Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
NCT ID: NCT07288190
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2026-03-15
2028-03-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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DPP/2PR/Choice
Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
DPP
Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
2PR
Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
Free Choice
Choice of either DPP or 2PR
2PR/DPP/Choice
Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice
DPP
Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
2PR
Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
Free Choice
Choice of either DPP or 2PR
Interventions
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DPP
Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
2PR
Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
Free Choice
Choice of either DPP or 2PR
Eligibility Criteria
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Inclusion Criteria
* Adults must be able and willing to provide informed consent. Adolescents (16- and 17-year-olds) will be consented according to applicable local guidelines, by obtaining participant assent and where applicable parental or guardian permission.
* Able and willing to provide adequate locator information.
* Able and willing to comply with all study procedures.
* Must be post-menarche and pre-menopausal and could potentially become pregnant.
* Sexually active, defined as having had penile-vaginal sex within the 3 months before Screening (per self-report)
* Negative pregnancy test at Screening and Enrollment.
* Does not intend to become pregnant within the next 12 months.
* Willing to use COCs for at least 48 weeks as their method of contraception.
* HIV negative at Screening and Enrollment.
* Willing to use oral PrEP for at least 48 weeks.
* Hepatitis B (HBV) surface antigen (HbsAg) negative per blood test at Screening.
* Hepatitis C (HCV) negative at Screening.
* Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening.
Exclusion Criteria
* Unable to become pregnant e.g., had a tubal ligation or hysterectomy or otherwise lacks a uterus, or is currently using another form of contraception.
* Medically ineligible for combined hormonal contraception and specifically COCs per World Health Organization (WHO) medical eligibility criteria for contraceptive use or similar local medical eligibility guidelines (e.g., Centers for Disease Control and Prevention eligibility criteria).
* Medically ineligible for PrEP based on WHO and/or local guidelines.
* Using or planning to use another pregnancy prevention product other than oral contraception (condoms are permitted) during the next 48 weeks.
* Using or planning to use another HIV prevention product other than condoms during the next 48 weeks.
* Any other condition the clinician feels would jeopardize the health and wellbeing of the participant
16 Years
39 Years
FEMALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
HIV Prevention Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Lisa Haddad, MD
Role: STUDY_CHAIR
Population Council
Harriet Nuwagaba-Biribonwoha, MD
Role: STUDY_CHAIR
ICAP at Columbia University
Central Contacts
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Other Identifiers
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HPTN 104
Identifier Type: -
Identifier Source: org_study_id