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MOBILEMEN: Oral vs Long-acting PrEP in Mobile Men
NCT06133686Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Apr 2024
- Primary completion
- Dec 2025
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Modality
- Small Molecules
- Drugs
- cabotegravir
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 3, randomised, open-label trial of cabotegravir in human immunodeficiency virus infection (HIV) (2 arms), sponsored by MRC/UVRI and LSHTM Uganda Research Unit. Primary endpoints: Persistent use of PrEP at 18 months and PrEP adoption (uptake and choice) at 18 months. Planned start Apr 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Oral TDF-FTC
Oral Tenofovir disoproxil fumarate/emtricitabine (daily or event-driven)
CAB-LA
Long-acting injectable cabotegravir
03
Who it enrols
HIV negative men aged 18+ who are mobile for work, weigh at least 35kg, and are willing to be randomized to oral or injectable PrEP.
04
Endpoints
Primary
Persistent use of PrEP
PrEP adoption (uptake and choice)
Secondary
Effective coital coverage
Safety, tolerability and acceptance
Reach of PrEP
Total and average cost
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