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
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 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
- 是
入选标准
- •Self identify as Black African, Caribbean and or Canadian
- •HIV sero-negative
- •Not in a monogamous sexual partnership with a recently tested HIV negative man
- •Self report unprotected anal sex with a man in the past six months
- •Diagnosed with gonorrhea, chlamydia or syphilis in the past six months
- •Are in an ongoing sexual relationship with an HIV positive partner
- •Currently live in the Greater Toronto metropolitan area
- •Can speak and understand either English or French
排除标准
- •Non Black African Caribbean and or Canadian person
- •Diagnosed with HIV and or AIDS
- •Unable to consent to provide documentation of negative HIV status
研究组 & 干预措施
Experimental Condition
Patients assigned to the experimental condition (LDQ + DS and HDQ + DS) will be asked to use the bookmarked link to the decision-aid within the first 7-14 days (and thereafter as needed) during the study period. The routine care group will be asked to use a bookmarked link to frequently asked questions on tenofovir + emtricitabine for PrEP. All groups will be compared on decision-quality at 14-days, self-reported PrEP initiation at 30-days, and PrEP adherence at 60-days post enrollment.
干预措施: Decision Support Aid and PrEP for Black Canadians (Behavioral)
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