Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men

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dc.citation.issue1
dc.citation.volume25
dc.contributor.authorLelutiu-Weinberger C
dc.contributor.authorFilimon ML
dc.contributor.authorZavodszky AM
dc.contributor.authorLixandru M
dc.contributor.authorHanu L
dc.contributor.authorFierbinteanu C
dc.contributor.authorPatrascu R
dc.contributor.authorStreinu-Cercel A
dc.contributor.authorLuculescu S
dc.contributor.authorBora M
dc.contributor.authorFilipescu I
dc.contributor.authorJianu C
dc.contributor.authorHeightow-Weidman LB
dc.contributor.authorRochelle A
dc.contributor.authorYi B
dc.contributor.authorBuckner N
dc.contributor.authorGolub SA
dc.contributor.authorvan Dyk IS
dc.contributor.authorBurger J
dc.contributor.authorLi F
dc.contributor.authorPachankis JE
dc.coverage.spatialEngland
dc.date.accessioned2024-11-13T00:30:29Z
dc.date.available2024-11-13T00:30:29Z
dc.date.issued2024-07-10
dc.description.abstractBACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) represent a high-risk group for HIV transmission in Romania, yet they possess few resources for prevention. Despite having no formal access to pre-exposure prophylaxis (PrEP) through the health system, GBMSM in Romania demonstrate a high need for and interest in this medication. In anticipation of a national rollout of PrEP, this study tests the efficacy of a novel strategy, Prepare Romania, that combines two evidence-based PrEP promotion interventions for GBMSM living in Romania. METHODS: This study uses a randomized controlled trial design to examine whether GBMSM living in Romania receiving Prepare Romania, a culturally adapted counseling and mobile health intervention (expected n = 60), demonstrate greater PrEP adherence and persistence than those assigned to a PrEP education control arm (expected n = 60). Participants from two main cities in Romania are prescribed PrEP and followed-up at 3 and 6 months post-randomization. PrEP adherence data are obtained through weekly self-report surveys and dried blood spot testing at follow-up visits. Potential mediators (e.g., PrEP use motivation) of intervention efficacy are also assessed. Furthermore, Prepare Romania's implementation (e.g., proportion of enrolled participants attending medical visits, intervention experience) will be examined through interviews with participants, study implementers, and healthcare officials. DISCUSSION: The knowledge gained from this study will be utilized for further refinement and scale-up of Prepare Romania for a future multi-city effectiveness trial. By studying the efficacy of tools to support PrEP adherence and persistence, this research has the potential to lay the groundwork for PrEP rollout in Romania and similar contexts. Trial registration This study was registered on ClinicalTrials.gov, identifier NCT05323123 , on March 25, 2022.
dc.description.confidentialfalse
dc.edition.edition2024
dc.format.pagination470-
dc.identifier.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/38987812
dc.identifier.citationLelutiu-Weinberger C, Filimon ML, Zavodszky AM, Lixandru M, Hanu L, Fierbinteanu C, Patrascu R, Streinu-Cercel A, Luculescu S, Bora M, Filipescu I, Jianu C, Heightow-Weidman LB, Rochelle A, Yi B, Buckner N, Golub SA, van Dyk IS, Burger J, Li F, Pachankis JE. (2024). Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men.. Trials. 25. 1. (pp. 470-).
dc.identifier.doi10.1186/s13063-024-08313-4
dc.identifier.eissn1745-6215
dc.identifier.elements-typejournal-article
dc.identifier.issn1745-6215
dc.identifier.number470
dc.identifier.pii10.1186/s13063-024-08313-4
dc.identifier.urihttps://mro.massey.ac.nz/handle/10179/71987
dc.languageeng
dc.publisherBMC, part of Springer Nature
dc.publisher.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08313-4
dc.relation.isPartOfTrials
dc.rights(c) 2024 The Author/s
dc.rightsCC BY 4.0
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectGay, bisexual, and other men who have sex with men (GBMSM)
dc.subjectHIV/AIDS
dc.subjectMental health
dc.subjectMobile health (mHealth)
dc.subjectPre-exposure prophylaxis (PrEP)
dc.subjectStigma
dc.subjectHumans
dc.subjectMale
dc.subjectHIV Infections
dc.subjectPre-Exposure Prophylaxis
dc.subjectRomania
dc.subjectMedication Adherence
dc.subjectHomosexuality, Male
dc.subjectAnti-HIV Agents
dc.subjectRandomized Controlled Trials as Topic
dc.subjectSexual and Gender Minorities
dc.subjectCounseling
dc.subjectHealth Knowledge, Attitudes, Practice
dc.subjectTime Factors
dc.subjectMulticenter Studies as Topic
dc.subjectTreatment Outcome
dc.titlePrepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men
dc.typeJournal article
pubs.elements-id490705
pubs.organisational-groupOther
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