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临床试验/NCT03637244
NCT03637244Unknown不适用

Pilot Randomized Controlled Trial of a Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis Adoption and Adherence Among African, Caribbean and Black Canadian Patients

Unity Health Toronto2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年4月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians

研究概览

简要总结

Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design

详细描述

Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of ACB Canadian patients. Investigators propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with PrEP eligible patients and surveys with health professionals involved in HIV PrEP management. Under this aim two research questions will be investigated.

Q1) What factors do ACB Canadian patients consider when deciding whether to adopt HIV PrEP? Q2. How do SDT constructs of autonomy, competence and relatedness influence ACB Canadian's decision-making experiences regarding PrEP adoption?

AIM 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design.Hypothesis testing will be de-emphasized in favor of generating effect size estimates. Under this aim three research questions will be investigated. Preliminary hypotheses include:

H1: PrEP decision support increases decision quality in both LDQ and HDQ groups, H2: HDQ + decision-support group more likely to initiate PrEP than HDQ control, H3: HDQ PrEP initiators are more likely than LDQ initiators to have serum levels consistent with adherence at 60-days.

Data on decision quality survey and PrEP initiation data will generated by the subject from self-administered assessments via the decision-support app on the study-issued smartphone. Investigators will also collect biological specimens to measure adherence to HIV PrEP at 60-days post enrollment.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians

时间窗: Self-reported PrEP initiation at 30-days and PrEP adherence at 60-days post enrollment.

PrEP Initiation (does the person fill a prescription for PrEP) PrEP Adherence (analysis of intracellular tenofovir+emtricitabine concentration in dried blood spot)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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