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. 2024 Jul 10;25(1):470.
doi: 10.1186/s13063-024-08313-4.

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

Corina Lelutiu-Weinberger  1 , Mircea L Filimon  2 , Anna M Zavodszky  2 , Mihai Lixandru  3 , Lucian Hanu  3 , Cristina Fierbinteanu  3 , Raluca Patrascu  4 , Adrian Streinu-Cercel  4 , Sergiu Luculescu  3 , Maria Bora  5 , Irina Filipescu  5 , Cristian Jianu  5 , Lisa B Hightow-Weidman  6 , Aimee Rochelle  6 , Brian Yi  7 , Nickie Buckner  7 , Sarit A Golub  8 , Ilana Seager van Dyk  9 , Julian Burger  10 , Fan Li  11   12 , John E Pachankis  10
Affiliations

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

Corina Lelutiu-Weinberger et al. Trials. .

Erratum in

Abstract

Background: 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.

Keywords: Gay, bisexual, and other men who have sex with men (GBMSM); HIV/AIDS; Mental health; Mobile health (mHealth); Pre-exposure prophylaxis (PrEP); Stigma.

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Conflict of interest statement

John E. Pachankis receives royalties from Oxford University Press for books related to LGBTQ-affirmative mental health practice. The other authors have no conflicts to declare.

Figures

Fig. 1
Fig. 1
Participant timeline
Fig. 2
Fig. 2
SPIRIT figure summarizing schedule of enrollment, interventions, and assessments
See this image and copyright information in PMC

References

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