| 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 |
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 (<=42 days) postpartum
3. For women 35 and older, currently smokes cigarettes
4. History of deep vein thrombosis or pulmonary embolism
5. Prolonged immobilization or anticipating major surgery in the next year
6. Thrombogenic valvular or thrombogenic rhythm diseases of the heart
7. Inherited or acquired hyper-coagulopathies
8. Current or history of cerebrovascular disease, coronary artery disease, or ischemic heart disease
9. Uncontrolled hypertension or hypertension with vascular disease (self-report and clinic assessment)
10. Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
11. Migraines with aura
12. For women over 35 years old, migraines without aura
13. Current breast cancer or within 5 years of past breast cancer
14. Diabetes for > 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) |
Adult: 19 Year-44 Year |
18 Year(s) |
45 Year(s) |
Female |