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

HIV/AIDS Clinical Trial

— PrEPDSA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03637244
• Other study ID #: StMichaelnelsonla
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: April 2019
• Source: St. Michael's Hospital, Toronto
• Contact: LaRon E Nelson, PhD
• Phone: 416-864-6060
• Email: nelsonla[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 15, 2020
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital Academic Family Health Team	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians	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.