Correlates of concordance between self-reported and lab-confirmed viral load among Black and Latine men who have sex with men (BLMSM) living with HIV in New York City.

Sustained viral suppression is one of the four strategies in the U.S. Department of Health and Human Services' (HHS) plan to end the HIV epidemic in the United States. Individuals living with HIV must understand their viral load accurately for this strategy to be effective. We conducted cross-sectional analyses using baseline data from the NNHIV longitudinal study among men who have sex with men (MSM) living with HIV in New York City to identify factors associated with concordant knowledge between self-reported and lab-confirmed viral load. Of 164 Black and/or Latine participants, 67% (n = 110) reported that their viral load was undetectable, however lab tests showed only 44% (n = 72) had an undetectable viral load (<20 copies/ml). Overall, 62% of the sample (n = 102) had concordant HIV viral load knowledge (agreement of self-reported and lab viral load). In multivariable regression, those with unstable housing (PR = 0.52, 0.30-0.92) and those who had higher levels of beliefs of racism in medicine scale (PR = 0.76, 0.59-0.97) were less likely to have concordant knowledge. Our study underscores the need for implementing measures to improve viral load knowledge, U = U messaging, and strategies to achieve and maintain undetectable viral load status to reduce the burden of HIV at the population level.

The Moderating Effects of HIV Relevant Factors on the Relationship Between Intimate Partner Violence and Intention to Start HIV Pre-exposure Prophylaxis (PrEP) Among Cisgender Women.

Intimate partner violence (IPV) and HIV are serious and related public health problems that detrimentally impact women's health. Because women who experience IPV are more likely to acquire HIV, it is critical to promote HIV prevention strategies, such as HIV pre-exposure prophylaxis (PrEP), that increase autonomy. This study of cisgender women eligible for HIV PrEP took place between 2017 and 2019 in Philadelphia and New York City. This study aimed to examine the relationship between four types of IPV (control, psychological, physical, sexual) and intention to start PrEP among PrEP-eligible cisgender women and assess the extent to which HIV relevant factors moderated the association between IPV experience and intention to start PrEP. In this sample of PrEP-eligible women (n = 214), 68.7% indicated intention to start PrEP in the next 3 months. Ethnicity was strongly associated with intention to start PrEP, with Hispanic women having the highest odds of intending to start PrEP in the next 3 months. Having a controlling partner significantly predicted intention to start PrEP. Women with more than one sex partner and a controlling partner had higher odds of intending to start PrEP as compared with those who had one or no partners and had no IPV control. These findings point to a need for patient-centered interventions that address the need for safety and autonomy among cisgender, PrEP-eligible women.

A Randomized Controlled Pilot Study of Just4Us, a Counseling and Navigation Intervention to Promote Oral HIV Prophylaxis Uptake Among PrEP-Eligible Cisgender Women.

HIV pre-exposure prophylaxis (PrEP) uptake among cisgender women in the United States is low. Just4Us, a theory-based counseling and navigation intervention, was evaluated in a pilot randomized controlled trial among PrEP-eligible women (n = 83). The comparison arm was a brief information session. Women completed surveys at baseline, post-intervention, and at three months. In this sample, 79% were Black, and 26% were Latina. This report presents results on preliminary efficacy. At 3 months follow-up, 45% made an appointment to see a provider about PrEP; only 13% received a PrEP prescription. There were no differences in PrEP initiation by study arm (9% Info vs. 11% Just4Us). PrEP knowledge was significantly higher in the Just4Us group at post-intervention. Analysis revealed high PrEP interest with many personal and structural barriers along the PrEP continuum. Just4Us is a promising PrEP uptake intervention for cisgender women. Further research is needed to tailor intervention strategies to multilevel barriers.Clinicaltrials.gov registration NCT03699722: A Women-Focused PrEP Intervention (Just4Us).

