| 1) Aged 18 to 45 years (inclusive) at Screening, verified per site SOP.
2) Assigned female sex at birth.
3) Able and willing to provide written informed consent to be screened for and enrolled in MATRIX-002 in one of the study languages (as specified in site SOP).
4) Able and willing to provide adequate contact/locator information, as defined in site SOP.
5) Able and willing to comply with all protocol requirements, including:
• Abstaining from all receptive sexual intercourse (vaginal, anal, digital, oral) for the first month of product use.
• Abstaining from using other intravaginal products for the first month of product use.
• Abstaining from engaging in intravaginal practices for the first month of product use.
• Refraining from participation in other research studies for the duration of the study unless approved by the Protocol Safety Review Team (PSRT).
• Responding to scheduled phone/short message service (SMS) contacts.
• Attending all clinic follow-up visits.
6) HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithms in Appendix II).
7) Per participant report, if in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive or to currently have a sexually transmitted infection (STI).
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8) Negative urine pregnancy test at Screening and Enrollment.
9) Participants over the age of 21 (inclusive) must have documentation of a Grade 0 Pap smear within the past 3 years prior to Enrollment, or a Grade 1 Pap smear at Screening with no treatment required, per 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, Corrected Version 2.1, July 2017.
10) Protected from pregnancy starting two weeks before Screening and continuing for the duration of study participation by an effective contraceptive method as confirmed by site SOP; effective methods include:
• Hormonal methods except vaginal rings
• Copper intrauterine device (IUD)
• Sterilization of participant
• Correct and consistent condom use (for US site only)
• Abstinence from penile-vaginal intercourse
5.2.2 Sexual Partners
Potential participants for the sexual partner IDI subset must meet all of the following criteria to be eligible for inclusion in the study:
1. Identifies as a sexual partner of a MATRIX-002 participant.
2. Identified by participant as a sexual partner during MATRIX-002 for whom the participant has given permission to contact (as specified in site SOP).
3. Able and willing to provide written informed consent in one of the study languages (as specified in site SOP).
4. Able and willing to complete the required study procedures.
5. Must be 18 years old or above at the time of their study participation, verified per site SOP. |
1) Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period:
• Become pregnant.
• Breastfeed.
• Relocate away from the study site.
• Travel away from the study site for a time period that would interfere with product resupply and/or study participation.
2) Positive HIV test at Screening or Enrollment.
3) Positive test for Trichomonas vaginalis (TV), Neisseria gonorrhea (GC), Chlamydia trachomatis (CT), or Treponema pallidum (Syphilis) at Screening or (per participant report) treated for potential STI within past 12 months.
4) Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), or reproductive tract infection (RTI) requiring treatment per WHO guidelines at Enrollment.
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Note: Otherwise eligible participants diagnosed during screening with a UTI, symptomatic yeast infection or symptomatic BV infection are offered treatment consistent with WHO recommendations. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
5) Clinically apparent Grade 2 or higher pelvic exam finding per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) at Enrollment.
Note: Otherwise eligible participants with exclusionary pelvic exam findings at Screening may be enrolled/randomized if treatment is begun at least 7 days prior to enrollment and findings have improved to a non-exclusionary severity grading or resolved by the time of enrollment. Spotting/bleeding will be considered exclusionary only if greater than what would be expected from contraceptive use.
6) Participant report and/or clinical evidence of any of the following:
• Known adverse reaction to any of the study product materials (ever).
• Hysterectomy.
• Use of diaphragm, NuvaRing, or (for African sites only) spermicide for contraception in the two weeks prior to Screening.
• Antibiotic or antifungal (oral or intravaginal) therapy within 7 days of Enrollment.
• Prior use of post-exposure prophylaxis (PEP) or oral pre-exposure prophylaxis (PrEP) (including FTC/TDF) in the 4 weeks prior to Screening or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir).
• Use of any of the following in the 12 months prior to Screening: stimulants (cocaine [including crack], methamphetamine, or non-physician prescribed pharmaceutical-grade stimulants), or inhaled nitrates, or illicit injection drug use of any kind.
• At Screening or Enrollment, as determined by the Investigator of Record (IoR)/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease.
7) Has any of the following laboratory abnormalities at Screening:
• Grade 2 or higher Aspartate aminotransferase (AST), alanine transaminase (ALT), creatinine, or Hemoglobin per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
8) Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. |
Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
45 Year(s) |
Female |