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.

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.

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.

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.

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.

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.

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.

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.

CROI 2022: advances in antiviral therapy for HIV, COVID-19, and viral hepatitis.

The 2022 Conference on Retroviruses and Opportunistic Infections provided a rich source of new data and comprehensive reviews on antiviral therapy. For COVID-19, intramuscular sotrovimab was noninferior to intravenous sotrovimab, serostatus did not predict the efficacy of sotrovimab, and molnupiravir appeared safe and modestly effective in decreasing hospitalization rates. Trials from low- and middle-income countries provided data to support transitioning those on first-line therapy with or without virologic suppression and those virologically suppressed on second-line therapy to dolutegravir-based regimens. Additional data supported the use of lenacapavir as a long-acting antiretroviral drug. Data across the United States demonstrate the negative impact of the COVID-19 pandemic on the HIV care continuum, although enhanced outreach efforts and decentralization of antiretroviral therapy delivery were associated with improvements in care engagement outcomes. Researchers described potential mechanisms for the emergence of integrase strand transfer inhibitor resistance. Studies on proviral genotyping high-lighted the limitations of its use in predicting clinically significant resistance. Several studies looked at the epidemiology and treatment of hepatitis C and B and the status of current hepatitis C virus elimination efforts. Data presented on HIV, COVID-19, and maternal and pediatric health included 2-year virologic outcome data of very early antiretroviral therapy in potentially reducing the latent HIV reservoir in infants with HIV. Data presented on COVID-19 and HIV therapeutics in children included SARS-CoV-2-neutralizing monoclonal antibodies in children younger than 12 years of age, remdesivir in hospitalized infants and children, and long-acting therapies for HIV treatment in children.

Durability of protection and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine over 6 months.

BackgroundWe report updated safety, efficacy, and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) from an ongoing phase 3 trial.MethodsAdults at increased risk of SARS-CoV-2 infection were randomized (2:1), stratified by age, to receive 2 doses of AZD1222 or placebo. The primary efficacy end point was confirmed SARS-CoV-2 reverse-transcriptase PCR-positive (RT-PCR-positive) symptomatic COVID-19 at 15 or more days after a second dose in baseline SARS-CoV-2-seronegative participants. The 21,634 and 10,816 participants were randomized to AZD1222 and placebo, respectively.FindingsData cutoff for this analysis was July 30, 2021; median follow-up from second dose was 78 and 71 days for the double-blind period (censoring at unblinding or nonstudy COVID-19 vaccination) and 201 and 82 days for the period to nonstudy COVID-19 vaccination (regardless of unblinding) in the AZD1222 and placebo groups, respectively. For the primary efficacy end point in the double-blind period (141 and 184 events; incidence rates: 39.2 and 118.8 per 1,000 person years), vaccine efficacy was 67.0% (P < 0.001). In the period to nonstudy COVID-19 vaccination, incidence of events remained consistently low and stable through 6 months in the AZD1222 group; for the primary efficacy end point (328 and 219 events; incidence rates: 36.4, 108.4) and severe/critical disease (5 and 13 events; incidence rates: 0.6, 6.4), respective vaccine efficacy estimates were 65.1% and 92.1%. AZD1222 elicited humoral immune responses over time, with waning at day 180. No emergent safety issues were seen.ConclusionAZD1222 is safe and well tolerated, demonstrating durable protection and immunogenicity with median follow-up (AZD1222 group) of 6 months.Trial registrationClinicalTrials.gov NCT04516746.FundingAstraZeneca; US government.

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.

HIV-1 Nucleic Acids Identify Rectal HIV Exposures in Self-Collected Rectal Swabs, Whereas Y-Chromosome Single Tandem Repeat Mixtures Are Not Reliable Biomarkers of Condomless Receptive Anal Intercourse.

