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1.
J Infect Dis ; 230(1): 78-85, 2024 Jul 25.
Artigo em Inglês | MEDLINE | ID: mdl-39052738

RESUMO

As use of human immunodeficiency virus (HIV) integrase strand transfer inhibitors (INSTI) increases and formulations are being developed for maintenance therapies and chemoprophylaxis, assessing virus suppression under INSTI-based regimens in prevention-relevant biologic compartments, such as the male genital tract, is timely. We used cell-source marker virion immunocapture to examine amplification of particle RNA then assessed the phylogenetic relatedness of seminal and blood viral sequences from men with HIV who were prescribed INSTI-based regimens. Seminal plasma immunocaptures yielded amplifiable virion RNA from 13 of 24 (54%) men, and the sequences were primarily associated with markers indicative of macrophage and resident dendritic cell sources. Genetic distances were greatest (>2%) between seminal virions and circulating proviruses, pointing to ongoing low-level expression from tissue-resident cells. While the low levels in semen predict an improbable likelihood of transmission, viruses with large genetic distances are expressed under potent INSTI therapy and have implications for determining epidemiologic linkages if adherence is suboptimal.


Assuntos
Infecções por HIV , Inibidores de Integrase de HIV , Sêmen , Sêmen/virologia , Humanos , Masculino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , Inibidores de Integrase de HIV/farmacologia , Inibidores de Integrase de HIV/uso terapêutico , Adulto , Filogenia , RNA Viral/genética , HIV-1/genética , HIV-1/efeitos dos fármacos , Vírion/metabolismo , Pessoa de Meia-Idade
2.
J Infect Dis ; 229(6): 1614-1627, 2024 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-38232978

RESUMO

BACKGROUND: Data on the epidemiology of sexually transmitted infections (STIs) among transgender women (TGW) with and without human immunodeficiency virus (HIV) are limited. METHODS: We analyzed baseline data collected from a cohort of adult TGW across 6 eastern and southern US cities between March 2018 and August 2020 (n = 1018). Participants completed oral HIV screening, provided self-collected rectal and urogenital specimens for chlamydia and gonorrhea testing, and provided sera specimens for syphilis testing. We assessed associations with ≥1 prevalent bacterial STI using modified Poisson regression. RESULTS: Bacterial STI prevalence was high and differed by HIV status: 32% among TGW with HIV and 11% among those without HIV (demographic-adjusted prevalence ratio = 1.91; 95% confidence interval = 1.39-2.62). Among TGW without HIV, bacterial STI prevalence differed by geographic region, race and ethnicity, and gender identity, and was positively associated with reporting >1 sexual partner, hazardous alcohol use, homelessness, having safety concerns regarding transit to health care, and no prior receipt of gender-affirming health services. Among TGW with HIV, older age was inversely associated with bacterial STI. CONCLUSIONS: TGW had a high prevalence of bacterial STIs. The prevalence and correlates of bacterial STI differed by HIV status, highlighting the unique needs and risks of TGW with and without HIV. Tailored interventions may reduce sexual health-related inequities.


Assuntos
Infecções por HIV , Infecções Sexualmente Transmissíveis , Pessoas Transgênero , Humanos , Feminino , Adulto , Pessoas Transgênero/estatística & dados numéricos , Prevalência , Infecções por HIV/epidemiologia , Infecções Sexualmente Transmissíveis/epidemiologia , Adulto Jovem , Estados Unidos/epidemiologia , Adolescente , Pessoa de Meia-Idade , Gonorreia/epidemiologia , Masculino , Parceiros Sexuais , Sudeste dos Estados Unidos/epidemiologia , Infecções por Chlamydia/epidemiologia , Sífilis/epidemiologia , Comportamento Sexual , Fatores de Risco
3.
Clin Infect Dis ; 78(4): 991-994, 2024 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-37963086

RESUMO

We examined changes in the proportion of people with human immunodeficiency virus (PWH) with virologic suppression (VS) in a multisite US cohort before and since the coronavirus disease 2019 (COVID-19) pandemic. Overall, prior gains in VS slowed during COVID-19, with disproportionate impacts on Black PWH and PWH who inject drugs.


