Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 18, 2019
Open Peer Review Period: Jun 21, 2019 - Jul 5, 2019
Date Accepted: Feb 4, 2020
Date Submitted to PubMed: Apr 29, 2020
(closed for review but you can still tweet)
A web-based intervention to reduce decision conflict regarding HIV pre-exposure prophylaxis: A clinical trial protocol
ABSTRACT
Background:
HIV pre-exposure chemoprophylaxis (PrEP) is recommended for populations at high ongoing risk for infection.There are noted racial disparities in the incidence of HIV and other sexually transmitted infections (STIs) for African, Caribbean, and Canadian Black (Black) populations in Ontario. Although Blacks represent only 4.7% of the Ontario population, they account for 30% of HIV prevalence and 25% of new infections in the province. The existing clinical public health practice toolkit has not been sufficient to optimize PrEP uptake,despite the overwhelming evidence of PrEP’s efficacy for reducing HIV transmission risk. Since its establishment as an effective HIV prevention tool, the major focus in behavioral research on PrEP has been on understanding and improving adherence . To date there is no known formalized intervention in place designed to support ACB men and women at high-risk to make high quality decisions regarding the adoption of PrEP as an HIV prevention practice.
Objective:
We propose two aims to address these gaps in HIV prevention and implementation science. 1. Adapt the Ottawa Decision Support Framework for use in the PrEP decisional needs of Black patients. 2. Pilot test the decision-support intervention to estimate effect size compared to control condition in reducing decision-conflict and predicting adherence over 60-days.
Methods:
Aim 1: We propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with PrEP eligible patients (n=30) and surveys with health professionals (n=20) involved in HIV PrEP management. Data obtained from Aim 1 will be used to develop a decision support intervention based on the Ottawa Decision Support Framework. AIM 2. Pilot test the adopted decision-support intervention using a block randomized design to estimate effect size compared to control condition in reducing decision-conflict and predicting adherence over 60-days. Hypothesis testing will be de-emphasized in favor of generating effect size estimates.
Results:
Research award was funded on March 25, 2017. Ethical approval was received on March 25 , 2019 (with supplemental approval received on May 10, 2019). Data collection started on April 9, 2019. As of June 16, 2019, we enrolled 9 patients and 16 health care providers for Aim 1. Aim 2 is scheduled to start in January 2020. Qualitative analysis have started with the development of the codebook. Expected results to be published by April 2020.
Conclusions:
This study will provide evidence-based information on the decisional needs of black patients who are at risk of HIV, and have been offered PrEP. The study will also test the effect of Decision Support Intervention in reducing decision conflict, adoption of PrEP and adherence among black patients. Clinical Trial: Clinicaltrials.gov NCT 03637244
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