BACKGROUND: To focus interventions, biomarkers of HIV-1 exposure could help in identifying subpopulations at highest risk of acquisition. We assessed whether Y-chromosome single tandem repeat (YSTR) mixtures obtained from rectal swabs could serve as a biomarker of condomless receptive anal intercourse (CRAI) among men who have sex with men and transgender women and evaluated the feasibility of detecting HIV-1 virions to assess exposures. METHODS: Twenty-nine sexually active HIV-seronegative men who have sex with men and one transgender woman from New York City answered on-site and mobile app sexual behavior questionnaires. They were randomized to collecting self-administered rectal swabs every morning or after receptive anal intercourse (RAI). YSTR profiles were assessed from blood sample and swabs; HIV-1 exposure was measured by conducting quantitative polymerase chain reaction in swabs. RESULTS: After 2 months, the daily mobile survey had 135%-201% more instances of anal sex acts and 170%-193% more RAI than on-site surveys. Daily mobile reporting had 11%-35% less CRAI events than those reported on-site (Pdaily = 0.001; Pper-sex = 0.047). The daily swabbing arm reported less RAI (P < 0.001) and CRAI (P < 0.038) and had 2.95 lower odds of detecting YSTR mixtures (P = 0.021) than the per-sex-event arm. Surprisingly, YSTR detection was not significantly modified by report of bowel movements and lubricant, enema, or condom use. No participant became HIV-1 infected, yet HIV-1 total nucleic acids were detected in 6 independent episodes of CRAI in 2 participants taking pre-exposure prophylaxis. CONCLUSIONS: YSTR mixtures demonstrated 80% specificity but only 30% sensitivity as a biomarker of CRAI in self-collected rectal swabs. However, detection of HIV-1 exposures in self-collected swabs may help in identifying those needing further HIV risk reduction strategies.

CROI 2021: Advances in Antiretroviral Therapy for HIV and Antiviral Therapy for COVID-19.

The 2021 Conference on Retroviruses and Opportunistic Infections included advances in therapy for HIV as well as for SARS-CoV-2. Data presented on COVID-19 therapies included trials showcasing the use of monoclonal antibodies for prevention and treatment of COVID-19. Promising new data were presented on lenacapavir, an investigational HIV capsid inhibitor given as a subcutaneous injection every 6 months. Although encouraging data from settings across the globe reported achievement of 90-90-90 HIV care cascade targets, disparities exist in care engagement and viral suppression, particularly for people of color and young people with HIV. Several interventions were associated with improved care cascade outcomes. The COVID-19 pandemic has impacted HIV care engagement, but mitigation strategies can allow programs to continue to serve people with HIV during the pandemic. Studies examining the resistance patterns of existing antiretroviral therapy (ART) agents were presented, as were resistance mechanisms of novel agents such as lenacapavir and resistance patterns among individuals who seroconverted while on preexposure prophylaxis. Data from large observational cohorts were presented on patterns of ART uptake and trends in mortality and in virologic failure. Pertinent findings relating to pediatric and maternal health issues included data on dolutegravir-based ART in children and adolescents with HIV; safety and tolerability of dolutegravir-based ART in children and pregnant women; similarly high maternal viral suppression at 50 weeks postpartum in women receiving certain ART regimens; weight gain in pregnant women receiving dolutegravir plus tenofovir alafenamide/emtricitabine; and viral suppression with dolutegravir-based ART when started during the third trimester of pregnancy.

Rectal tissue and vaginal tissue from intravenous VRC01 recipients show protection against ex vivo HIV-1 challenge.

BackgroundVRC01, a potent, broadly neutralizing monoclonal antibody, inhibits simian-HIV infection in animal models. The HVTN 104 study assessed the safety and pharmacokinetics of VRC01 in humans. We extend the clinical evaluation to determine intravenously infused VRC01 distribution and protective function at mucosal sites of HIV-1 entry.MethodsHealthy, HIV-1-uninfected men (n = 7) and women (n = 5) receiving VRC01 every 2 months provided mucosal and serum samples once, 4-13 days after infusion. Eleven male and 8 female HIV-seronegative volunteers provided untreated control samples. VRC01 levels were measured in serum, secretions, and tissue, and HIV-1 inhibition was determined in tissue explants.ResultsMedian VRC01 levels were quantifiable in serum (96.2 µg/mL or 1.3 pg/ng protein), rectal tissue (0.11 pg/ng protein), rectal secretions (0.13 pg/ng protein), vaginal tissue (0.1 pg/ng protein), and cervical secretions (0.44 pg/ng protein) from all recipients. VRC01/IgG ratios in male serum correlated with those in paired rectal tissue (r = 0.893, P = 0.012) and rectal secretions (r = 0.9643, P = 0.003). Ex vivo HIV-1Bal26 challenge infected 4 of 21 rectal explants from VRC01 recipients versus 20 of 22 from controls (P = 0.005); HIV-1Du422.1 infected 20 of 21 rectal explants from VRC01 recipients and 12 of 12 from controls (P = 0.639). HIV-1Bal26 infected 0 of 14 vaginal explants of VRC01 recipients compared with 23 of 28 control explants (P = 0.003).ConclusionIntravenous VRC01 distributes into the female genital and male rectal mucosa and retains anti-HIV-1 functionality, inhibiting a highly neutralization-sensitive but not a highly resistant HIV-1 strain in mucosal tissue. These findings lend insight into VRC01 mucosal infiltration and provide perspective on in vivo protective efficacy.FundingNational Institute of Allergy and Infectious Diseases and Bill & Melinda Gates Foundation.

