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Background: Pre-exposure prophylaxis (PrEP) is a highly effective pharmaceutical intervention that prevents HIV infection, but PrEP uptake across the US has been slow among men who have sex with men (MSM), especially among Black/African American (B/AA) and Hispanic /Latino (H/L) MSM. This study investigates the acceptability and essential components of a peer-driven intervention (PDI) for promoting PrEP uptake among MSM, with a specific focus on B/AA and H/L communities. Methods: We conducted 28 semi-structured, qualitative interviews with MSM in southern New England to explore the components of a PDI, including attitudes, content, and effective communication methods. A purposive sampling strategy was used to recruit diverse participants who reflect the communities with the highest burden of HIV infection. Results: Of 28 study participants, the median age was 28 years (interquartile range [IQR]: 25, 35). The sample comprised B/AA (39%, n = 11) and H/L (50%, n = 14) individuals. Notably, nearly half of the participants (46%) were current PrEP users. We found that many participants were in favor of using a PDI approach for promoting PrEP. Additionally, several participants showed interest in becoming peer educators themselves. They emphasized the need for strong communication skills to effectively teach others about PrEP. Moreover, participants noted that peer education should cover key topics like how PrEP works, how effective it is, and any possible side effects. Conclusions: Our study shows that effective PDIs, facilitated by well-trained peers knowledgeable about PrEP, could enhance PrEP uptake among MSM, addressing health disparities and potentially reducing HIV transmission in B/AA and H/L communities. [ABSTRACT FROM AUTHOR]

Background: In Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes. Methods: Design: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam. Participants: Sexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35). Intervention: Study participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use. Outcomes: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders. Discussion: This proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings. Trial registration: NCT06094634 on clinicaltrials.gov. Registered 16 October 2023. [ABSTRACT FROM AUTHOR]

Abstract Background Pre-exposure prophylaxis (PrEP) is a highly effective pharmaceutical intervention that prevents HIV infection, but PrEP uptake across the US has been slow among men who have sex with men (MSM), especially among Black/African American (B/AA) and Hispanic /Latino (H/L) MSM. This study investigates the acceptability and essential components of a peer-driven intervention (PDI) for promoting PrEP uptake among MSM, with a specific focus on B/AA and H/L communities. Methods We conducted 28 semi-structured, qualitative interviews with MSM in southern New England to explore the components of a PDI, including attitudes, content, and effective communication methods. A purposive sampling strategy was used to recruit diverse participants who reflect the communities with the highest burden of HIV infection. Results Of 28 study participants, the median age was 28 years (interquartile range [IQR]: 25, 35). The sample comprised B/AA (39%, n = 11) and H/L (50%, n = 14) individuals. Notably, nearly half of the participants (46%) were current PrEP users. We found that many participants were in favor of using a PDI approach for promoting PrEP. Additionally, several participants showed interest in becoming peer educators themselves. They emphasized the need for strong communication skills to effectively teach others about PrEP. Moreover, participants noted that peer education should cover key topics like how PrEP works, how effective it is, and any possible side effects. Conclusions Our study shows that effective PDIs, facilitated by well-trained peers knowledgeable about PrEP, could enhance PrEP uptake among MSM, addressing health disparities and potentially reducing HIV transmission in B/AA and H/L communities.

Abstract Background In Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes. Methods Design: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam. Participants: Sexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35). Intervention: Study participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use. Outcomes: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders. Discussion This proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings. Trial registration NCT06094634 on clinicaltrials.gov. Registered 16 October 2023.

Background HIV pre-exposure prophylaxis (PrEP) uptake in women remains low. We developed a laboratory result–driven protocol to link women with a positive bacterial sexually transmitted infection (STI) to HIV PrEP at an urban safety-net hospital. Methods Electronic health records of women with positive chlamydia, gonorrhea, and/or syphilis tests were reviewed, and those eligible for PrEP were referred for direct or primary care provider-driven outreach. We assessed the proportion of women with STIs who received PrEP offers, acceptance, and prescriptions before (July 1, 2018–December 31, 2018) and after (January 1, 2019–June 30, 2020) implementation to evaluate changes in the delivery of key elements of the PrEP care cascade (ie, PrEP offers, acceptance, and prescribing) for women with STIs after protocol implementation. Results The proportion of women who received PrEP offers increased from 7.6% to 17.6% (P <.001). After multivariable adjustment, only the postintervention period was associated with PrEP offers (odds ratio [OR], 2.49; 95% CI, 1.68–3.68). In subgroup analyses, PrEP offers increased significantly among non-Hispanic Black (OR, 2.75; 95% CI, 1.65–4.58) and Hispanic (OR, 5.34; 95% CI, 1.77–16.11) women but not among non-Hispanic White women (OR, 1.49; 95% CI, 0.54–4.05). Significant changes in PrEP acceptance and prescriptions were not observed in the sample overall. Conclusions A laboratory result–driven protocol was associated with a significant increase in PrEP offers to Black and Hispanic women with STI. These results provide concrete suggestions for health systems seeking to increase PrEP access and equity among women. [ABSTRACT FROM AUTHOR]

