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1.
J Acquir Immune Defic Syndr ; 88(2): 138-148, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34506358

RESUMO

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.

2.
Top Antivir Med ; 29(3): 361-378, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34370418

RESUMO

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.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Pesquisa Biomédica , COVID-19/tratamento farmacológico , Congressos como Assunto , Infecções por HIV/tratamento farmacológico , Compostos Heterocíclicos com 3 Anéis/uso terapêutico , Oxazinas/uso terapêutico , Piperazinas/uso terapêutico , Piridonas/uso terapêutico , Adolescente , Adulto , Feminino , Humanos , Masculino , Gravidez , SARS-CoV-2
3.
J Clin Invest ; 131(16)2021 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-34166231

RESUMO

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.

4.
AIDS Care ; : 1-11, 2021 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-33719816

RESUMO

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.

5.
J Assoc Nurses AIDS Care ; 32(2): 188-204, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33427767

RESUMO

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.


Assuntos
Fármacos Anti-HIV/administração & dosagem , Conselheiros , Infecções por HIV/prevenção & controle , Conhecimentos, Atitudes e Prática em Saúde , Navegação de Pacientes , Envio de Mensagens de Texto , Adulto , Feminino , Infecções por HIV/tratamento farmacológico , Humanos , Entrevistas como Assunto , Cidade de Nova Iorque , Philadelphia , Profilaxia Pré-Exposição/métodos , Desenvolvimento de Programas , Avaliação de Programas e Projetos de Saúde , Inquéritos e Questionários
6.
Stigma Health ; 5(2): 240-246, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-33184608

RESUMO

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.

7.
Transgend Health ; 5(2): 116-121, 2020 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-32656354

RESUMO

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.

8.
Arch Sex Behav ; 49(6): 2213-2221, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32270399

RESUMO

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.


Assuntos
Infecções por HIV/prevenção & controle , Profilaxia Pré-Exposição/métodos , Adulto , Feminino , Humanos , Intenção , Estados Unidos
9.
J Urban Health ; 97(5): 592-608, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-29845586

RESUMO

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.


Assuntos
Antirretrovirais/uso terapêutico , Serviços de Saúde Comunitária/organização & administração , Serviços de Saúde Comunitária/estatística & dados numéricos , Continuidade da Assistência ao Paciente/organização & administração , Continuidade da Assistência ao Paciente/estatística & dados numéricos , Infecções por HIV/tratamento farmacológico , Características de Residência/estatística & dados numéricos , Adulto , Afro-Americanos/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Bissexualidade/estatística & dados numéricos , Grupos Étnicos , Grupo com Ancestrais do Continente Europeu/estatística & dados numéricos , Feminino , Infecções por HIV/epidemiologia , Homossexualidade Masculina/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Minorias Sexuais e de Gênero/estatística & dados numéricos , Meio Social , Rede Social , Estados Unidos/epidemiologia
10.
Arch Sex Behav ; 49(6): 2029-2043, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-31858309

RESUMO

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.


Assuntos
Aculturação , Infecções por HIV/etnologia , Homossexualidade Masculina/etnologia , Assunção de Riscos , Adulto , Bissexualidade/etnologia , Humanos , Masculino
11.
J Clin Invest ; 129(11): 4769-4785, 2019 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-31566579

RESUMO

BACKGROUNDRV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODSOne hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTSAll regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final vaccination at high magnitude. While IgG3 responses were highest in T3, a lower IgA/IgG ratio was observed in T4. Binding antibodies persisted at 12 months in 35%-100% of participants. Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively. CD4+ T cell responses were detectable in all treatment groups (32%-64%) without appreciable CD8+ T cell responses.CONCLUSIONThe DNA/protein combination regimens induced high-magnitude and long-lasting HIV V1V2-binding antibody responses, and early coadministration of the 2 vaccines led to a more rapid induction of these potentially protective responses.TRIAL REGISTRATIONClinicalTrials.gov NCT02207920.FUNDINGNational Institute of Allergy and Infectious Diseases (NIAID) grants UM1 AI068614, UM1 AI068635, UM1 AI068618, UM1 AI069511, UM1 AI069470, UM1 AI069534, P30 AI450008, UM1 AI069439, UM1 AI069481, and UM1 AI069496; the National Center for Advancing Translational Sciences, NIH (grant UL1TR001873); and the Bill & Melinda Gates Foundation (grant OPP52845).