RESUMEN: La aceptación de la profilaxis previa a la exposición (PrEP) al VIH entre las mujeres cisgénero en los Estados Unidos es baja. Just4Us, una intervención de asesoramiento y navegación basada en la teoría, se evaluó en un ensayo piloto controlado aleatorizado con mujeres aptas para la PrEP (n = 83). El brazo de comparación fue una breve sesión de información. Las mujeres completaron encuestas al inicio, después de la intervención ya los 3 meses. En la muestra, el 79% eran negros y el 26% eran latinas. Este informe presenta resultados sobre la eficacia preliminar. A los 3 meses de seguimiento, el 45% hizo una cita para ver a un proveedor acerca de la PrEP; solo el 13% recibió una receta de PrEP. No hubo diferencias en el inicio de la PrEP por brazo de estudio (9% Info frente a 11% Just4Us). El conocimiento fue significativamente mayor en el grupo Just4Us después de la intervención. El análisis reveló un alto interés por la PrEP con muchas barreras personales y estructurales a lo largo del continuo de la PrEP. Just4Us es una prometedora intervención de adopción de PrEP para mujeres cisgénero. Se necesita más investigación para adaptar las estrategias de intervención a las barreras multinivel.

Individual, social and structural factors influencing PrEP uptake among cisgender women: a theory-informed elicitation study.

The underutilization of pre-exposure prophylaxis (PrEP) among cisgender women in the U.S. limits this population's ability to reduce their risk for HIV infection, especially within the unique individual, social and structural systems they navigate. There is a need to identify the relevant multi-level barriers and facilitators to PrEP use among cisgender women to inform theory-guided efforts that address HIV disparities by race/ethnicity among cisgender women. Guided by the Integrated Behavioral Model and the Behavioral Model of Vulnerble Populations we conducted 41 interviews with PrEP eligible cisgender women in New York City and Philadelphia. Directed content analysis identified 11 modal behavioral beliefs crucial to PrEP uptake, including anticipated negative social consequences, 5 normative beliefs centered on available social supports, and 9 control beliefs such as anticipated barriers such as cost. Awareness and knowledge of PrEP as a biobehavioral HIV prevention method is limited for this sample. Through conventional content analysis we identified interpersonal and structural barriers to PrEP uptake including lack of partner support, transportation, mental health challenges, and challenges in accessing PrEP care. Potential solutions to structural barriers were enumerated along with implications for future intervention work and public health programming.

Neighborhood and Network Characteristics and the HIV Care Continuum among Gay, Bisexual, and Other Men Who Have Sex with Men.

In order for treatment as prevention to work as a national strategy to contain the HIV/AIDS epidemic in the United States (US), the HIV care continuum must become more robust, retaining more individuals at each step. The majority of people living with HIV/AIDS (PLWHA) in the US are gay, bisexual, and other men who have sex with men (MSM). Within this population, there are distinct race- and ethnicity-based disparities in rates of HIV infection, engagement, and retention in HIV care, and viral suppression. Compared with White MSM, HIV-infected Black MSM are less likely to be on anti-retroviral therapy (ART), adhere to ART, and achieve viral suppression. Among MSM living in urban areas, falling off the continuum may be influenced by factors beyond the individual level, with new research identifying key roles for network- and neighborhood-level characteristics. To inform multi-level and multi-component interventions, particularly to support Black MSM living in urban areas, a clearer understanding of the pathways of influence among factors at various levels of the social ecology is required. Here, we review and apply the empirical literature and relevant theoretical perspectives to develop a series of potential pathways of influence that may be further evaluated. Results of research based on these pathways may provide insights into the design of interventions, urban planning efforts, and assessments of program implementation, resulting in increased retention in care, ART adherence, and viral suppression among urban-dwelling, HIV-infected MSM.

Acculturation as a Moderator of HIV Risk Behavior Correlates Among Latino Men Who Have Sex with Men.