In response to increased HIV prevention efforts (PEP and PrEP), HIV rates in Ontario have decreased among gay men. By extension, the proportion of first-time HIV diagnoses in cis and trans women has increased, prompting concern for ongoing HIV transmissions. Presently, uptake of HIV prevention services among women is limited, largely due to variability of HIV-specific risk factors. To explore HIV prevention use among women, a retrospective review was completed of participants in a nurse-led HIV prevention service (PEP-RN and PrEP-RN) in Ottawa, Canada. Results showed 10% uptake for PEP and 3% uptake for PrEP among women. For PEP, 32 women presented for assessment, and 25 were initiated. Most PEP initiations were made following a potential sexual exposure to HIV, and 36% involved a partner who was HIV positive and not virally suppressed. For PrEP, offers for referral were made to 59 women; 28 declined, and 31 accepted. Among women who declined PrEP, 32% were HIV contacts, and among those who accepted, 80% were due to reported sexual or substance use practices. The highest PrEP engagement occurred among women receiving services in a safer opiate supply program. The high uptake of PEP suggests this could be a useful strategy to reducing HIV transmission rates in women. In addition, women receiving PrEP could benefit from a more supportive approach to care, including assistance with mediation use and regular contact with nurses. In using a more collaborative and gender-based approach to HIV prevention care, progress can be made in addressing ongoing HIV inequities among women. [ABSTRACT FROM AUTHOR]

Introduction: Objectives of this study, as part of a nation-wide HIV pre-exposure prophylaxis (PrEP) evaluation project, were to determine the incidence of infections with HIV, chlamydia, gonorrhea, syphilis, hepatitis A/B/C in persons using PrEP, and to describe the health care funded PrEP use in Germany. Additionally, factors associated with chlamydia/gonorrhea and syphilis infections were assessed. Methods: Anonymous data of PrEP users were collected at 47 HIV-specialty centers from 09/2019–12/2020. Incidence rates were calculated per 100 person years (py). Using longitudinal mixed models, we analyzed risk factors associated with sexually transmitted infections (STIs). Results: 4620 PrEP users were included: 99.2% male, median age 38 years (IQR 32–45), 98.6% men who have sex with men (MSM). The median duration of PrEP exposure was 451 days (IQR 357–488), totaling 5132 py. Four HIV infections were diagnosed, incidence rate 0,078/100py (95% CI 0.029–0.208). For two, suboptimal adherence was reported and in the third case, suboptimal adherence and resistance to emtricitabine were observed. One infection was likely acquired before PrEP start. Incidence rates were 21.6/100py for chlamydia, 23.7/100py for gonorrhea, 10.1/100py for syphilis and 55.4/100py for any STI and decreased significantly during the observation period. 65.5% of syphilis, 55.6% of chlamydia and 50.1% of gonorrhea cases were detected by screening of asymptomatic individuals. In a multivariable analysis among MSM younger age, PrEP start before health insurance coverage and daily PrEP were associated with greater risk for chlamydia/gonorrhea. Symptom triggered testing and a history of STI were associated with a higher risk for chlamydia/gonorrhea and syphilis. A significantly lower risk for chlamydia/gonorrhea and syphilis was found for observations during the COVID-19 pandemic period. Conclusions: We found that HIV-PrEP is almost exclusively used by MSM in Germany. A very low incidence of HIV infection and decreasing incidence rates of STIs were found in this cohort of PrEP users. The results were influenced by the SARS-CoV-2 pandemic. Rollout of PrEP covered by health insurance should be continued to prevent HIV infections. Increased PrEP availability to people at risk of HIV infection through the elimination of barriers requires further attention. Investigation and monitoring with a longer follow-up would be of value. [ABSTRACT FROM AUTHOR]