Assuntos
Vacinas contra a AIDS/administração & dosagem , Anticorpos Anti-HIV/imunologia , Proteína gp120 do Envelope de HIV/administração & dosagem , Imunização Secundária , Imunoglobulina A/imunologia , Imunoglobulina G/imunologia , Vacinas de DNA/administração & dosagem , Vacinas contra a AIDS/imunologia , Adolescente , Adulto , Anticorpos Neutralizantes/imunologia , Citotoxicidade Celular Dependente de Anticorpos/efeitos dos fármacos , Linfócitos T CD4-Positivos/imunologia , Linfócitos T CD4-Positivos/patologia , Linfócitos T CD8-Positivos/imunologia , Linfócitos T CD8-Positivos/patologia , Feminino , Proteína gp120 do Envelope de HIV/imunologia , Humanos , Masculino , Pessoa de Meia-Idade , Vacinas de DNA/imunologia
12.
Top Antivir Med ; 27(1): 50-68, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31137003

RESUMO

The 2019 Conference on Retroviruses and Opportunistic Infections included many exciting advances in antiretroviral therapy (ART). Investigators presented a case report of a second patient possibly cured of HIV through an allogeneic hematopoietic stem cell transplant from a CC chemokine receptor 5-delta 32 donor. Two clinical trials of long-acting injectable cabotegravir and rilpivirine showed promising safety, efficacy, and tolerability as maintenance ART. Test-and-treat and rapid-ART-start strategies show promise in advancing progress toward the HIV care cascade 90-90-90 Joint United Nations Programme on HIV/AIDS/World Health Organization targets. However, late diagnosis and mortality after ART initiation remain high, even in the context of HIV service scale-up, and mortality from unintentional opioid overdose in people living with HIV in the United States is on the rise. In vitro studies were presented that identified and evaluated the effect of resistance-associated mutations on ART susceptibility and elucidated mechanisms of resistance. Epidemiologic data were reported on the prevalence, impact, regional variation, and changes over time of resistance-associated mutations. Decreasing regional and national rates of resistance may be a benefit of increasing use of integrase strand transfer inhibitors (InSTIs). New findings were presented on maternal and fetal health outcomes in women of reproductive potential, drug-drug interactions between hormonal contraception and ART, and further exploration of the association between InSTIs and birth defects.


Assuntos
Antirretrovirais/uso terapêutico , Terapia Antirretroviral de Alta Atividade/métodos , Infecções por HIV/terapia , Transplante de Células-Tronco Hematopoéticas/métodos , Antirretrovirais/farmacocinética , Continuidade da Assistência ao Paciente , Anticoncepcionais Orais Hormonais/farmacocinética , Anticoncepcionais Orais Hormonais/farmacologia , Gerenciamento Clínico , Interações Medicamentosas , Farmacorresistência Viral , HIV/efeitos dos fármacos , HIV/genética , Infecções por HIV/diagnóstico , Humanos , Mutação , Resultado do Tratamento , Estados Unidos
13.
AIDS Behav ; 23(6): 1387-1395, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30377980

RESUMO

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.


