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In the United States, immigrant Latino men who have sex with men (ILMSM) are, compared to white MSM, disproportionately burdened by HIV and lack access to highly effective HIV prevention strategies, such as pre-exposure prophylaxis (PrEP). Qualitative research centered on exploring barriers that ILMSM experience in accessing PrEP and other sexual services is extremely limited, despite a high prevalence of HIV in this population. In this study, a purposive sample of ILMSM (n = 25) was recruited to participate in a semi-structured in-depth interview to identify the distinct barriers and facilitators ILMSM experience in accessing sexual health services given their complex intersectional identities of being an immigrant, Latino, and a sexual minority man. Using a thematic analysis approach, nine themes were generated from the data representing barriers and facilitators. Barriers included: (1) cost and a lack of health insurance, (2) complexity of PrEP assistance programs; (3) challenges related to the immigrant experience; (4) impact of gay stigma; and (5) communication challenges. Facilitators included: (1) improving affordability and accessibility of PrEP services; (2) receiving services from LGBT- or Latine LGBT-centered clinics; (3) receiving services from medical providers who are gay and/or Latino; and (4) providing targeted community outreach, education, and promotion of PrEP to ILMSM. While many of the barriers illuminated in the study were structural (e.g., cost and lack of health insurance), and not easy to overcome, the findings highlight a range of facilitators that can support access to PrEP and other sexual health services for ILMSM. Considering these findings, we suggest strategies that may enhance access to needed sexual health services among ILMSM.

Mycoplasma genitalium causes a sexually transmitted infection and is also emerging as an important antimicrobial resistant pathogen. Data on M. genitalium infections among men who have sex with men (MSM) in low-resource settings are sparse.From January to December 2022, participants in an HIV pre-exposure prophylaxis (PrEP) program in Hanoi, Vietnam were enrolled into the study. Demographic, behavioral, and clinical characteristics were collected. Self-collected urine, rectal, and pharyngeal specimens were tested for M. genitalium using the Alinity m STI Assay (Abbott Molecular, USA). Univariate and multivariate logistic regression were performed to assess for factors associated with infections.Among 477 participants, the median age was 25.3 years (21.7-29.6) and 92.2% (n = 440) identified as MSM; 48.6% had ≥2 sex partners and 38.1% reported condomless anal sex in the prior month. The overall prevalence of M. genitalium infection was 10.9% (52/477); 7.3% (34/464) rectal, 3.2% (15/476) urethral, and 1.9% (9/476) pharyngeal. Infections were asymptomatic in 71.2% (37/52). Among those with M. genitalium, 30.7% (16/52) were co-infected with either N. gonorrhoeae or C. trachomatis. Among those reporting rectal (n = 51) or urethral (n = 35) symptoms, but without C. trachomatis or N. gonorrhoeae co-infections, five (9.8%) had rectal infections and one (2.9%) had urethral infection. Participants with M. genitalium were more likely to be asymptomatic than participants without M. genitalium (aOR 1.93; 95% CI 1.01-3.71).M. genitalium infections were common among primarily MSM engaged in an HIV PrEP program in Vietnam. The prevalence was highest in rectal specimens and nearly three quarters of M. genitalium infections were asymptomatic. Testing for M. genitalium infections among those with symptoms is important to enable pathogen-directed therapy. Additional research on antimicrobial resistance and treatment strategies for M. genitalium in low-resource settings is needed.

Cisgender women and transgender men are less likely to be assessed for PrEP eligibility, prescribed PrEP, or retained in PrEP care. Thus, this pilot PrEP educational intervention was tailored for healthcare providers (HCPs) in obstetrics/gynecology who provide care to cisgender women and transgender men in an academically-affiliated, public hospital women's health clinic. The three-lecture educational curriculum designed for HCPs focused on PrEP eligibility and counseling, formulations and adherence, and prescription and payment assistance programs. Pre- and post-intervention surveys assessed HCP knowledge and barriers to PrEP counseling and prescription. Among n = 49 participants (mean age = 32.8 years; 85.7% cisgender women, mean years practicing = 4.2 years) pre-intervention, 8.7% had prior PrEP training and 61.2% felt very/somewhat uncomfortable prescribing PrEP. Post-intervention, knowledge of PrEP contraindications, eligibility, follow-up care, and assistance programs all increased. HCPs identified key barriers to PrEP care including lack of a dedicated PrEP navigator, culturally and linguistically appropriate patient materials on PrEP resources/costs, and PrEP-related content integrated into EHRs. Ongoing PrEP educational sessions can provide opportunities to practice PrEP counseling, including information on financial assistance. At the institutional level, incorporating PrEP screening in routine clinical practice via EMR prompts, facilitating PrEP medication monitoring, and enhancing telehealth for follow-up care could enhance PrEP prescription. [ABSTRACT FROM AUTHOR]

This study aimed to assess the attitude, and Practice of female sex workers towards Pre-exposure Prophylaxis for HIV prevention in the Kicukiro district, Rwanda. The study used a descriptive cross-sectional design, using a probability sampling method, and the Yamane formula was used to calculate the sample size of 300 female sex workers including a 10% non-response rate. Primary data was collected using a structured questionnaire, at 10 health centers. Analysis was conducted using IBM SPSS software, with chi-square tests and logistic regression for inferential analysis. The ethical clearance was acquired from the Mount Kenya University ethics committee and the Young Women Christian Association Rwanda. The study findings showed that (60%) of female sex workers have a positive attitude towards PrEP, and 60.4% of respondents were using PrEP. Demographic factors like age group, marital status, and Ubudehe category were significantly associated with practices. Female sex workers aged between 25 and 29 had 4 times more chance to have good practices. This study provides insights into improving PrEP education and interventions targeting female sex workers and other key populations. These findings highlighted the concerns about stigma and privacy, and the need for public health interventions that target it in the community.

Objective: HIV Pre-Exposure Prophylaxis (PrEP) has been used in France since 2016. Its effectiveness is no longer to be demonstrated. However, follow-up and adherence remain the main pitfalls. The main objective of this study was to identify factors associated with persistence or loss of PrEP follow-up. Design: An historic cohort of PrEP users was compiled from the database of consultations in the Indre-et-Loire dedicated sexual health centers (CeGIDD) from June 2016 to June 2021. Methods: Kaplan–Meier curves were performed to compare the group of persistent PrEP users to the discontinuation group. Factors associated with PrEP discontinuation were identified using Cox modelling, considering time-dependent variables. Final variables included in the model were selected based on the Akaike Information Criterion (AIC) and clinical relevance. Results: Over the period, 568 PrEP users were included in the cohort. Median follow-up was 2.3 years. A quarter of users were lost to follow-up within 3 months after PrEP initiation. Sexual risk reduction AIDS community-based support (HR = 0.65[0.42;0.99]), being in a couple (HR = 0.51[0.38;0.68]), and history of syphilis (HR = 0.57[0.40;0.81]) were significantly associated with persistence of follow-up. Remote consultations (HR = 2.74[1.63;4.61]), chemsex practices (HR = 2.01[1.29;3.14]), and side effects (HR=1.72[1.03;2.88]) were significantly associated with a loss of follow-up. Conclusion: These results suggest that more sexual risk reduction AIDS community-based counseling could be a key, necessary for supporting PrEP users in their follow-up pathway. Indeed, AIDS community-based support could be used to build a basis for developing safe pathways. Remote consultations could represent a response to the issue of access to PrEP. To create a significant impact on global HIV incidence, the PrEP offer must be extended, and at-risk PrEP users supported to maintain PrEP use. [ABSTRACT FROM AUTHOR]

Introduction: Fewer than a quarter of people considered to have factors associated with HIV acquisition are prescribed pre-exposure prophylaxis (PrEP) in the United States. Prior studies demonstrate disparities in provider comfort and knowledge regarding PrEP, suggesting a need for provider capacity building to support widespread PrEP availability. This study examined real-world PrEP clinical questions/cases from providers to a teleconsultation service to identify knowledge gaps and improve PrEP-related training materials and clinical guidelines. Methods: The National Clinician Consultation Center (NCCC) PrEPline provides educational teleconsultation services on clinical decision-making related to PrEP for U.S. health care providers. The NCCC PrEP consultation data collected between 2017 and 2020 were reviewed and systematically categorized by clinical topics, subtopics, and complexity levels (low, moderate, and high). Results: Within the study period, the PrEPline provided 1,754 teleconsultations. More than three quarters came from advanced practice nurses and physicians. The topics of questions commonly focused on medication-based HIV prevention strategies (22.7%), PrEP laboratory ordering/monitoring (17.4%), and side effects and contraindications (14.6%). The majority of teleconsultations (57.9%) involved sharing information that was directly available/addressed in the Centers for Disease Control and Prevention (CDC) 2017 PrEP Guidelines (i.e., low complexity). Discussion: The low frequency of consultations from nonphysician and non-nurse practitioner providers may suggest a need for increased training and collaborative opportunities for other types of providers. The high percentage of low-complexity inquiries may reveal a desire for capacity-building materials specifically designed for practicing providers (e.g., abridged versions of guidelines). This study may inform future research, best clinical practices, and aid in the development of training materials to increase providers' HIV prevention comfort and knowledge.

Background: Oral pre-exposure prophylaxis (PrEP) using co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is a potent HIV prevention method for men and women, with its efficacy highly dependent on adherence. A pivotal HIV efficacy study combined with a directly observed pharmacological study defined the thresholds for HIV protection in men who have sex with men (MSM), which are the keys to PrEP promotion and development of new PrEP agents. For African women at risk for HIV and belonging to a priority group considered due to disproportionately high incident HIV infections, the variable adherence in PrEP clinical trials and the limited pharmacologic data have resulted in a lack of clarity about the PrEP adherence required for HIV protection. We propose a study to quantify the adherence–concentration–efficacy thresholds of TDF/FTC PrEP among African cisgender women to inform decisions about optimal PrEP dosing and adherence for HIV protection. Methods: We randomized 45 low-risk HIV-uninfected African women, aged 18–30 years old, to directly observe the TDF/FTC PrEP of two, four, or seven doses per week for 8 weeks. A complementary age-matched pregnant women cohort at high risk of HIV, who will receive seven doses per week, was recruited (N = 15) with the primary aim of establishing benchmark concentrations in dried blood spots and peripheral blood mononuclear cells. Plasma, whole blood (WB), urine, hair, vaginal fluid, and vaginal tissue (non-pregnant women only) were archived for future testing. Drug concentrations were measured using methods validated for each biological matrix. Pharmacokinetic models were fitted to drug concentrations to quantify concentration–adherence thresholds. To define the drug concentrations associated with HIV protection, we applied the newly defined thresholds from the primary pharmacologic trial to the subset of women randomized to TDF/FTC or TDF in the Partners PrEP Study with the drug concentration assessed in plasma and WB samples. Multiple imputation was used to construct a data set with drug concentrations at each visit when an HIV test was performed for the entire cohort, replicating the work for MSM. Discussion: The proposed study generated the first African women-specific TDF– PrEP adherence–concentration–efficacy thresholds essential for guiding the accurate interpretation of TDF/FTC PrEP programs and clinical trials of novel HIV prevention products using TDF/FTC as an active control. [ABSTRACT FROM AUTHOR]

In a pilot study providing HIV self-testing to persons who use drugs (N = 40), we identified 3 new HIV cases when partnering with a community-based organization. Most (82%) participants were interested in preexposure prophylaxis. HIV self-testing could contribute to efforts to Ending the HIV Epidemic in the United States. ClinicalTrials.gov registration: NCT05528562 [ABSTRACT FROM AUTHOR]

In the United States, youth experience suboptimal HIV pre-exposure prophylaxis (PrEP) adherence. One common idea posits that this is due to their developing decision-making skills. However, quantitative evidence of this assumption is limited. We therefore examined whether individual decision-making factors, such as HIV risk perception and sexual behavior, predicted PrEP adherence in a national trial of young sexual and gender minorities (YSGMs). In 2019–2021, the Adolescent Medicine Trials Network for HIV Interventions 142 study enrolled 225 PrEP users (ages 16–24) throughout the country. Regression models estimated the associations between HIV risk perception (using a modified Perceived HIV Risk Scale), sexual behavior (condomless anal sex in ≤ 3 months), and self-reported oral PrEP adherence (≥4 pills in the past week) at the same time point (baseline) and longitudinally (3 months). Baseline risk perception (risk ratio [RR]: 0.92, 95% confidence interval [CI]: 0.82, 1.04) and condomless anal sex (RR: 1.10, 95% CI: 0.97, 1.25) were not associated with PrEP adherence at the same time point and did not predict 3-month adherence (RR: 0.97, 95% CI: 0.85, 1.11; RR: 1.05, 95% CI: 0.93, 1.19, respectively). Baseline risk perception was not associated with condomless anal sex at either time point (baseline RR: 1.16, 95% CI: 0.94, 1.43; 3-month RR: 1.07, 95% CI: 0.90, 1.28). In this national trial of YSGM, HIV risk perception and condomless anal sex did not predict PrEP adherence. Targeting individual-level perceptions and behaviors will likely insufficiently address youth's suboptimal PrEP use. Future research should identify YSGM-specific adherence drivers and train providers to recognize such motivations. [ABSTRACT FROM AUTHOR]

Introduction: Simplified hepatitis C virus (HCV) diagnostic strategies have the potential to improve HCV diagnoses and treatment. We aimed to investigate the impact of simplified HCV diagnostic strategies on HCV incidence and its effect on HCV diagnosis and treatment among men who have sex with men (MSM) regardless of HIV status and use of HIV pre‐exposure prophylaxis (PrEP) in Taiwan. Methods: A compartmental deterministic model was developed to describe the natural history of HCV disease progression, the HCV care cascade and the HIV status and PrEP using among MSM. The model was calibrated to available data for HCV and HIV epidemiology and population demographics in Taiwan. We simulated the epidemic from 2004 and projected the impact of simplified testing strategies on the HCV epidemic among MSM over 2022–2030. Results: Under the current testing approach in Taiwan, total HCV incidence would increase to 12.6 per 1000 person‐years among MSM by 2030. Single‐visit point‐of‐care RNA testing had the largest impact on reducing the number of new HCV infections over 2022–2030, with a 31.1% reduction (interquartile range: 24.9%−32.8%). By 2030, single‐visit point‐of‐care HCV testing improved HCV diagnosis to 90.9%, HCV treatment to 87.7% and HCV cure to 81.5% among MSM living with HCV. Compared to status quo, prioritized simplified HCV testing for PrEP users and MSM living with diagnosed HIV had considerable impact on the broader HCV epidemic among MSM. A sensitivity analysis suggests that reinfection risk would have a large impact on the effectiveness of each point‐of‐care testing scenario. Conclusions: Simplified HCV diagnostic strategies could control the ongoing HCV epidemic and improve HCV testing and treatment among Taiwanese MSM. Single‐visit point‐of‐care RNA testing would result in large reductions in HCV incidence and prevalence among MSM. Efficient risk‐reduction strategies will need to be implemented alongside point‐of‐care testing to achieve HCV elimination among MSM in Taiwan. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Background: HIV pre-exposure prophylaxis (PrEP) is a highly effective method to mitigate the HIV epidemic, but uptake of PrEP has been slow and is associated with racial and gender disparities. Oral PrEP requires high levels of adherence to be effective, which may disadvantage certain high-risk groups. The first injectable HIV PrEP, a drug given every 2 months rather than as a daily pill, was approved by the US Food & Drug Administration in December 2021. Setting: A Family Medicine practice in a single health organization in the United States (November 2022 to February 2023). Methods: We conducted interviews with patients and key stakeholders to characterize factors affecting long-acting injectable (LAI) PrEP implementation. Data collection and analysis were guided by the Consolidated Framework for Implementation Research. Interviews were transcribed and analyzed using guided content analysis. Results: Twenty-five patients (n = 13) and practice stakeholders (n = 12) were interviewed. Overall, stakeholders described a very low uptake of LAI PrEP. Barriers to LAI PrEP included a lack of awareness, insurance and access issues, a lack of streamlined workflow, and a trust in pills over injectables. Facilitators to LAI PrEP implementation included the absence of a pill burden, a culture of shared decision making, and pharmacy support. Conclusions: Although uptake has been slow, we have identified several promising strategies for improving rollout and implementation of LAI PrEP. Approaches that can bolster rollout of LAI PrEP include having an interdisciplinary care team that is supported by PrEP navigators and pharmacists and are informed by a patient-centered model of care to increase patient engagement and trust. [ABSTRACT FROM AUTHOR]

BackgroundPre-exposure prophylaxis (PrEP) prevention-effective adherence is of critical importance but challenging particularly among key populations where periods of high HIV risk are frequent. We assessed the use of PrEP with reference to periods of unprotected sex among female sex workers in the city of Tanga.MethodsThis was part of the pragmatic quasi-experimental trial for HIV PrEP rollout in Tanzania involving a control cohort of 313 female sex workers aged ≥18 years recruited by respondent-driven sampling and followed for 12 months. PrEP use and periods of condomless or unprotected sex were assessed at the 6th and 12th month of follow-up. Prevention-effective adherence was defined as PrEP use of ≥2 pills/week and ≥6 pills/week for anal and vaginal condomless sex. Multivariable modified Poisson regression was conducted to determine factors influencing PrEP use (≥2 pills/week).ResultsOverall, 59.2 and 45.9% of participants had unprotected anal and vaginal sex with a client, respectively. The prevention-effective adherence for anal sex ranged from 8.0% (months 6) to 10.0% (months 12) while that of vaginal sex was from 10.1% (month 6) to 3.8% (month 12). Participants who lived with friends were 25.5 times more likely to use ≥2 PrEP doses per week than those who lived alone (aPR = 25.5; 95%CI: 2.55–255.42, p = 0.006). Compared to self-reporting poor health status, self-reporting good health status significantly increased the use of ≥2 PrEP doses per week (aPR = 17.4; 95%CI: 3.01–101.02, p = 0.001). Refusing condomless sex with a steady partner increased the likelihood of using ≥2 PrEP doses per week than accepting condomless sex with a steady partner (aPR = 11.2; 95%CI: 1.55–80.48, p = 0.017). The prevalence of using ≥2 PrEP doses per week was less among participants accepting condomless sex at high pay than those who refused (aPR = 0.1; 95%CI: 0.03–0.26, p = 0.000).ConclusionUse of PrEP during periods of unprotected sex was rare among female sex workers. Living with friends, self-reporting good health status, and refusing condomless sex with steady partners were associated with increased use of ≥2 PrEP doses per week. However, accepting condomless sex for increased payment was associated with reduced use of ≥2 PrEP doses per week. This calls for an in-depth study to understand the perspectives and circumstances shaping poor adherence during periods of unprotected sex among female sex workers.