Abstract Background Gay, bisexual, and other men-who-have-sex-with-men (GBMSM) continue to be disproportionately affected by Human Immunodeficiency Virus (HIV). Although HIV pre-exposure prophylaxis (PrEP) offers an effective means of reducing incident HIV among this population, the HIV-preventive success of oral-based PrEP is contingent upon regimen adherence. Elevated rates of alcohol-, substance use-, and mental health-related issues among GBMSM potentially hinder PrEP-taking efforts, however the evidence for this remains mixed. Accordingly, the present study entailed a comprehensive qualitative investigation to explore PrEP-prescribed GBMSM’s perceptions surrounding the influence of alcohol, substance use, and mental health on PrEP adherence. Methods PrEP-prescribed GBMSM (age ≥ 18 years; prescribed PrEP for ≥ 3 months) were recruited from two PrEP-delivery clinics in Toronto, Canada for focus groups as part of the formative phase of an alcohol-, substance use-, and mental health-focused randomized controlled intervention trial. Focus group discussions qualitatively explored perceived strengths and barriers associated with adherence to PrEP treatment; with an emphasis on alcohol, substance use, and mental health concerns. Condom use among PrEP-prescribed GBMSM within the context of these concerns was also discussed. Results A total of five focus groups involving 35 GBMSM were conducted (4–10/group; mean age = 42.4; white = 71.4%). Although participants themselves generally reported successfully adhering to their PrEP regimens—resulting from a strong, underlying motivation for self-care—they recognized the detrimental impact that alcohol, substance use, and mental health had on adherence among their peers. In this regard, alcohol and substances were perceived as detracting from adherence only when consumption was excessive or temporally linked to PrEP dosing. Pronounced mental health issues (e.g., severe depression) were also seen as hindering adherence, although these effects were nuanced and perceived as person-dependent. Alcohol and substances were linked to condomless sex, regardless of PrEP use, and PrEP was therefore viewed as an HIV-protective ‘safety net.’ Conclusions Overall, findings suggest that PrEP adherence can often be successfully achieved in the presence of alcohol-, substance use-, and mental health-related issues. Augmenting self-care, and addressing pronounced addictions- and mental health-related concerns, may enhance PrEP treatment among GBMSM.

In 2019, Colombia approved the combination of tenofovir disoproxil fumarate/emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP). Therefore, we conducted a situational analysis in HIV-care providers to identify barriers and facilitators for PrEP implementation. A survey was applied to a non-probabilistic sample of health care workers of HIV-specialized clinics. We examined PrEP awareness and familiarity, comfort with PrEP-related activities, perceived barriers for PrEP implementation, concerns, and attitudes. Poisson regressions assessed the relationship between these factors and the variable "having a plan to offer PrEP". The participation rate was 41% and included physicians (42.6%) and other health professionals (57.4%). Fifty-one percent of the participants reported more than five years of experience caring for people living with HIV. Forty-two percent of non-physician health care workers were nurses. Most reported high familiarity/comfort with PrEP-relevant activities. Concerns about PrEP were prevalent (> 50%) and included causing more harm than good, reducing condom use, medication non-adherence, drug resistance, and healthcare system barriers. Physicians had a plan to offer PrEP (72.2%) more often than other health professionals (52.6). Having a plan to offer PrEP was related to PrEP knowledge and comfort assessing sexual behavior and providing HIV counseling. Overall, about half of HIV-care providers seemed ready to offer PrEP and constitute an asset for PrEP implementation efforts in Colombia. PrEP awareness among non-physicians, PrEP concerns, and negative attitudes need to be addressed to enhance implementation. [ABSTRACT FROM AUTHOR]

