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
Adult females aged 18 years or older who are HIV-seronegative
Cohort
Prospective
Long-acting injectable cabotegravir (CAB-LA)
DrugInjectable cabotegravir 600 mg administered as long-acting HIV pre-exposure prophylaxis (PrEP).
No PrEP
Other interventionNo HIV pre-exposure prophylaxis administered
To evaluate any associations between CAB-LA exposure and hormonal contraceptive use in the three groups of IM DMPA, ETG implant, and non-hormonal method users by generating geometric mean hormone concentrations (Aim 1a)
Mean hormone concentrations starting at 0 week (when feasible), 4 weeks, 8 weeks, 12 weeks, and 24 weeks, as applicable to the three contraceptive groups, after contraceptive method initiation and at least after receiving 3rd dose of CAB-LA if in the CAB-LA groups.
To evaluate any associations between hormonal contraceptive exposure and CAB-LA use by generating geometric mean trough CAB-LA concentrations measured immediately prior to dosing of next CAB-LA (Aim 1b)
Mean trough CAB-LA concentrations prior to next dosing of CAB-LA
Incidence of adverse events associated with CAB-LA and hormonal contraceptive methods (Aim 2a1)
Number and proportion of participants experiencing adverse events, graded using the Division of AIDS (DAIDS) Adverse Event Grading Table.
Participant satisfaction with CAB-LA and hormonal contraceptive method measured by questionnaire (Aim 2a2)
Participant-reported satisfaction scores assessed using a questionnaire.
Continuation rates of CAB-LA and hormonal contraceptive method (Aim 2a3)
Proportion of participants continuing use of CAB-LA and the contraceptive method at each time point.
Participants' experiences and decision-making regarding CAB-LA and contraceptive method options assessed by semi-structured interviews (Aim 2b)
Qualitative assessment of participants' experiences, preferences, and decision-making processes regarding CAB-LA and contraceptive method use or switching, collected through semi-structured interviews conducted by trained study staff and audio-recorded, transcribed, and analyzed using thematic analysis.
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University 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
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