HIV pre-exposure prophylaxis (PrEP) has shown high efficacy and effectiveness for HIV prevention; however, many individuals with PrEP indications are not receiving PrEP. PrEP Coordinators work closely with patients and health care providers to increase PrEP access, and they provide unique insights into the inner workings of PrEP care and service delivery. In this study, we discuss key challenges and recommendations for improved PrEP service delivery (including training PrEP Coordinators to manage PrEP panels, making PrEP a part of routine care and optimizing electronic health records, designating a PrEP "champion" who can strengthen communication and leadership, using a proactive approach to increase PrEP retention, and training providers and PrEP Coordinators to meet youth-specific needs) from our discussions with the PrEP Coordinators who led PrEP panel management in San Francisco Department of Public Health primary care clinics.

HIV Pre-Exposure Prophylaxis (PrEP) consists of a daily antiretroviral regimen that prevents HIV acquisition. In this article, we discuss ways in which individuals on PrEP deal with risks and uncertainties through their life experiences amid PrEP risk rituals and rational and non-rational individualisation processes. We analysed data from a web-based group of mostly gays, bisexuals and other men who have sex with men on PrEP through a thematic-content approach. We found that individuals, influenced by medical and health institutions, were involved in 'risk rituals' with profound effects on their subjective embodiment, emotions and feelings. These processes became amalgamated into conflicting objective consequences to themselves and their social networks, which included the acquisition of new diseases amid increasing ambivalences of being on PrEP. Our theoretical argument is that risk rituals were symptomatic of social iatrogenesis amid the contemporary risk and individualised society. By developing an analytical dialogue between our empirical data and modernisation theories of risk and individualisation, we sought to understand risk rituals through conflict, relational, group and institutional domains, as these layers of analysis help us grasp the core characterisation of social iatrogenesis. Drawing on these insights, we also pay attention to potential futures of injectable PrEP, considering the role of hope, the collective production of the unknown and medical action as a type of intensification of risk rituals and social iatrogenesis. [ABSTRACT FROM AUTHOR]

Prescription rates of pre-exposure prophylaxis (PrEP) have remained low among noninfectious disease providers in the United States despite almost a decade since their introduction. For future primary care doctors, residency is the optimal time to build practice patterns around HIV prevention. We assessed baseline knowledge of PrEP in specific pre- and post-exposure prophylaxis content areas among internal medicine trainees who completed the Physician Education and Assessment Center HIV learning module between 2013 to 2020 (N = 12,060). Resident baseline PrEP knowledge was universally low; despite rising awareness of antiretroviral therapy for PrEP in successive years following the nadir of 41% in 2014, still only 56% of residents affirmed this means of HIV prevention by 2020. Knowledge remained limited regardless of academic year, local HIV prevalence, or training program type. Online module completion increased competence across all content areas. There is still a deficit in HIV prevention knowledge across U.S. internal medicine residents, suggesting insufficient education and exposure to HIV-related care. [ABSTRACT FROM AUTHOR]

Cabotegravir is an integrase strand transfer inhibitor (INSTI) for HIV treatment and prevention. Cabotegravir-based long-acting pre-exposure prophylaxis (PrEP) presents an emerging paradigm for infectious disease control. In this scheme, a combination of a high efficacy and low solubility of anti-infection drugs permits the establishment of a pharmaceutical firewall in HIV-vulnerable groups over a long period. Although the structure-activity-relationship (SAR) of cabotegravir as an INSTI is known, the structural determinants of its low solubility have not been identified. In this work, we have integrated multiple experimental and computational methods, namely X-ray diffraction, solid-state NMR (SSNMR) spectroscopy, solution NMR spectroscopy, automated fragmentation (AF)-QM/MM and density functional theory (DFT) calculations, to address this question. The molecular organization of cabotegravir in crystal lattice has been determined. The combination of very-fast magic-angle-sample-spinning (VF MAS) SSNMR and solution NMR, as supported by AF-QM/MM and DFT calculations, permits the identification of structural factors that contribute to the low aqueous solubility of cabotegravir. Our study reveals the multitasking nature of pharmacophores in cabotegravir, which controls the drug solubility and, meanwhile, the biological activity. By unraveling these function-defining molecular features, our work could inspire further development of long-acting HIV PrEP drugs. [ABSTRACT FROM AUTHOR]

Abstract Introduction Simplified hepatitis C virus (HCV) diagnostic strategies have the potential to improve HCV diagnoses and treatment. We aimed to investigate the impact of simplified HCV diagnostic strategies on HCV incidence and its effect on HCV diagnosis and treatment among men who have sex with men (MSM) regardless of HIV status and use of HIV pre‐exposure prophylaxis (PrEP) in Taiwan. Methods A compartmental deterministic model was developed to describe the natural history of HCV disease progression, the HCV care cascade and the HIV status and PrEP using among MSM. The model was calibrated to available data for HCV and HIV epidemiology and population demographics in Taiwan. We simulated the epidemic from 2004 and projected the impact of simplified testing strategies on the HCV epidemic among MSM over 2022–2030. Results Under the current testing approach in Taiwan, total HCV incidence would increase to 12.6 per 1000 person‐years among MSM by 2030. Single‐visit point‐of‐care RNA testing had the largest impact on reducing the number of new HCV infections over 2022–2030, with a 31.1% reduction (interquartile range: 24.9%−32.8%). By 2030, single‐visit point‐of‐care HCV testing improved HCV diagnosis to 90.9%, HCV treatment to 87.7% and HCV cure to 81.5% among MSM living with HCV. Compared to status quo, prioritized simplified HCV testing for PrEP users and MSM living with diagnosed HIV had considerable impact on the broader HCV epidemic among MSM. A sensitivity analysis suggests that reinfection risk would have a large impact on the effectiveness of each point‐of‐care testing scenario. Conclusions Simplified HCV diagnostic strategies could control the ongoing HCV epidemic and improve HCV testing and treatment among Taiwanese MSM. Single‐visit point‐of‐care RNA testing would result in large reductions in HCV incidence and prevalence among MSM. Efficient risk‐reduction strategies will need to be implemented alongside point‐of‐care testing to achieve HCV elimination among MSM in Taiwan.

BackgroundWe evaluated the association of inflammation and dysbosis on cervicovaginal fluid (CVF) tenofovir (TFV) concentrations in women taking oral tenofovir disoproxil fumarate/emtricitable for HIV pre-exposure prophylaxis (PrEP) in the United States.SettingThirty-five women in a HIV PrEP implementation study attended their week 24 visit at a San Diego research clinic and provided CVF specimens.MethodsWomen in the Adherence Enhancement Guided by Individualized Texting and Drug Levels study had their CVF specimens evaluated for (1) sexually transmitted bacterial (Neisseria gonorrhoeae, Chlamydia trachomatis, Gardnerella, and Trichomonas vaginalis), viral (human papillomavirus, cytomegalovirus and herpes simplex virus-1/2) and fungal (Candida) infections; (2) microbiome composition by 16 S sequencing (V3-V4 region); and (3) cytokine profiles by enzyme-linked immunoassay (Interleukin-8, macrophage Inflammatory protein-1a, macrophage Inflammatory Protein-1b and interferon-γ-inducible protein-10). Univariate statistical analysis was used to determine factors associated with CVF TFV concentrations. CVF TFV of 100-1000 ng/mL benchmarked typical genital concentrations and TFV-diphosphate in dried blood spots of 700 fmol/punch was considered adequate adherence.ResultsThirty-five women had CVF specimens collected. No factor was associated with CVF TFV concentrations or discordance of blood and vaginal concentrations. Among 27 participants assessed for vaginosis (Candida, Gardnerella or Trichomonas), women with Gardnerella (n = 11) were more likely to have high (>1000 ng/mL) CVF TFV concentrations (82% versus 33%, P = 0.02).ConclusionsPresence of genital viruses, cytokines, or vaginal community state types were not associated with low CVF TFV concentrations in cisgender women taking oral tenofovir disoproxil fumarate/emtricitable for PrEP. The surprising association observed between presence of Gardnerella and higher vaginal TFV concentrations needs further evaluation.