Acculturation is associated with increased sexual risk behaviors among heterosexual Latinos, but its influence among Latino gay, bisexual, and other men who have sex with men (MSM) remains less clear. Elements of acculturation may create distinct lived experiences among sexual minority Latinos, moderating how beneficial and adverse influences contribute to their sexual risk behaviors. Latino MSM living in New York City (n = 412) were recruited using a modified time-space venue- and web-based sampling method. Negative binomial regression models estimated associations between indicators of acculturation (i.e., language use, nativity status, ethnic identification), sexual minority stressors (i.e., internalized homophobia, sexual orientation-based discrimination), peer condom use norms, and the number of serodiscordant condomless anal intercourse (SDCAI) encounters. Acculturation indicators were then tested as simultaneous moderators of the influence of each predictor variable on the outcome. The association between internalized homophobia and SDCAI was significant only among English language speakers (aIRR = 3.05 [2.13, 4.37]) and those born outside of the U.S. (foreign-born = 0, aIRR = 0.17 [0.08, 0.36]). Sexual orientation-based discrimination and SDCAI were also positively associated among both English-speaking (aIRR = 1.82 [1.22, 2.72]) and foreign-born men (aIRR = 0.34 [0.14, 0.84]). Stronger ethnic identification also moderated the protective effects of peer condom use norms on SDCAI (aIRR = 0.28 [0.15, 0.52]). Results suggest that different dimensions of acculturation help shape how both stressors and protective factors influence HIV risk among Latino MSM. Future research is needed to examine the mechanisms through which these differences in acculturation may act on sexual risk behaviors among Latino MSM.

Beliefs Associated with Intention to Use PrEP Among Cisgender U.S. Women at Elevated HIV Risk.

Women comprise 19% of those newly diagnosed with HIV in the U.S. There is a wide gap between recommended use of pre-exposure prophylaxis (PrEP) and actual uptake among women who are eligible for PrEP. In order to identify women's beliefs and intentions about starting PrEP, a survey, informed by the reasoned action approach, was administered to 160 cisgender PrEP-eligible women, age 18-55, in Philadelphia and New York City. The mean age was 40.2 years (SD = 11.78), 44% had completed high school, 75% were unemployed, and 85% experienced financial instability in the past 3 months. Multivariate linear regression analyses identified sets of behavioral and normative beliefs associated with intention to start PrEP in the next 3 months. Behavioral beliefs reflected views about PrEP benefits such as preventing HIV, and normative beliefs reflected perceptions of support or lack thereof from others including partners, friends, mother, and children. These findings can be used to inform interventions to foster greater PrEP uptake among women.

The Association Between Condomless Anal Sex and Social Support Among Black Men Who Have Sex With Men (MSM) in Six U.S. Cities: A Study Using Data from the HIV Prevention Trials Network BROTHERS Study (HPTN 061).

We assessed how egocentric (i.e., self-generated descriptions of a person's social contacts) network structure and composition corresponded with reported instances of condomless receptive and insertive anal intercourse with men who were reportedly HIV-infected or of unknown HIV serostatus in a sample of black men who have sex with men (MSM) in six U.S. cities. Ratings showing a higher percentage of network members who provided social participation and medical support were positively associated with reporting condomless sex. There were also significant positive associations between stimulant use and condomless insertive and receptive anal sex. Future research should examine the social processes that underlie these associations and explore ways that social support can affect HIV prevention efforts for black MSM.

Post-exposure Prophylaxis Awareness, Knowledge, Access and Use Among Three Populations in New York City, 2016-17.

Post-exposure prophylaxis (PEP) is a cost-effective, but underused HIV prevention strategy. PEP awareness, knowledge, access, and usage was assessed among young men of color who have sex with men (YMSMOC; n = 177), transgender women (TW; n = 182), and cisgender women of color (CWOC; n = 170) in New York City. 59% were aware of PEP: 80% among YMSMOC, 63% among TW and 34% among CWOC (p < 0.001). 13% had ever used PEP. PEP awareness was higher among YMSMOC with a recent HIV test and lower among those with ≥ 4 partners. PEP awareness was lower among TW who anticipated stigma and reported barriers to taking PEP, and higher among TW who exchanged sex for resources. Among CWOC, more barriers to taking PEP reduced the odds of PEP awareness. PEP education and outreach needs to be deliberate about population-specific campaigns, with a need to focus on reducing PEP stigma and other barriers which impede PEP access.

