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Since the beginning of the HIV epidemic in the USA, effective interventions to reduce HIV risk among cisgender women have been lacking. Although oral HIV pre-exposure prophylaxis (PrEP) is effective in pharmacologically preventing HIV infection, there is a gap between the recommended use of PrEP and PrEP uptake among eligible women. This study aimed to identify the role of patient-provider communication in PrEP decision-making among women considering PrEP. Semi-structured in-depth interviews were conducted with 41 PrEP-eligible women in Philadelphia and New York City. A thematic analysis of the responses was conducted, and a conceptual model developed and confirmed as analysis continued. Of the women interviewed, 53.6% were African American and 29.3% were Latina. Women noted that having a trusting relationship with their health care provider, receiving a tailored recommendation for PrEP based upon their specific needs and using their health care provider as support were crucial facilitators of PrEP decision-making. Lack of provider knowledge about PrEP, perceived health care provider stigma about their drug use and sexual activity, and lack of care continuity were all identified as barriers to effective communication. Study findings can inform future interventions to enhance patient-provider communication about PrEP and increase PrEP uptake among women. [ABSTRACT FROM AUTHOR]

Background: Understanding donor perception of the blood donation experience is central to maintaining an adequate blood supply. Studies that use questionnaires to assess barriers/facilitators to donation may be influenced by response bias. To address this, we conducted an innovative study integrating quantitative informatic techniques with qualitative data analysis of YouTube video content to explore donor experiences and barriers and facilitators to whole blood donation. Methods: Sampling of YouTube videos was conducted using search parameters for identifying relevant videos, based on donors' language used to describe their whole blood donation experiences (e.g., blood donation, blood donor, donated blood, gave/give blood). We eliminated duplicate videos; filtered out non‐English videos, those made outside the United States, and those with no transcripts; and restricted the time period during which videos were posted from 2015 to 2019. Search parameters were fed into a Python script, which downloaded video transcripts for all search results. The final sample was 102 noncommercial and 34 commercial transcripts. The subsequent transcriptions were uploaded into qualitative analysis software and coded two coders. A third coder randomly selected transcripts to review to ensure consistency. Results: Barriers to whole blood donation include having prior negative experiences with donation and donation‐related fear. Facilitators included altruism, having a personal connection to donation, donation center incentives, and positive experiences with blood center staff. Conclusion: Themes identified in this study were similar to those in the existing literature. This suggests that current questionnaires to address barriers/facilitators to donation are unlikely to be meaningfully impacted by response bias. [ABSTRACT FROM AUTHOR]

Background: Despite multiple available HIV prevention methods, the HIV epidemic continues to affect South Africa the most. We sought to understand willingness to use actual and hypothetical HIV prevention methods among participants enrolled in a preventative HIV vaccine efficacy trial in Soweto, South Africa.Methods: We conducted a qualitative study with 38 self-reporting HIV-uninfected and consenting 18-35 year olds participating in the HVTN 702 vaccine efficacy trial in Soweto. Using a semi-structured interview guide, five focus group discussions (FGDs) were held, stratified by age, gender and sexual orientation. The FGDs were composed of: (i) 10 heterosexual women aged 18-24 years; (ii) 9 heterosexual and bisexual women aged 25-35 years; (iii & iv) heterosexual men aged 25-35 years with 7 in both groups; and (v) 5 men aged 18-35 years who have sex with men. FGDs were audio-recorded, transcribed verbatim, translated into English and analysed using thematic analysis.Results: We present five main themes: (i) long-lasting methods are preferable; (ii) condoms are well-known but not preferred for use; (iii) administration route of HIV prevention method is a consideration for the user; (iv) ideal HIV prevention methods should blend into the lifestyle of the user; and the perception that (v) visible prevention methods indicate sexual indiscretion.Conclusions: The participants' candour about barriers to condom and daily oral pre-exposure prophylaxis (PrEP) use, and expressed preferences for long-lasting, discreet, lifestyle-friendly methods reveal a gap in the biomedical prevention market aiming to reduce sexually acquired HIV in South Africa. Product developers should consider long-acting injectable formulations, such as vaccines, passive antibodies and chemoprophylaxis, for HIV prevention technologies. Future innovations in HIV prevention products may need to address the desire for the method to blend easily into lifestyles, such as food-medication formulations. [ABSTRACT FROM AUTHOR]