Objectives: People who inject drugs (PWID) may experience high human immunodeficiency virus (HIV) risk and inadequate access to biomedical HIV prevention. Emerging data support integrating HIV post-exposure and pre-exposure prophylaxis (PEP, PrEP) into services already accessed by PWID. We describe PEP/PrEP eligibility and receipt in a low-barrier substance use disorder bridge clinic located in an area experiencing an HIV outbreak among PWID at the onset of the COVID-19 pandemic. Methods: Retrospective chart review of new patients at a substance use disorder bridge clinic in Boston, MA (January 15, 2020–May 15, 2020) to determine rates of PEP/PrEP eligibility and prescribing. Results: Among 204 unique HIV-negative patients, 85.7% were assessed for injection-related and 23.0% for sexual HIV risk behaviors. Overall, 55/204 (27.0%) met CDC criteria for HIV exposure prophylaxis, including 7/204 (3.4%) for PEP and 48/204 (23.5%) for PrEP. Four of 7 PEP-eligible patients were offered PEP and all 4 were prescribed PEP. Thirty-two of 48 PrEP eligible patients were offered PrEP, and 7/48 (14.6%) were prescribed PrEP. Additionally, 6 PWID were offered PrEP who lacked formal CDC criteria. Conclusions: Bridge clinics patients have high rates of PEP/PrEP eligibility. The majority of patients with identified eligibility were offered PEP/PrEP, suggesting that upstream interventions that increase HIV risk assessment may support programs in initiating PEP/PrEP care. Additional work is needed to understand why patients declined PEP/PrEP. PrEP offers to PWID who did not meet CDC criteria also suggested provider concern regarding the sensitivity of CDC criteria among PWID. Overall, bridge clinics offer a potential opportunity to increase biomedical HIV prevention service delivery. [ABSTRACT FROM AUTHOR]

Background: Gay, bisexual, and other men-who-have-sex-with-men (GBMSM) continue to be disproportionately affected by Human Immunodeficiency Virus (HIV). Although HIV pre-exposure prophylaxis (PrEP) offers an effective means of reducing incident HIV among this population, the HIV-preventive success of oral-based PrEP is contingent upon regimen adherence. Elevated rates of alcohol-, substance use-, and mental health-related issues among GBMSM potentially hinder PrEP-taking efforts, however the evidence for this remains mixed. Accordingly, the present study entailed a comprehensive qualitative investigation to explore PrEP-prescribed GBMSM's perceptions surrounding the influence of alcohol, substance use, and mental health on PrEP adherence.Methods: PrEP-prescribed GBMSM (age ≥ 18 years; prescribed PrEP for ≥ 3 months) were recruited from two PrEP-delivery clinics in Toronto, Canada for focus groups as part of the formative phase of an alcohol-, substance use-, and mental health-focused randomized controlled intervention trial. Focus group discussions qualitatively explored perceived strengths and barriers associated with adherence to PrEP treatment; with an emphasis on alcohol, substance use, and mental health concerns. Condom use among PrEP-prescribed GBMSM within the context of these concerns was also discussed.Results: A total of five focus groups involving 35 GBMSM were conducted (4-10/group; mean age = 42.4; white = 71.4%). Although participants themselves generally reported successfully adhering to their PrEP regimens-resulting from a strong, underlying motivation for self-care-they recognized the detrimental impact that alcohol, substance use, and mental health had on adherence among their peers. In this regard, alcohol and substances were perceived as detracting from adherence only when consumption was excessive or temporally linked to PrEP dosing. Pronounced mental health issues (e.g., severe depression) were also seen as hindering adherence, although these effects were nuanced and perceived as person-dependent. Alcohol and substances were linked to condomless sex, regardless of PrEP use, and PrEP was therefore viewed as an HIV-protective 'safety net.'Conclusions: Overall, findings suggest that PrEP adherence can often be successfully achieved in the presence of alcohol-, substance use-, and mental health-related issues. Augmenting self-care, and addressing pronounced addictions- and mental health-related concerns, may enhance PrEP treatment among GBMSM. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis, or PrEP, is a once-daily preventative prescription pill against HIV for adults or adolescents who have sex or inject drugs. PrEP may be especially useful among Black and Hispanic Americans, who are particularly at risk for HIV in the United States. In spite of this vulnerability, rates of PrEP use in Black and Hispanic communities are low. Here, we examined familiarity with, prior usage of, and future interest in PrEP among 364 Black and Hispanic Indiana residents. Indiana is an important context for this work, due to severe HIV outbreaks in the area over the last 8 years. Around half of all participants had never heard of PrEP, with Hispanic participants being less familiar than Black participants. Prior PrEP use was low, at around 10%, and was lower for Hispanic than Black participants. Around 21% of all participants reported interest in PrEP after learning of it in our study. Further, participants identified strategies that would make discussions about PrEP with a medical provider more comfortable. Black and Hispanic participants reported feeling the most comfortable with addressing PrEP usage with providers if: (a) the provider was the one who brought up the subject of PrEP, (b) there was written information available to the patient (i.e., brochures), and (c) the patient already knew they qualified for the prescription in terms of personal eligibility and insurance coverage. Additional provider and patient education, as well as openness on the part of the provider, can help to lessen the disparities associated with PrEP need and actual PrEP usage.