Bezza Ademe,1 Eyob Ketema Bogale,2 Tadele Fentabil Anagaw2 1Department of Nursing, Tibebe Ghion Specialized Hospital, Bahir Dar University, Bahir Dar, Ethiopia; 2Department of Health Promotion and Behavioral Science, School of Public Health, College of Medicine and Health Science, Bahir Dar University, Bahir Dar, EthiopiaCorrespondence: Tadele Fentabil Anagaw, Department of Health Promotion and Behavioral Science, School of Public Health, College of Medicine and Health Science, Bahir Dar University, PoBox:079, Bahir Dar, Ethiopia, Tel +251-927692916, Email tadele27@gmail.comObjective: This study aimed to assess the utilization of HIV pre-exposure prophylaxis and associated factors among commercial female sex workers in Bahir Dar City, Northwest Ethiopia, in 2022.Methods: An institution-based cross-sectional study was conducted in Bahir Dar City from November 1 to 30, 2022. The random sampling technique was used to select 396 commercial female sex workers. Kobo Collector was used to gather the data, which was then exported to STATA 14 for analysis. In bivariate regression analysis, all variables with a P-value of < 0.2 were entered into multivariable logistic regression. Multivariable logistic regression variables with P-values ≤ 0.05 at a 95% confidence interval were declared to be significantly linked with the utilization of HIV pre-exposure prophylaxis.Results: In this study, 183 (46.2%) (95%CI: 41.33– 51.16) of respondents utilized HIV pre-exposure prophylaxis. Educational status: secondary and above (AOR: 2.18, 95%CI: 1.05– 4.53). Age of sex workers 26– 36 (AOR: 0.20, 95%CI: 0.17– 0.84); experience of sex work 3– 5 years (AOR: 0.25, 95%CI: 0.24– 0.83); and having good knowledge (AOR: 4.98, 95%CI: 3.90– 10.65) were significantly associated with the utilization of HIV pre-exposure prophylaxis.Conclusion: In this study, HIV pre-exposure prophylaxis was not widely used by commercial female sex workers. Therefore, social and behavioral change communication strategies focus on creating awareness and building knowledge on HIV pre-exposure prophylaxis utilization.Keywords: pre-exposure prophylaxis, HIV pre-exposure prophylaxis, female sex workers, Ethiopia

Abstract Background Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality and incidence. Effective ART based prevention has not translated into population-level impact in southern Africa due to sub-optimal coverage among youth. We aim to investigate the effectiveness, implementation and cost effectiveness of peer-led social mobilisation into decentralised integrated HIV and sexual reproductive health (SRH) services amongst adolescents and young adults in KwaZulu-Natal (KZN). Methods We are conducting a type 1a hybrid effectiveness/implementation study, with a cluster randomized stepped-wedge trial (SWT) to assess effectiveness and a realist process evaluation to assess implementation outcomes. The SWT will be conducted in 40 clusters in rural KZN over 45 months. Clusters will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). 1) Intervention arm: Resident peer navigators in each cluster will approach young men and women aged 15–30 years living in their cluster to conduct health, social and educational needs assessment and tailor psychosocial support and health promotion, peer mentorship, and facilitate referrals into nurse led mobile clinics that visit each cluster regularly to deliver integrated SRH and differentiated HIV prevention (HIV testing, UTT for those positive, and PrEP for those eligible and negative). Standard of Care is UTT and PrEP delivered to 15–30 year olds from control clusters through primary health clinics. There are 3 co-primary outcomes measured amongst cross sectional surveys of 15–30 year olds: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention; 3) cost of transmissible HIV infection averted. We will use a realist process evaluation to interrogate the extent to which the intervention components support demand, uptake, and retention in risk-differentiated biomedical HIV prevention. Discussion The findings of this trial will be used by policy makers to optimize delivery of universal differentiated HIV prevention, including HIV pre-exposure prophylaxis through peer-led mobilisation into community-based integrated adolescent and youth friendly HIV and sexual and reproductive health care. Trial registration ClinicalTrials.gov Identifier—NCT05405582. Registered: 6th June 2022.

The prevention of HIV and unintended pregnancies is a public health priority. Multi-purpose prevention technologies capable of long-acting HIV and pregnancy prevention are desirable for women. Here, we utilized a preclinical macaque model to evaluate the pharmacokinetics of biodegradable ε-polycaprolactone implants delivering the antiretroviral islatravir (ISL) and the contraceptive etonogestrel (ENG). Three implants were tested: ISL-62 mg, ISL-98 mg, and ENG-33 mg. Animals received one or two ISL-eluting implants, with doses of 42, 66, or 108 µg of ISL/day with or without an additional ENG-33 mg implant (31 µg/day). Drug release increased linearly with dose with median [range] plasma ISL levels of 1.3 [1.0–2.5], 1.9 [1.2–6.3] and 2.8 [2.3–11.6], respectively. The ISL-62 and 98 mg implants demonstrated stable drug release over three months with ISL-triphosphate (ISL-TP) concentr54ations in PBMCs above levels predicted to be efficacious for PrEP. Similarly, ENG implants demonstrated sustained drug release with median [range] plasma ENG levels of 495 [229–1110] pg/mL, which suppressed progesterone within two weeks and showed no evidence of altering ISL pharmacokinetics. Two of the six ISL-98 mg implants broke during the study and induced implant-site reactions, whereas no reactions were observed with intact implants. We show that ISL and ENG biodegradable implants are safe and yield sufficient drug levels to achieve prevention targets. The evaluation of optimized implants with increased mechanical robustness is underway for improved durability and vaginal efficacy in a SHIV challenge model. [ABSTRACT FROM AUTHOR]

Background: Potential risk contacts for HIV transmission may lead to presentations to the emergency department (ED) for counseling and initiation of post-exposure prophylaxis (PEP). Objective: To examine the impact of German health insurance covering pre-exposure prophylaxis (PrEP) following Sept 1st 2019 for certain risk groups on the frequency and reasons for PEP counseling in a university-based ED in Germany. Methods: In a before-after study design, all persons aged ≥18 years who presented for PEP counseling were analyzed retrospectively. We compared characteristics of presentations in the 18 months prior to PrEP coverage on Sept 1st, 2019, with those in the following 18 months. Results: 154 ED presentations occurred in the first study period, and 155 ED presentations in the second period. Regarding the reasons for ED visits, no statistically significant difference was found [occupational risk contact (18.2 vs. 26.5%, p = 0.081), sexual risk contact (74.7 vs. 69.0%, p = 0.266), other non-occupational risk contact (7.1 vs. 4.5%, p = 0.329)]. For men who have sex with men (MSM), no statistically significant differences were found [38.9 (n = 60) vs. 35.5% (n = 55), p = 0.537]. All persons presenting to the HIV outpatient clinic after ED PEP initiation (n = 60 vs. n = 52) tested negative for HIV 3 months later. Conclusion: In this study, reasons to present for PEP counseling to a university ED showed no change following the implementation of PrEP coverage by health insurances. Therefore, PEP remains an important prevention for HIV transmission and presentations to the ED for PEP counseling may provide an opportunity to educate persons at risk of HIV infection about PrEP, thereby helping to prevent new HIV infections. [ABSTRACT FROM AUTHOR]

Introduction: In Eswatini, HIV incidence among women of childbearing age is 1.45%. Eswatini introduced oral pre-exposure prophylaxis (PrEP) for HIV prevention in 2016 and requires that all HIV-negative pregnant and post-natal women (PPW) visiting health care facilities be offered PrEP. Methods: Between September-November 2021, we conducted a survey among HIV-negative PPW from 16 purposively selected healthcare facilities in the Hhohho and Shiselweni regions in Eswatini. We interviewed consenting HIVnegative PPW using a structured questionnaire to collect data on PrEP knowledge, attitudes, intentions, and practices, as well as information on partner HIV status and stigma. Multivariate logistic regression was used to determine predictors of PrEP use and intention, adjusted for significant covariates. Results: Of 1,484 PPWwomen approached, 1,149 consented andwere interviewed, of whom 704 (61.3%) were post-partum and 445 (38.7%) pregnant. The median age was 25 years [Interquartile Range (IQR) = 21-30 years], with 533 (46.4%) 18-24 years old. Among the 1,149 women, 930 (80.7%) had ever heard about PrEP; 635 (55.3%) had knowledge about PrEP; 183 (15.9%) were currently using PrEP; and 285 (24.8%) had ever used PrEP. Increased odds of PrEP use were associated having HIV-positive male partner (aOR:7.76, 95%CI 3.53-17.04); positive attitudes to PrEP (aOR:1.56, 95% CI: 1.02-2.40); and high self-efficacy (aOR:1.49, 95%CI:1.13-1.98). Among 864 women who never used PrEP, 569 (65.3%) intended to use PrEP in the future. Odds of intention to use PrEP were higher among women with low levels of education (aOR:2.23, 95% CI: 1.32-3.77); who ever heard about PrEP (aOR:1.69, 95%CI: 1.12-2.56); and had high self-efficacy (aOR:1.57, 95%CI: 1.31-1.87). Regarding stigma, among all women, 759 (66%) either agreed or strongly agreed that people would think they have HIV if they were to use PrEP; 658 (57.3%) reported they would be labelled as having multiple sex partners; 468 (40.7%) reported that their partner would think they are having risky sex with other people. Of 102 women who had discontinued PrEP, a majority stopped due to side effects 32 (35.2%). Conclusion: Only about 50% of women had knowledge of PrEP, and PrEP uptake among PPW was low, though intention to use appeared high. More efforts to reduce stigma and promote PrEP use, including adequate information on side effects, are needed. [ABSTRACT FROM AUTHOR]

