HIV/AIDSNCT03343223
Rural PrEP Delivery
A study testing Intervention Group in people with HIV/AIDS, run by Michael Ohl at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- OR
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
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
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Intervention Group
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of TelePrEP on overall rate of PrEP engagement
Rates of PrEP engagement among PrEP-eligible clients in intervention and control regions
Measured: 30 days
Secondary outcomes (1)
Retention of clients in TelePrEP
Proportion of clients who are retained in PrEP six months following engagement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Ohl
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Michael Ohl, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343223
- Sponsor's protocol ID
- 201711710
- Status last verified
- Oct 2020
- First submitted
- 10 Nov 2017
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03343223
- Acronym / sponsor ID
- 201711710
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Michael OhlUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention Group1. 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe 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. | Behavioural | Intervention Group |
Primary outcome
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
1 secondary outcome
Retention of clients in TelePrEP
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with HIV/AIDS, run by Michael Ohl at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of TelePrEP on overall rate of PrEP engagement (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.