Just4Us: Development of a Counselor-Navigator and Text Message Intervention to Promote PrEP Uptake Among Cisgender Women at Elevated Risk for HIV.

ABSTRACT: In the United States, pre-exposure prophylaxis (PrEP) uptake among eligible cisgender women has been slow, despite the availability of oral PrEP since 2012. Although women make up nearly 20% of those living with HIV, there are currently few PrEP uptake interventions for cisgender women at elevated risk for acquiring HIV. Here we describe the process used to design and pre-pilot test Just4Us, a theory-based behavioral intervention to promote PrEP initiation and adherence among PrEP-eligible cisgender women. This work was part of a multiphase study conducted in New York City and Philadelphia, two locations with HIV rates higher than the national average. The counselor-navigator component of the intervention was designed to be delivered in a 60- to 90-min in-person session in the community, followed by several phone calls to support linkage to care. An automated text messaging program was also designed for adherence support. Just4Us addressed personal and structural barriers to PrEP uptake using an empowerment framework by building on women's insights and resources to overcome barriers along the PrEP cascade. Usability pre-pilot testing results were favorable and provided valuable feedback used to refine the intervention.

PrEP Stigma, HIV Stigma, and Intention to Use PrEP among Women in New York City and Philadelphia.

BACKGROUND: Stigma is an important contributor to the continued HIV epidemic in the United States (US). In 2016, women made up nearly one in five of all new infections. Pre-exposure HIV Prophylaxis or PrEP is a medication that can be taken to prevent HIV acquisition; however, PrEP is significantly underutilized by women at risk for infection. How PrEP stigma relates to PrEP initiation among women is not well understood. METHODS: Surveys were completed by 160 PrEP-eligible women aged 18-55 in Philadelphia, PA and New York City, NY. Associations between PrEP stigma, HIV stigma, and PrEP initiation intention were modeled using multinomial logistic regression, controlling for sociodemographic and theoretically-relevant variables. RESULTS: Participants ranged in age from 18 to 55 years (M = 40.2; SD = 11.78). Most (79%) identified as Black or African-American and/or Latina and 36% had completed high-school or less. Higher PrEP stigma was significantly associated with lower PrEP initiation intention, while controlling for other theoretically-relevant and sociodemographic variables. HIV stigma was not related to PrEP initiation intention. CONCLUSIONS: HIV prevention interventions seeking to increase PrEP initiation among PrEP-eligible, urban women need to address the role that PrEP stigma plays in PrEP uptake.

Assessing Knowledge of HIV Vaccines and Biomedical Prevention Methods Among Transgender Women in the New York City Tri-State Area.

Purpose: To lower the HIV risk of transgender women, it is imperative to understand their unique HIV prevention needs and design biomedical prevention interventions that are responsive to the psychosocial, behavioral, and clinical needs of these communities. Preventive HIV vaccines are an important modality under investigation in diverse study participants. We sought to assess the knowledge of HIV vaccine research and the most common barriers and facilitators to participation in HIV vaccine studies among HIV-negative transgender women living in New York City. Methods: Six focus groups were conducted among 29 participants recruited in the New York City tri-state area from December 2014 to July 2015. Prefocus group quantitative questionnaire assessed demographic, behavioral information, knowledge of preventive vaccine research, and reasons for potential participation in prevention studies. Results: Median age of participants was 29 years and 41.4% identified as white. Over half of participants have heard of preventive vaccine research and majority indicated that an important factor in participating in HIV prevention research is to help the community collective effort. Key barriers that emerged were fear of side effects, feelings of exclusion from biomedical research. Facilitators to participation in prevention studies included trusting relationships with providers. Conclusions: These barriers and facilitators are important to consider in the design of studies inclusive of trans communities and transgender-specific prevention strategies. Barriers may be overcome by disseminating accurate information via social media or health providers.

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.