Assuntos
Afro-Americanos , Infecções por HIV/prevenção & controle , Homossexualidade Masculina , Comportamento Sexual/estatística & dados numéricos , Sexo sem Proteção/estatística & dados numéricos , Adulto , Afro-Americanos/estatística & dados numéricos , Cidades , Infecções por HIV/transmissão , Humanos , Masculino , Apoio Social , Estados Unidos/epidemiologia
14.
JMIR Public Health Surveill ; 4(4): e10847, 2018 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-30389648

RESUMO

BACKGROUND: Suboptimal antiretroviral therapy (ART) adherence and disengagement in care present significant public health challenges because of the increased probability of HIV transmission. In the United States, men who have sex with men (MSM) continue to be disproportionately affected by HIV, highlighting a critical need to engage high-risk MSM living with HIV who are not engaged or retained in care. OBJECTIVE: The aim of the study was to assess the feasibility of at-home blood self-collection and laboratory quantification of HIV-1 RNA viral load (VL) to report laboratory-based VL outcomes and compare self-reported and laboratory-reported VL. METHODS: Between 2016 and 2017, 766 US HIV-positive MSM enrolled in a Web-based behavioral intervention were invited to participate in an at-home dried blood spot (DBS) collection study using HemaSpot-HF kits (Spot On Sciences, Inc, Austin, TX) for laboratory-quantified VL. RESULTS: Of those invited to participate, 72.3% (554/766) enrolled in the DBS study. Most (79.2%, 439/554) men enrolled reported attempting to collect their blood, 75.5% (418/554) of participants mailed a DBS specimen to the research laboratory, and 60.8% (337/554) had an adequate blood sample for VL testing. Of the 337 specimens tested for VL by the laboratory, 52.5% (177/337) had detectable VL (median: 3508 copies/mL; range: 851-1,202,265 copies/mL). Most men (83.9%, 135/161) who returned a DBS specimen with laboratory-quantified detectable VL self-reported an undetectable VL during their last clinical visit. CONCLUSIONS: Home collection of DBS samples from HIV-positive MSM is feasible and has the potential to support clinical VL monitoring. Discrepant laboratory HIV-1 RNA values and self-reported VL indicate a need to address perceived VL status, especially in the era of treatment as prevention. Most participants were willing to use an at-home DBS kit in the future, signaling an opportunity to engage high-risk MSM in long-term HIV care activities.

15.
PLoS One ; 13(9): e0202753, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30235286

RESUMO

BACKGROUND: The addition of plasmid cytokine adjuvants, electroporation, and live attenuated viral vectors may further optimize immune responses to DNA vaccines in heterologous prime-boost combinations. The objective of this study was to test the safety and tolerability of a novel prime-boost vaccine regimen incorporating these strategies with different doses of IL-12 plasmid DNA adjuvant. METHODS: In a phase 1 study, 88 participants received an HIV-1 multiantigen (gag/pol, env, nef/tat/vif) DNA vaccine (HIV-MAG, 3000 µg) co-administered with IL-12 plasmid DNA adjuvant at 0, 250, 1000, or 1500 µg (N = 22/group) given intramuscularly with electroporation (Ichor TriGrid™ Delivery System device) at 0, 1 and 3 months; followed by attenuated recombinant vesicular stomatitis virus, serotype Indiana, expressing HIV-1 Gag (VSV-Gag), 3.4 ⊆ 107 plaque-forming units (PFU), at 6 months; 12 others received placebo. Injections were in both deltoids at each timepoint. Participants were monitored for safety and tolerability for 15 months. RESULTS: The dose of IL-12 pDNA did not increase pain scores, reactogenicity, or adverse events with the co-administered DNA vaccine, or following the VSV-Gag boost. Injection site pain and reactogenicity were common with intramuscular injections with electroporation, but acceptable to most participants. VSV-Gag vaccine often caused systemic reactogenicity symptoms, including a viral syndrome (in 41%) of fever, chills, malaise/fatigue, myalgia, and headache; and decreased lymphocyte counts 1 day after vaccination. CONCLUSIONS: HIV-MAG DNA vaccine given by intramuscular injection with electroporation was safe at all doses of IL-12 pDNA. The VSV-Gag vaccine at this dose was associated with fever and viral symptoms in some participants, but the vaccine regimens were safe and generally well-tolerated. TRIAL REGISTRATION: Clinical Trials.gov NCT01578889.


