Improving the HIV PrEP Cascade Using an Intervention for Healthcare Providers

Despite data indicating nearly 80,000 individuals starting HIV pre-exposure prophylaxis
(PrEP) by the end of 2015, the Centers for Disease Control and Prevention (CDC) estimates
that there are over 1.2 million adults with a substantial risk for HIV acquisition.
Therefore, only 6% of these individuals are receiving PrEP. One of the barriers to PrEP
implementation is lack of healthcare provider (HCP) knowledge and willingness to prescribe
it. In a 2015 national survey, only 66% of primary care clinicians were aware of PrEP.
However, once PrEP was defined, 91% indicated a willingness to prescribe it for high risk
patients and expressed an interest in education about how to deliver PrEP. A descriptive
report on the early experiences with PrEP uptake and delivery in San Francisco identified the
following priority steps for HCPs to address PrEP delivery issues and to maximize PrEP's
public health impact: (1) increase PrEP knowledge among HCPs and (2) expand PrEP access by
training HCPs and developing tools to facilitate PrEP delivery in clinical settings.
Additionally, based on the framework of the PrEP care continuum, interventions to enhance
PrEP uptake include HCP education, tools to assess sexual risk, and systems to minimize HCP
burden. Given these proposals and recommendations, innovative and effective approaches are
needed to support and provide guidance to HCPs regardless of level of experience prescribing
PrEP.

The investigators propose a PrEP optimization intervention targeted at HCPs to increase PrEP
uptake and persistence among those at risk for HIV acquisition. This intervention includes:
(1) an integrated web-based panel management tool called PrEP-Rx, which provides structured
HIV risk assessment, automates reminders for laboratory testing and appointments, and reports
patients' history of PrEP use; and (2) a centralized PrEP coordination overseen by a clinical
support staff (referred to as the PrEP coordinator) who can identify individuals at high risk
for HIV through direct patient contact or by reviewing registries for sexually transmitted
infections (STIs) and who can support multiple HCPs. PrEP-Rx consists of three components:
(a) Risk Assessment, (b) Provider Dashboard, and (c) Knowledge Base. The brief online
behavioral Risk Assessment will be provided to patients to complete prior to their initial
visits with HCPs. This assessment allows patients to respond to sensitive risk questions in
private, removes the need for HCPs to ask detailed risk questions, provides a standardized
and comprehensive view of patient's HIV risk, and decreases the time burden on HCPs. Based on
responses to the Risk Assessment, a patient's risk is categorized (high, medium, or low) and
results are presented to the HCP on a "Provider Dashboard" along with laboratory test results
that are required prior to PrEP initiation, and the patient's history of PrEP use (if
applicable). Based on these data, the HCP and patient can discuss the risks and benefits of
PrEP initiation. If a PrEP prescription is given, PrEP-Rx will generate automated follow-up
reminders which are sent to the PrEP Coordinator for scheduling office appointments or
laboratory visits. The activities of PrEP-Rx and the role of the HCP are augmented and
managed by the PrEP Coordinator, who has the ability to identify and contact patients who
have tested positive for STIs, follow-up with patients to minimize loss-to-follow-up and
improve adherence, and ensure timely laboratory monitoring. PrEP-Rx also contains a Knowledge
Base for HCP education and ongoing training.

Therefore, the investigators propose the following aims:

Primary Aim: Evaluate the efficacy of the PrEP optimization intervention (PrEP Coordinator +
PrEP-Rx) to increase PrEP prescriptions through a stepped-wedge design among 11 San Francisco
primary care clinics. The investigators hypothesize that the mean number of prescriptions
issued will be significantly higher when the clinics use the PrEP intervention versus when
they do not.

Secondary Aims:

1. Explore differences in PrEP initiation, duration of use, and reasons for discontinuation
based on patient's age, race/ethnicity, and sex/gender, and by clinic and HCP
characteristics among study clinics.

2. Explore sustainability of the intervention during an eight-month follow-up after the
Stepped-wedge Phase.

3. Investigate facilitators and barriers of PrEP delivery and experiences with the proposed
PrEP intervention through qualitative interviews with HCPs, PrEP Coordinators, and
clinic directors of study clinics.

The combination of the PrEP Coordinator plus PrEP-Rx has the potential to improve all steps
of the PrEP continuum and enhance overall care by identifying individuals at high risk of HIV
acquisition, standardizing HIV risk assessment, helping in PrEP initiation, systematizing
follow-up visits or laboratory assessments, and educating HCPs about emerging PrEP data.
These goals can have a significant public health impact and be attained with minimal burden
on existing clinic resources.

Inclusion Criteria:

- San Francisco Department of Public Health (DPH) clinics that have agreed to
participate

- HCPs and medical directors employed at the study clinics

- PrEP Coordinators who will be assigned to the study clinics

- Patients who are seen at these study clinics and are started on HIV PrEP during the
study