A Pharmacist-run PrEP Program for Women

Inclusion Criteria

• •Aged 18-65 years at the time of signing the informed consent
• •Cisgender women with a negative/non-reactive HIV test (for those who choose LA-CAB, a negative or non-reactive HIV Ag/Ab assay and negative qualitative HIV-1 RNA test will be used to confirm negative HIV status, for those who choose TDF/FTC, a negative HIV Ag/Ab assay alone will be used to confirm negative HIV status)
• •If insured, must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
• •If un-or-underinsured, must be enrolled in the study sponsor's assistance program which will provide study medications and study-required laboratory tests at no cost
• •Must be at "high-risk" of sexually acquired HIV-1 infection which will be defined as any condomless vaginal or anal sex in the past 6 months plus ≥1 of the following:
• •1. Partner living with HIV with unknown viral load
• •2. ≥1 sex partner of unknown HIV status
• •3. Bacterial STI in the past 6 months (GC/Chlamydia or syphilis)
• •Cisgender women
• •An individual of child-bearing potential (IOCBP) is eligible to participate if they are not pregnant \[as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and a negative urine hCG test at Day 1 (a local serum hCG test at Day 1 is allowed if it can be done, and results obtained, within 24 hours prior to Day 1)\], not lactating, and at least one of the following conditions applies:
• •Non-reproductive potential defined as:
• •Pre-menopausal IOCBP with one of the following:
• •Documented tubal ligation Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion Hysterectomy Documented Bilateral Oophorectomy Post-menopausal IOCBP defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. IOCBP on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
• •Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in IOCBP (see Appendix 7) from at least 14 days prior to the first dose of study medication. Participants will be counseled on the recommendation to continue use of a highly effective method of contraception for at least 14 days after discontinuation of oral CAB and at least 52 weeks after discontinuation of LA-CAB due to the unknown risk to the fetus. This discussion will be recorded in the participant's source notes.
• •The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. All subjects participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of STI transmission to an uninfected partner.