Pilot Randomized Controlled Trial of a Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis Adoption and Adherence among African, Caribbean, and Black Canadian STD Clinic Patients
|Dates:||1/1/2017 - 12/31/2019|
|Principal Investigator:||LaRon Earnest Nelson, PhD, RN, FNP, FNAP, FAAN|
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 Black (ACB) populations in Ontario. Although ACBs represent only 12% of the Ontario population, they account for 30% of HIV prevalence and 25% of new infections in the province. ACB individuals seeking sexual health clinic services are an important high risk population to target for PrEP use. Significant scientific gaps remain regarding the best strategies for supporting PrEP scale up among ACB individuals. Research evidence on self-determination theory (SDT) indicates that informed and autonomous decision making is a central component to facilitating motivation for long term maintenance of health behaviors, such as daily oral PrEP. There is no known intervention that provides decision support to ACB individuals making choices regarding PrEP initiation. There is also a gap in evidence for how the quality of ACB individuals’ decisions to initiate PrEP is related to PrEP adherence. We propose two aims to address these gaps in HIV prevention and implementation science. Our first primary aim is to adapt the Ottawa Decision Aid Framework for use in the HIV PrEP decisional needs of ACB sexual health clinic patients. We will purposively select ACB patients from four Peel Region sexual health clinics who want to start PrEP (n = 10), do not want to start (n = 10) and remain undecided (n = 10) for one-one-one qualitative interviews. We will target 50% recruitment of MSM in each of these three decision-groups. In the interviews we will inquire about their (1) concerns about PrEP and barriers to PrEP initiation, (2) normative beliefs on PrEP and (3) decision-making process regarding PrEP use. We will use the qualitative findings to guide the adaptation of the Ottawa Decision-Support Framework for use in support of PrEP decisional-needs of ACB patients. Our second primary aim is to pilot test the decision-aid intervention using a two-arm randomized design to estimate effect size compared to control condition in increasing PrEP adoption and adherence over 60-days. We will recruit 40 PrEP-eligible ACB patients through four Peel Region STI clinics to participate in a 60-day trial of a PrEP decision aid. All participants will complete a baseline questionnaire assessing decision-quality with regard to their initiation of PrEP. We will dichotomize scores into low decision-quality (LDQ) (n=20) v. high (HDQ) group (n=20). We will randomly assign half of the individuals in each group to a control condition and the other half to a PrEP decision-support condition. All groups will be compared on decision-quality at 14-days post-enrollment, PrEP initiation at 30-days, and PrEP adherence at 60-days post enrollment. Hypothesis testing will be deemphasized in favor of generating effect size estimates. We will use findings from the pilot RCT to inform the preliminary studies section of a R01 application to conduct an implementation science study of multicomponent HIV prevention intervention packages customized for African, Caribbean and Blacks patients.