Recruiting

HIV PrEP

Sponsor:

Unity Health Toronto

Code:

NCT03637244

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Decision Support Aid and PrEP for Black Canadians

Study Details

Brief 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

Conditions

HIV/AIDS

Study ID

NCT03637244

Start date

Apr 9, 2019

Status verified date

Apr, 2019

Completion date

Jan 15, 2020

Anticipated

Primary completion date

Oct 15, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

LaRon E Nelson, PhD

416-864-6060nelsonla@smh.ca

Pascal Djiadeu, PhD

416-360-4000djiadeup@smh.ca

Locations

St. Michael's Hospital Academic Family Health Team

Recruiting

Toronto, Ontario, Canada, M5B 1T8

Contacts

Rebecca Brown

416-864-6060BrownRe@smh.ca

Cheryl Pedersen

416-864-6060PedersenC@smh.ca

Principal Investigator:

Aisha Lofters, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 12, 2019

Last verified

Apr, 2019

Keywords

  • HIV PrEP Decision support African Caribbean Black Canadians

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-04-12.