Assuntos
COVID-19 , Infecções por HIV , Humanos , HIV , Análise de Séries Temporais Interrompida , Infecções por HIV/complicações , Infecções por HIV/epidemiologia
4.
Clin Infect Dis ; 2024 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-39377755

RESUMO

INTRODUCTION: Since its global reemergence in 2022, monkeypox (mpox) has demonstrated increased incidence and severity among people with human immunodeficiency virus (HIV [PWH]). Predictors of mpox diagnosis, vaccination, and outcomes among PWH are limited. METHODS: We included PWH with primary care visits after 1 January 2022 at 9 US sites participating in the Centers for AIDS Research Network of Integrated Clinic Systems Network. We identified mpox diagnosed between 1 June 2022 and 31 May 2023, through a combination of polymerase chain reaction result, diagnosis code, and/or tecovirimat receipt. We examined validated clinical diagnoses, laboratory results, vaccine data, and patient reported outcomes. We evaluated relative risks (RR) of mpox diagnosis, hospitalization, tecovirimat treatment, and vaccine receipt. FINDINGS: Among 19 777 PWH in care, 413 mpox cases (all male sex at birth) occurred (2.2 cases/100 person-years). Age <40 years, geographic region, Hispanic/Latine ethnicity, lack of antiretroviral therapy, detectable HIV viral load, and recent bacterial sexually transmitted infection predicted mpox diagnosis. PWH with CD4 200-349 cells/mm3 were most likely to be hospitalized (adjusted RR, 3.20; 95% confidence interval: 1.44-7.09) compared to CD4 ≥500, but half as likely as those with CD4 <200 to receive tecovirimat. Overall, smallpox/mpox vaccine effectiveness of ≥1 vaccine was 71% (adjusted RR, 0.29; 95% confidence interval: .14-.47) at preventing mpox, and 86% or better with CD4 ≥350 or HIV viral suppression. Non-Hispanic Black PWH were less likely to be vaccinated than other racial/ethnic identities. INTERPRETATION: PWH not on antiretroviral therapy or with unsuppressed HIV were more likely to be diagnosed with, and hospitalized for, mpox. Mpox/smallpox vaccine effectiveness was high, inclusive of those with low CD4 count and HIV viremia.

5.
Clin Infect Dis ; 2024 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-38484128

RESUMO

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

6.
PLoS Med ; 21(5): e1004409, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38805509

RESUMO

BACKGROUND: India accounts for about one-quarter of people contracting tuberculosis (TB) disease annually and nearly one-third of TB deaths globally. Many Indians do not navigate all care cascade stages to receive TB treatment and achieve recurrence-free survival. Guided by a population/exposure/comparison/outcomes (PECO) framework, we report findings of a systematic review to identify factors contributing to unfavorable outcomes across each care cascade gap for TB disease in India. METHODS AND FINDINGS: We defined care cascade gaps as comprising people with confirmed or presumptive TB who did not: start the TB diagnostic workup (Gap 1), complete the workup (Gap 2), start treatment (Gap 3), achieve treatment success (Gap 4), or achieve TB recurrence-free survival (Gap 5). Three systematic searches of PubMed, Embase, and Web of Science from January 1, 2000 to August 14, 2023 were conducted. We identified articles evaluating factors associated with unfavorable outcomes for each gap (reported as adjusted odds, relative risk, or hazard ratios) and, among people experiencing unfavorable outcomes, reasons for these outcomes (reported as proportions), with specific quality or risk of bias criteria for each gap. Findings were organized into person-, family-, and society-, or health system-related factors, using a social-ecological framework. Factors associated with unfavorable outcomes across multiple cascade stages included: male sex, older age, poverty-related factors, lower symptom severity or duration, undernutrition, alcohol use, smoking, and distrust of (or dissatisfaction with) health services. People previously treated for TB were more likely to seek care and engage in the diagnostic workup (Gaps 1 and 2) but more likely to suffer pretreatment loss to follow-up (Gap 3) and unfavorable treatment outcomes (Gap 4), especially those who were lost to follow-up during their prior treatment. For individual care cascade gaps, multiple studies highlighted lack of TB knowledge and structural barriers (e.g., transportation challenges) as contributing to lack of care-seeking for TB symptoms (Gap 1, 14 studies); lack of access to diagnostics (e.g., X-ray), non-identification of eligible people for testing, and failure of providers to communicate concern for TB as contributing to non-completion of the diagnostic workup (Gap 2, 17 studies); stigma, poor recording of patient contact information by providers, and early death from diagnostic delays as contributing to pretreatment loss to follow-up (Gap 3, 15 studies); and lack of TB knowledge, stigma, depression, and medication adverse effects as contributing to unfavorable treatment outcomes (Gap 4, 86 studies). Medication nonadherence contributed to unfavorable treatment outcomes (Gap 4) and TB recurrence (Gap 5, 14 studies). Limitations include lack of meta-analyses due to the heterogeneity of findings and limited generalizability to some Indian regions, given the country's diverse population. CONCLUSIONS: This systematic review illuminates common patterns of risk that shape outcomes for Indians with TB, while highlighting knowledge gaps-particularly regarding TB care for children or in the private sector-to guide future research. Findings may inform targeting of support services to people with TB who have higher risk of poor outcomes and inform multicomponent interventions to close gaps in the care cascade.


