Home or Office Visit for the Insertion of Implantable Birth Control

Study Overview
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Brief Summary
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This is a pilot study in which women who desire an etonogestrel implant will be randomized to either a home or office insertion visit. The purpose of this research is to study the interest in, feasibility of, and rates of insertion for implantable birth control (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office visit appointments. The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant and increase consistent and correct contraception use by introducing a previously unexplored method of access, the home visit.

Official Title
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Home or Office Visit for Insertion of Etonogestrel Implant: A Pilot Study

Conditions
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Contraception

Intervention / Treatment
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* Procedure: Home Visit
* Procedure: Office visit


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Women aged 18 and over Was pregnant within the last 10 weeks Interested in using the etonogestrel implant for contraception Willing to have investigators come to the home for an insertion visit Presenting to University Hospitals for delivery or contraception. Has running water and a working bathroom in the home Has a safe and private location in the home for the implant to be inserted Exclusion criteria Current or history of thrombosis or thromboembolic disorders Liver tumors or active liver disease Undiagnosed abnormal genital bleeding Known or suspected breast cancer or history of breast cancer Allergic reaction to components (ethylene vinylacetate, etonogestrel, barium sulfate) of etonogestrel implant or local anesthetics Women currently taking hepatic enzyme inducers including but not exclusive to barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenylbutazone, phenytoin, rifampin, topiramate, protease inhibitors, and St. John's wort Uncontrolled hypertension Housing located greater than 10 miles from University Hospitals Center for Women's Health The location of the home is in a place that would not be safe for investigators Participant is homeless

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Visit<br>20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit. | Procedure: Home Visit<br>* The intervention is the location of the insertion visit.<br>|
| Placebo Comparator: Office Visit<br>20 participants will be randomized to receive an office visit (standard of care). | Procedure: Office visit<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion rates of implantable birth control | Assess rates of insertion of etonogestrel contraceptive implant in women randomly assigned to home visits or standard office visits. | Two weeks post-implant insertion at the follow-up telephone call | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest in home visit option | Questionnaires will be distributed at enrollment (Enrollment Questionnaire) and at the insertion visit (Post-Implant Insertion Questionnaire) | Within 6-8 weeks of enrollment | 
| Rates of return for postpartum follow-up | Data will be collected via electronic medical records to assess if women returned to clinic for their scheduled postpartum visits. | Within 6-8 weeks of enrollment |