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Project PrEPare
NCT01772823Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2012
- Primary completion
- Nov 2015
- Countries
- 1
- Sponsor
- University of North Carolina at Chapel Hill
- Modality
- Small Molecules
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 2, open-label trial of emtricitabine + tenofovir disoproxil in human immunodeficiency virus infection (HIV) (2 arms), sponsored by University of North Carolina at Chapel Hill. Primary endpoints: Number of Participants With Serum Creatinine Event of Grade 1 or Higher at 48 weeks, Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) at 48 weeks and 9 more. Started Nov 2012; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
3MV + PrEP
Many Men, Many Voices behavioral intervention followed by daily Truvada PrEP
PCC + PrEP
Personalized Cognitive Counseling behavioral intervention followed by daily Truvada PrEP
03
Who it enrols
HIV-uninfected young men who have sex with men (18-22 years) at high risk of HIV acquisition, with normal renal function and no history of non-traumatic bone fractures.
04
Endpoints
Primary
Number of Participants With Serum Creatinine Event of Grade 1 or Higher
Number of Participants With Decrease in Absolute Bone Mineral Density (BMD)
Lumbar Spine Bone Mineral Density
Femoral Neck Bone Mineral Density
Total Body Bone Mineral Density
Secondary
Acceptability and Feasibility of Sexual Risk Reduction Interventions
Acceptability and Feasibility of Text Message Reminders
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