Inclusion Criteria:

1. Patients of legal age willing to provide independent informed consent for research per local regulations and guidelines.
2. Able and willing to provide independent informed consent for research per local regulations and guidelines.
3. Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.
4. Sexually active, defined as having had vaginal intercourse at least once in the three months prior to screening.
5. HIV-uninfected based on testing performed by study staff.

Exclusion Criteria:

1. History of adverse reaction to latex.
2. History of non-therapeutic injection drug use in the 12 moths prior to screening.
3. History of vaginal intercourse more than an average of two times per day in the two weeks prior to screening.
4. For Phase II participants, Grade 3 or higher laboratory abnormality, as defined by the Division of AIDS (DAIDS) Toxicity Tables, based on hematology, liver and renal function, and coagulation testing performed by study staff.

5. Plans any of the following during the next 30 months:

   • To become pregnant
   • To travel away from the study site for more than three consecutive months.
   • To relocate away from the study site.
6. Enrolled in any other study of vaginally-applied product.
7. Pregnant, based on self-report of testing performed by study staff.
8. Within 42 days of last pregnancy outcome.
9. Has a clinically apparent pelvic exam finding (observed by study staff) involving deep epithelial disruption.
10. Diagnosed by study staff with a current sexually transmitted disease and/or other reproductive tract infection requiring treatment according to World Health Organization (WHO) guidelines.
11. Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.