A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings

Assigned female sex at birth Note: Participants who are female at birth, who now identify as male, will not be excluded so long as they are not on female-to-male transition therapy.

Age 18 through 45 years (inclusive) at Screening, verified per site SOPs

Able and willing to provide written informed consent to be screened for and enrolled in MTN-036/IPM 047

Able and willing to provide adequate locator information, as defined in site SOPs

Able to communicate in spoken and written English

Available for all visits and able and willing to comply with all study procedural requirements

Willing to comply with abstinence and other protocol requirements

Willing to use male condoms for penile-vaginal intercourse (PVI) and penile-rectal intercourse for the duration of study participation

Per participant report, using an effective method of contraception for at least 30 days (inclusive) prior to Enrollment, and intending to continue use of an effective method for the duration of study participation; effective methods include:

1. hormonal methods (except contraceptive ring)

2. intrauterine device (IUD)

3. sterilization (of participant or partner, as defined in site SOPs)

4. having sex exclusively with cis-women

5. abstinence from PVI for 90 days prior to Enrollment, and intending to remain abstinent from PVI for the duration of study participation

HIV-uninfected based on testing performed at Screening and Enrollment

Per participant report at Screening, regular menstrual cycles with at least 21 days between menses Note: This criterion is not applicable to participants who report using a progestin-only method of contraception at Screening (e.g., Depo-Provera or levonorgestrel-releasing IUD) nor to participants using continuous combination oral contraceptive pills, as the absence of regular menstrual cycles is an expected, normal consequence in this context.

Per participant report at Screening and Enrollment, states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina including, but not limited to spermicides, female condoms, diaphragms, intravaginal rings, vaginal medications, menstrual cups, cervical caps, douches, lubricants, and sex toys (vibrators, dildos, etc.) for the 24 hours preceding the Enrollment Visit and for the duration of study participation.

Note: Use of tampons is permitted except for 24 hours prior to clinic visits in which CVF samples are scheduled to be collected.

Participants over the age of 21 (inclusive) must have documentation of a satisfactory Pap within the past 3 years prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.1, March 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result

At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products or vaccines after the Screening Visit and for the duration of study participation

What this study is about