Assuntos
Tuberculose , Humanos , Índia/epidemiologia , Tuberculose/terapia , Tuberculose/diagnóstico , Tuberculose/epidemiologia , Acessibilidade aos Serviços de Saúde , Resultado do Tratamento , Masculino
7.
PLoS Med ; 21(6): e1004329, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38913710

RESUMO

BACKGROUND: Broadly neutralizing antibodies (bnAbs) are a promising approach for HIV-1 prevention. In the Antibody Mediated Prevention (AMP) trials, a CD4-binding site targeting bnAb, VRC01, administered intravenously (IV), demonstrated 75% prevention efficacy against highly neutralization-sensitive viruses but was ineffective against less sensitive viruses. VRC07-523LS is a next-generation bnAb targeting the CD4-binding site and was engineered for increased neutralization breadth and half-life. We conducted a multicenter, randomized, partially blinded Phase I clinical trial to evaluate the safety and serum concentrations of VRC07-523LS, administered in multiple doses and routes to healthy adults without HIV. METHODS AND FINDINGS: Participants were recruited between 2 February 2018 and 9 October 2018. A total of 124 participants were randomized to receive 5 VRC07-523LS administrations via IV (T1: 2.5 mg/kg, T2: 5 mg/kg, T3: 20 mg/kg), subcutaneous (SC) (T4: 2.5 mg/kg, T5: 5 mg/kg), or intramuscular (IM) (T6: 2.5 mg/kg or P6: placebo) routes at 4-month intervals. Participants and site staff were blinded to VRC07-523LS versus placebo for the IM group, while all other doses and routes were open-label. Safety data were collected for 144 weeks following the first administration. VRC07-523LS serum concentrations were measured by ELISA through Day 112 in all participants and by binding antibody multiplex assay (BAMA) thereafter in 60 participants (10 per treatment group) through Day 784. Compartmental population pharmacokinetic (PK) analyses were conducted to evaluate the VRC07-523LS serum PK. Neutralization activity was measured in a TZM-bl assay and antidrug antibodies (ADAs) were assayed using a tiered bridging assay testing strategy. Injections and infusions were well tolerated, with mild pain or tenderness reported commonly in the SC and IM groups, and mild to moderate erythema or induration reported commonly in the SC groups. Infusion reactions were reported in 3 of 20 participants in the 20 mg/kg IV group. Peak geometric mean (GM) concentrations (95% confidence intervals [95% CIs]) following the first administration were 29.0 µg/mL (25.2, 33.4), 58.5 µg/mL (49.4, 69.3), and 257.2 µg/mL (127.5, 518.9) in T1-T3 with IV dosing; 10.8 µg/mL (8.8, 13.3) and 22.8 µg/mL (20.1, 25.9) in T4-T5 with SC dosing; and 16.4 µg/mL (14.7, 18.2) in T6 with IM dosing. Trough GM (95% CIs) concentrations immediately prior to the second administration were 3.4 µg/mL (2.5, 4.6), 6.5 µg/mL (5.6, 7.5), and 27.2 µg/mL (23.9, 31.0) with IV dosing; 0.97 µg/mL (0.65, 1.4) and 3.1 µg/mL (2.2, 4.3) with SC dosing, and 2.6 µg/mL (2.05, 3.31) with IM dosing. Peak VRC07-523LS serum concentrations increased linearly with the administered dose. At a given dose, peak and trough concentrations, as well as serum neutralization titers, were highest in the IV groups, reflecting the lower bioavailability following SC and IM administration. A single participant was found to have low titer ADA at a lone time point. VRC07-523LS has an estimated mean half-life of 42 days across all doses and routes (95% CI: 40.5, 43.5), over twice as long as VRC01 (15 days). CONCLUSIONS: VRC07-523LS was safe and well tolerated across a range of doses and routes and is a promising long-acting bnAb for inclusion in HIV-1 prevention regimens. TRIAL REGISTRATION: ClinicalTrials.gov/ NCT03387150 (posted on 21 December 2017).


