Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
Key facts
- Where
- Harare, ZimbabweSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 39 years old?
Source: NCT07288190, who can take part
Where in Zimbabwe
- Spilhaus CRSHarare, ZimbabweNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HIV Prevention Trials Network
- Trial code
- NCT07288190
- Record updated
- 19 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; 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: 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); 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; Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past; 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.