Abstract Background Although HIV pre-exposure prophylaxis (PrEP) substantially diminishes the likelihood of HIV acquisition, poor adherence can decrease the HIV-protective benefits of PrEP. The present investigation sought to identify the extent to which alcohol consumption, substance use, and depression were linked to PrEP nonadherence among gay, bisexual, and other men-who-have-sex-with-men (gbMSM). Methods gbMSM (age ≥ 18, prescribed PrEP for ≥3 months) were recruited from two clinics in Toronto, Canada for an e-survey assessing demographics; PrEP nonadherence (4-day PrEP-focused ACTG assessment); hazardous and harmful alcohol use (AUDIT scores of 8–15 and 16+, respectively); moderate/high risk substance use (NIDA M-ASSIST scores > 4); depression (CESD-10 scores ≥10); and other PrEP-relevant factors. The primary outcome, PrEP nonadherence, entailed missing one or more PrEP doses over the past 4 days. A linear-by-linear test of association assessed whether increasing severity of alcohol use (i.e., based on AUDIT categories) was linked to a greater occurrence of PrEP nonadherence. Univariate logistic regression was employed to determine factors associated with PrEP nonadherence, and factors demonstrating univariate associations at the p

Identifying candidates for HIV pre-exposure prophylaxis (PrEP) is a barrier to improving PrEP uptake in priority populations. Syphilis infection is an indication for PrEP in all individuals and can be easily assessed by primary care providers (PCP) and health systems. This retrospective study evaluated the impact of a multidisciplinary provider outreach intervention on PrEP uptake in patients with a positive syphilis test result in a safety-net hospital-based primary care practice. The PCPs of PrEP-eligible patients with a positive syphilis result were notified via the electronic medical record (EMR) about potential PrEP eligibility and institutional HIV PrEP resources. Rates of PrEP offers and prescriptions were compared in the pre (8/1/2018-12/31/2018, n = 60) and post (1/1/2019-5/31/2019, n = 86) intervention periods. Secondary analyzes evaluated receipt of appropriate syphilis treatment and contemporaneous screening for HIV, gonorrhea, and chlamydia. No significant differences in the overall proportion of patients offered (15% vs 19%) and prescribed (7% vs 5%) PrEP were observed between the pre- and post-periods. Overall, 7% of positive tests represented infectious syphilis. The rate of appropriate syphilis treatment was equivalent (57% vs 56%) and contemporaneous screening for other sexually transmitted infections was suboptimal across the entire study period. Although any positive syphilis test may be an easily abstracted metric from the EMR, this approach was inclusive of many patients without current HIV risk and did not increase PrEP uptake significantly. Future research into population health approaches to increase HIV prevention should focus on patients with infectious syphilis and other current risk factors for incident HIV infection. [ABSTRACT FROM AUTHOR]