Despite evidence supporting HIV pre-exposure prophylaxis (PrEP) effectiveness, very few women with opioid use disorder (OUD) take PrEP. Interventions that improve medication assisted treatment (MAT) uptake and adherence may also be beneficial for PrEP. The reSET-O mobile phone app is a component of the evidence-based Therapeutic Education System, which improves retention and abstinence for people with OUD. To better understand use of this mobile health tool as a support for PrEP among women with OUD, pre-implementation contextual inquiry is needed. Therefore, we set out to assess target user characteristics, implementation barriers, feasibility, and acceptability of reSET-O. We recruited women with OUD receiving care from a community-based organization in Philadelphia to complete semi-structured interviews. All participants were prescribed reSET-O. We interviewed 20 participants (average age 37 years; 70% white, 15% Hispanic, 5% Black) from 5/2021 to 2/2022. We used an integrated analysis approach combining modified grounded theory and implementation science constructs. Half reported recent injection drug use, and 6 were taking buprenorphine. Mental health symptoms were common, and half described engaging in transactional sex. The majority expressed strong interest in PrEP. Participants reported the app would be highly acceptable for PrEP and MAT adherence support, but only two redeemed the prescription. The most common barriers included phone and internet access. Our findings highlight potential implementation challenges for the use of such an app to support PrEP use in this population. Poor uptake of the app at follow-up indicates that initial prescription redemption is a major barrier to reSET-O implementation. [ABSTRACT FROM AUTHOR]

Abstract Background The impact of starting HIV pre-exposure prophylaxis (PrEP) on diagnoses of sexually transmitted infections (STI) remains unclear. We used data from German HIV/STI Checkpoints collected from 01/2019 to 08/2021 to determine the impact of PrEP use on syphilis, gonorrhoea and chlamydia diagnoses. Methods We used self-reported data on demographics, sexual behaviour, testing and PrEP use, as well as lab-confirmed diagnoses from visits to HIV/STI Checkpoints in Germany. PrEP use was categorized as (1) never used; (2) intention to use; (3) former use; (4) current on-demand use; (5) daily use. In multivariate regression analyses (MRA) with gonorrhoea, chlamydia, and syphilis diagnoses as outcomes, we controlled for age, number of sexual partners, number of condomless anal intercourse (CAI) partners in the last six months, and testing recency. Results For the analysis, we included 9,219 visits for gonorrhoea and chlamydia testing and 11,199 visits for syphilis testing conducted at checkpoints from 01/2019 to 08/2021. MRA identified age (aOR 0.98; 95%CI 0.97–0.99), number of sexual partners in the past six months (aOR 4.90; 95%CI 2.53–9.52 for 11 + partners), and use of chemsex substances (aOR 1.62; 95%CI 1.32-2.00) as risk factors for gonorrhoea, while age (aOR 0.99; 95%CI 0.98-1.00), number of CAI partners (aOR 3.19; 95%CI 2.32–4.41 for 5 + partners), partner sorting (aOR 1.30; 95%CI 1.09–1.54), and use of chemsex substances (aOR 1.29; 95%CI 1.05–1.59) were risk factors for chlamydia infections. For syphilis, the number of CAI partners (aOR 3.19; 95%CI 1.60–6.34 for 5 + partners) was found to be the only significant risk factor. There was a strong association between PrEP use and the number of sexual partners (≤ 5 vs.>5: aOR 3.58; 95%CI 2.15–5.97 for daily PrEP use), the number of CAI partners in the past six months (≤ 1 vs.>1: aOR 3.70; 95%CI 2.15–6.37 for daily PrEP use), and the number of STI tests performed (suggesting higher testing frequency). Both outcomes were also related to partner sorting, chemsex, and selling sex. Conclusions Checkpoint visits reporting current PrEP use or intention to start PrEP correlated with eligibility criteria for PrEP, i.e. high partner numbers, inconsistent condom use during anal intercourse, and use of chemsex drugs. Use of HIV-specific prevention methods such as HIV serosorting, PrEP sorting, and viral load sorting was reported more frequently. (Daily) PrEP use was an independent risk factor for a chlamydia diagnosis only.

IntroductionIn Eswatini, HIV incidence among women of childbearing age is 1.45%. Eswatini introduced oral pre-exposure prophylaxis (PrEP) for HIV prevention in 2016 and requires that all HIV-negative pregnant and post-natal women (PPW) visiting health care facilities be offered PrEP.MethodsBetween September-November 2021, we conducted a survey among HIV-negative PPW from 16 purposively selected healthcare facilities in the Hhohho and Shiselweni regions in Eswatini. We interviewed consenting HIV-negative PPW using a structured questionnaire to collect data on PrEP knowledge, attitudes, intentions, and practices, as well as information on partner HIV status and stigma. Multivariate logistic regression was used to determine predictors of PrEP use and intention, adjusted for significant covariates.ResultsOf 1,484 PPW women approached, 1,149 consented and were interviewed, of whom 704 (61.3%) were post-partum and 445 (38.7%) pregnant. The median age was 25 years [Interquartile Range (IQR) = 21–30 years], with 533 (46.4%) 18–24 years old. Among the 1,149 women, 930 (80.7%) had ever heard about PrEP; 635 (55.3%) had knowledge about PrEP; 183 (15.9%) were currently using PrEP; and 285 (24.8%) had ever used PrEP. Increased odds of PrEP use were associated having HIV-positive male partner (aOR:7.76, 95%CI 3.53- 17.04); positive attitudes to PrEP (aOR:1.56, 95%CI: 1.02–2.40); and high self-efficacy (aOR:1.49, 95%CI:1.13–1.98). Among 864 women who never used PrEP, 569 (65.3%) intended to use PrEP in the future. Odds of intention to use PrEP were higher among women with low levels of education (aOR:2.23, 95% CI: 1.32–3.77); who ever heard about PrEP (aOR:1.69, 95%CI: 1.12–2.56); and had high self-efficacy (aOR:1.57, 95%CI: 1.31–1.87). Regarding stigma, among all women, 759 (66%) either agreed or strongly agreed that people would think they have HIV if they were to use PrEP; 658 (57.3%) reported they would be labelled as having multiple sex partners; 468 (40.7%) reported that their partner would think they are having risky sex with other people. Of 102 women who had discontinued PrEP, a majority stopped due to side effects 32 (35.2%).ConclusionOnly about 50% of women had knowledge of PrEP, and PrEP uptake among PPW was low, though intention to use appeared high. More efforts to reduce stigma and promote PrEP use, including adequate information on side effects, are needed.

Aims: We aim to estimate the number of HIV pre-exposure prophylaxis (PrEP) users among men having sex with men (MSM) in Germany from 2017 through 2020, and analyse if PrEP needs expressed in 2017 might have been met by the expansion of PrEP until 2020. Subject and methods: We estimated the number of PrEP users by using drug prescription data and information on on-demand/intermittent PrEP use from online surveys to determine the proportion of on-demand/intermittent and daily PrEP use as well as the average number of PrEP pills used. The number of MSM in need of PrEP in 2017 was estimated based on four groups defined among respondents to a large online survey, combining respondents with PrEP use intention and respondents indicating substantial sexual risks. The size of each group was estimated based on self-selection biases. MSM with PrEP need in 2017 were compared with the estimated number of persons taking PrEP by June 2020. Results: We estimated a total of 15,600 to 21,600 PrEP users in Germany by the end of June 2020, corresponding to 40–55% of men with PrEP use intention in 2017. A correlation between the regional distribution of PrEP use intention in 11/2017 and actual PrEP use by 06/2020 suggested an unequal regional distribution of unsatisfied needs. The number of men with unmet PrEP needs ranged between 27,500 and 93,000 in 06/2020. Conclusion: PrEP use in Germany has increased considerably between 10/2017 and 06/2020, but large regional inequalities persist. PrEP is not yet readily accessible, and there is a need to expand services and encourage uptake. [ABSTRACT FROM AUTHOR]

Background: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality and incidence. Effective ART based prevention has not translated into population-level impact in southern Africa due to sub-optimal coverage among youth. We aim to investigate the effectiveness, implementation and cost effectiveness of peer-led social mobilisation into decentralised integrated HIV and sexual reproductive health (SRH) services amongst adolescents and young adults in KwaZulu-Natal (KZN). Methods: We are conducting a type 1a hybrid effectiveness/implementation study, with a cluster randomized stepped-wedge trial (SWT) to assess effectiveness and a realist process evaluation to assess implementation outcomes. The SWT will be conducted in 40 clusters in rural KZN over 45 months. Clusters will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). 1) Intervention arm: Resident peer navigators in each cluster will approach young men and women aged 15–30 years living in their cluster to conduct health, social and educational needs assessment and tailor psychosocial support and health promotion, peer mentorship, and facilitate referrals into nurse led mobile clinics that visit each cluster regularly to deliver integrated SRH and differentiated HIV prevention (HIV testing, UTT for those positive, and PrEP for those eligible and negative). Standard of Care is UTT and PrEP delivered to 15–30 year olds from control clusters through primary health clinics. There are 3 co-primary outcomes measured amongst cross sectional surveys of 15–30 year olds: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention; 3) cost of transmissible HIV infection averted. We will use a realist process evaluation to interrogate the extent to which the intervention components support demand, uptake, and retention in risk-differentiated biomedical HIV prevention. Discussion: The findings of this trial will be used by policy makers to optimize delivery of universal differentiated HIV prevention, including HIV pre-exposure prophylaxis through peer-led mobilisation into community-based integrated adolescent and youth friendly HIV and sexual and reproductive health care. Trial registration: ClinicalTrials.gov Identifier—NCT05405582. Registered: 6th June 2022. [ABSTRACT FROM AUTHOR]

