Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR

Sponsor
HIV Prevention Trials Network
Study ID
NCT07288190
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • DPP — DRUG
    Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
  • 2PR — DRUG
    Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
  • Free Choice — DRUG
    Choice of either DPP or 2PR

Study Details

To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.

Key Dates

First listed
Dec 17, 2025
Start date
May 15, 2026
Status verified
Feb 2026
Primary completion
May 15, 2028
Completion
May 15, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: DPP/2PR/Choice
    Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
  • Experimental: 2PR/DPP/Choice
    Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice

Primary Outcome Measure

PrEP adherence to DPP during randomized crossover period 1 [ Time Frame: Week 12 ]

Central Contacts

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