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

NCT03637244 | Unknown

• 1 other identifier: StMichaelnelsonla
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

HIV PrEP Decision support African Caribbean Black Canadians

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Experimental Condition

EXPERIMENTAL

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

Interventions

Decision Support Aid and PrEP for Black Canadians BEHAVIORAL

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.

Experimental Condition

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: men, women cisgender and transgender inclusive based on self representation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital Academic Family Health Team

Toronto, Ontario, M5B 1T8, Canada

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• LaRon E Nelson, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LaRon E Nelson, PhD

CONTACT

416-864-6060; nelsonla@smh.ca

Pascal Djiadeu, PhD

CONTACT

416-360-4000; djiadeup@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: August 17, 2018
• Study Start: April 9, 2019
• Primary Completion: October 15, 2019
• Study Completion: January 15, 2020
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)