Assuntos
Anticorpos Neutralizantes , Anticorpos Anti-HIV , Humanos , Masculino , Feminino , Adulto , Anticorpos Neutralizantes/sangue , Anticorpos Anti-HIV/sangue , Pessoa de Meia-Idade , Infecções por HIV/tratamento farmacológico , Infecções por HIV/imunologia , HIV-1/imunologia , Adulto Jovem , Anticorpos Amplamente Neutralizantes/administração & dosagem , Anticorpos Amplamente Neutralizantes/efeitos adversos , Adolescente , Injeções Intramusculares
8.
Am J Epidemiol ; 193(1): 6-16, 2024 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-37073419

RESUMO

Antiretroviral preexposure prophylaxis (PrEP) is highly effective in preventing human immunodeficiency virus (HIV) infection, but uptake has been limited and inequitable. Although interventions to increase PrEP uptake are being evaluated in clinical trials among men who have sex with men (MSM), those trials cannot evaluate effects on HIV incidence. Estimates from observational studies of the causal effects of PrEP-uptake interventions on HIV incidence can inform decisions about intervention scale-up. We used longitudinal electronic health record data from HIV-negative MSM accessing care at Fenway Health, a community health center in Boston, Massachusetts, from January 2012 through February 2018, with 2 years of follow-up. We considered stochastic interventions that increased the chance of initiating PrEP in several high-priority subgroups. We estimated the effects of these interventions on population-level HIV incidence using a novel inverse-probability weighted estimator of the generalized g-formula, adjusting for baseline and time-varying confounders. Our results suggest that even modest increases in PrEP initiation in high-priority subgroups of MSM could meaningfully reduce HIV incidence in the overall population of MSM. Interventions tailored to Black and Latino MSM should be prioritized to maximize equity and impact.


Assuntos
Infecções por HIV , Profilaxia Pré-Exposição , Minorias Sexuais e de Gênero , Masculino , Humanos , Homossexualidade Masculina , Incidência , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Antirretrovirais/uso terapêutico , Profilaxia Pré-Exposição/métodos
9.
J Clin Microbiol ; 62(6): e0013624, 2024 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-38727213

RESUMO

HIV genotyping is used to assess HIV susceptibility to antiretroviral drugs. The Applied Biosystems HIV-1 Genotyping Kit with Integrase (AB kit, Thermo Fisher Scientific) detects resistance-associated mutations (RAMs) in HIV protease (PR), reverse transcriptase (RT), and integrase (IN). We compared results from the AB kit with results obtained previously with the ViroSeq HIV-1 Genotyping System. DNA amplicons from the AB kit were also analyzed using next-generation sequencing (NGS). HIV RNA was extracted using the MagNA Pure 24 instrument (Roche Diagnostics; 96 plasma samples, HIV subtype B, viral load range: 530-737,741 copies/mL). FASTA files were generated from AB kit data using Exatype (Hyrax Biosciences). DNA amplicons from the AB kit were also analyzed by NGS using the Nextera XT kit (Illumina). Drug resistance was predicted using the Stanford HIV Drug Resistance Database. The mean genetic distance for sequences from ViroSeq and the AB kit was 0.02% for PR/RT and 0.04% for IN; 103 major RAMs were detected by both methods. Four additional major RAMs were detected by the AB kit only. These four major RAMs were also detected by NGS (detected in 18.1%-38.2% of NGS reads). NGS detected 27 major RAMs that were not detected with either of the Sanger sequencing-based kits. All major RAMs detected with ViroSeq were detected with the AB kit; additional RAMs were detected with the AB kit only. DNA amplicons from the AB kit can be used for NGS for more sensitive detection of RAMs.


Assuntos
Farmacorresistência Viral , Técnicas de Genotipagem , Infecções por HIV , Integrase de HIV , HIV-1 , Sequenciamento de Nucleotídeos em Larga Escala , HIV-1/genética , HIV-1/efeitos dos fármacos , HIV-1/enzimologia , HIV-1/isolamento & purificação , HIV-1/classificação , Humanos , Infecções por HIV/virologia , Técnicas de Genotipagem/métodos , Farmacorresistência Viral/genética , Integrase de HIV/genética , Sequenciamento de Nucleotídeos em Larga Escala/métodos , Genótipo , Kit de Reagentes para Diagnóstico/normas , RNA Viral/genética , Mutação , Transcriptase Reversa do HIV/genética , Protease de HIV/genética
10.
Sex Transm Dis ; 2024 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-39115204