Women worldwide confront two major reproductive health challenges: the need for contraception and protection from sexually transmitted infections, including Human Immunodeficiency Virus (HIV). Multipurpose Prevention Technologies (MPTs) that simultaneously prevent unintended pregnancy and HIV could address these challenges with a single product. Here, we developed a long-acting (LA) subcutaneously administered and biodegradable implant system that provides sustained delivery of contraceptive and antiretroviral (ARV) with zero-order release kinetics. The MPT system involves two implants comprising an extruded tube of a biodegradable polymer, poly(ε-caprolactone) (PCL). Each implant is filled with a formulation of progestin [levonorgestrel (LNG) or etonogestrel (ENG)], or a formulation of a potent ARV [tenofovir alafenamide (TAF), or 4′-Ethynyl-2-fluoro-2′-deoxyadenosine (EFdA)]. We demonstrated sustained in-vitro release of LNG, ENG, and EFdA from the implant system for 13–17 months, while maintaining high stability of the drugs (>99%) within the implant reservoirs. We further elucidated the controlled release mechanism of the implant and leveraged several tunable parameters (e.g., type and quantity of the excipient, PCL properties, and implant wall thickness) to tailor the release kinetics and enhance the mechanical integrity of the MPT implant. The optimized MPT showed sustained in-vitro release of ENG and EFdA over 1 year while maintaining a high level of formulation stability and structural integrity. The MPT implant system was further evaluated in a preclinical study using a rodent model and demonstrated sustained release of EFdA (6 months) and ENG (12 months) with high stability of the drug formulation (>95%). This manuscript supports the continued advancement of LA delivery systems for MPTs. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Although HIV pre-exposure prophylaxis (PrEP) substantially diminishes the likelihood of HIV acquisition, poor adherence can decrease the HIV-protective benefits of PrEP. The present investigation sought to identify the extent to which alcohol consumption, substance use, and depression were linked to PrEP nonadherence among gay, bisexual, and other men-who-have-sex-with-men (gbMSM).Methods: gbMSM (age ≥ 18, prescribed PrEP for ≥3 months) were recruited from two clinics in Toronto, Canada for an e-survey assessing demographics; PrEP nonadherence (4-day PrEP-focused ACTG assessment); hazardous and harmful alcohol use (AUDIT scores of 8-15 and 16+, respectively); moderate/high risk substance use (NIDA M-ASSIST scores > 4); depression (CESD-10 scores ≥10); and other PrEP-relevant factors. The primary outcome, PrEP nonadherence, entailed missing one or more PrEP doses over the past 4 days. A linear-by-linear test of association assessed whether increasing severity of alcohol use (i.e., based on AUDIT categories) was linked to a greater occurrence of PrEP nonadherence. Univariate logistic regression was employed to determine factors associated with PrEP nonadherence, and factors demonstrating univariate associations at the p < .10 significance level were included in a multivariate logistic regression model. Additive and interactive effects involving key significant factors were assessed through logistic regression to evaluate potential syndemic-focused associations.Results: A total of 141 gbMSM (Mean age = 37.9, white = 63.1%) completed the e-survey. Hazardous/harmful drinking (31.9%), moderate/high risk substance use (43.3%), and depression (23.7%) were common; and one in five participants (19.9%) reported PrEP nonadherence. Increasing alcohol use level was significantly associated with a greater likelihood of nonadherence (i.e., 15.6, 25.0, and 44.4% of low-risk, hazardous, and harmful drinkers reported nonadherence, respectively (χ2(1) = 4.79, p = .029)). Multivariate logistic regression demonstrated that harmful alcohol use (AOR = 6.72, 95%CI = 1.49-30.33, p = .013) and moderate/high risk cocaine use (AOR = 3.11, 95%CI = 1.01-9.59, p = .049) independently predicted nonadherence. Furthermore, an additive association emerged, wherein the likelihood of PrEP nonadherence was highest among those who were hazardous/harmful drinkers and moderate/high risk cocaine users (OR = 2.25, 95%CI = 1.19-4.25, p = .013). Depression was not associated with nonadherence.Conclusions: Findings highlight the need to integrate alcohol- and substance-focused initiatives into PrEP care for gbMSM. Such initiatives, in turn, may help improve PrEP adherence and reduce the potential for HIV acquisition among this group. [ABSTRACT FROM AUTHOR]

Long-acting (LA) HIV pre-exposure prophylaxis (PrEP) can mitigate challenges of adhering to daily or on-demand regimens of antiretrovirals (ARVs). We are developing a subcutaneous implant comprising polycaprolactone (PCL) for sustained delivery of ARVs for PrEP. Here we use tenofovir alafenamide (TAF) as a model drug. Previously, we demonstrated that the release rates of drugs are controlled by the implant surface area and wall thickness, and the molecular weight (MW) of PCL. Here, we further advance the implant design and tailor the release rates of TAF and the mechanical integrity of the implant through unique polymer blend formulations. In vitro release of TAF from the implant exhibited zero-order release kinetics for ~120 days. TAF release rates were readily controlled via the MW of the polymer blend, with PCL formulations of higher MW releasing the drug faster than implants with lower MW PCL. Use of polymer MW to tune drug release rates is partly explained by PCL crystallinity, as higher PCL crystalline material is often associated with a slower release rate. Moreover, results showed the ability to tailor mechanical properties via PCL blends. Blending PCL offers an effective approach for tuning the ARV release rates, implant duration, and integrity, and ultimately the biodegradation profiles of the implant.

