Rural PrEP Delivery
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|ClinicalTrials.gov Identifier: NCT03343223|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Intervention Group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Brief, Pragmatic Experiment to Determine the Impact of a Public-health-partnered Tele-pharmacist Model for PrEP Delivery in a Rural State|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Intervention Group
Behavioral: Intervention Group
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.
No Intervention: Control Group
- Impact of TelePrEP on overall rate of PrEP engagement [ Time Frame: 30 days ]Rates of PrEP engagement among PrEP-eligible clients in intervention and control regions
- Retention of clients in TelePrEP [ Time Frame: 6 months ]Proportion of clients who are retained in PrEP six months following engagement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343223
|Contact: Michael Ohl, MDfirstname.lastname@example.org|
|Contact: Shelby L Francis, PhDemail@example.com|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Shelby L Francis, PhD 319-775-0689 firstname.lastname@example.org|