Sexual Networks, Dyadic Characteristics, and HIV Acquisition and Transmission Behaviors Among Black Men Who Have Sex With Men in 6 US Cities.

The role of sexual networks in the epidemiology of human immunodeficiency virus (HIV) among black men who have sex with men (MSM) is poorly understood. Using data from 1,306 black MSM in the BROTHERS Study (2009-2010) in the United States, we examined the relationships between multiple sexual dyadic characteristics and serodiscordant/serostatus-unknown condomless sex (SDCS). HIV-infected participants had higher odds of SDCS when having sex at least weekly (odds ratio (OR) = 2.41, 95% confidence interval (CI): 1.37, 4.23) or monthly (OR = 1.94, 95% CI: 1.17, 3.24) versus once to a few times a year. HIV-uninfected participants had higher odds of SDCS with partners met offline at sex-focused venues (OR = 1.79, 95% CI: 1.15, 2.78) versus partners met online. In addition, having sex upon first meeting was associated with higher odds of SDCS (OR = 1.49, 95% CI: 1.21, 1.83) than was not having sex on first meeting, while living/continued communication with sexual partner(s) was associated with lower odds of SDCS (weekly: OR = 0.64, 95% CI: 0.47, 0.85; monthly: OR = 0.60, 95% CI: 0.44, 0.81; yearly: OR = 0.58, 95% CI: 0.39, 0.85) versus discontinued communication. Persons with primary/steady nonprimary partners versus commercial partners had lower odds of SDCS regardless of HIV serostatus. This suggests the need for culturally relevant HIV prevention efforts for black MSM that facilitate communication with sexual partners especially about risk reduction strategies, including preexposure prophylaxis.

A Longitudinal Analysis of Treatment Optimism and HIV Acquisition and Transmission Risk Behaviors Among Black Men Who Have Sex with Men in HPTN 061.

Little is known about HIV treatment optimism and risk behaviors among Black men who have sex with men (BMSM). Using longitudinal data from BMSM in the HPTN 061 study, we examined participants' self-reported comfort with having condomless sex due to optimistic beliefs regarding HIV treatment. We assessed correlates of treatment optimism and its association with subsequent risk behaviors for HIV acquisition or transmission using multivariable logistic regression with generalized estimating equations. Independent correlates of treatment optimism included age ≥35 years, annual household income <$20,000, depressive symptoms, high HIV conspiracy beliefs, problematic alcohol use, and previous HIV diagnosis. Treatment optimism was independently associated with subsequent condomless anal sex with a male partner of serodiscordant/unknown HIV status among HIV-infected men, but this association was not statistically significant among HIV-uninfected men. HIV providers should engage men in counseling conversations to assess and minimize willingness to have condomless sex that is rooted in optimistic treatment beliefs without knowledge of viral suppression.

Congruence of Home, Social and Sex Neighborhoods among Men Who Have Sex with Men, NYCM2M Study.

