Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians (PrEPDSA)
Verified April 2019 by St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Information provided by (Responsible Party)
St. Michael's Hospital, Toronto
First received: January 22, 2018
Last updated: April 10, 2019
Last Verified: April 2019
History of Changes
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
Behavioral : Decision Support Aid and PrEP for Black Canadians
Intervention Model: Single Group Assignment
Intervention Model Description: 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. Investigators supply one smartphone/ participant,each registered to St. Mike's Hospital to protect participant privacy. The decision support aid will be a pre-programmed bookmark, an RA will give participants a brief tutorial on its use. Patients assigned to the experimental condition (LDQ + DS and HDQ + DS) will 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.
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||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|
Further study details as provided by St. Michael's Hospital, Toronto:
Primary Outcome Measures
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)
|Study Start Date:||April 9, 2019|
|Estimated Study Completion Date:||January 15, 2020|
|Estimated Primary Completion Date:||October 15, 2019 (Final data collection date for primary outcome measure)|
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.
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.
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- Non Black African Caribbean and or Canadian person
- Diagnosed with HIV and or AIDS
- Unable to consent to provide documentation of negative HIV status
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03637244
|Contact: LaRon E Nelson, PhD||416-864-6060 ext email@example.com|
|Contact: Pascal Djiadeu, PhD||416-360-4000 ext firstname.lastname@example.org|
Locations Show More
|St. Michael's Hospital Academic Family Health Team||Recruiting|
|Toronto, Ontario, Canada, M5B 1T8|
Contact: Rebecca Brown  416-864-6060 ext 77492  BrownRe@smh.ca
Contact: Cheryl Pedersen  416-864-6060 ext 77374  PedersenC@smh.ca
Principal Investigator: Aisha Lofters, MD
Sponsors and CollaboratorsSt. Michael's Hospital, Toronto
|Principal Investigator:||LaRon E Nelson, PhD||St. Michael's Hospital, Toronto|
|Responsible Party:||St. Michael's Hospital, Toronto|
|ClinicalTrials.gov Identifier:||NCT03637244 History of Changes|
|Other Study ID Numbers:||StMichaelnelsonla|
|Study First Received:||January 22, 2018|
|Last Updated:||April 10, 2019|
|Individual Participant Data|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by St. Michael's Hospital, Toronto:HIV PrEP Decision support African Caribbean Black Canadians
ClinicalTrials.gov processed this data on May 20, 2019
This information is provided by ClinicalTrials.gov.