Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)

Detalhes bibliográficos
Autor(a) principal: Cespedes, Michelle
Data de Publicação: 2022
Outros Autores: Das, Moupali, Hojilla, J. Carlo, Blumenthal, Jill, Mounzer, Karam, Ramgopal, Moti, Hodge, Theo, Torres, Thiago S., Peterson, Charles, Shibase, Senzokuhle, Elliott, Ayana, Demidont, A. C., Callaghan, Larkin, Watson, C. Chauncey, Carter, Christoph, Kintu, Alex, Baeten, Jared M., Ogbuagu, Onyema
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/55691
Resumo: Icahn School of Medicine at Mount Sinai. Division of Infectious Disease. New York, NY, United States of America.
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spelling Cespedes, MichelleDas, MoupaliHojilla, J. CarloBlumenthal, JillMounzer, KaramRamgopal, MotiHodge, TheoTorres, Thiago S.Peterson, CharlesShibase, SenzokuhleElliott, AyanaDemidont, A. C.Callaghan, LarkinWatson, C. ChaunceyCarter, ChristophKintu, AlexBaeten, Jared M.Ogbuagu, Onyema2022-11-17T19:16:23Z2022-11-17T19:16:23Z2022CESPEDES, Michelle et al. Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP). PloS one, v. 17, n. 6, p. 1-12, 2022.1932-6203https://www.arca.fiocruz.br/handle/icict/5569110.1371/journal.pone.0267780engPublic Library of ScienceProactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleIcahn School of Medicine at Mount Sinai. Division of Infectious Disease. New York, NY, United States of America.Gilead Sciences. Foster City, CA, United States of America.Gilead Sciences. Foster City, CA, United States of America.University of California San Diego. Department of Medicine. San Diego, CA, United States of America.Philadelphia FIGHT Community Health Centers. Philadelphia, PA, United States of America.Midway Research Center. Fort Pierce, FL, United States of America.Washington Health Institute. Washington, DC, United States of America.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.University of Illinois Chicago. College of Medicine. Department of Medicine. Chicago, IL, United States of America.National LGBTI Health Campaign. Johannesburg, South Africa.Gilead Sciences. Foster City, CA, United States of America.Gilead Sciences. Foster City, CA, United States of America.Gilead Sciences. Foster City, CA, United States of America.Gilead Sciences. Foster City, CA, United States of America.Gilead Sciences. Foster City, CA, United States of America.Gilead Sciences. Foster City, CA, United States of America.Gilead Sciences. Foster City, CA, United States of America.Yale School of Medicine. Section of Infectious Diseases. Department of Internal Medicine. New Haven, CT, United States of America.Introduction: Black and Hispanic/Latinx cisgender men who have sex with men (MSM), transgender women, transgender men, and gender nonbinary (TGNB) individuals have been historically underrepresented in HIV pre-exposure prophylaxis (PrEP) clinical trials. There is an urgent need for ongoing engagement with communities that have been the most impacted by HIV and diverse representation in clinical trials. Here we describe strategic approaches undertaken in the PURPOSE 2 trial to optimize engagement of underrepresented individuals. Methods and results: PURPOSE 2 is an ongoing Phase 3 trial evaluating the safety and efficacy of lenacapavir as PrEP in cisgender MSM and TGNB individuals. In PURPOSE 2, we used a multipronged approach aimed at enriching participation of underrepresented individuals. We conducted a review to identify evidence-informed recommendations from literature, engaged with stakeholders, and established the Global Community Advisory and Accountability Group (GCAG) to represent the needs of the community. Insights from stakeholders and GCAG members resulted in an expansion of the study population to include transgender men, gender nonbinary persons, and adolescents, and evaluation of population-specific outcomes. Feedback from stakeholders and GCAG members also informed investigator and site selection; these were selected based on prior experience working with persons from diverse racial, ethnic and gender identities, and estimates of local HIV incidence. Site selection was also expanded to include community-based clinics with services tailored towards Black, Hispanic/Latinx, and TGNB populations. We established a study-wide recruitment goal of 50% Black MSM and 20% Hispanic/Latinx MSM in US sites and 20% transgender women globally. Site-specific recruitment goals were also developed based on local demographics and HIV incidence. Mandatory trainings included Good Participatory Practice guidelines, gender inclusivity, and antiracism. Conclusion: While further work is needed to achieve equitable representation, the strategies we describe may serve as a framework for future clinical trials.HIVPre-exposure prophylaxis (PrEP)HIV preventionMen who have sex with menTransgender womenTransgender menGender nonbinaryinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/55691/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALProactive_Thiago_Torres_etal_INI_2022.pdfProactive_Thiago_Torres_etal_INI_2022.pdfapplication/pdf523081https://www.arca.fiocruz.br/bitstream/icict/55691/2/Proactive_Thiago_Torres_etal_INI_2022.pdf62fcb95bbffa848804b6469bab634b53MD52icict/556912022-11-17 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dc.title.en_US.fl_str_mv Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
title Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
spellingShingle Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
Cespedes, Michelle
HIV
Pre-exposure prophylaxis (PrEP)
HIV prevention
Men who have sex with men
Transgender women
Transgender men
Gender nonbinary
title_short Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
title_full Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
title_fullStr Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
title_full_unstemmed Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
title_sort Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
author Cespedes, Michelle
author_facet Cespedes, Michelle
Das, Moupali
Hojilla, J. Carlo
Blumenthal, Jill
Mounzer, Karam
Ramgopal, Moti
Hodge, Theo
Torres, Thiago S.
Peterson, Charles
Shibase, Senzokuhle
Elliott, Ayana
Demidont, A. C.
Callaghan, Larkin
Watson, C. Chauncey
Carter, Christoph
Kintu, Alex
Baeten, Jared M.
Ogbuagu, Onyema
author_role author
author2 Das, Moupali
Hojilla, J. Carlo
Blumenthal, Jill
Mounzer, Karam
Ramgopal, Moti
Hodge, Theo
Torres, Thiago S.
Peterson, Charles
Shibase, Senzokuhle
Elliott, Ayana
Demidont, A. C.
Callaghan, Larkin
Watson, C. Chauncey
Carter, Christoph
Kintu, Alex
Baeten, Jared M.
Ogbuagu, Onyema
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Cespedes, Michelle
Das, Moupali
Hojilla, J. Carlo
Blumenthal, Jill
Mounzer, Karam
Ramgopal, Moti
Hodge, Theo
Torres, Thiago S.
Peterson, Charles
Shibase, Senzokuhle
Elliott, Ayana
Demidont, A. C.
Callaghan, Larkin
Watson, C. Chauncey
Carter, Christoph
Kintu, Alex
Baeten, Jared M.
Ogbuagu, Onyema
dc.subject.en.en_US.fl_str_mv HIV
Pre-exposure prophylaxis (PrEP)
HIV prevention
Men who have sex with men
Transgender women
Transgender men
Gender nonbinary
topic HIV
Pre-exposure prophylaxis (PrEP)
HIV prevention
Men who have sex with men
Transgender women
Transgender men
Gender nonbinary
description Icahn School of Medicine at Mount Sinai. Division of Infectious Disease. New York, NY, United States of America.
publishDate 2022
dc.date.accessioned.fl_str_mv 2022-11-17T19:16:23Z
dc.date.available.fl_str_mv 2022-11-17T19:16:23Z
dc.date.issued.fl_str_mv 2022
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv CESPEDES, Michelle et al. Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP). PloS one, v. 17, n. 6, p. 1-12, 2022.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/55691
dc.identifier.issn.en_US.fl_str_mv 1932-6203
dc.identifier.doi.none.fl_str_mv 10.1371/journal.pone.0267780
identifier_str_mv CESPEDES, Michelle et al. Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP). PloS one, v. 17, n. 6, p. 1-12, 2022.
1932-6203
10.1371/journal.pone.0267780
url https://www.arca.fiocruz.br/handle/icict/55691
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/55691/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/55691/2/Proactive_Thiago_Torres_etal_INI_2022.pdf
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