Background: VRC01 is an HIV-1 CD4 binding site broadly neutralizing antibody (bnAb) that is active against a broad range of HIV-1 primary isolates in vitro and protects against simian-human immunodeficiency virus (SHIV) when delivered parenterally to nonhuman primates. It has been shown to be safe and well tolerated after short-term administration in humans; however, its clinical and functional activity after longer-term administration has not been previously assessed.Methods and Findings: HIV Vaccine Trials Network (HVTN) 104 was designed to evaluate the safety and tolerability of multiple doses of VRC01 administered either subcutaneously or by intravenous (IV) infusion and to assess the pharmacokinetics and in vitro immunologic activity of the different dosing regimens. Additionally, this study aimed to assess the effect that the human body has on the functional activities of VRC01 as measured by several in vitro assays. Eighty-eight healthy, HIV-uninfected, low-risk participants were enrolled in 6 United States clinical research sites affiliated with the HVTN between September 9, 2014, and July 15, 2015. The median age of enrollees was 27 years (range, 18-50); 52% were White (non-Hispanic), 25% identified as Black (non-Hispanic), 11% were Hispanic, and 11% were non-Hispanic people of diverse origins. Participants were randomized to receive the following: a 40 mg/kg IV VRC01 loading dose followed by five 20 mg/kg IV VRC01 doses every 4 weeks (treatment group 1 [T1], n = 20); eleven 5 mg/kg subcutaneous (SC) VRC01 (treatment group 3 [T3], n = 20); placebo (placebo group 3 [P3], n = 4) doses every 2 weeks; or three 40 mg/kg IV VRC01 doses every 8 weeks (treatment group 2 [T2], n = 20). Treatment groups T4 and T5 (n = 12 each) received three 10 or 30 mg/kg IV VRC01 doses every 8 weeks, respectively. Participants were followed for 32 weeks after their first VRC01 administration and received a total of 249 IV infusions and 208 SC injections, with no serious adverse events, dose-limiting toxicities, nor evidence for anti-VRC01 antibodies observed. Serum VRC01 levels were detected through 12 weeks after final administration in all participants who received all scheduled doses. Mean peak serum VRC01 levels of 1,177 μg/ml (95% CI: 1,033, 1,340) and 420 μg/ml (95% CI: 356, 494) were achieved 1 hour after the IV infusion series of 30 mg/kg and 10 mg/kg doses, respectively. Mean trough levels at week 24 in the IV infusion series of 30 mg/kg and 10 mg/kg doses, respectively, were 16 μg/ml (95% CI: 10, 27) and 6 μg/ml (95% CI: 5, 9) levels, which neutralize a majority of circulating strains in vitro (50% inhibitory concentration [IC50] > 5 μg/ml). Post-infusion/injection serum VRC01 retained expected functional activity (virus neutralization, antibody-dependent cellular cytotoxicity, phagocytosis, and virion capture). The limitations of this study include the relatively small sample size of each VRC01 administration regimen and missing data from participants who were unable to complete all study visits.Conclusions: VRC01 administered as either an IV infusion (10-40 mg/kg) given monthly or bimonthly, or as an SC injection (5 mg/kg) every 2 weeks, was found to be safe and well tolerated. In addition to maintaining drug concentrations consistent with neutralization of the majority of tested HIV strains, VRC01 concentrations from participants' sera were found to avidly capture HIV virions and to mediate antibody-dependent cellular phagocytosis, suggesting a range of anti-HIV immunological activities, warranting further clinical trials.Trial Registration: Clinical Trials Registration: NCT02165267. [ABSTRACT FROM AUTHOR]

Purpose: We examined the relationship between economic, physical, and social characteristics of neighborhoods, where men who have sex with men (MSM) lived and socialized, and symptom scores of depression and generalized anxiety disorder (GAD).Methods: Participants came from a cross-sectional study of a population-based sample of New York City MSM recruited in 2010-2012 (n = 1126). Archival and survey-based data were obtained on neighborhoods, where the men lived and where they socialized most often.Results: MSM who socialized in neighborhoods with more economic deprivation and greater general neighborhood attachment experienced higher GAD symptoms. The relationship between general attachment to neighborhoods where MSM socialized and mental health depended on the level of gay community attachment: in neighborhoods characterized by greater gay community attachment, general neighborhood attachment was negatively associated with GAD symptoms, while in low gay community attachment neighborhoods, general neighborhood attachment had a positive association with GAD symptoms.Conclusions: This study illustrates the downsides of having deep ties to social neighborhoods when they occur in the absence of broader access to ties with the community of one's sexual identity. Interventions that help MSM cross the spatial boundaries of their social neighborhoods and promote integration of MSM into the broader gay community may contribute to the reduction of elevated rates of depression and anxiety in this population. [ABSTRACT FROM AUTHOR]