RESUMO

BACKGROUND: Doxycycline used as post-exposure prophylaxis (doxyPEP) within 72 hours of sex reduces the risk of bacterial sexually transmitted infections (STIs) in people assigned male sex at birth. Little is known about current use of antibiotics as STI prophylaxis in U.S. populations likely to benefit from doxyPEP. METHODS: We conducted an online survey in September 2023 of U.S. adults recruited via sexual networking apps used mainly by gay and bisexual men (GBM). Respondents were asked about the use of antibiotics around the time of sex to prevent bacterial STIs. RESULTS: Of 903 respondents, most (96.2%) identified as GBM; 19.0% were living with HIV and 42.5% using HIV pre-exposure prophylaxis. Half (49.1%) had heard of using antibiotics to prevent STIs and 95.6% were interested in use. Overall, 21.0% had used antibiotic STI prophylaxis and 15.9% had done so in the past year. Among those reporting any use, most (78.1%) had used doxycycline; some used amoxicillin (16.7%), azithromycin (14.5%), or other antibiotics (14.1%). Among those reporting use in the past year, 46.9% used it for some, 28.1% for most, and 25.0% for all sex acts with casual partners during that period. Most (78.3%) of STI prophylaxis users reported their condom use did not change during periods of STI prophylaxis use, 17.2% indicated their condom use declined, and 4.5% indicated their condom use increased. For doxyPEP specifically, 35.7% had heard of it and 13.0% had used it in the past year, of whom 21.0% had used a dosage other than the 200 mg dose shown to be effective. CONCLUSIONS: In this sample of primarily GBM, interest in bacterial STI prophylaxis was nearly universal. However, some of the use was not informed by current clinical guidance or evidence from research studies. Efforts are needed to increase awareness of effective dosing and monitor real-world use.

11.
Sex Transm Dis ; 51(6): e26-e29, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38733975

RESUMO

ABSTRACT: Among 8455 people engaged in HIV care in 4 US cities, 4925 (58%) had treponemal testing at care entry. Of the 4925 tested, 3795 (77%) had a nonreactive result and might benefit from the reverse algorithm for a future incident syphilis diagnosis. Furthermore, low-barrier treponemal testing as a first step in the reverse algorithm may increase syphilis screening and decrease time to treatment.


Assuntos
Algoritmos , Infecções por HIV , Programas de Rastreamento , Sorodiagnóstico da Sífilis , Sífilis , Humanos , Sífilis/diagnóstico , Sífilis/epidemiologia , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Masculino , Adulto , Feminino , Programas de Rastreamento/métodos , Estados Unidos/epidemiologia , Pessoa de Meia-Idade , Incidência
12.
MMWR Morb Mortal Wkly Rep ; 73(39): 876-882, 2024 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-39361539

RESUMO

Adults aged ≥65 years experience the highest risk for COVID-19-related hospitalization and death, with risk increasing with increasing age; outpatient antiviral treatment reduces the risk for these severe outcomes. Despite the proven benefit of COVID-19 antiviral treatment, information on differences in use among older adults with COVID-19 by age group is limited. Nonhospitalized patients aged ≥65 years with COVID-19 during April 2022-September 2023 were identified from the National Patient-Centered Clinical Research Network. Differences in use of antiviral treatment among patients aged 65-74, 75-89, and ≥90 years were assessed. Multivariable logistic regression was used to estimate the association between age and nonreceipt of antiviral treatment. Among 393,390 persons aged ≥65 years, 45.9% received outpatient COVID-19 antivirals, including 48.4%, 43.5%, and 35.2% among those aged 65-75, 76-89, and ≥90 years, respectively. Patients aged 75-89 and ≥90 years had 1.17 (95% CI = 1.15-1.19) and 1.54 (95% CI = 1.49-1.61) times the adjusted odds of being untreated, respectively, compared with those aged 65-74 years. Among 12,543 patients with severe outcomes, 2,648 (21.1%) had received an outpatient COVID-19 antiviral medication, compared with 177,874 (46.7%) of 380,847 patients without severe outcomes. Antiviral use is underutilized among adults ≥65 years; the oldest adults are least likely to receive treatment. To prevent COVID-19-associated morbidity and mortality, increased use of COVID-19 antiviral medications among older adults is needed.


Assuntos
Antivirais , Tratamento Farmacológico da COVID-19 , Humanos , Idoso , Estados Unidos/epidemiologia , Idoso de 80 Anos ou mais , Feminino , Masculino , Antivirais/uso terapêutico , Assistência Ambulatorial/estatística & dados numéricos , COVID-19/epidemiologia , Assistência Centrada no Paciente/estatística & dados numéricos
13.
AIDS Behav ; 28(7): 2175-2182, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38605250

RESUMO

The FDA's approval of long-acting injectable cabotegravir pre-exposure prophylaxis (LAI PrEP) as an alternative to daily oral PrEP represents a crucial development in HIV prevention, particularly for American Black cisgender women who face high HIV-1 risks. Yet, uptake may be hindered by racial and gender inequities. Addressing these requires learning from the roll-out of oral PrEP, creating culturally tailored PrEP campaigns, and enhancing provider training to meet Black women's needs. Tools for discussing PrEP within personal relationships and product preference research tailored to Black women's needs are essential for effective LAI PrEP delivery. Deliberative implementation of LAI PrEP must employ strategies that are community-sensitive, -responsive, and -inclusive. It should prioritize the incorporation of Black women's voices in decision-making and should promote community-led strategies. By addressing historical injustices and fostering trust, healthcare systems can enhance LAI PrEP uptake by Black women. Emphasizing a community-centered approach that ensures health equity and acknowledges the crucial role that social media and Black-led organizations play in promoting PrEP awareness and adoption within Black communities is necessary for successful implementation.


Assuntos
Fármacos Anti-HIV , Negro ou Afro-Americano , Infecções por HIV , Profilaxia Pré-Exposição , Humanos , Profilaxia Pré-Exposição/métodos , Feminino , Infecções por HIV/prevenção & controle , Negro ou Afro-Americano/psicologia , Fármacos Anti-HIV/administração & dosagem , Estados Unidos , Preparações de Ação Retardada , Injeções , Piridonas , Dicetopiperazinas
14.
AIDS Behav ; 2024 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-39352601

RESUMO

PrEP stigma measurement remains a challenge to the validity of studies and interventions addressing HIV prevention. It may lead to inaccurate assessment of the relationship between PrEP stigma and health outcomes such as PrEP persistence and care retention in groups experiencing HIV-related inequities. The present research explored the psychometric properties of a novel IV pre-exposure prophylaxis (PrEP) stigma scale in a cohort of racially diverse men who have sex with men (MSM). Using item response theory, analyses explored presence of differential item functioning (DIF) among Black and White respondents. Participants completed baseline surveys measuring psychosocial factors, sociodemographic factors, and PrEP stigma items. The primary analysis used a machine learning approach to assess (a) the presence of DIF; and (b) compare latent stigma between Black and White respondents, after correcting for any DIF. The model identified four out of 13 scale items as having a high probability of DIF for Black respondents, which is relatively good given that the original PrEP stigma scale was neither designed nor tested for validation comparing Black and White respondents. The DIF-adjusted latent PrEP stigma measure reveals statistically and substantially significantly higher levels of stigma for Black compared to White respondents (Diff.: 1.05 +/- 0.19). While most items performed well, findings demonstrate the importance of assessing measurement error in populations where stigma is rampant and being studied or intervened upon (and in this case, where multilevel and intersectional stigma may be present).

15.
AIDS Behav ; 2024 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-39266891

RESUMO

This clinical trial examined the individual and combined effects of three different approaches to reducing alcohol misuse among a sample of sexual minority men (SMM) with HIV. Specifically, we used a 2 × 2 × 2 randomized factorial design to compare: (a) behavioral intervention based in motivational interviewing (MI) vs. brief intervention (BI), (b) interactive text messaging (ITM) for alcohol use vs. no ITM, and (c) extended intervention (EI) length of nine months vs. a one-month intervention duration. Participants (N = 188) were SMM with HIV and alcohol misuse recruited in Miami, FL, and Boston, MA. Participants were randomized to one of eight intervention combinations and assessed at 6- and 12-month follow-ups. Large reductions of over 50% in drinks per week and heavy drinking days were observed in all conditions at follow-up. Those who received ITM, compared to those who did not, reported significantly lower drinks consumed per week at 6 and 12 months (incidence rate ratios = 0.73 [95% CI = 0.57, 0.90] and 0.72 [95% CI = 0.56, 0.87], respectively), and increased odds of cessation of alcohol misuse at 12 months, odds ratio = 1.46, 95% CI = 1.03, 2.08. Results provided no evidence of better alcohol use outcomes for either MI or EI relative to their comparison conditions, and no specific combination of intervention components demonstrated a notable benefit. This study suggests a two-session BI can effectuate substantial reductions in alcohol use in SMM with HIV and that adding one month of ITM can yield further improvements. Clinical Trials Number: NCT02709759.