Assuntos
Vacinas contra a AIDS/administração & dosagem , Vetores Genéticos/administração & dosagem , Interleucina-12/genética , Vacinas Atenuadas/administração & dosagem , Vacinas de DNA/administração & dosagem , Vírus da Estomatite Vesicular Indiana/genética , Vacinas contra a AIDS/efeitos adversos , Adulto , Terapia Combinada , Método Duplo-Cego , Eletroporação , Feminino , Vetores Genéticos/efeitos adversos , HIV-1 , Voluntários Saudáveis , Humanos , Imunização Secundária , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Plasmídeos/genética , Vacinas Atenuadas/efeitos adversos , Vacinas de DNA/efeitos adversos , Adulto Jovem , Produtos do Gene gag do Vírus da Imunodeficiência Humana
16.
PLoS One ; 13(7): e0200269, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30020960

RESUMO

Emerging sexually transmitted hepatitis C virus (HCV) epidemics among men who have sex with men (MSM) have been reported worldwide, with higher HCV infection rates among those who are HIV-infected. This study aims to determine prevalence of recent and chronic HCV infections among community-recruited MSM in New York City (NYC), map HCV infections by home, social, and sexual neighborhoods, and identify clusters of genetically linked HCV variants using phylogenetic analysis. The NYC M2M study recruited MSM via modified time-space, venue-based sampling and internet/mobile app-based recruitment during 2010-13. Participants completed a Google Earth map on neighborhoods of where they lived, socialized, and had sex in the last 3 months, an ACASI questionnaire, and a sexual network inventory about their sex partners. The men received HIV testing and provided serum samples. Testing on stored serum samples included HCV antibody and RNA viral load, HCV antibody avidity assay (avidity index <30% with positive viral load is considered recently infected), and HCV RNA extraction and amplification to generate a 432 base-pair region of Core/E1 for sequencing and phylogenetic analysis. Historic local controls were included in the phylogenetic analysis. Of 1,028 MSM, 79.7% were HIV-negative and 20.3% HIV-positive. Twenty nine MSM (2.8%) were HCV antibody-positive. MSM who were HCV antibody-positive reported a median of 2 male sex partners in last 3 months, with 6.9% aged 18-24, 17.2% 25-29, 13.8% 30-39, and 62.1% 40 and over. 8.1% of HIV-positive MSM were HCV antibody-positive vs. 1.5% of HIV-negative men (p<0.0001). Of 29 HCV-antibody positive MSM, 12 (41%) were HCV RNA-positive (11 subtype 1a and 1 subtype 1b). Two of 12 HCV RNA-positive participants had low antibody avidity values, suggesting recent HCV infection. HCV antibody seropositivity was significantly associated with older age >40 years, adjusted odds ratio (aOR) 3.56 (95% CI 1.57, 8.08), HIV-positive serostatus, aOR 3.18 (95% CI 1.40, 7.22), any sexually transmitted infection (STI) in the last 3 months, aOR 2.81 (95% CI 1.11, 7.13), and injection drug use (IDU) ever, aOR 4.34 (95% CI 1.69, 11.17). Mapping of HCV infections differed slightly by home, social, and sexual neighborhoods. Based on phylogenetic analysis from 12 HCV RNA-positive samples, no evidence of a clustered HCV epidemic was found. Overall HCV seroprevalence was 2.8% among community-recruited MSM in NYC, with higher prevalence among HIV-positive MSM compared to HIV-negative MSM. Only two participants were found to have recent HCV infection, with no evidence of a clustered HCV epidemic based on phylogenetic analysis. Our results support testing of HCV infection among HIV-negative MSM if they report having a recent STI and IDU in the past rather than universal HCV testing in all HIV-negative MSM.


