Clinical trial NCT03637244: Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV PrEP Decision support African Caribbean Black Canadians
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians
timeFrame: Self-reported PrEP initiation at 30-days and PrEP adherence at 60-days post enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital Academic Family Health Team
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: LaRon E Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: