Using Smart Phone Technology to Support PrEP Uptake and Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using Smart Phone Technology to Support PrEP Uptake and Adherence in Virginia - Pilot Study

Conditions
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HIV Prevention, PrEP, Adherence, Medication

Intervention / Treatment
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* Behavioral: Use of smart phone technology to support medication adherence and uptake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: HIV positive individuals Persons under the age of 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single pilot arm<br>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. | Behavioral: Use of smart phone technology to support medication adherence and uptake<br>* Use of smart phone technology to support medication adherence and uptake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Overall percentage of PrEP medication adherence | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | How usable is the app to both patient participants and provider participants | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Prevention, Adherence, Uptake