Assuntos
Hepatite C/epidemiologia , Homossexualidade Masculina/estatística & dados numéricos , Adolescente , Adulto , Coinfecção/epidemiologia , Marcadores Genéticos/genética , Infecções por HIV/epidemiologia , Hepacivirus/genética , Hepatite C/virologia , Hepatite C Crônica/epidemiologia , Hepatite C Crônica/virologia , Humanos , Masculino , Cidade de Nova Iorque/epidemiologia , Filogenia , Prevalência , Características de Residência/estatística & dados numéricos , Fatores de Risco , Parceiros Sexuais , Inquéritos e Questionários , Adulto Jovem
17.
AIDS Behav ; 22(8): 2718-2732, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29858737

RESUMO

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.


Assuntos
Infecções por HIV/prevenção & controle , Conhecimentos, Atitudes e Prática em Saúde , Profilaxia Pós-Exposição , Estigma Social , Adolescente , Adulto , Feminino , Heterossexualidade , Homossexualidade Masculina , Humanos , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Comportamento Sexual , Parceiros Sexuais , Minorias Sexuais e de Gênero , Fatores Socioeconômicos , Adulto Jovem
18.
Top Antivir Med ; 26(1): 40-53, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29727296

RESUMO

The 2018 Conference on Retroviruses and Opportunistic Infections (CROI) showcased exciting data on new investigational agents including MK-8591 and tri-specific antibody targeting 3 highly conserved epitopes on HIV-1 in a single antibody. Clinical trials of initial antiretroviral therapy (ART) and switch studies involving bictegravir/emtricitabine/tenofovir alafenamide were presented. Intensification of initial ART with integrase strand transfer inhibitors did not increase the risk of immune reconstitution inflammatory syndrome. Pharmacokinetic issues were discussed, including the substantial drug-drug interactions between efavirenz-based ART and hormonal contraception delivered via a vaginal ring. Studies on pre-ART drug resistance and emergence of drug resistance after initial and second-line ART in different settings and populations were highlighted. Novel technologies to identify drug resistance included a free, cloud-based web service for HIV genotyping analysis and a promising technology for point-of-care drug resistance mutations testing. New strategies to improve the HIV care continuum included home-based testing with initiation of same-day ART and stratified care with specialized clinics to serve those disengaged in care, but the data on financial incentives were not encouraging. Several studies provided insights into the impact of early ART on decreasing the size of the HIV reservoir in HIV-infected infants. Pertinent conference findings relating to women's health issues included similar clinical outcomes between breastfeeding and formula feeding HIV-infected women, the problem of viral rebound and ART nonadherence in pregnancy and postpartum.


Assuntos
Adenina/análogos & derivados , Antirretrovirais/uso terapêutico , Congressos como Assunto/tendências , Emtricitabina/uso terapêutico , Infecções por HIV/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Tenofovir/uso terapêutico , Adenina/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Desoxiadenosinas/uso terapêutico , Quimioterapia Combinada , HIV-1/genética , Humanos , Carga Viral
19.
J Acquir Immune Defic Syndr ; 78(2): 163-168, 2018 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-29424789

RESUMO

BACKGROUND AND SETTING: Black men who have sex with men (BMSM) in the United States have disproportionately high HIV infection rates. Social networks have been shown to influence HIV risk behavior; however, little is known about whether they affect the risk of HIV seroconversion. This study uses data from the BROTHERS (HPTN 061) study to test whether contextual factors related to social networks are associated with HIV seroconversion among BMSM. METHODS: We analyzed data from the BROTHERS study (2009-2011), which examined a multicomponent intervention for BMSM in 6 US cities. We ran a series of Cox regression analyses to examine associations between time-dependent measures of network support (personal/emotional, financial, medical, and social participation) and time to HIV seroconversion. We ran unadjusted models followed by models adjusted for participant age at enrollment and study location. RESULTS: A total of 1000 BMSM tested HIV negative at baseline and were followed at 6- and 12-month study visits. Twenty-eight men tested HIV positive. In adjusted hazard ratio models, study participants who remained HIV negative had higher proportions of social network members who provided personal/emotional {0.92 [95% confidence interval (CI): 0.85 to 0.99]}, medical [0.92 (95% CI: 0.85 to 0.99)], or social participation [0.91 (95% CI: 0.86 to 0.97)] support. CONCLUSION: Findings suggest that the increased presence of social network support can be protective against HIV acquisition. Future research should explore the processes that link social network support with sexual and other transmission risk behaviors as a basis to inform HIV prevention efforts.