16.
AIDS Behav ; 28(9): 2970-2978, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39126557

RESUMO

Pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission, but uptake and adherence among young men who have sex with men (YMSM) remains suboptimal. New PrEP formulations may enhance PrEP use, but little is known about their acceptability. We enrolled 39 cis- and transgender YMSM (age 18-34) from Boston, MA; Jackson, MS; Birmingham, AL; and New Orleans, LA, who participated in video-based focus groups (n = 30) or in-depth interviews (n = 9) to examine how new PrEP products (e.g., injections, monthly pills, implants) are perceived and might be improved for YMSM. Focus groups were transcribed, coded, and analyzed using grounded theory and content analysis. Nearly half (46%) of participants were Black; 11% identified as Hispanic. Seventy-nine percent were PrEP experienced. Product preference was driven by the desire for flexible, safe, effective, and affordable PrEP options. A majority of participants preferred subcutaneous injections every 6 months or monthly pills dispersed in 3 or 4 doses. Subcutaneous injections and batched monthly pills were favored by those with demanding schedules and those who desired fewer provider visits; monthly pills were more appealing for those who feared needles. Despite broad preferences for longer-acting products for convenience, participants raised concerns regarding side effects and waning protection after missed doses. Participants felt that more education about safety and efficacy profiles of new products could influence their attitudes. These findings suggest that it is important to prioritize YMSM's dynamic lifestyles during product development, and that product safety and efficacy information should be accessible in youth-friendly language.


Assuntos
Fármacos Anti-HIV , Grupos Focais , Infecções por HIV , Homossexualidade Masculina , Profilaxia Pré-Exposição , Minorias Sexuais e de Gênero , Humanos , Masculino , Infecções por HIV/prevenção & controle , Homossexualidade Masculina/psicologia , Homossexualidade Masculina/estatística & dados numéricos , Adulto , Fármacos Anti-HIV/administração & dosagem , Estados Unidos , Adolescente , Adulto Jovem , Minorias Sexuais e de Gênero/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Pesquisa Qualitativa , Entrevistas como Assunto , Bissexualidade , Comportamento de Escolha
17.
AIDS Behav ; 2024 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-39287732

RESUMO

Black sexual minority men (BSMM) remain disproportionately affected by HIV, yet Pre-exposure prophylaxis (PrEP) uptake in this population remains relatively low. Informed by minority stress theory, PrEP stigma may manifest in and exacerbate societal marginalization based on sexuality and race. We used an exploratory sequential mixed-methods approach to determine if PrEP-specific stigma was associated with reduced PrEP uptake among BSMM, and qualitatively explored how PrEP use is stigmatized among BSMM. We analyzed cross-sectional data from a pilot sample of BSMM (n = 151) collected in late 2020 in the United States, testing for associations between PrEP stigma and PrEP use using modified Poisson regression. Subsequently, we selected participants (n = 23) from this sample for qualitative interviews starting in 2022. Responses to questions related to PrEP stigma were analyzed using thematic analysis. PrEP stigma was associated less than half the PrEP use (aPR = 0.43, 95% CI = 0.24, 0.75) among BSMM after adjustment. Qualitatively, we identified three major themes in how PrEP use is stigmatized among BSMM: PrEP-specific sexual stigma, intersections between PrEP and HIV stigma, and PrEP misinformation and disinformation. Aligned with minority stress theory, each theme was based in part in stigma related to sexuality or race. We found strong relationships between PrEP stigma and PrEP use independent of several sociobehavioral factors. Each of our themes were based in part in minority stressors, and underscore the importance of culturally competent PrEP promotion efforts towards BSMM. Addressing stigma is a core component of health equity efforts towards ending the HIV epidemic.

18.
AIDS Behav ; 28(10): 3373-3380, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-38985403

RESUMO

Daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, though efficacy depends on adherence. Digital pill systems (DPS) can enable direct, real-time adherence measurement. HIV-negative men who have sex with men (MSM) with substance use (excluding alcohol) utilized a DPS over 90 days and completed weekly surveys reporting sexual activity, condom use, and substance use. Responses indicating (1) any sexual activity and substance use or (2) condomless anal intercourse (CAI) in the prior week were categorized as high risk for HIV acquisition. PrEP adherence data for the 7-day period preceding each response was dichotomized as ≤ 3 and ≥ 4 doses/week, indicating prevention-effective adherence, and compared by HIV risk level. Thirteen MSM were analyzed (median age: 32). Of 113 surveys, 48.7% indicated high HIV risk, with 12.4% reporting CAI alone, 16.8% any sexual activity and substance use, and 19.5% both CAI and substance use. Weekly mean PrEP adherence was 90.3% (6.3 of 7 doses/week), with ≥ 4 doses/week recorded during 92.0% of weeks. The proportion of participants with ≥ 4 recorded doses/week was 88.9% during weeks with CAI alone, 89.5% during weeks with any sexual activity and substance use, 92.0% during weeks with both CAI and substance use, and 92.8% during lower risk weeks. Participants ingested ≥ 4 doses/week during 89.1% of all high-risk weeks and 94.8% of low-risk weeks. Overall, participants maintained high levels of PrEP adherence while engaging in HIV risk behaviors. DPS can be deployed concurrently with data collection tools to assess ingestion patterns during periods of elevated risk.


