for HIV prevention services.

Background Prior to implementing a pre-exposure prophylaxis (PrEP) demonstration study, we sought to explore cisgender women’s experiences with HIV prevention, PrEP knowledge and attitudes, and anticipated barriers and facilitators for PrEP uptake and adherence in Southern California. Methods Three focus groups were held with cisgender women of mixed HIV serostatus in San Diego and Los Angeles between November 2015 and January 2016. Women were recruited through local testing sites, community-based organizations, and social media. Focus groups were audio-recorded and transcripts were analyzed using thematic analysis. Results Twenty-two women participated in focus groups, with median age 44 (IQR 30–53) and 6 identifying as non-Hispanic Black, 7 non-Hispanic White, 8 Latina and 1 mixed race. Despite limited prior PrEP knowledge and no PrEP experience, participants expressed interest in taking PrEP. Anticipated benefits were freedom from worry about HIV and control over sexual health; however, these were tempered by concerns including the possibility of increased HIV risk behaviors and potential side effects. Cisgender women reported potential barriers to PrEP uptake and adherence barriers, like competing priorities and poor PrEP access. Conversely, PrEP facilitators included utilizing practical tools such as phone apps and pill boxes as well as receiving encouragement from loved ones and support from other cisgender women on PrEP, women living with HIV and their medical providers. Conclusions Although PrEP awareness was low, participants recognized the importance of PrEP and ways to facilitate adherence. Exploring perspectives of cisgender women is integral to developing effective interventions to support PrEP uptake and adherence for women at elevated risk for HIV.

Background Transgender patients often cannot access a provider who is knowledgeable about providing gender-affirming hormone therapy (GAHT). This study evaluated primary care provider (PCP) comfort and experience with, opinions about, and knowledge of prescribing GAHT to adults. Methods An anonymous Qualtrics survey was distributed to PCPs in San Diego County. Fisher’s exact test assessed any association between age, years in practice, or practice setting and 1) comfort in prescribing GAHT and 2) favorable statements about learning about, providing, and benefitting from training in GAHT. T-tests determined relationship between age, years in practice, or practice type setting with number of correctly answered multiple choice knowledge-based questions out of 4. Results Out of 220 responses, median age was 41, 60% had practiced for ≤ 10 years, and 19% had practiced in an academic setting. Forty-two percent did not receive any education about transgender healthcare during medical training. The most commonly reported barrier to providing GAHT was lack of training (74%). PCPs age ≤ 41 (67% vs 49%, p  = 0.009), PCPs practicing for ≤ 10 years (65% vs 51%, p  = 0.037), and PCPs in non-academic settings (64% vs. 41%, p  = 0.013) were more likely to report being comfortable with prescribing GAHT. PCPs age ≤ 41 (89% vs 62%, p  < 0.001) and PCPs practicing for ≤ 10 years (86% vs 66%, p  < 0.001) were more likely to show interest in learning about GAHT. PCPs age ≤ 41 (74% vs 46%, p  < 0.001) and PCPs practicing for ≤ 10 years (70% vs 50%, p  = 0.003) were more likely to show interest in prescribing GAHT. Knowledge scores were higher for PCPs age  ≥42 (mean 1.7 vs 1.4, p  = 0.033) and PCPs working in academic centers (mean 2.0 vs 1.4, p  = 0.002). Conclusion Younger (age ≤ 41) and early career (practicing for ≤ 10 years) PCPs reported being more comfortable with prescribing GAHT and had more favorable opinions in learning about, providing, and benefitting from training in GAHT. They are interested in providing GAHT; however, few prescribe GAHT with most reporting lack of training as a major barrier. This was evident with overall low knowledge scores regardless of age, experience, or clinical setting and underscores the need for increased educational efforts in transgender care throughout medical training.

ObjectivesRectal douching/enema (RD) is a common practice among men who have sex with men (MSM) in preparation for sex. RD can break down the rectal mucosal barrier and potentially affect the rectal microbiome. The objective of this study was to understand if RD is associated with acquiring rectal infections (RI) with rectal gonorrhoea (NG) and/or chlamydia (CT).MethodsFrom 2013 to 2015, 395 adult HIV-uninfected MSM were enrolled in a randomised controlled study for pre-exposure prophylaxis (PrEP) adherence with routine sexual risk survey and testing. Using data from this cohort, baseline differences by RI were assessed using Pearson’s χ² and Wilcoxon-Mann-Whitney test. Association between RD and RI was modelled using multivariable logistic regression adjusted for potential confounders (sexual behaviour, substance use and age) selected a priori. Effect modification by number of male partners and sensitivity analysis to rule out reverse causality were also conducted.ResultsOf 395 participants, 261 (66%) performed RD and 133 (33%) had at least one NG/CT RI over 48 weeks. Number of condomless anal receptive sex (med: 4, p<0.001), male partners (med:6, p<0.001) and substance use (any of methamphetamine/hallucinogens/dissociative/poppers) (p<0.001) were associated with increased odds of RI. Controlling for potential confounders, odds of prevalent RI were 3.59 (p<0.001, 95% CI 1.90 to 6.78) and incident RI 3.87 (p=0.001, 95% CI 1.78 to 8.39) when douching weekly or more compared with not douching. MSM with more than six male partners had 5.34 (p=0.002, 95% CI 1.87 to 15.31) increased odds of RI when douching weekly or more compared with not douching.ConclusionRectal hygiene with RD is a common practice (66%) among HIV-uninfected MSM on PrEP in this study, which increases the odds of acquiring rectal NG and/or CT independent of sexual risk behaviour, substance use and other factors. This suggests interventional approaches targeting rectal hygiene products and practices could reduce sexually transmitted infections.

The FDA approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) in 2012 has raised questions about the delivery of PrEP in a real-world setting. iPad-based questionnaires were given to providers at conferences in California and New York to assess knowledge, experience and attitudes regarding PrEP in HIV and non-HIV providers. HIV provider status was defined either by self-identification or by having greater than 5 years of HIV care experience. Knowledge scores were the sum of correct answers from five PrEP knowledge questions. Univariate analyses used t -test to compare knowledge scores and Fisher’s exact test for past or future PrEP prescription between HIV and non-HIV providers. Multivariable linear or logistic regression models were used to assess factors associated with the outcomes. Of 233 respondents, the mean age was 40 years, 59 % were White, 59 % were physicians and 52 % were HIV providers. In univariate analysis, mean PrEP knowledge scores (max 5) were significantly higher for HIV providers (2.8 versus 2.2; p < 0.001), age > 41 (mean 2.8 versus 2.3; p = 0.004), White race (2.7 versus 2.2; p = 0.026) and participants in the New York region (3.0 versus 2.3; p < 0.001). In a multivariable model of knowledge scores, all but age remained significant. Among 201 potential prescribers, the rate of prior PrEP prescription was higher among HIV providers than non-HIV providers (34 versus 9 %; p < 0.001) and by knowledge score, but the association with provider status was no longer significant in multivariable analysis that controlled for knowledge. Intent to prescribe PrEP in the future was high for all provider types (64 %) and was associated with knowledge scores in multivariable analysis. The most common concerns about PrEP (>40 % of providers) were drug toxicities, development of resistance and patient adherence to follow-up; 32 % identified risk compensation as a concern. HIV providers had significantly greater PrEP knowledge than non-HIV providers, but differences by provider type in past PrEP prescription were largely dependent on knowledge. Future PrEP prescription was also associated with knowledge, though all providers expressed greater future use. Education of potential PrEP providers will be a key component of successful PrEP implementation.