PDF(Pubmed)
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：同性恋，双性恋,和其他男男性行为者（GBMSM）是罗马尼亚艾滋病毒传播的高危人群，然而，他们拥有很少的预防资源。尽管无法通过卫生系统正式获得暴露前预防（PrEP），罗马尼亚的GBMSM对这种药物表现出很高的需求和兴趣。预期在全国范围内推出PrEP，这项研究测试了一种新策略的功效，准备罗马尼亚，结合了两种基于证据的PrEP促进罗马尼亚GBMSM的干预措施。
方法：本研究使用随机对照试验设计来检查居住在罗马尼亚的GBMSM是否接受罗马尼亚的准备，文化适应的咨询和移动健康干预(预期n=60)，与分配到PrEP教育控制组的患者相比，PrEP的依从性和持久性更高（预期n=60）。来自罗马尼亚两个主要城市的参与者在随机分组后3个月和6个月接受PrEP和随访。PrEP依从性数据是通过每周自我报告调查和随访时的干血斑点测试获得的。潜在的调解员(例如，还评估了PrEP使用动机）的干预效果。此外，准备罗马尼亚的实施(例如，参加医疗就诊的登记参与者比例，干预经验)将通过与参与者的访谈进行检查，研究实施者，和医疗官员。
结论：从这项研究中获得的知识将用于进一步完善和扩大罗马尼亚的规模，以进行未来的多城市有效性试验。通过研究支持PrEP依从性和持久性的工具的功效，这项研究有可能为PrEP在罗马尼亚和类似情况下的推广奠定基础。试验注册这项研究在ClinicalTrials.gov上注册，标识符NCT05323123,2022年3月25日
方法：本研究使用随机对照试验设计来检查居住在罗马尼亚的GBMSM是否接受罗马尼亚的准备，文化适应的咨询和移动健康干预(预期n=60)，与分配到PrEP教育控制组的患者相比，PrEP的依从性和持久性更高（预期n=60）。来自罗马尼亚两个主要城市的参与者在随机分组后3个月和6个月接受PrEP和随访。PrEP依从性数据是通过每周自我报告调查和随访时的干血斑点测试获得的。潜在的调解员(例如，还评估了PrEP使用动机）的干预效果。此外，准备罗马尼亚的实施(例如，参加医疗就诊的登记参与者比例，干预经验)将通过与参与者的访谈进行检查，研究实施者，和医疗官员。
结论：从这项研究中获得的知识将用于进一步完善和扩大罗马尼亚的规模，以进行未来的多城市有效性试验。通过研究支持PrEP依从性和持久性的工具的功效，这项研究有可能为PrEP在罗马尼亚和类似情况下的推广奠定基础。试验注册这项研究在ClinicalTrials.gov上注册，标识符NCT05323123,2022年3月25日
