Implants on Mobile Health Unit

NCT03347539 | Completed FDA Device

• 1 other identifier: IRB17-0233
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Reasons for choosing Nexplanon

  Information will be collected through a survey regarding why adolescents choose to receive Nexplanon.

  One time, immediately before receiving implant.

Secondary Outcomes (1)

• Reasons for choosing to remove Nexplanon

  One time, immediately before removing implant.

Study Arms (2)

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.

Device: Nexplaon

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.

Interventions

Nexplaon 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.

Nexplanon

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be adolescent females seeking reproductive healthcare on a mobile health unit.

You may qualify if:

• 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.

You may not qualify if:

• Be biologically male
• Be 13 and younger or 20 and older.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: September 13, 2017
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be shared after all data has been collected. This will be after December 2019. Data will be shared by analytical closeout date, in December 2021.

Locations

US (1)