Substantial literature demonstrates the influence of the neighborhood environment on health behaviors and outcomes. But limited research examines on how gay and bisexual men experience and exist in various geographic and virtual spaces and how this relates to their sexual behavior. New York City Men 2 Men (NYCM2M) was a cross-sectional study designed to identify neighborhood-level characteristics within the urban environment that influence sexual risk behaviors, substance use, and depression among men who have sex with men (MSM) living in NYC. The sample was recruited using a modified venue-based time-space sampling methodology and through select websites and mobile applications. Whether key neighborhoods of human activity, where a participant resided (termed home), socialized (termed social), or had sex most often (termed sex), were the same or different was evaluated. "Congruence" (or the sameness) of home, social, and most often sex neighborhood was reported by 17 % of men, while 30 % reported that none of their neighborhoods were the same. The largest group of men (39 %) reported that their home and sex neighborhoods were the same but their social neighborhood was different while 10 % reported that their home neighborhood was different than their social and sex neighborhood; 5 % men reported same home and social neighborhoods with a different sex neighborhood. Complete neighborhood incongruence was highest among men who were Black and/or Latino, had lower education and personal income levels, and had greater financial insecurity. In adjusted analysis, serodiscordant condomless anal intercourse and condomless anal intercourse with partners from the Internet or mobile applications were significantly associated with having the same social and sex (but not home) neighborhoods. Understanding the complexity of how different spaces and places relate to the health and sexual behavior of MSM is essential for focusing interventions to best reach various populations of interest.

Concurrent partnerships and HIV risk among men who have sex with men in New York City.

BACKGROUND: Concurrent partnerships are a significant public health concern among men who have sex with men (MSM). This study describes the prevalence of concurrency and its association with serodiscordant/serostatus unknown unprotected anal or vaginal intercourse (SDUI) among MSM in New York City. METHODS: A total of 1458 MSM completed a social and sexual network inventory about their male and female sex partners, including concurrency, in the last 3 months. Logistic regression identified factors associated with SDUI. RESULTS: Median age was 29 years. The proportion of participants who reported being HIV+ was 23.5%. The men reported a mean of 3.2 male partners in the last 3 months. The proportion of MSM who reported having recent SDUI was 16.6%. More than half (63.2%) described having concurrent sex partners (individual concurrency based on overlapping dates of relationships); 71.5% reported having partners whom they believed had concurrent partners (perceived partner concurrency); and 56.1% reported that both they and their partners had concurrent partners (reciprocal concurrency). Among HIV+ men by self-report, having SDUI was positively associated with individual concurrency, any alcohol use during sex, having more male sex partners, and not having a main partner. Among self-reported HIV- men, having SDUI was positively associated with perceived partner concurrency, lower education level, any alcohol and drug use during sex, having more male sex partners, and having an anonymous partner. CONCLUSIONS: Concurrency was common among MSM. The association of SDUI with individual and perceived partner concurrency, along with substance use during sex, having an anonymous partner, and having many sex partners likely further increases HIV acquisition and transmission risk among MSM. HIV prevention interventions should address concurrency among MSM.

Factors associated with discussing HIV pre-exposure prophylaxis (PrEP) among Jamaican medical providers.

BACKGROUND: The Ministry of Health and Wellness of Jamaica has endorsed the use of pre-exposure prophylaxis (PrEP) as an HIV prevention strategy; however, PrEP was not included in the national HIV prevention program in 2021. METHODS: A cross-sectional online study involving physicians in Jamaica was conducted in 2021 to describe PrEP awareness, beliefs, attitudes, and practices. The study also assessed individual and social factors associated with discussing PrEP with patients and willingness to prescribe PrEP. FINDINGS: The mean age and standard deviation (SD) of the 69 physicians who completed the survey were 45.5 ± 13.6 years. Most of the participants (80%) reported that they were somewhat familiar with PrEP. PrEP attitude and perceived comfort in prescribing PrEP were moderate among participating physicians, with a mean and SD of 3.9 ± 0.8 and 3.6 ± 0.9 respectively. Six percent of physicians reported that they had prescribed PrEP and 17% had discussed PrEP with their patients in the past year. However, most (90%) reported that they were willing to prescribe PrEP after being informed about it. In the unadjusted model, identifying as Christian (compared to non-Christian) and reporting stronger homophobic beliefs were associated with reduced odds of discussing PrEP with patients. In the multivariable model, only homophobia remained statistically significant (OR, 0.24; 95% CI: 0.07-0.63). CONCLUSION: The findings suggest that physicians in Jamacia may be willing to prescribe PrEP; however, homophobia is a barrier to discussions, underscoring the need for the Ministry of Health and Wellness to recognize the role that homophobia plays in the national HIV program to further reduce HIV incidence in Jamaica.

