Implants on Mobile Health Unit

NCT ID: NCT03347539

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-13

Study Completion Date

2020-04-06

Brief Summary

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This study explores reasons why adolescents choose to receive a nexplanon implant and remove a Nexplanon implant. Nexplanon is provided as part of the standard of care on the University of Chicago mobile health unit. This study explores reasons for implantation and removal of Nexplanon on this mobile health unit.

Detailed Description

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Conditions

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Contraception

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Nexplanon

This group is participants who choose to receive the nexplanon implant. This group will only have one study interaction in the form of filling out a survey, at the time of implant.

Nexplaon

Intervention Type DEVICE

This study is an exploratory study of user reasons for Nexplanon implant and removal, and NOT a study on the efficacy or safety of Nexplanon. Nexplanon has already been FDA approved and its efficacy and safety studied.

Removal participants

This group is participants who choose to remove the nexplanon implant. This group will only have one study interaction in the form of filling out a survey, at the time of removal. Anyone with a Nexplanon implant can have the implant removed on the mobile health unit and become part of this group - removal participants do not need to be in the Nexplanon group.

No interventions assigned to this group

Interventions

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Nexplaon

This study is an exploratory study of user reasons for Nexplanon implant and removal, and NOT a study on the efficacy or safety of Nexplanon. Nexplanon has already been FDA approved and its efficacy and safety studied.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be biologically female
* Be seeking reproductive healthcare on a mobile health unit
* Be interested in receiving Nexplanon for birth control.
* Be between 14 and 19 years of age.

Exclusion Criteria

* Be biologically male
* Be 13 and younger or 20 and older.
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Chicago Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB17-0233

Identifier Type: -

Identifier Source: org_study_id

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