Table 2

Study products

RegimenDescriptionDose, route and frequency
A: dual prevention pill (DPP)Each DPP kit contains 28 capsules divided into 4 pouches, 1 per cycle week.
Each pouch contains a blister strip of 7 capsules (plus desiccant).

  • 3 pouches contain 21 pink and white capsules which each have 1 Truvada tablet (FTC 200 mg/TDF 300 mg) and one Zinnia F tablet (EE/LNG 30/150 µg).

  • 1 pouch contains 7 white capsules containing 1 Truvada tablet.

  • Participants will take 1 DPP capsule orally, once daily at approximately the same time each day for 12 weeks (cross-over period), taking the next consecutively numbered capsule from each pouch, in order (week 1, week 2, week 3, week 4). In South Africa, the DPP may be taken for ≤6 additional months (choice period).

  • If they miss 1 DPP capsule, participants will be instructed to take it as soon as they remember, up to the time of their next dose, but no more than 2 doses in a 24-hour period.

  • Participants will be counselled to use back-up contraception (eg, condoms or abstinence) for 7 days if they miss 2 or more consecutive doses.

B: 2 separate tabletsBottle of 30* Truvada (FTC/TDF 200/300 mg) tablets (PrEP)
Blister card of Zinnia F COCs: 21 white active EE/LNG 30/150 µg pills and 7 brown placebo pills (no hormone)

  • Participants will take 1 Zinnia F tablet and 1 Truvada tablet once daily. Tablets may be taken together or separately, but each tablet (Zinnia F, Truvada) should be taken at the same time each day.

  • Zinnia F tablets are to be taken in the order indicated on the pack, including the 7 placebo tablets. If a participant misses a COC dose, she will be instructed to take it as soon as she remembers. If a full day has passed, she should take 2 tablets the next day, per the label. Participants will be counselled to use back-up protection for 7 days if they miss ≥2 consecutive doses.

  • If a participant misses 1 Truvada dose, she will be counselled to take 1 tablet the next day, per the label, but not to take more than 1 dose in 24 hours.

  • Participants will be counselled that the effectiveness of PrEP may be reduced if doses are missed.

  • *At the end of the 28-day period, participants should have 2 Truvada tablets remaining in the bottle and will be instructed to return those tablets to the study clinic.

  • EE, ethinyl estradiol; FTC, emtricitabine; LNG, levonorgestrel; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate.