Motivational Interviewing for PrEP Uptake
2017年7月20日 更新者:Richard Crosby
A Pilot Study Assessing a Single Motivational Interviewing Session to Improve Uptake of PrEP Among Young Black Men Who Have Sex With Men
The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes.
研究概览
详细说明
The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes.
In the parent study we had the foresight to include a cross-sectional survey of men's attitudes toward PrEP use as part of their first follow-up assessment.
Using that data, we will identify the predictors of readiness to accept PrEP and we will use these findings to inform the design of a brief Motivational Interviewing session (MI-PrEP) that will promote uptake of PrEP.
We will enroll 65 YBMSM who have completed the 12-month follow-up assessment from the parent study and 35 YBMSM (same inclusion criteria) from either of two clinics used in the parent study (the Crossroads Clinic or the Open Arms Clinic) who did not participate in the parent study.
Using small block randomization, these 100 men will be assigned to the MI-PrEP condition or to the standard of care only control condition.
At the conclusion of the enrollment session men will be asked if they would like to schedule an appointment to begin taking PrEP.
This same offer will be made again approximately 14 days after the enrollment session.
The dependent variables will thus include measures of whether men made/kept an appointment to begin PrEP and, if so, how much time elapsed before doing so and whether they filled the prescription for PrEP.
For those who do fill the prescription we will test their blood for levels of tenofovir and emtricitabine after 3 months of time has elapsed.
Group differences (Intervention vs. Control) in uptake, time to uptake, and actual use/adherence of PrEP are hypothesized to favor those receiving the MI-PrEP intervention program.
If this is the case then an initial body of evidence will exist supporting the potential efficacy of a Motivational Interviewing-based, single session intervention that can be delivered to YBMSM in clinical settings.
研究类型
介入性
注册 (实际的)
100
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 29年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
self-identify as being Black/African American and they must be 18 to 29 years of age. In addition, these men must answer yes to the following screening question: "have you had anal sex with a male in the past 6 months?" Also, to be eligible all men (including those having completed the 12-month follow-up assessment in the parent study) must have an HIV-negative test result in the past 30 days.
Exclusion Criteria:
already taking PrEP
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Intervention Group
This group receives a brief motivational interviewing session about PrEP
|
|
|
无干预:Control Group
This group receives standard of care clinic based counseling about PrEP
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Obtains first prescription for PrEP
大体时间:3 months
|
first prescription will be determined by self report
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年1月3日
初级完成 (实际的)
2017年3月30日
研究完成 (实际的)
2017年3月30日
研究注册日期
首次提交
2017年7月20日
首先提交符合 QC 标准的
2017年7月20日
首次发布 (实际的)
2017年7月21日
研究记录更新
最后更新发布 (实际的)
2017年7月21日
上次提交的符合 QC 标准的更新
2017年7月20日
最后验证
2017年7月1日
更多信息
与本研究相关的术语
其他研究编号
- #2015-0210
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