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.
Who can participate
Age range
16 Years – 39 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 Worl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PrEP adherence to DPP during randomized crossover period 1
Timeframe: Week 12
2
PrEP adherence to 2PR during randomized crossover period 1
Timeframe: Week 12
3
PrEP adherence to DPP during randomized crossover period 2
Timeframe: Week 24
4
PrEP adherence to 2PR during randomized crossover period 2