Introduction: With recent approvals of long-acting (LA) HIV pre-exposure prophylaxis (PrEP) in the form of injectable cabotegravir and the dapivirine ring, programmes need to consider how to optimize the delivery of PrEP methods, including by leveraging lessons from the past decade of oral PrEP delivery. Discussion: Framed around differentiated service delivery building blocks, the major considerations for the delivery of LA PrEP are how to reach the populations who would most benefit from PrEP, where to locate PrEP services, how to reduce the user burden of accessing and continuing with PrEP, and how to integrate PrEP with other services. Demand creation for LA PrEP and education about new LA PrEP options should be co-developed with communities and be positively framed. Client-facing clinical decision support tools provide information about HIV prevention and PrEP options in non-technical ways and can support their informed decision-making about PrEP. Training for providers is needed to increase their ability to ask about sexual and drug use behaviours in a non-judgmental and comfortable manner as part of risk assessment, discuss harm reduction strategies and counsel about available PrEP options that fit clients' circumstances and needs. PrEP adherence support should include supportive counselling and be tailored to address an individual's particular barriers and needs. Reminders through text messaging or calls can foster PrEP persistence, given the narrow the window around dosing for injectable cabotegravir. Strategies are needed to expand PrEP delivery options, including telePrEP, pharmacy-based PrEP, key population-led services and mobile venues. Integrated delivery models are needed which include sexually transmitted infection testing and treatment, contraception for cis-women not desiring to become pregnant, PrEP for pregnant women in high HIV prevalence settings, and gender-affirming hormones and support for transgender persons. Conclusions: The outcome of expanding PrEP options through LA PrEP formulations is to increase PrEP coverage, adherence, persistence and effectiveness by offering a choice of PrEP that meets the needs of persons who would benefit from PrEP. The lessons learned from the delivery of oral PrEP about demand creation, informed client decision-making, provider training, adherence support and service delivery model are relevant to the delivery of LA PrEP and integration with other services. [ABSTRACT FROM AUTHOR]

Purpose: Long-acting formulations of the potent antiretroviral prodrug tenofovir alafenamide (TAF) hold potential as biomedical HIV prevention modalities. Here, we present a rigorous comparison of three animal models, C57BL/6 J mice, beagle dogs, and merino sheep for evaluating TAF implant pharmacokinetics (PKs). Methods: Implants delivering TAF over a wide range of controlled release rates were tested in vitro and in mice and dogs. Our existing PK model, supported by an intravenous (IV) dosing dog study, was adapted to analyze mechanistic aspects underlying implant TAF delivery. Results: TAF in vitro release in the 0.13 to 9.8 mg d−1 range with zero order kinetics were attained. Implants with equivalent fabrication parameters released TAF in mice and sheep at rates that were not statistically different, but were 3 times higher in dogs. When two implants were placed in the same subcutaneous pocket, a two-week creep to Cmax was observed in dogs for systemic drug and metabolite concentrations, but not in mice. Co-modeling IV and TAF implant PK data in dogs led to an apparent TAF bioavailability of 9.6 in the single implant groups (compared to the IV group), but only 1.5 when two implants were placed in the same subcutaneous pocket. Conclusions: Based on the current results, we recommend using mice and sheep, with macaques as a complementary species, for preclinical TAF implant evaluation with the caveat that our observations may be specific to the implant technology used here. Our report provides fundamental, translatable insights into multispecies TAF delivery via long-acting implants. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Background: Transgender and gender nonbinary (TNB) people have been disproportionately affected by HIV and the COVID-19 pandemic. This study explored the prevalence of HIV prevention and treatment (HPT) interruptions during the pandemic and identified factors associated with these interruptions. Setting: Data were drawn from LITE Connect, a US-based, nationwide, online, self-administered survey designed to examine the experiences of TNB adults during the COVID-19 pandemic. A convenience sample of 2134 participants were recruited between June 14, 2021, and May 1, 2022. Methods: The analytic sample was restricted to participants taking antiretroviral medications to prevent or treat HIV before the onset of the pandemic (n = 153). We calculated descriptive statistics as well as Pearson χ2 bivariate tests and multivariable models to identify factors associated with HPT interruptions during the pandemic. Results: Thirty-nine percent of participants experienced an HPT interruption. We found a lower odds of HPT interruptions among participants living with HIV [adjusted odds ratios (aOR) 0.45; 95% Confidence Intervals (CI): 0.22, 0.92; P = 0.02] and essential workers [aOR 0.49; 95% CI: 0.23, 1.0; P = 0.06] and higher odds among people with chronic mental health conditions [aOR 2.6; 95% CI: 1.1, 6.2; P = 0.03]. When sex and education were included, we found a lower odds of interruptions among people with higher education. CI widened, but the magnitude and direction of effects did not change for the other variables. Conclusions: Focused strategies to address longstanding psychosocial and structural inequities are needed to mitigate HPT treatment interruptions in TNB people and prevent similar challenges during future pandemics. [ABSTRACT FROM AUTHOR]

Abstract Background We aimed to explore the association between PrEP-related stereotypes and perceived disapproval (hereafter PrEP-related stigma), and PrEP use. Methods We used data from a cross-sectional online survey among adult gay, bisexual, other men who have sex with men in Ontario and British Columbia, Canada. Participants were recruited 2019–2020 in-person from sexual health clinics and outreach programs, and online through dating mobile applications and websites. We used logistic regression models to explore the relationship between PrEP-related stigma and: 1-being a ‘never’ versus ‘current’ PrEP user, and 2-being a ‘former’ versus ‘current’ user. Results The median age of the sample was 32 (Q1-Q3 = 27–40), most were white born in Canada (48%), 45% had never used PrEP, 16% were former PrEP users and 39% were current PrEP users. Of 1527 individuals who started the survey, 1190 participants answered questions about PrEP-related stigma: 254 (21.3%) were classified as having low level of PrEP-related stigma, 776 (65.2%) intermediate, and 160 (13.5%) high. No significant association was found when never PrEP users and current PrEP users were compared: adjusted OR = 1.44 (95%-CI: 0.8–2.5). High PrEP-related stigma was positively associated with being a former PrEP user compared to being a current PrEP user: adjusted OR = 2.5 (95%-CI: 1.3–4.9). Conclusion PrEP-related stigma is associated with not using PrEP, particularly with PrEP discontinuation. Our findings indicate that stigma persists as a barrier to PrEP use.

Abstract Background The global expansion of HIV pre-exposure prophylaxis (PrEP) includes health systems that face a shortage of skilled health care workers (HCWs). We estimated the human resource needs and costs for providing PrEP in nurse-led primary care clinics in Eswatini. Furthermore, we assessed potential cost savings from task sharing between nurses and other HCW cadres. Methods We conducted a time-and-motion and costing study in a PrEP demonstration project between August 2017 and January 2019. A form for recording time and performed activities (“motion”) was filled by HCWs of six primary care clinics. To estimate the human resource needs for specific PrEP activities, we allocated recorded times to performed PrEP activities using linear regression with and without adjusting for a workflow interruption, that is, if a client was seen by different HCWs or by the same HCW at different times. We assessed a base case in which a nurse provides all PrEP activities and five task shifting scenarios, of which four include workflow interruptions due to task sharing between different HCW cadres. Results On average, PrEP initiation required 29 min (95% CI 25–32) of HCW time and PrEP follow-up 16 min (95% CI 14–18). The HCW time cost $4.55 (uncertainty interval [UI] 1.52–9.69) for PrEP initiation and $2.54 (UI 1.07–4.64) for PrEP follow-up when all activities were performed by a nurse. Time costs were $2.30–4.25 (UI 0.62–9.19) for PrEP initiation and $1.06–2.60 (UI 0.30–5.44) for PrEP follow-up when nurses shared tasks with HCWs from lower cadres. Interruptions of the workflow added, on average, 3.4 min (95% CI 0.69–6.0) to the time HCWs needed for a given number of PrEP activities. The cost of an interrupted workflow was estimated at $0.048–0.87 (UI 0.0098–1.63) depending on whose time need increased. Conclusions A global shortage of skilled HCWs could slow the expansion of PrEP. Task shifting to lower-cadre HCW in nurse-led PrEP provision can free up nurse time and reduce the cost of PrEP provision even if interruptions associated with task sharing increase the overall human resource need.

