NCT07288190

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

A Multisite, Open-label, Randomized Crossover Study Comparing Adherence to a Single Daily Dual Prevention Pill (DPP) Versus FTC/TDF and Combined Oral Contraception Separate Pill Dosing (2PR), Given for Pre-exposure Prophylaxis and Pregnancy Prevention in Women

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: HIV Prevention Trials Network · Network
• Sex: Female
• Age: 16 Years – 39 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

To evaluate adherence to a single DPP consisting of co-formulated Tenofovir Disoproxil Fumarate and Emtricitabine (FTC/TDF) plus combined ethinyl estradiol/levonorgestrel oral contraceptive (COC), compared with a two-pill regimen (2PR) consisting of daily oral FTC/TDF pill and combined COC pill, for pre-exposure prophylaxis PrEP and pregnancy prevention in women without HIV.

Conditions

• Pregnancy
• HIV Infections

Interventions

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

Timeline

• Start date: 2026-05-15
• Primary completion: 2028-05-15
• Completion: 2028-05-15
• First posted: 2025-12-17
• Last updated: 2026-02-19

Locations

3 sites across 3 countries: Eswatini, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study