PrEP for HBCUs (Study 2)

NCT03080597 | Completed

• 1 other identifier: Pro00076107
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

At Risk for HIV

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Acceptability will be assessed during the final laboratory visit with an open ended qualitative interview assessing overall feedback

  8 weeks

• Acceptability will be assessed by feedback specific to each of the six individual PrEP Smart features

  8 weeks

• 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

  8 weeks

Study Arms (1)

Smartphone app condition

EXPERIMENTAL

English-speaking males, between the ages of 18-30, who are enrolled at a HBCU or identify as Black/African American, who are currently prescribed PrEP (Truvada) for HIV Prevention, and owners of either an Android or iOS smartphone, will be asked to use an application on their smart phones called "PrEP Smart".

Device: PrEP Smart app

Interventions

PrEP Smart app DEVICE

English-speaking males, between the ages of 18-30, who are enrolled at a HBCU or identify as Black/African American, who are currently prescribed PrEP (Truvada) for HIV Prevention, and owners of either an Android or iOS smartphone, will be asked to use an application on their smart phones called "PrEP Smart".an application on their smart phones called "PrEP Smart".

Smartphone app condition

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• History of a chronic/significant medical or psychiatric condition that will interfere with study participation
• Unable to attend sessions

Sponsors & Collaborators

• Duke University: lead
• Intelligent Automation, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• John T Mitchell, Ph.D.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: March 15, 2017
• Study Start: March 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2018-03

Locations

US (1)