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 range16 Years – 39 Years
SexFEMALE
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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…
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