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The human immunodeficiency virus (HIV) type-1 is a human-specific virus. The lack of a widely available small-animal model has seriously hampered HIV research. In 2004, a new humanised mouse model was reported. It was based on the intrahepatic injection of human CD34+ cord blood cells into newborn, highly immunodeficient mice. These mice develop a lymphoid system of human origin and are highly susceptible to HIV infection and showed disseminated infection, persistent viraemia and characteristic helper CD4+ T-cell loss. Here, we will briefly review the various existing humanised mouse models and highlight their value to the study of HIV infection.

Pre-exposure prophylaxis, or PrEP, is a once-daily preventative prescription pill against HIV for adults or adolescents who have sex or inject drugs. PrEP may be especially useful among Black and Hispanic Americans, who are particularly at risk for HIV in the United States. In spite of this vulnerability, rates of PrEP use in Black and Hispanic communities are low. Here, we examined familiarity with, prior usage of, and future interest in PrEP among 364 Black and Hispanic Indiana residents. Indiana is an important context for this work, due to severe HIV outbreaks in the area over the last 8 years. Around half of all participants had never heard of PrEP, with Hispanic participants being less familiar than Black participants. Prior PrEP use was low, at around 10%, and was lower for Hispanic than Black participants. Around 21% of all participants reported interest in PrEP after learning of it in our study. Further, participants identified strategies that would make discussions about PrEP with a medical provider more comfortable. Black and Hispanic participants reported feeling the most comfortable with addressing PrEP usage with providers if: (a) the provider was the one who brought up the subject of PrEP, (b) there was written information available to the patient (i.e., brochures), and (c) the patient already knew they qualified for the prescription in terms of personal eligibility and insurance coverage. Additional provider and patient education, as well as openness on the part of the provider, can help to lessen the disparities associated with PrEP need and actual PrEP usage., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Campbell, Adams, Bennett-Brown, Woodward, Gesselman and Carter.)

[Display omitted] Worldwide, women face compounding reproductive health risks, including human immunodeficiency virus (HIV), sexually-transmitted infections (STIs), and unintended pregnancy. Multipurpose prevention technologies (MPTs) offer combined protection against these overlapping risks in singular prevention products that offer potential for simplified use, lower burden, higher acceptability, and increased public health benefits. Over the past decade, substantial progress has been made in development of extended-release MPTs, which have further potential to grant sexual and reproductive health autonomy to women globally and to offer choice for women to accommodate varying needs during their reproductive lives. Here, we highlight the advances made in injectable, implant, and ring delivery forms, and the importance of incorporating end-user preferences early in the research and development of these products. [ABSTRACT FROM AUTHOR]

Long-acting (LA) HIV pre-exposure prophylaxis (PrEP) can mitigate challenges of adhering to daily or on-demand regimens of antiretrovirals (ARVs). We are developing a subcutaneous implant comprising polycaprolactone (PCL) for sustained delivery of ARVs for PrEP. Here we use tenofovir alafenamide (TAF) as a model drug. Previously, we demonstrated that the release rates of drugs are controlled by the implant surface area and wall thickness, and the molecular weight (MW) of PCL. Here, we further advance the implant design and tailor the release rates of TAF and the mechanical integrity of the implant through unique polymer blend formulations. In vitro release of TAF from the implant exhibited zero-order release kinetics for ~120 days. TAF release rates were readily controlled via the MW of the polymer blend, with PCL formulations of higher MW releasing the drug faster than implants with lower MW PCL. Use of polymer MW to tune drug release rates is partly explained by PCL crystallinity, as higher PCL crystalline material is often associated with a slower release rate. Moreover, results showed the ability to tailor mechanical properties via PCL blends. Blending PCL offers an effective approach for tuning the ARV release rates, implant duration, and integrity, and ultimately the biodegradation profiles of the implant. [ABSTRACT FROM AUTHOR]

The diagnosis and treatment of sexually transmitted infections is a crucial component of providing evidence-based care in the emergency department. Understanding how to make the diagnosis and implement effective treatment is essential to maintaining and improving public health. Providers should also be adept at giving care to sexual assault survivors and seeking out the expertise of specially trained professionals within networks known as SANE, SAFE, or SART. These networks are critical to providing standardized care to sexual assault patients. Prophylaxis remains a key element for the prevention of sexually transmitted infections in all patients who are considered high risk., (Copyright © 2019 Elsevier Inc. All rights reserved.)