Assuntos
Afro-Americanos , Bissexualidade , Infecções por HIV/epidemiologia , Homossexualidade Masculina , Soroconversão , Rede Social , Apoio Social , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Fatores de Risco , Estados Unidos/epidemiologia
20.
Clin Vaccine Immunol ; 24(11)2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28931520

RESUMO

The HIV Vaccine Trials Network (HVTN) 087 vaccine trial assessed the effect of increasing doses of pIL-12 (interleukin-12 delivered as plasmid DNA) adjuvant on the immunogenicity of an HIV-1 multiantigen (MAG) DNA vaccine delivered by electroporation and boosted with a vaccine comprising an attenuated vesicular stomatitis virus expressing HIV-1 Gag (VSV-Gag). We randomized 100 healthy adults to receive placebo or 3 mg HIV-MAG DNA vaccine (ProfectusVax HIV-1 gag/pol or ProfectusVax nef/tat/vif, env) coadministered with pIL-12 at 0, 250, 1,000, or 1,500 µg intramuscularly by electroporation at 0, 1, and 3 months followed by intramuscular inoculation with 3.4 × 107 PFU VSV-Gag vaccine at 6 months. Immune responses were assessed after the prime and boost and 6 months after the last vaccination. High-dose pIL-12 increased the magnitude of CD8+ T-cell responses postboost compared to no pIL-12 (P = 0.02), while CD4+ T-cell responses after the prime were higher in the absence of pIL-12 than with low- and medium-dose pIL-12 (P ≤ 0.05). The VSV boost increased Gag-specific CD4+ and CD8+ T-cell responses in all groups (P < 0.001 for CD4+ T cells), inducing a median of four Gag epitopes in responders. Six to 9 months after the boost, responses decreased in magnitude, but CD8+ T-cell response rates were maintained. The addition of a DNA prime dramatically improved responses to the VSV vaccine tested previously in the HVTN 090 trial, leading to broad epitope targeting and maintained CD8+ T-cell response rates at early memory. The addition of high-dose pIL-12 given with a DNA prime by electroporation and boosted with VSV-Gag increased the CD8+ T-cell responses but decreased the CD4+ responses. This approach may be advantageous in reshaping the T-cell responses to a variety of chronic infections or tumors. (This study has been registered at ClinicalTrials.gov under registration no. NCT01578889.).


Assuntos
Vacinas contra a AIDS/imunologia , Linfócitos T CD8-Positivos/imunologia , Imunogenicidade da Vacina , Interleucina-12/imunologia , Vacinas de DNA/imunologia , Vírus da Estomatite Vesicular Indiana/genética , Vacinas contra a AIDS/administração & dosagem , Adjuvantes Imunológicos , Adulto , Mapeamento de Epitopos , Feminino , Vetores Genéticos , Infecções por HIV/imunologia , Infecções por HIV/prevenção & controle , HIV-1/imunologia , Humanos , Imunização Secundária , Interleucina-12/genética , Masculino , Pessoa de Meia-Idade , Plasmídeos , Vacinação , Vacinas de DNA/administração & dosagem , Vírus da Estomatite Vesicular Indiana/imunologia , Adulto Jovem , Produtos do Gene gag do Vírus da Imunodeficiência Humana/genética , Produtos do Gene gag do Vírus da Imunodeficiência Humana/imunologia
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