Incidence and prevalence of hepatitis C and B infections among men who have sex with men and transgender women enrolled in a United States HIV vaccine trial.

Background: Rising hepatitis C and B virus (HCV and HBV) rates have been reported in men who have sex with men (MSM) and transgender women (TGW). This study characterizes HCV and HBV infections longitudinally among 2,496 MSM/TGW aged 18-50 years and at risk for HIV acquisition enrolled in an HIV-1 vaccine trial in 18 U.S. cities between 2009-2013. Methods: Participants completed behavioral surveys, HIV testing, and blood collection over 24 months. Of the 2,397 participants who consented for future testing, 1,792 (74.8%) had available paired stored blood samples at baseline and a later timepoint (Month 24 [N = 999]; if unavailable, M12 [N = 775] or M15 [N = 18]). Results: Among 1,792 participants, 98.1% were MSM, 0.8% were TGW, and the median age was 30 years (IQR 24, 40). Participants reported a median number of 3 male sex partners (IQR 1,5) within the past 3 months. Condomless insertive anal sex was reported by 55.8% and condomless receptive anal sex by 46.7%.1.3% reported injection drug use. During follow-up, 1.4% reported pre-exposure prophylaxis (PrEP) use. At baseline 11/1792 (0.61%) participants had HCV infection (HCV AB positive, RNA detectable), with all having persistent detectable RNA and chronic HCV infection at follow-up. Phylogenetic analysis showed no clusters of HCV infection. 8 participants had HCV AB positive, RNA undetectable at baseline and follow-up, representing past HCV infection with clearance; only 2 acquired HCV, which cleared over 12-24 months. At baseline, 2 participants (2/1792 = 0.11%) had positive HBsAg, indicating chronic HBV infection. Over 12-24 months, 4 (4/1790, 0.22%) developed HBsAg positivity; these participants had HBcAB positivity at baseline, thereby likely representing reactivation. There were no new HBV infections during follow-up. Conclusion: Among 1,792 men who have sex with men and transgender women aged 18-50 years and at risk for HIV acquisition enrolled in a U.S. HIV-1 vaccine trial, incident hepatitis C infection rates were extremely low, with no cases of incident hepatitis B infection. These rates of incident HCV infection and HBSAg positivity are lower than previously reported among MSM/TGW.

Seasonal human coronavirus humoral responses in AZD1222 (ChaAdOx1 nCoV-19) COVID-19 vaccinated adults reveal limited cross-immunity.

Background: Immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now widespread; however, the degree of cross-immunity between SARS-CoV-2 and endemic, seasonal human coronaviruses (HCoVs) remains unclear. Methods: SARS-CoV-2 and HCoV cross-immunity was evaluated in adult participants enrolled in a US sub-study in the phase III, randomized controlled trial (NCT04516746) of AZD1222 (ChAdOx1 nCoV-19) primary-series vaccination for one-year. Anti-HCoV spike-binding antibodies against HCoV-229E, HCoV-HKU1, HCoV-OC43, and HCoV-NL63 were evaluated in participants following study dosing and, in the AZD1222 group, after a non-study third-dose booster. Timing of SARS-CoV-2 seroconversion (assessed via anti-nucleocapsid antibody levels) and incidence of COVID-19 were evaluated in those who received AZD1222 primary-series by baseline anti-HCoV titers. Results: We evaluated 2,020/21,634 participants in the AZD1222 group and 1,007/10,816 in the placebo group. At the one-year data cutoff (March 11, 2022) mean duration of follow up was 230.9 (SD: 106.36, range: 1-325) and 94.3 (74.12, 1-321) days for participants in the AZD1222 (n = 1,940) and placebo (n = 962) groups, respectively. We observed little elevation in anti-HCoV humoral titers post study-dosing or post-boosting, nor evidence of waning over time. The occurrence and timing of SARS-CoV-2 seroconversion and incidence of COVID-19 were not largely impacted by baseline anti-HCoV titers. Conclusion: We found limited evidence for cross-immunity between SARS-CoV-2 and HCoVs following AZD1222 primary series and booster vaccination. Susceptibility to future emergence of novel coronaviruses will likely persist despite a high prevalence of SARS-CoV-2 immunity in global populations.

