Implants on Mobile Health Unit

May 3, 2023 updated by: University of Chicago

Adolescent Uptake of Implants on a Mobile Health Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for choosing Nexplanon
Time Frame: One time, immediately before receiving implant.
Information will be collected through a survey regarding why adolescents choose to receive Nexplanon.
One time, immediately before receiving implant.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for choosing to remove Nexplanon
Time Frame: One time, immediately before removing implant.
Information will be collected through a survey regarding why adolescents choose to remove Nexplanon.
One time, immediately before removing implant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2017

Primary Completion (Actual)

April 6, 2020

Study Completion (Actual)

April 6, 2020

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB17-0233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Information regarding reasons for choosing the implant and choosing to remove will be shared with Merck, the maker of Nexplanon.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe