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

NCT07288190 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • HIV Prevention Trials Network

    lead NETWORK

Principal Investigators

  • Lisa Haddad, MD · Population Council

  • Harriet Nuwagaba-Biribonwoha, MD · ICAP at Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-05-15
Completion
2028-05-15
FDA Drug
Yes

Countries

  • Eswatini
  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288190 on ClinicalTrials.gov