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Same-day initiation of oral pre-exposure prophylaxis among gay, bisexual, and other cisgender men who have sex with men and transgender women in Brazil, Mexico, and Peru (ImPrEP): a prospective, single-arm, open-label, multicentre implementation study

dc.creatorVeloso, Valdiléa G.es_ES
dc.creatorCáceres, Carlos F.es_ES
dc.creatorHoagland, Brendaes_ES
dc.creatorMoreira, Ronaldo I.es_ES
dc.creatorVega-Ramírez, Hamides_ES
dc.creatorKonda, Kelika A.es_ES
dc.creatorLeite, Iuri C.es_ES
dc.creatorBautista-Arredondo, Sergioes_ES
dc.creatorVinícius de Lacerda, Marcuses_ES
dc.creatorValdez Madruga, Josées_ES
dc.creatorFarias, Alessandroes_ES
dc.creatorLima, Josué N.es_ES
dc.creatorZonta, Ronaldoes_ES
dc.creatorLauria, Lilianes_ES
dc.creatorOsco Tamayo, Cesar Vidales_ES
dc.creatorSalvatierra Flores, Hector Javieres_ES
dc.creatorCabrera Santa Cruz, Yovanna Margotes_ES
dc.creatorMoreno Aguayo, Ricardo Martínes_ES
dc.creatorCunha, Marceloes_ES
dc.creatorMoreira, Júlioes_ES
dc.creatorRamos Makkeda, Alessandraes_ES
dc.creatorDíaz, Stevenes_ES
dc.creatorGuanira, Juan V.es_ES
dc.creatorVermandere, Heleenes_ES
dc.creatorBenedetti, Marcoses_ES
dc.creatorIngold, Heather L.es_ES
dc.creatorPimenta, M. Cristinaes_ES
dc.creatorTorres, Thiago S.es_ES
dc.creatorGrinsztejn, Beatrizes_ES
dc.creatorImPrEP Study Group§es_ES
dc.date2023
dc.date.accessioned2025-02-24T16:53:46Z
dc.date.available2025-02-24T16:53:46Z
dc.date.issued2023
dc.identifierJC06DIEP23es_ES
dc.identifier.issn2405-4704
dc.identifier.urihttp://repositorio.inprf.gob.mx/handle/123456789/8225
dc.identifier.urihttps://doi.org/10.1016/S2352-3018(22)00331-9
dc.descriptionBackground: Although gay, bisexual, and other cisgender men who have sex with men (MSM) and transgender women have the highest HIV burden in Latin America, pre-exposure prophylaxis (PrEP) implementation is poor. We aimed to assess the feasibility of same-day oral PrEP delivery in Brazil, Mexico, and Peru. Methods: Implementation PrEP (ImPrEP) was a prospective, single-arm, open-label, multicentre PrEP implementation study conducted in Brazil (14 sites), Mexico (four sites), and Peru (ten sites). MSM and transgender women were eligible to participate if they were aged 18 years or older, HIV-negative, and reported one or more prespecified criteria. Enrolled participants received same-day initiation of daily oral PrEP (tenofovir disoproxil fumarate [300 mg] coformulated with emtricitabine [200 mg]). Follow-up visits were scheduled at week 4 and quarterly thereafter. We used logistic regression models to identify factors associated with early loss to follow-up (not returning after enrolment), PrEP adherence (medication possession ratio ≥0·6), and long-term PrEP engagement (attending three or more visits within 52 weeks). This study is registered at the Brazilian Registry of Clinical Trials, U1111-1217-6021. Findings: From Feb 6, 2018, to June 30, 2021, 9979 participants were screened and 9509 were enrolled (Brazil n=3928, Mexico n=3288, and Peru n=2293). 543 (5·7%) participants were transgender women, 8966 (94·3%) were cisgender men, and 2481 (26·1%) were aged 18-24 years. There were 12 185·25 person-years of follow-up. 795 (8·4%) of 9509 participants had early loss to follow-up, 6477 (68·1%) of 9509 were adherent to PrEP, and 5783 (70·3%) of 8225 had long-term PrEP engagement. Transgender women (adjusted odds ratio 1·60, 95% CI 1·20-2·14), participants aged 18-24 years (1·80, 1·49-2·18), and participants with primary education (2·18, 1·29-3·68) had increased odds of early loss to follow-up. Transgender women (0·56, 0·46-0·70), participants aged 18-24 years (0·52, 0·46-0·58), and those with primary education (0·60, 0·40-0·91) had lower odds of PrEP adherence. Transgender women (0·56, 0·45-0·71), participants aged 18-24 years (0·56, 0·49-0·64), and those with secondary education (0·74, 0·68-0·86) had lower odds of long-term PrEP engagement. HIV incidence was 0·85 per 100 person-years (95% CI 0·70-1·03) and was higher for transgender women, participants from Peru, those aged 18-24 years, Black and mixed-race participants, and participants who were non-adherent to PrEP. Interpretation: Same-day oral PrEP is feasible for MSM and transgender women in Latin America. Social and structural determinants of HIV vulnerability need to be addressed to fully achieve the benefits of PrEP. Funding: Unitaid, WHO, and Ministries of Health in Brazil, Mexico, and Peru. Translations: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.es_ES
dc.formatPDFes_ES
dc.language.isoenges_ES
dc.publisherElsevieres_ES
dc.relation10(2):e84-e96
dc.rightsAcceso Cerradoes_ES
dc.titleSame-day initiation of oral pre-exposure prophylaxis among gay, bisexual, and other cisgender men who have sex with men and transgender women in Brazil, Mexico, and Peru (ImPrEP): a prospective, single-arm, open-label, multicentre implementation studyes_ES
dc.typeArtículoes_ES
dc.contributor.affiliationInstituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (INI-Fiocruz), Rio de Janeiro, Brazil
dc.contributor.emailvaldilea.veloso@ini.fiocruz.br (Valdilea G. Veloso)
dc.relation.jnabreviadoLANCET HIV
dc.relation.journalThe lancet. HIV
dc.identifier.placePaíses Bajos
dc.date.published2023
dc.identifier.organizacionInstituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
dc.identifier.eissn2352-3018
dc.identifier.doi10.1016/S2352-3018(22)00331-9


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