Background: Black men who have sex with men (MSM) have a high prevalence of bacterial sexually transmitted infections (STIs), and individual risk behavior does not fully explain the higher prevalence when compared with other MSM. Using the social-ecological framework, we evaluated individual, social and sexual network, and structural factors and their association with prevalent STIs among Black MSM. Methods: The HIV Prevention Trials Network 061 was a multi-site cohort study designed to determine the feasibility and acceptability of a multi-component intervention for Black MSM in six US cities. Baseline assessments included demographics, risk behavior, and social and sexual network questions collected information about the size, nature and connectedness of their sexual network. Logistic regression was used to estimate the odds of having any prevalent sexually transmitted infection (gonorrhea, chlamydia, or syphilis). Results: A total of 1,553 Black MSM were enrolled in this study. In multivariate analysis, older age (aOR = 0.57; 95% CI 0.49–0.66, p<0.001) was associated with a lower odds of having a prevalent STI. Compared with reporting one male sexual partner, having 2–3 partners (aOR = 1.74; 95% CI 1.08–2.81, p<0.024) or more than 4 partners (aOR = 2.29; 95% CI 1.43–3.66, p<0.001) was associated with prevalent STIs. Having both Black and non-Black sexual partners (aOR = 0.67; 95% CI 0.45–0.99, p = 0.042) was the only sexual network factor associated with prevalent STIs. Conclusions: Age and the number and racial composition of sexual partners were associated with prevalent STIs among Black MSM, while other sexual network factors were not. Further studies are needed to evaluate the effects of the individual, network, and structural factors on prevalent STIs among Black MSM to inform combination interventions to reduce STIs among these men. [ABSTRACT FROM AUTHOR]

In the USA, the impact of psychological distress may be greater for Black men who have sex with men given that they may experience both racial discrimination in society at large and discrimination due to sexual orientation within Black communities. Attachments to community members may play a role in addressing psychological distress for members of this vulnerable population. This analysis is based on 312 Black men who have sex with men recruited for a behavioural intervention trial in New York City. Analyses were conducted using bivariate and multivariable logistic regression to examine the relationship of discrimination and community attachment to psychological distress. Most participants (63%) reported exposure to both discrimination due to race and sexual orientation. However, a majority of participants (89%) also reported racial and/or sexual orientation community attachment. Psychological distress was significant and negatively associated with older age (40 years and above), being a high school graduate and having racial and/or sexual orientation community attachments. Psychological distress was significantly and positively associated with being HIV-positive and experiencing both racial and sexual orientation discrimination. Similar results were found in the multivariable model. Susceptibility to disparate psychological distress outcomes must be understood in relation to social membership, including its particular norms, structures and ecological milieu. [ABSTRACT FROM AUTHOR]

In the USA, the impact of psychological distress may be greater for Black men who have sex with men given that they may experience both racial discrimination in society at large and discrimination due to sexual orientation within Black communities. Attachments to community members may play a role in addressing psychological distress for members of this vulnerable population. This analysis is based on 312 Black men who have sex with men recruited for a behavioural intervention trial in New York City. Analyses were conducted using bivariate and multivariable logistic regression to examine the relationship of discrimination and community attachment to psychological distress. Most participants (63%) reported exposure to both discrimination due to race and sexual orientation. However, a majority of participants (89%) also reported racial and/or sexual orientation community attachment. Psychological distress was significant and negatively associated with older age (40 years and above), being a high school graduate and having racial and/or sexual orientation community attachments. Psychological distress was significantly and positively associated with being HIV-positive and experiencing both racial and sexual orientation discrimination. Similar results were found in the multivariable model. Susceptibility to disparate psychological distress outcomes must be understood in relation to social membership, including its particular norms, structures and ecological milieu. [ABSTRACT FROM PUBLISHER]

US guidelines recommend at least annual HIV testing for those at risk. This analysis assessed frequency and correlates of infrequent HIV testing and late diagnosis among black men who have sex with men (BMSM).HIV testing history was collected at enrollment from participants in HPTN 061, an HIV prevention trial for at-risk US BMSM. Two definitions of late HIV diagnosis were assessed: CD4 cell count <200 cells per cubic millimeter or <350 cells per cubic millimeter at diagnosis.HPTN 061 enrolled 1553 BMSM. HIV testing questions were completed at enrollment by 1284 (98.7%) of 1301 participants with no previous HIV diagnosis; 272 (21.2%) reported no HIV test in previous 12 months (infrequent testing); 155 of whom (12.1% of the 1284 with testing data) reported never testing. Infrequent HIV testing was associated with: not seeing a medical provider in the previous 6 months (relative risk [RR]: 1.08, 95% confidence interval [CI]: 1.03 to 1.13), being unemployed (RR: 1.04, CI: 1.01 to 1.07), and having high internalized HIV stigma (RR: 1.03, CI: 1.0 to 1.05). New HIV diagnoses were more likely among infrequent testers compared with men tested in the previous year (18.4% vs. 4.4%; odds ratio: 4.8, 95% CI: 3.2 to 7.4). Among men with newly diagnosed HIV, 33 (39.3%) had a CD4 cell count <350 cells per cubic millimeter including 17 (20.2%) with CD4 <200 cells per cubic millimeter.Infrequent HIV testing, undiagnosed infection, and late diagnosis were common among BMSM in this study. New HIV diagnoses were more common among infrequent testers, underscoring the need for additional HIV testing and prevention efforts among US BMSM. [ABSTRACT FROM AUTHOR]