Background: Long‐acting injectable cabotegravir (CAB‐LA) represents a new additional option for HIV prevention in people at substantial risk of HIV infection that may fill the gaps in pre‐exposure prophylaxis (PrEP) uptake, adherence, and retention in users having difficulty with oral PrEP. Data from clinical trials demonstrated that CAB‐LA was safe, highly effective, and well‐accepted for HIV prevention. However, the occurrence of breakthrough HIV infections despite timely injections, HIV seroconversion timing and patterns, risk of selection and dissemination of resistance‐associated mutations to integrase inhibitors, complexity of follow‐up, logistical considerations, and its cost effectiveness compared with oral PrEP constitute significant issues for the integration of CAB‐LA into clinical routine. Findings: These concerns need to be addressed before moving forward with large‐scale implementation programmes. Pilot and implementation projects are required in the following areas: HIV testing algorithms, patient education, clinic procedures, protocols for switching and discontinuation, efficacy and safety in populations not included in clinical trials, and demedicalization processes. The development of models to increase the uptake of, adherence to, and persistence with and after CAB‐LA injections will also be of paramount importance for success. Lessons learned from these projects will increase experience, staff expertise, and organizational and training capacities to support the roll‐out of this new agent as part of HIV prevention programmes. Conclusion: CAB‐LA has not yet achieved its full potential in HIV prevention, and strong commitment from all stakeholders is required to push CAB‐LA as a game‐changer in HIV response. [ABSTRACT FROM AUTHOR]

The assessment of mood disorders and addiction linked to the practice of chemsex is of interest given the psychoactive substances used. The aim of this study was to assess risky sexual and addictive behavior to chemsex and related anxiety/depression symptoms in individuals receiving HIV pre‐exposure prophylaxis (PrEP). In this cross‐sectional study, all adults presenting for PrEP renewal at French sexual health centers were enrolled from January 2018 to March 2019. Participants completed a questionnaire on chemsex (i.e., the use of psychoactive substances before/during sex), including adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) to chemsex addiction (questions of ASSIST were modified to focus on chemsex). Anxiety/depression was assessed with the Hospital Anxiety and Depression Scale. In the last 3 months before enrollment, 39.8% (94/236) of participants reported chemsex. The main psychoactive substances consumed during chemsex were cathinones (74.6%), gamma‐hydroxybutyrate (66.3%), and other psychostimulants (60%). The median score of the chemsex‐focused ASSIST was 8 [IQR25–75: 3–15]; 72.2% of participants had a score justifying at least a brief intervention (>4). In multivariate analyses, anxiety and cathinones consumption were associated with an ASSIST score >4: OR 13.65 (95%CI 1.68–662.7), P = 0.0062, and OR 8.468 (95%CI 2.066–43.059), P = 0.0014, respectively. The level of addiction to the practice of chemsex can be difficult to estimate for the user, and the ASSIST makes it possible to evaluate this addiction and to direct the subjects toward specialized consultations of addictology, sexual health, or PrEP renewals. The implementation of the modified ASSIST in these consultations can allow early systematic screening and counseling. [ABSTRACT FROM AUTHOR]

Background: HIV pre-exposure prophylaxis (PrEP) persistence and adherence are critical to ending the HIV epidemic in the United States. Setting: In 2017 National HIV Behavioral Surveillance, HIV-negative men who have sex with men (MSM) in 4 US cities completed a survey, HIV testing, and dried blood spots at recruitment. Methods: We assessed 3 PrEP outcomes: persistence (self-reported PrEP use at any time in the past 12 months and had tenofovir, emtricitabine, or tenofovir diphosphate detected in dried blood spots), adherence at ≥4 doses/week (self-reported past-month PrEP use and tenofovir diphosphate concentration ≥700 fmol/punch), and adherence at 7 doses/week (self-reported past-month PrEP use and tenofovir diphosphate concentration ≥1250 fmol/punch). Associations with key characteristics were examined using log-linked Poisson regression models with generalized estimating equations. Results: Among 391 MSM who took PrEP in the past year, persistence was 80% and was lower among MSM who were younger, had lower education, and had fewer sex partners. Of 302 MSM who took PrEP in the past month, adherence at ≥4 doses/week was 80% and adherence at 7 doses/week was 66%. Adherence was lower among MSM who were younger, were Black, and had fewer sex partners. Conclusions: Although persistence and adherence among MSM were high, 1 in 5 past-year PrEP users were not persistent and 1 in 5 past-month PrEP users were not adherent at levels that would effectively protect them from acquiring HIV (ie, ≥4 doses/week). Efforts to support PrEP persistence and adherence should include MSM who are young, are Black, and have less education. [ABSTRACT FROM AUTHOR]

Despite efficacy in HIV prevention, Pre-exposure Prophylaxis (PrEP) is underutilized in the US, especially among populations at highest risk. PrEP-related stigma may play a role. We developed measures of PrEP-related stigma dimensions and PrEP adherence. We administered them to current PrEP users. We hypothesized that PrEP-related stigma would negatively impact PrEP adherence. Questionnaire measures were developed using data from previous qualitative work and existing validated HIV-related stigma measures. The resultant survey was administered to current PrEP users from two Birmingham, Alabama PrEP clinics. Plasma tenofovir disoproxil fumarate levels were collected to measure PrEP adherence. Exploratory factor analyses were performed to determine the factor structure of each PrEP-related stigma dimension (internalized, perceived, experienced, anticipated, disclosure concerns). Separate binary logistic (or linear) regressions were performed to assess associations between PrEP-related stigma dimensions and adherence (treatment adherence self-efficacy, self-reported adherence, and plasma tenofovir levels), adjusting for education, race, and time on PrEP. In 2018, 100 participants completed the survey, with 91 identifying as male and 66 as white. Only internalized stigma was associated with lower self-reported PrEP adherence. Exploratory mediation analyses suggested that the association between all stigma dimensions and self-reported PrEP adherence is mediated by PrEP adherence self-efficacy. No associations were found between any PrEP-related stigma measures and plasma tenofovir levels. Internalized PrEP stigma may reduce PrEP adherence, possibly by reducing PrEP adherence self-efficacy among experienced PrEP users. Further investigation of how stigma dimensions affect PrEP adherence in populations at risk for HIV may shed light on drivers of PrEP underutilization. [ABSTRACT FROM AUTHOR]

Background: The impact of starting HIV pre-exposure prophylaxis (PrEP) on diagnoses of sexually transmitted infections (STI) remains unclear. We used data from German HIV/STI Checkpoints collected from 01/2019 to 08/2021 to determine the impact of PrEP use on syphilis, gonorrhoea and chlamydia diagnoses. Methods: We used self-reported data on demographics, sexual behaviour, testing and PrEP use, as well as lab-confirmed diagnoses from visits to HIV/STI Checkpoints in Germany. PrEP use was categorized as (1) never used; (2) intention to use; (3) former use; (4) current on-demand use; (5) daily use. In multivariate regression analyses (MRA) with gonorrhoea, chlamydia, and syphilis diagnoses as outcomes, we controlled for age, number of sexual partners, number of condomless anal intercourse (CAI) partners in the last six months, and testing recency. Results: For the analysis, we included 9,219 visits for gonorrhoea and chlamydia testing and 11,199 visits for syphilis testing conducted at checkpoints from 01/2019 to 08/2021. MRA identified age (aOR 0.98; 95%CI 0.97–0.99), number of sexual partners in the past six months (aOR 4.90; 95%CI 2.53–9.52 for 11 + partners), and use of chemsex substances (aOR 1.62; 95%CI 1.32-2.00) as risk factors for gonorrhoea, while age (aOR 0.99; 95%CI 0.98-1.00), number of CAI partners (aOR 3.19; 95%CI 2.32–4.41 for 5 + partners), partner sorting (aOR 1.30; 95%CI 1.09–1.54), and use of chemsex substances (aOR 1.29; 95%CI 1.05–1.59) were risk factors for chlamydia infections. For syphilis, the number of CAI partners (aOR 3.19; 95%CI 1.60–6.34 for 5 + partners) was found to be the only significant risk factor. There was a strong association between PrEP use and the number of sexual partners (≤ 5 vs.>5: aOR 3.58; 95%CI 2.15–5.97 for daily PrEP use), the number of CAI partners in the past six months (≤ 1 vs.>1: aOR 3.70; 95%CI 2.15–6.37 for daily PrEP use), and the number of STI tests performed (suggesting higher testing frequency). Both outcomes were also related to partner sorting, chemsex, and selling sex. Conclusions: Checkpoint visits reporting current PrEP use or intention to start PrEP correlated with eligibility criteria for PrEP, i.e. high partner numbers, inconsistent condom use during anal intercourse, and use of chemsex drugs. Use of HIV-specific prevention methods such as HIV serosorting, PrEP sorting, and viral load sorting was reported more frequently. (Daily) PrEP use was an independent risk factor for a chlamydia diagnosis only. [ABSTRACT FROM AUTHOR]

Objective: We aimed to evaluate the usability and acceptability of a co‐designed mobile health (mHealth) application (PrEP‐EmERGE) within a digital health pathway to support HIV pre‐exposure prophylaxis (PrEP). Methods: This was a cross‐sectional study to evaluate the usability and acceptability of the PrEP‐EmERGE app. Data were collected via an online survey sent to all PrEP EmERGE users in September 2021. Usability was assessed with a validated usability tool, the System Usability Scale (SUS). Acceptability was assessed using modified patient‐reported experience measures (PREMs). Quantitative data were analysed using descriptive and/or inferential statistics and qualitative data (free text responses) using thematic analysis. Results: In total, 81/133 (61%) active PrEP EmERGE users completed the online survey, which was available directly from their PrEP EmERGE app: 78/81 (96%) identified as cis‐male, 74/81 (91%) reported their ethnicity as 'white', 69/81 (85%) reported daily PrEP use, 7/81 (9%) reported using an event‐based dosing schedule, and 5/81 (6%) were switching between dosing schedules. Overall, the median SUS score was 78/100 (interquartile range: 70–92). There were no differences in median SUS scores by PrEP dosing schedules (p = 0.78) or months of experience of using the app (p = 0.31). Overall, 73/81 (90%) would recommend the PrEP EmERGE app to a friend and 78/81 (96%) rated their satisfaction of the app as excellent, good or satisfactory. The free text responses generated three key themes: accessibility (for results and information); autonomy [taking responsibility for their (sexual) health] and functionality (including technical recommendations for app development and the digital health pathway). Conclusions: Innovative, co‐designed digital health pathways, such as PrEP EmERGE can help sexual health services to manage increasing numbers of people accessing PrEP – ensuring that they retain access for those who need to be seen face‐to‐face. We report high levels of acceptability and usability during the first 4 months of this novel pathway. [ABSTRACT FROM AUTHOR]

