Rural PrEP Delivery
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The goal of this research study is to evaluate the preliminary impact of a
      public-health-partnered tele-pharmacist model for pre-exposure prophylaxis (PrEP) delivery in
      a rural state ("TelePrEP"). In brief, PrEP involves daily use of a medication (i.e. Truvada)
      to prevent HIV infection among people at risk for infection due to sexual exposure or needle
      sharing. In this study, PrEP eligible rural and small urban-dwelling public health clients
      wil be enrolled in a prospective study to follow their progression through PrEP care
      following public health referrals. The study will involve a baseline survey to gather data on
      participant beliefs and attitudes about PrEP and a follow up telephone survey 30-40 days
      later to ascertain whether participants have engaged in PrEP. Medical records will be
      requested as a second method to determine whether participants have started PrEP and whether
      they are still using PrEP after six months. The hypotheses that PrEP initiation and retention
      are higher in regions with TelePrEP programs will be tested against control regions.
    

Detailed description: 
      The Iowa Department of Public Health (IDPH) and The University of Iowa (UI) have collaborated
      to develop a public-health-partnered tele-pharmacist model that meets these needs
      ("TelePrEP"). TelePrEP was developed and piloted as a quality improvement program and uses
      only standard of care interventions (e.g. PrEP) and routinely applied healthcare delivery
      strategies (e.g. telemedicine, pharmacist collaborative practice models). In overview,
      TelePrEP begins by systematically identifying clients with PrEP indications in county public
      health clinics and affiliated sexually-transmitted disease (STD) programs serving rural and
      small urban communities in Iowa. Public health personnel then refer clients with PrEP
      indications to a tele-pharmacist service at UIHC that uses mobile video visits,
      locally-obtained laboratory studies, and medication delivery by mail to provide PrEP, without
      requiring in-person provider visits. The overall goal is to improve PrEP access and
      engagement in rural and small urban areas by systematically identifying high risk-individuals
      in public health programs, and referring these individuals to a geographically-scalable
      tele-pharmacist PrEP clinic that overcomes barriers related to distance and stigma.

      The TelePrEP program was piloted locally in Johnson County, and in 2018 the IDPH and UI will
      collaborate to scale it up across Iowa. In parallel with scale up of the TelePrEP program, a
      research study will be conducted to determine the impact of TelePrEP on PrEP use among rural
      and small urban -dwelling public health clients. In a quasi-experimental study, the local
      public health departments in Iowa and their affiliated HIV/STD programs will be divided into
      TelePrEP intervention and control groups, based on geographic region. This is appropriate
      because it will not be feasible to implement the TelePrEP program in all Public health sites
      simultaneously, so some sites will start the program later than others by necessity. Public
      health personnel in control regions will refer PrEP-eligible clients to available
      community-based PrEP providers, the current "standard of care." Public health personnel in
      TelePrEP intervention regions will refer clients to their choice of in-person visits with
      available community PrEP providers or TelePrEP.

      Primary Objective: Estimate the impact of TelePrEP on the overall rate of PrEP engagement
      among rural and small urban public health clients.

        -  To compare total rates of PrEP engagement among PrEP-eligible clients in intervention
           and control regions, defining PrEP engagement as any provider visit (i.e. in-person
           community provider visit or tele-pharmacist) to discuss PrEP AND a Truvada® prescription
           within 30 days of public health referral.

        -  Hypothesis 1: TelePrEP will increase PrEP engagement from 5% in control regions to 25%
           in TelePrEP intervention regions.

      Secondary Objective: Quantify retention of public health clients in TelePrEP.

        -  Following PrEP engagement, we will measure the proportion of clients who are retained in
           PrEP six months following engagement, defining retention as a tele-pharmacist video or
           community PrEP provider visit between days 150 and 210 with self-reported Truvada® use
           in the past week.

        -  Hypothesis 2a: Over 50% of clients engaging in TelePrEP will be retained at 6 months.

        -  Hypothesis 2b: Retention in PrEP will be greater in TelePrEP regions.
    

Intervention name(s): Intervention Group
Intervention type(s): Behavioral
Intervention description(s): The goal of this research study is to evaluate the preliminary impact of a public-health-partnered tele-pharmacist model for pre-exposure prophylaxis (PrEP) delivery in a rural state ("TelePrEP"). In brief, PrEP involves daily use of a medication (i.e. Truvada) to prevent HIV infection among people at risk for infection due to sexual exposure or needle sharing.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention