ContraceptionNCT03347539
Implants on Mobile Health Unit
An observational study of Contraception, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Nexplaon
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 6 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will be adolescent females seeking reproductive healthcare on a mobile health unit.
Who may be able to join
- 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.
Who cannot join
- Be biologically male
- Be 13 and younger or 20 and older.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: 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.
- Conditions
- Contraception
- Being tested
- Nexplaon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexplaonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasons for choosing Nexplanon
Information will be collected through a survey regarding why adolescents choose to receive Nexplanon.
Measured: One time, immediately before receiving implant.
Secondary outcomes (1)
Reasons for choosing to remove Nexplanon
Information will be collected through a survey regarding why adolescents choose to remove Nexplanon.
Measured: One time, immediately before removing implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start13 Sep 2017
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347539
- Sponsor's protocol ID
- IRB17-0233
- Status last verified
- May 2023
- First submitted
- 15 Nov 2017
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Information regarding reasons for choosing the implant and choosing to remove will be shared with Merck, the maker of Nexplanon.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Uptake of Implants on a Mobile Health Unit
- ClinicalTrials.gov ID
- NCT03347539
- Acronym / sponsor ID
- IRB17-0233
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nexplanon | – | Device: NexplaonThis 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. |
| 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will be adolescent females seeking reproductive healthcare on a mobile health unit.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Be biologically male
- Be 13 and younger or 20 and older.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexplaonThis 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. | Device | Nexplanon |
Primary outcome
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.
1 secondary outcome
Reasons for choosing to remove Nexplanon
Time frame: One time, immediately before removing implant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Yes. Information regarding reasons for choosing the implant and choosing to remove will be shared with Merck, the maker of Nexplanon.
Related trials for Contraception
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
Not yet recruiting
Safety of a Contraceptive Copper Vaginal Ring
Contraception, Birth Control
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reasons for choosing Nexplanon (time frame: One time, immediately before receiving implant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.