Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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.

The study will take place in the Toronto metropolitan area (pop. 2.5 million). Over half (59%) of Canada's ACB population is settled in the province of Ontario. Moreover, the majority (70%) of ACB people in Ontario live in metro Toronto, making it the ideal location for this study. The trial procedures will be conducted at sites within the St. Michael's Hospital (SMH) system, including the SMH Li Ka Shing Knowledge Institute. ;

Study Design

Related Conditions & MeSH terms

HIV/AIDS

Clinical Trial Details

NCT number	NCT03637244
Study type	Interventional
Source	St. Michael's Hospital, Toronto
Contact	LaRon E Nelson, PhD
Phone	416-864-6060
Email	nelsonla@smh.ca
Status	Recruiting
Phase	N/A
Start date	April 9, 2019
Completion date	January 15, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians — PrEPDSA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms