This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.
Female 18 years of age or older and willing and able to provide an informed consent
< 14 days after delivery (calendar day of birth = day 0)
Negative HIV screening test (conducted at the time of enrolment)
Female <30 years old or has had < 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (>1 dose oral/IV), or St. John's wort
Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)
Previous hypersensitivity reaction to CAB or other INSTI
Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months
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BotswanaUniversity of Alabama at Birmingham
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborator
University of Nebraska
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Botswana Harvard Health Partnership
Collaborator