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

April 10, 2019 updated by: Unity Health Toronto

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1T8
        • Recruiting
        • St. Michael's Hospital Academic Family Health Team
        • Contact:
          • Rebecca Brown
          • Phone Number: 77492 416-864-6060
          • Email: BrownRe@smh.ca
        • Contact:
        • Principal Investigator:
          • Aisha Lofters, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • Non Black African Caribbean and or Canadian person
  • Diagnosed with HIV and or AIDS
  • Unable to consent to provide documentation of negative HIV status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Decision Support Aid and PrEP for Black Canadians
Ottawa Decision Support Framework Adaptation.Investigators will use the inputs from the qualitative findings, CDC public health guidance and the tenofovir + emtricitabine product monograph to tailor the ODSF for use in the C5TM PrEP decision support web-app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians
Time Frame: 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)
Self-reported PrEP initiation at 30-days and PrEP adherence at 60-days post enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: LaRon E Nelson, PhD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2019

Primary Completion (Anticipated)

October 15, 2019

Study Completion (Anticipated)

January 15, 2020

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StMichaelnelsonla

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study findings (no identifiable data is included) will be shared via study participant focused community meeting first. Then findings will be published in peer reviewed journals and other relevant publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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