Although roll-out of HIV pre-exposure prophylaxis (PrEP) has been reported to have changed contexts of HIV risk in areas where it was well-implemented. The rate of its uptake and retention amongst young females has not been described in Gauteng Province. This paper aimed at assessing PrEP uptake and retention among young females in Gauteng Province. Total of young females who tested HIV across five clinics from 01/January/2017 to 31/December/2020 was 19,671 with 17,937 tested HIV negative. Of the HIV tested negative, PrEP was initiated to 1307 (7%). The analysis revealed that 27% of young females returned for their first follow up visit after PrEP initiation, while third month declined to 14%, fourth month to 11%, and fifth month to 3%, sixth month to 2% and seventh month at 1% and from the eighth month, the rate of follow up was 0%. Uptake and retention of PrEP was low among young females as measured against the total tested HIV negative. [ABSTRACT FROM AUTHOR]

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Abstract Introduction With recent approvals of long‐acting (LA) HIV pre‐exposure prophylaxis (PrEP) in the form of injectable cabotegravir and the dapivirine ring, programmes need to consider how to optimize the delivery of PrEP methods, including by leveraging lessons from the past decade of oral PrEP delivery. Discussion Framed around differentiated service delivery building blocks, the major considerations for the delivery of LA PrEP are how to reach the populations who would most benefit from PrEP, where to locate PrEP services, how to reduce the user burden of accessing and continuing with PrEP, and how to integrate PrEP with other services. Demand creation for LA PrEP and education about new LA PrEP options should be co‐developed with communities and be positively framed. Client‐facing clinical decision support tools provide information about HIV prevention and PrEP options in non‐technical ways and can support their informed decision‐making about PrEP. Training for providers is needed to increase their ability to ask about sexual and drug use behaviours in a non‐judgmental and comfortable manner as part of risk assessment, discuss harm reduction strategies and counsel about available PrEP options that fit clients’ circumstances and needs. PrEP adherence support should include supportive counselling and be tailored to address an individual's particular barriers and needs. Reminders through text messaging or calls can foster PrEP persistence, given the narrow the window around dosing for injectable cabotegravir. Strategies are needed to expand PrEP delivery options, including telePrEP, pharmacy‐based PrEP, key population‐led services and mobile venues. Integrated delivery models are needed which include sexually transmitted infection testing and treatment, contraception for cis‐women not desiring to become pregnant, PrEP for pregnant women in high HIV prevalence settings, and gender‐affirming hormones and support for transgender persons. Conclusions The outcome of expanding PrEP options through LA PrEP formulations is to increase PrEP coverage, adherence, persistence and effectiveness by offering a choice of PrEP that meets the needs of persons who would benefit from PrEP. The lessons learned from the delivery of oral PrEP about demand creation, informed client decision‐making, provider training, adherence support and service delivery model are relevant to the delivery of LA PrEP and integration with other services.

Cabotegravir is an integrase strand transfer inhibitor (INSTI) for HIV treatment and prevention. Cabotegravir-based long-acting pre-exposure prophylaxis (PrEP) presents an emerging paradigm for infectious disease control. In this scheme, a combination of a high efficacy and low solubility of anti-infection drugs permits the establishment of a pharmaceutical firewall in HIV-vulnerable groups over a long period. Although the structure-activity-relationship (SAR) of cabotegravir as an INSTI is known, the structural determinants of its low solubility have not been identified. In this work, we have integrated multiple experimental and computational methods, namely X-ray diffraction, solid-state NMR (SSNMR) spectroscopy, solution NMR spectroscopy, automated fragmentation (AF)-QM/MM and density functional theory (DFT) calculations, to address this question. The molecular organization of cabotegravir in crystal lattice has been determined. The combination of very-fast magic-angle-sample-spinning (VF MAS) SSNMR and solution NMR, as supported by AF-QM/MM and DFT calculations, permits the identification of structural factors that contribute to the low aqueous solubility of cabotegravir. Our study reveals the multitasking nature of pharmacophores in cabotegravir, which controls the drug solubility and, meanwhile, the biological activity. By unraveling these function-defining molecular features, our work could inspire further development of long-acting HIV PrEP drugs.

BackgroundPre-exposure prophylaxis (PrEP) for HIV is effective, yet many providers continue to lack knowledge and comfort in providing this intervention. It remains unclear whether internal medicine (IM) residents receive appropriate training in PrEP care and if this affects their future practices.ObjectiveWe sought to evaluate the relationship between current IM residents' prior PrEP training and knowledge, comfort, and practice regarding the provision of PrEP.Design and participantsWe created an online survey to assess IM residents' knowledge, attitudes, and behaviors related to PrEP. The survey was distributed among five IM programs across the USA.Key resultsWe had a 35% response rate. Of 229 respondents, 96% (n = 220) had heard of PrEP but only 25% (n = 51) had received prior training and 11% (n = 24) had prescribed PrEP. Compared with those without, those with prior training reported good to excellent knowledge scores regarding PrEP (80% versus 33%, p

We examined associations of 25-hydroxy vitamin D (25-OHD), tenofovir disoproxil fumarate (TDF), and bone toxicity. We studied TDF/emtricitabine (FTC) HIV pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). Bone toxicity was predefined using bone mineral density/content change from baseline to week 48. Baseline serum 25-OHD was dichotomized as 700 fmol/punch (protective against HIV acquisition) versus ≤700. Associations were examined by univariate and multivariable logistic regression, reporting crude and adjusted odds ratios (ORs), with 95% confidence intervals (CIs). Of 101 enrolled, 69 had complete bone assessments and 25-OHD; of these, 59 had week 48 TFV-DP data. Median (Q1-Q3) age was 20 (18-21) years; 54% were black/African American. In univariate analysis, participants with baseline 25-OHD 700 (OR = 11.5; 95% CI = 1.4-169.6), 25-OHD 700 (OR = 32.3; 95% CI = 3.3-653.6) had greater odds of bone toxicity after adjusting for race. In multivariable models, 25-OHD insufficiency, protective TFV-DP concentrations, and black race were significantly associated with bone toxicity after 48 weeks of TDF/FTC PrEP in YMSM. Clinical Trials Registration: NCT01769469.

Background: Potential risk contacts for HIV transmission may lead to presentations to the emergency department (ED) for counseling and initiation of post-exposure prophylaxis (PEP). Objective: To examine the impact of German health insurance covering pre-exposure prophylaxis (PrEP) following Sept 1st 2019 for certain risk groups on the frequency and reasons for PEP counseling in a university-based ED in Germany. Methods: In a before-after study design, all persons aged ≥18 years who presented for PEP counseling were analyzed retrospectively. We compared characteristics of presentations in the 18 months prior to PrEP coverage on Sept 1st, 2019, with those in the following 18 months. Results: 154 ED presentations occurred in the first study period, and 155 ED presentations in the second period. Regarding the reasons for ED visits, no statistically significant difference was found [occupational risk contact (18.2 vs. 26.5%, p = 0.081), sexual risk contact (74.7 vs. 69.0%, p = 0.266), other non-occupational risk contact (7.1 vs. 4.5%, p = 0.329)]. For men who have sex with men (MSM), no statistically significant differences were found [38.9 (n = 60) vs. 35.5% (n = 55), p = 0.537]. All persons presenting to the HIV outpatient clinic after ED PEP initiation (n = 60 vs. n = 52) tested negative for HIV 3 months later. Conclusion: In this study, reasons to present for PEP counseling to a university ED showed no change following the implementation of PrEP coverage by health insurances. Therefore, PEP remains an important prevention for HIV transmission and presentations to the ED for PEP counseling may provide an opportunity to educate persons at risk of HIV infection about PrEP, thereby helping to prevent new HIV infections.

MTN-025/HOPE was an open-label trial of the dapivirine vaginal ring conducted in four African countries between 2016 and 2018. Women were first offered one ring monthly (at baseline, months 1 and 2), thereafter, transitioned to a more applicable real-world dispensation schedule, − 3 rings quarterly (at months 3, 6 and 9). Logistic regression analysis was used to assess correlates of ring acceptance at baseline and through follow-up. A total of 1456 women (median age 31 years) enrolled, 1342 (92.2%) accepted the ring at baseline and 1163 (79.9%) accepted the ring(s) at all visits. Changing ring dispensation from a monthly to a quarterly schedule had no negative effect on acceptance. Having a primary partner and him knowing about the ring being offered in HOPE, use of long-acting contraception (implants, injections, IUDs) or sterilization were associated with ring acceptance, along with prior strong intention to use the ring in the future. Efforts should consider these factors when rolling out the ring for HIV prevention. [ABSTRACT FROM AUTHOR]