A HIV-1 Gp41 Peptide-Liposome Vaccine Elicits Neutralizing Epitope-Targeted Antibody Responses in Healthy Individuals.

Background: HIV-1 vaccine development is a global health priority. Broadly neutralizing antibodies (bnAbs) which target the HIV-1 gp41 membrane-proximal external region (MPER) have some of the highest neutralization breadth. An MPER peptide-liposome vaccine has been found to expand bnAb precursors in monkeys. Methods: The HVTN133 phase 1 clinical trial (NCT03934541) studied the MPER-peptide liposome immunogen in 24 HIV-1 seronegative individuals. Participants were recruited between 15 July 2019 and 18 October 2019 and were randomized in a dose-escalation design to either 500 mcg or 2000 mcg of the MPER-peptide liposome or placebo. Four intramuscular injections were planned at months 0, 2, 6, and 12. Results: The trial was stopped prematurely due to an anaphylaxis reaction in one participant ultimately attributed to vaccine-associated polyethylene glycol. The immunogen induced robust immune responses, including MPER+ serum and blood CD4+ T-cell responses in 95% and 100% of vaccinees, respectively, and 35% (7/20) of vaccine recipients had blood IgG memory B cells with MPER-bnAb binding phenotype. Affinity purification of plasma MPER+ IgG demonstrated tier 2 HIV-1 neutralizing activity in two of five participants after 3 immunizations. Conclusions: MPER-peptide liposomes induced gp41 serum neutralizing epitope-targeted antibodies and memory B-cell responses in humans despite the early termination of the study. These results suggest that the MPER region is a promising target for a candidate HIV vaccine.

CROI 2023: Advances in Antiviral Therapy in HIV and Viral Hepatitis.

Several innovative methods were presented at the 2023 Conference on Retroviruses and Opportunistic Infections (CROI) targeting different aspects of the HIV care continuum to improve testing, linkage to care, and viral suppression. Some of these approaches were directed at more vulnerable groups, such as pregnant women, adolescents, and individuals who inject drugs. In contrast was the devastating impact of the COVID-19 pandemic, with negative outcomes on HIV viral load suppression and retention in care. Data were presented on hepatitis B virus (HBV) suppression showing that tenofovir alafenamide (TAF)/emtricitabine (FTC)/bictegravir (BIC) may be superior to tenofovir disoproxil fumarate/FTC plus dolutegravir in suppressing HBV in HIV/HBV-coinfected individuals. A pilot study examining a 4-week trial of direct-acting antiviral therapy to treat hepatitis C in recently infected individuals showed lower rates of sustained virologic response at 12 weeks than longer courses. Additional data were presented on the use of long-acting cabotegravir/rilpivirine, comparing this regimen with oral TAF/FTC/BIC and the use of long-acting cabotegravir/rilpivirine in those with viremia. Data were presented on a novel strategy of lenacapavir with 2 broadly neutralizing antibodies given every 6 months as maintenance antiretroviral therapy (ART). Data were presented on improving HIV care outcomes in adolescents, interventions to prevent mother-to-child transmission, and HIV reservoirs in children and adolescents. Data were also presented on interactions between ART and hormonal contraception, as well as ART-related weight gain and impact on pregnancy. A study examining BIC pharmacokinetics in pregnancy was presented, as well as retrospective data on outcomes of adolescents receiving TAF/FTC/BIC.

