NCT07288190Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 15 May 2026
- Primary completion date
- 15 May 2028
- Lead sponsor
- HIV Prevention Trials Network
- Diseases
- HIV
- NCT number
- NCT07288190
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 15 May 2026 to the primary completion date, 15 May 2028
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 16 years to 39 years · Sex: Female · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eswatini Prevention Center CRS Coordinator of this site? Confirm its status | Mbabane | Eswatini | Unknown status |
| MU-JHU Research Collaboration (MUJHU CARE LTD) CRS Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Spilhaus CRS Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.