Evidence map›Paper›PMID 38987812›Full record

ArticleTrials2024

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, Mircea L Filimon, Anna M Zavodszky, Mihai Lixandru, Lucian Hanu, Cristina Fierbinteanu, Raluca Patrascu, Adrian Streinu-Cercel, Sergiu Luculescu, Maria Bora and 11 more

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05323123 (Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05323123 nacompletednot on this map

Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention

TypeinterventionalSponsorColumbia UniversityRan2021 to 2024Enrolled120ConditionsHuman Immunodeficiency VirusArmsSPARK, HealthMpowerment, PrEP Education
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Corina Lelutiu-WeinbergerSchool of Nursing, Columbia University, 560 West 168th Street, New York, NY, 10032, USA. cl4265@cumc.columbia.edu.ORCID http://orcid.org/0000-0001-9652-1852
Mircea L FilimonSchool of Nursing, Columbia University, 560 West 168th Street, New York, NY, 10032, USA.
Anna M ZavodszkySchool of Nursing, Columbia University, 560 West 168th Street, New York, NY, 10032, USA.
Mihai LixandruThe Romanian Association Against AIDS, Bulevardul Eroilor Sanitari 49, 050471, Bucharest, Romania.
Lucian HanuThe Romanian Association Against AIDS, Bulevardul Eroilor Sanitari 49, 050471, Bucharest, Romania.
Cristina FierbinteanuThe Romanian Association Against AIDS, Bulevardul Eroilor Sanitari 49, 050471, Bucharest, Romania.
Raluca PatrascuThe National Institute of Infectious Diseases "Professor Dr. Matei Bals", Strada Doctor Calistrat Grozovici 1, 021105, Bucharest, Romania.
Adrian Streinu-CercelThe National Institute of Infectious Diseases "Professor Dr. Matei Bals", Strada Doctor Calistrat Grozovici 1, 021105, Bucharest, Romania.
Sergiu LuculescuThe Romanian Association Against AIDS, Bulevardul Eroilor Sanitari 49, 050471, Bucharest, Romania.
Maria BoraThe Clinical Hospital of Infectious Diseases, Str. Iuliu Moldovan, nr. 23, 400000, Cluj-Napoca, Romania.
Irina FilipescuThe Clinical Hospital of Infectious Diseases, Str. Iuliu Moldovan, nr. 23, 400000, Cluj-Napoca, Romania.
Cristian JianuThe Clinical Hospital of Infectious Diseases, Str. Iuliu Moldovan, nr. 23, 400000, Cluj-Napoca, Romania.
Lisa B Hightow-WeidmanCollege of Nursing, Florida State University, 98 Varsity Way, Tallahassee, FL, 32305, USA.
Aimee RochelleCollege of Nursing, Florida State University, 98 Varsity Way, Tallahassee, FL, 32305, USA.
Brian YiOne Cow Standing, 300 W Morgan St Ste 1425, Durham, NC, 27701, USA.
Nickie BucknerOne Cow Standing, 300 W Morgan St Ste 1425, Durham, NC, 27701, USA.
Sarit A GolubDepartment of Psychology, Hunter College of the City University of New York, 695 Park Avenue, New York, 10065, NY, USA.
Ilana Seager van DykSchool of Psychology, Massey University, PO Box 756, Wellington, 6140, New Zealand.
Julian BurgerDepartment of Social and Behavioral Sciences, Yale School of Public Health, 60 College Street, New Haven, CT, 06610, USA.
Fan LiDepartment of Biostatistics, Yale School of Public Health, 60 College Street, New Haven, CT, 06520, USA.
John E PachankisDepartment of Social and Behavioral Sciences, Yale School of Public Health, 60 College Street, New Haven, CT, 06610, USA.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Preparing for pre-exposure prophylaxis implementation in Central-Eastern European Countries with low access to biomedical preventionR33TW011752 · FIC · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LELUTIU-WEINBERGER, CORINA, PACHANKIS, JOHN EDWARD · 2022 to 2024
$982k
FIC NIH HHS R33 TW011752FIC NIH HHS R33TW011752NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundGay, 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.

methodsThis 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.

Indexed as

Anti-HIV AgentsHIV InfectionsHomosexuality, MaleMedication AdherencePre-Exposure ProphylaxisCounselingHealth Knowledge, Attitudes, PracticeHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicRomaniaSexual and Gender MinoritiesTime FactorsTreatment OutcomeAnti-HIV AgentsGay, bisexual, and other men who have sex with men (GBMSM)HIV/AIDSMental healthMobile health (mHealth)Pre-exposure prophylaxis (PrEP)Stigma

Identifiers

PMID38987812
PMCPMC11238350

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.