Fertility-female
Conditions
Interventions
Annovera 103mg
Other contraceptive methods
Sponsors
The Population Council Inc NY USA
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: All female participants must meet the following criteria to be eligible for inclusion in the study: a. Ages 18 through 45 years old (inclusive) at screening, verified per site-specific SOPs b. Fluent in spoken Shona (Zimbabwe) or Swahili (Kenya) and/or English c. At risk for pregnancy (post-menarche, no prior sterilization, hysterectomy, oophorectomy, or menopause, per self-report) d. Contraceptive intentions: 1. for potential Annovera users, desiring to initiate a new contraceptive method or change from one currently being used; or 2. for non-Annovera users, has initiated or changed to OC or DMPA use at enrollment e. At least 12 weeks since last DMPA injection (per review of health record) if ever previously used DMPA f. Sexually active, defined as having had penile-vaginal intercourse with a man within the three months before screening g. Not pregnant at screening or enrollment (per negative pregnancy test) h. Not trying to become pregnant or intending to become pregnant within the next year i. No plans to move away from the study site in next 12 months j. Able and willing to provide informed consent k. Able and willing to provide adequate locator information l. In the opinion of the Site PI or designee, able and willing to comply with the protocol and all study procedures
Exclusion criteria
Exclusion criteria: a. BMI>29 (per exam at screening) b. Known hypersensitivity to or prior complications with estrogens, progestins, silicone or any of the other components of Annovera c. Not eligible for combined hormonal contraception; this includes an assessment of the following: 1. Breastfeeding 2. Less than 6 weeks ( 20 years and/or with nephropathy, retinopathy or neuropathy 15. Symptomatic gall bladder disease 16. Liver tumor, acute hepatitis or severe cirrhosis 17. Undiagnosed abnormal vaginal bleeding 18. Known condition where steroid hormones are contraindicated d. Use of medications that are contraindicated or believed to have a drug-drug interaction with Annovera e. Current abnormal vaginal discharge, genital tract lesions, or active pelvic infections (for woman in whom the clinician suspects a genitourinary tract infection, treatment should be offered and woman can enroll following resolution of symptoms) f. History of genital tract surgery (including cervical polypectomy, dilatation and curettage, hysteroscopy, or laparoscopy) in the three months prior to the screening visit g. History of toxic shock syndrome h. Recurrent vulvovaginal candidiasis (defined as more than 3 episodes in the preceding year)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women who report being satisfied or "very satisfied" with Annovera and with other contraceptive methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability | — |
Countries
Kenya, Zimbabwe
Contacts
Public ContactChelsea Polis
Principal investigator
Outcome results
None listed