HIV risk perception, pre-exposure prophylaxis (PrEP) awareness, and PrEP initiation intention among women who use drugs.

INTRODUCTION: Women who use drugs (WWUD) are prime candidates for pre-exposure prophylaxis (PrEP) due to their elevated risk of acquiring HIV through biological, behavioral, and contextual factors. However, PrEP uptake among WWUD remains low. The relationship between unhealthy drug use and correlates of PrEP uptake in this vulnerable population is not well defined. The purpose of this study is to characterize the relationships between specific types and routes of drug use and several precursors of PrEP uptake among WWUD. METHODS: The study collected data via a computer-based survey from 233 women living in New York City and Philadelphia who participated in a study designed to develop and pilot a women-focused intervention for PrEP uptake. The sample of cisgender, HIV-negative women were not currently taking PrEP but considered PrEP eligible. This analysis is focused on women's HIV risk perception, PrEP awareness, PrEP initiation intention, and any use of the following drugs: barbiturates, benzodiazepines, crack cocaine, powder cocaine, hallucinogens, heroin, methamphetamines, and prescription opioids. RESULTS: Within the three months prior to study enrollment, 63.1 % of participants reported any drug use; 42 % reported polydrug use; 19.8 % had injected drugs; 75 % reported getting high or drunk before sex; and 44 % had been enrolled in drug treatment. Of our total sample, 41.2 % perceived themselves at risk for HIV infection, 41.6 % were aware of PrEP prior to the study, and 62.7 % intended to initiate PrEP after they were informed. When compared to other PrEP-eligible women, women who reported prescription opioid use and polydrug use perceived themselves at higher risk for HIV infection and had higher intention to start PrEP. However, they and women who reported injecting drugs also reported lower awareness of PrEP. CONCLUSION: These findings have implications for increasing education about PrEP and the various modes of HIV exposure to support PrEP uptake in this vulnerable population.

Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1-uninfected adult participants in the US.

BACKGROUND: An approach to a preventive HIV vaccine is induction of effective broadly neutralizing antibodies (bnAbs) and effector binding antibodies (bAbs). Preclinical studies suggest that trimeric envelope (Env) proteins may elicit nAbs, which led to the development of the recombinant gp145 subtype C Env protein (gp145 C.6980) immunogen. HVTN 122 was a Phase 1 trial that evaluated the safety, tolerability, and immunogenicity of gp145 C.6980 in adults. METHODS: Healthy, HIV-1 seronegative adults received three intramuscular injections of gp145 C.6980 with aluminum hydroxide (alum) at months 0, 2, and 6 at either 300 mcg (high dose, n = 25) or 100 mcg (low dose, n = 15), or placebo/saline (placebo, n = 5). Participants were followed for 12 months. RESULTS: Forty-five participants were enrolled. High and low doses of the study protein were well-tolerated, with mild or moderate reactogenicity commonly reported. Only one adverse event (mild injection site pruritis) in one participant (low dose) was considered product-related; there were no dose-limiting toxicities. High and low dose recipients demonstrated robust bAb responses to vaccine-matched consensus gp140 Env and subtype-matched gp120 Env proteins two weeks post-last vaccination (response rates >90 %), while no responses were detected to a heterologous subtype-matched V1V2 antigen. No significant differences were seen between high and low dose groups. Participants in both experimental arms demonstrated nAb response rates of 76.5 % to a tier 1 virus (MW9635.26), but no responses to tier 2 isolates. Env-specific CD4 + T-cell responses were elicited in 36.4 % of vaccine recipients, without significant differences between groups; no participants demonstrated CD8 + T-cell responses. CONCLUSIONS: Three doses of novel subtype C gp145 Env protein with alum were safe and well-tolerated. Participants demonstrated bAb, Env-specific CD4 + T-cell, and tier 1 nAb responses, but the regimen failed to induce tier 2 or heterologous nAb responses. CLINICAL TRIALS REGISTRATION: NCT03382418.