Assuntos
Fármacos Anti-HIV , Infecções por HIV , Homossexualidade Masculina , Adesão à Medicação , Profilaxia Pré-Exposição , Transtornos Relacionados ao Uso de Substâncias , Humanos , Masculino , Infecções por HIV/prevenção & controle , Profilaxia Pré-Exposição/métodos , Homossexualidade Masculina/psicologia , Homossexualidade Masculina/estatística & dados numéricos , Adulto , Adesão à Medicação/estatística & dados numéricos , Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/uso terapêutico , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Comportamento Sexual , Preservativos/estatística & dados numéricos , Assunção de Riscos , Administração Oral , Pessoa de Meia-Idade , Parceiros Sexuais
19.
AIDS Behav ; 28(11): 3710-3718, 2024 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-39083151

RESUMO

Adherence drives efficacy in PrEP clinical trials. We compared drug concentrations and self-reported adherence in HPTN069/ACTG5305, a double-blinded, randomized trial of the safety and tolerability of candidate PrEP regimens that included maraviroc (MVC), tenofovir (TDF), and emtricitabine (FTC). Plasma drug concentrations and self-reported adherence by computer-assisted self-interview (CASI) were assessed at study weeks 24 and 48. Descriptive statistics and a generalized linear model were used to assess the association between selected demographic factors, self-report of daily medication adherence and plasma drug concentrations consistent with daily adherence. Among 718 paired observations from 370 participants, 43% (306/718) reported daily adherence by CASI, 65% (467/718) had drug concentrations consistent with daily adherence and 11% (81/718) had CASI responses that reported daily adherence despite having drug concentrations consistent with less-than-daily adherence. In adjusted analyses, participants who were assigned male at birth (aOR 1.42 [95% CI 1.02, 1.97]), older (5-year increments aOR 1.10 [95% CI 1.09, 1.11]), White (aOR 2.2 [95% CI 1.88, 2.56]), had advanced education (aOR 3.89 [95% CI 2.97, 5.09]), were employed (aOR 1.89 [95% CI 1.50, 2.40]), or partnered/married (aOR 2 [95% CI 1.72, 2.32]) were more likely to have drug concentrations consistent with daily adherence. Participants who were not employed (aOR 2.7 [95% CI 1.31, 5.55]) or who were single/not partnered (aOR 2.33 [CI 95% 1.25, 4.34]) were more likely to have drug concentrations that did not reflect daily adherence despite self-reported PrEP adherence. These findings support the need for ongoing adherence counseling in clinical trials of new PrEP regimens.


Assuntos
Fármacos Anti-HIV , Emtricitabina , Infecções por HIV , Maraviroc , Adesão à Medicação , Profilaxia Pré-Exposição , Autorrelato , Tenofovir , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Feminino , Infecções por HIV/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Fármacos Anti-HIV/sangue , Fármacos Anti-HIV/administração & dosagem , Tenofovir/uso terapêutico , Tenofovir/sangue , Tenofovir/administração & dosagem , Adulto , Emtricitabina/uso terapêutico , Emtricitabina/administração & dosagem , Método Duplo-Cego , Pessoa de Meia-Idade , Cicloexanos
20.
AIDS Behav ; 2024 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-39375289

RESUMO

Despite advances in HIV care and treatment in the U.S., disparities in outcomes along the HIV care continuum persist. The widespread replication of effective and sustainable interventions that prioritize the engagement of underserved populations has been identified as a promising path to ending the HIV epidemic in the U.S. Intervention dissemination products, however, rarely provide the comprehensive and accessible information needed to replicate interventions within community settings. To bridge the divide between research and community-based implementation, the Using Evidence-informed Interventions to Improve Health Outcomes among People Living with HIV (E2i) initiative-grounded in the HIV/AIDS Bureau Implementation Science Framework-created a suite of tools to promote the rapid replication of interventions focused on transgender women, Black men who have sex with men, behavioral health integration, and identifying and addressing trauma. The resulting dissemination products are detailed and digestible multimedia toolkits that follow adult learning theory principles and align with the Template for Intervention Description and Replication criteria for adapting non-pharmacological interventions. Each E2i toolkit consists of five components: implementation guides, narrative videos of site implementation, best practice demonstration videos, interactive learning modules, and recruitment posters and brochures. Over 2 years (2022-2024), the E2i toolkit webpages amassed 7703 unique users and 17,666 pageviews. These toolkits can serve as a blueprint for designing comprehensive and accessible dissemination products for replication of HIV interventions in care settings. Dissemination products that bridge the gap between intervention research and replication in community settings are a crucial missing tool for ending the HIV epidemic.

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