NCT03343223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

November 10, 2017

Last Update Submit

October 28, 2020

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • Impact of TelePrEP on overall rate of PrEP engagement

    Rates of PrEP engagement among PrEP-eligible clients in intervention and control regions

    30 days

Secondary Outcomes (1)

  • Retention of clients in TelePrEP

    6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Intervention Group

Control Group

NO INTERVENTION

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.

Interventions

Intervention GroupBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Public health client in CTR-PS programs
  • Rural or small urban-dwelling residents (Iowa residence NOT residing in Polk, Linn, Scott, or Pottawattamie counties)
  • Adults (age 18+)
  • Referred by public health for PrEP based on:
  • HIV-negative by recent (\< or = 14 days) testing AND one of following
  • 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,
  • 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,
  • 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.

You may not qualify if:

  • Self-reported current PrEP use
  • Self-reported inability to access a computer, smartphone, or tablet.
  • Residence in a large urban County (i.e. Polk, Linn, Scott, Pottawattamie)
  • HIV positive status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

February 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)