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临床试验/NCT03840382
NCT03840382已完成不适用

Telemedicine for PrEP Throughout Mississippi

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)

研究概览

简要总结

This study will develop and test a program to deliver PrEP care in underserved communities in Mississippi (MS) through telemedicine, distance-based, clinical care delivered in local community based organizations (CBOs). The intervention will be developed in collaboration with medical specialists at the University of Mississippi Medical Center (UMMC) and local CBO stakeholders (providers, administrators and patients). Approximately 75 individuals will be recruited from CBOs in MS. Participants will be able to receive PrEP counseling in the CBO and PrEP care via telemedicine from a PrEP specialist at UMMC. Participants will complete three assessments in the six months after enrolling. Our study will provide a wealth of information about PrEP-related outcomes and HIV testing among MS residents living in underserved communities. If successful, this program will be able to be disseminated to other CBOs in the South.

详细描述

Uptake of PrEP in the southern United States has been slow, especially in areas distant from academic medical centers that provide PrEP care. Despite underserved populations in the South having alarmingly high rates of HIV, a large percentage of at-risk individuals are not engaged in PrEP care due to limited access to academic medical centers. Mississippi (MS), the site of this proposed project, has the seventh highest incidence of HIV of any state and CBOs that provide HIV/STI testing outside of urban areas report that very few of their at-risk individuals use PrEP. Unfortunately, physicians outside of academic centers are often reluctant to prescribe PrEP because they lack the expertise, training, and the support necessary to provide comprehensive HIV prevention care. Those are at-risk do not seek PrEP from academic centers because of stigma, travel burdens, and financial concerns. To overcome these barriers, this project will develop and pilot test a program to deliver PrEP care in underserved remote communities in MS through telemedicine clinical care delivered in local CBOs. Telemedicine will allow specialists to provide care at a distance and while simultaneously enhancing the capacity of local CBOs to provide quality HIV testing and counseling, PrEP treatment, and linkage to HIV care if needed. It will allow patients to receive the highest level of medical care from trusted CBOs within their local communities. It will also enhance the CBO's mission by allowing it to provide a new, high-quality medical service.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old or older
  • Presented at a collaborating CBO for HIV testing during trial months
  • PrEP eligible based on HIV Risk Checklist
  • Able to read and speak English
  • Able to give meaningful consent as determined by research staff
  • No known HIV infection

排除标准

  • 未提供

结局指标

主要结局

Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)

时间窗: Assessed at 3 months

Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 3 months post-intervention.

Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction)

时间窗: Assessed at 6 months

Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 6-month follow-up.

Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record )

时间窗: Assessed at 3 months

Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up).

Adherence to PrEP (Self-report)

时间窗: Assessed at 3 months and 6 months

Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30.

Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction)

时间窗: Assessed at 6 months

Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 6 months post-intervention.

Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction)

时间窗: Assessed at 3 months

Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 3-month follow-up.

Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record)

时间窗: Assessed at 6 months

Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up).

次要结局

  • Motivational Readiness for PrEP and PrEP-related Care(Assessed at 3 months and 6 months)
  • Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8)(Assessed at 3 months and 6 months)
  • PrEP Knowledge(Assessed at 3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Larry K. Brown

Director, Division of Child and Adolescent Psychiatry

Rhode Island Hospital

研究点 (2)

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