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临床试验/NCT03308097
NCT03308097已完成不适用

A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年11月20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
70
试验地点
2
主要终点
Number of PrEP Services Appointments Attended-Full Sample

研究概览

简要总结

This study will develop and test an interactive mobile messaging intervention to improve engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors for Black men who have sex with men living in the Southern U.S. The mobile messaging intervention will include interactive text messaging and free, publicly available links to websites and YouTube videos. During the intervention participants will gain information about their health, improve motivation for engagement in PrEP related care, and build skills for healthy behaviors. Participants will also receive intervention materials to help decrease frequent barriers to care. If the intervention is found to be effective, it can be tested in a larger study and then disseminated.

详细描述

The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs) living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be texted interactive links to publicly available, online content about PrEP and HIV prevention. Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The material used in the intervention will be consistent with the Information Motivation Behavior (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A small randomized controlled study among 66 new participants in the clinics will examine the preliminary efficacy of the intervention compared to enhanced standard of care on attendance at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile Messaging Intervention will show greater attendance at a PrEP Services Appointment and decreased HIV risk behavior at 4 and 16 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • English speaking
  • Black MSM
  • Eligible for PrEP
  • Visit STI/HIV testing clinics at University of Mississippi Medical Center
  • Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment

排除标准

  • Involved in another PrEP or HIV prevention related study

结局指标

主要结局

Number of PrEP Services Appointments Attended-Full Sample

时间窗: 16 weeks

With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.

Number of Participants Who Received a PrEP Prescription-Restricted Sample

时间窗: 16 weeks

Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

Number of PrEP Services Appointments Attended- Restricted Sample

时间窗: 16 weeks

With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care. Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.

Number of Participants Who Received a PrEP Prescription-Full Sample

时间窗: 16 weeks

Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.

次要结局

  • Change in PrEP Knowledge-Restricted Sample(Baseline, 16 weeks)
  • Change in Social Motivational Readiness for PrEP Care-Full Sample(Baseline, 16 weeks)
  • Change in Social Motivational Readiness for PrEP Care-Restricted Sample(Baseline, 16 weeks)
  • Change in PrEP Self-efficacy-Full Sample(Baseline, 16 weeks)
  • Change in PrEP Self-efficacy-Restricted Sample(Baseline, 16 weeks)
  • Change in PrEP Knowledge-Full Sample(Baseline, 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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