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Rural PrEP Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343223
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Michael Ohl, University of Iowa

Tracking Information
First Submitted Date  ICMJE November 10, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
Impact of TelePrEP on overall rate of PrEP engagement [ Time Frame: 30 days ]
We will compare total rates of PrEP engagement among PrEP-eligible clients in intervention and control regions
Change History Complete list of historical versions of study NCT03343223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
Retention of clients in TelePrEP [ Time Frame: 6 months ]
Proportion of clients who are retained in PrEP six months following engagement
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
Retention of clients in TelePrEP [ Time Frame: 6 months ]
we will measure the proportion of clients who are retained in PrEP six months following engagement
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rural PrEP Delivery
Official Title  ICMJE A Brief, Pragmatic Experiment to Determine the Impact of a Public-health-partnered Tele-pharmacist Model for PrEP Delivery in a Rural State
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV/AIDS
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention Group
    1. Public health personnel identify PrEP-eligible clients.
    2. PrEP-eligible clients are given a list of PrEP providers in Iowa and a brochure with info on getting PrEP. Clients are referred to a PrEP navigator, who facilitates linkage to clients' choice of TelePrEP or to community PreP providers.
    3. Public health clients choosing TelePrEP complete a video visit with the tele-pharmacist and obtain PrEP relevant lab tests.
    4. PrEP medication is mailed to the client and follow up video visits and lab testing are performed.
    5. Within 7 days of enrollment, the subject will complete a survey regarding PrEP beliefs (20 minutes).
    6. 30 to 40 days after enrollment, the subject will complete a second survey with 4 questions about initiation of PrEP since study enrollment (10 minutes).
    7. 6 months following enrollment, a study team member will obtain medical records for the subject from PrEP providers in Iowa to determine if the subject has initiated and been retained in PrEP.
    Intervention: Behavioral: Intervention Group
  • No Intervention: Control Group
    1. Public health personnel identify PrEP-eligible.
    2. Public health personnel give PrEP-eligible clients a list of PrEP providers in Iowa, and a brochure with information on getting PrEP.
    3. The client initiates contact with a PrEP provider in Iowa and schedules an appointment.
    4. PrEP medication is mailed to the client and follow up video visits and lab testing are performed.
    5. Within 7 days of enrollment, the subject will complete a survey regarding PrEP beliefs (20 minutes).
    6. 30 to 40 days after enrollment, the subject will complete a second survey with 4 questions about initiation of PrEP since study enrollment (10 minutes).
    7. 6 months following enrollment, a study team member will obtain medical records for the subject from PrEP providers in Iowa to determine if the subject has initiated and been retained in PrEP.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 30, 2019)
234
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2017)
280
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03343223
Other Study ID Numbers  ICMJE 201711710
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Ohl, University of Iowa
Study Sponsor  ICMJE Michael Ohl
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE Not Provided
PRS Account University of Iowa
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP