At Risk for HIV Clinical Trial
— PrEP for HBCUsOfficial title:
PrEP for HBCUs (Study 2)
Verified date | March 2018 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators' overall goals are to target (a) pre-exposure prophylaxis (PrEP) uptake by addressing access and acceptability and (b) PrEP adherence among Historically Black Colleges and Universities (HBCU) students.
Status | Completed |
Enrollment | 16 |
Est. completion date | October 1, 2018 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Enrolled as a student in a Historically Black College or University, OR identify as Black/African American - Male - Self-report having sex with men in the past 6 months - 18-30 years of age - English-speaking - Currently prescribed PrEP (Truvada) for HIV prevention - Participant has an Android (using v5.x.x or lollipop) or iOS (v6.0) smartphone Exclusion Criteria: - History of a 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 number of times per day that subjects initiate an interaction with PrEP Smart | As measured by the number of times per day that subjects initiate an interaction with PrEP Smart | 8 weeks | |
Primary | Feasibility as measured by the number of times per day that subjects respond to a PrEP Smart prompt | As measured by the number of times per day that subjects respond to a PrEP Smart prompt | 8 weeks | |
Secondary | Acceptability will be assessed during the final laboratory visit with an open ended qualitative interview assessing overall feedback | Will be assessed during the final laboratory visit with an open ended qualitative interview assessing overall feedback. | 8 weeks | |
Secondary | Acceptability will be assessed by feedback specific to each of the six individual PrEP Smart features | Will be assessed by feedback specific to each of the six individual PrEP Smart features. | 8 weeks | |
Secondary | Adherence will be assessed by the number of times that PrEP was taken daily over the 8 week period and the number of times that it was taken outside of a one hour window in which it was prescribed | Will be assessed by the number of times that PrEP was taken daily over the 8 week period and the number of times that it was taken outside of a one hour window in which it was prescribed. | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02895893 -
PrEP SMART Phase I Trial
|
Phase 1 | |
Completed |
NCT01347164 -
Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men
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Phase 2 |