HIV Preventionprep'dNCT04868383
Using Smart Phone Technology to Support PrEP Uptake and Adherence
A study testing Use of smart phone technology to support medication adherence and uptake in people with HIV Prevention and PrEP, run by University of Virginia at 1 site in United States.
Trial summary
This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention, PrEP, Adherence, Medication
- What is being tested?
- Use of smart phone technology to support medication adherence and uptake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 30 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- one or considering being on PrEP for HIV prevention
- Patient at a VDH or VDH funded clinic
- ability to read at a 5th grade reading level
Who cannot join
- HIV positive individuals
- Persons under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Department of Health
Charlottesville, Virginia, 22908
About this study
Official title: Using Smart Phone Technology to Support PrEP Uptake and Adherence in Virginia - Pilot Study
This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia.
Read the detailed description
Testing the impact of a smart phone application's impact on PrEP uptake and adherence.
The app features daily medication reminders, daily mood and stress evaluations, a community message board for social support, and patient-provider secure, HIPAA compliant private messaging between patients and clinic providers. Participants will be recruited from VDH clinics. We will evaluate the adherence and uptake rates of PrEP among study participants. Usage data will be collected from the application, and from participant surveys at 30 day, 3 month, and 6 month study timepoints. Surveys will include questionnaires on medication adherence, empathy of providers, experiences with the app, stigma and disclosure attitudes, and social support, along with mental health screening. The study will be analyzed as a prospective one arm study by comparing baseline to 3M and 6M surveys, along with examining and characterizing app usage across time.
- Conditions
- HIV Prevention, PrEP, Adherence, Medication
- Being tested
- Use of smart phone technology to support medication adherence and uptake
- Keywords
- HIV, Prevention, Adherence, Uptake
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of smart phone technology to support medication adherence and uptakeBehavioural
Use of smart phone technology to support medication adherence and uptake
| Study group | Role | What they receive |
|---|---|---|
| Single pilot arm | Experimental | In this single arm pilot study, all participants will receive access to a novel smartphone app designed to support PrEP uptake and adherence for a 6 month period. Receives: Behavioral: Use of smart phone technology to support medication adherence and uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Overall percentage of PrEP medication adherence
Measured: 6 months
Secondary outcomes (1)
Usability
How usable is the app to both patient participants and provider participants
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 posted30 Apr 2021
- Study start1 Jan 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Department of Health
- Responsible party
- Principal investigator, Karen Ingersoll, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868383
- Sponsor's protocol ID
- 20478
- Acronym
- prep'd
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smart Phone Technology to Support PrEP Uptake and Adherence in Virginia - Pilot Study
- ClinicalTrials.gov ID
- NCT04868383
- Acronym / sponsor ID
- prep'd / 20478
- Conditions
- HIV Prevention, PrEP, Adherence, Medication
- Keywords
- HIV, Prevention, Adherence, Uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Virginia Department of Health
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 30 Apr 2021 (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.
This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia.
Detailed description
Testing the impact of a smart phone application's impact on PrEP uptake and adherence.
The app features daily medication reminders, daily mood and stress evaluations, a community message board for social support, and patient-provider secure, HIPAA compliant private messaging between patients and clinic providers. Participants will be recruited from VDH clinics. We will evaluate the adherence and uptake rates of PrEP among study participants. Usage data will be collected from the application, and from participant surveys at 30 day, 3 month, and 6 month study timepoints. Surveys will include questionnaires on medication adherence, empathy of providers, experiences with the app, stigma and disclosure attitudes, and social support, along with mental health screening. The study will be analyzed as a prospective one arm study by comparing baseline to 3M and 6M surveys, along with examining and characterizing app usage across time.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single pilot arm | Experimental | Behavioral: Use of smart phone technology to support medication adherence and uptakeIn this single arm pilot study, all participants will receive access to a novel smartphone app designed to support PrEP uptake and adherence for a 6 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- one or considering being on PrEP for HIV prevention
- Patient at a VDH or VDH funded clinic
- ability to read at a 5th grade reading level
Key exclusion criteria (2 listed)
- HIV positive individuals
- Persons under the age of 18
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 |
|---|---|---|
| Use of smart phone technology to support medication adherence and uptakeUse of smart phone technology to support medication adherence and uptake | Behavioural | Single pilot arm |
Primary outcome
Adherence
Time frame: 6 months
Overall percentage of PrEP medication adherence
1 secondary outcome
Usability
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 30 Apr 2021.
- 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 Use of smart phone technology to support medication adherence and uptake in people with HIV Prevention and PrEP, run by University of Virginia 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 4 inclusion and 2 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 30 Apr 2021. 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?
Adherence (time frame: 6 months). 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 30 Apr 2021.