At Risk for HIV Clinical Trial
— PrepSmartOfficial title:
PrEP SMART PHASE I TRIAL
Verified date | July 2016 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, "the app").
Status | Completed |
Enrollment | 12 |
Est. completion date | May 4, 2017 |
Est. primary completion date | May 4, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Male - 18-30 years of age - Self-report having sex with men in the past 6 months - Currently prescribed PrEP (Truvada) for HIV prevention - English-speaking - Participant has an Android or iOS smartphone Exclusion Criteria: - History of chronic/significant medical or psychiatric condition that will interfere with study participation - Unable to attend sessions |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Intelligent Automation, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility as measured by the average number of times per day participants initiate an interaction with PrEP Smart | 4 weeks | ||
Primary | Feasibility as measured by the average number of times per day subjects respond to a prompt from PrEP Smart over the course of the four week period. | 4 weeks | ||
Secondary | Barriers to adherence following missed doses as measured by daily PrEP Smart assessment. | 4 weeks | ||
Secondary | Acceptability as measured by questionnaire that includes questions about satisfaction and likelihood of recommending to others on a Likert scale of 1 to 4. | 4 weeks | ||
Secondary | Acceptability as measured by an interview that will be conducted by the Principal Investigator. | 4 weeks | ||
Secondary | Barriers to adherence will be measured by the number of times it was taken outside of a 1 hour window | 4 weeks | ||
Secondary | Barriers to adherence will be measured by self-report via the PrEP Smart application. | 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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