Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age16-39
SponsorHIV Prevention Trials Network
About this trial
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.
Eligibility criteria
Qualifiers
Age 16 through 39 years old (inclusive) at Screening.
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.
Disqualifiers
Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.
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.
Trial design
Treatments tested in this trial
- DPP
- 2PR
- Free Choice
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
HIV Prevention Trials Network
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov