Rural PrEP Delivery



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:12/20/2018
Start Date:February 1, 2018
End Date:October 2019
Contact:Michael Ohl, MD
Email:michael-ohl@uiowa.edu
Phone:319-384-8023

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A Brief, Pragmatic Experiment to Determine the Impact of a Public-health-partnered Tele-pharmacist Model for PrEP Delivery in a Rural State

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.

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.

Inclusion Criteria:

1. Public health client in CTR-PS programs

2. Rural or small urban-dwelling residents (Iowa residence NOT residing in Polk, Linn,
Scott, or Pottawattamie counties)

3. Adults (age 18+)

4. Referred by public health for PrEP based on:

HIV-negative by recent (< or = 14 days) testing AND one of following

1. men sexually active with male partner(s) in the past six months, not in a monogamous
partnership with a recently-tested HIV negative man, and reporting either anal sex
without condoms in the past six months, any STI in past six months, or relationship
with an HIV-positive partner,

OR

2. sexually-active heterosexual men and women not in a monogamous relationship with an
HIV-negative partner and reporting either condom-less sex with partners of unknown HIV
status at high risk for HIV infection, or an ongoing sexual relationship with an
HIV-positive partner,

OR

3. intravenous drug users (IDU) injecting drugs in the past six months and reporting
either sharing of drug equipment, receipt of methadone or buprenorphine treatment in
the past six months, or risk of sexual acquisition.

Exclusion Criteria:

1. Self-reported current PrEP use

2. Self-reported inability to access a computer, smartphone, or tablet.

3. Residence in a large urban County (i.e. Polk, Linn, Scott, Pottawattamie)

4. HIV positive status
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-775-0689
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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