ContraceptionNCT04889079
Assessing Adolescent Use of Nexplanon Over Time
An observational study of Contraception, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to compare Nexplanon decision-making, uptake, satisfaction and contraceptive outcomes (continuation, switching, discontinuation) over a 12-month period among adolescents ages 15-18 to adolescents ages 19-24, living in Utah. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Contraceptive use (continuation/switching/discontinuation)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2021to 30 May 2025
- 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 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents living in Utah seeking a contraceptive implant at a participating clinic.
Who may be able to join
- Between the ages of 15-24;
- Not currently pregnant;
- Planning to avoid pregnancy for the next 12 months;
- Selecting the contraceptive implant as their contraceptive method of choice;
- Willing to be contacted via email survey 4 times over 12-months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Adolescent Use of Nexplanon Over Time: a Prospective, Longitudinal Study
The purpose of this study is to compare Nexplanon decision-making, uptake, satisfaction and contraceptive outcomes (continuation, switching, discontinuation) over a 12-month period among adolescents ages 15-18 to adolescents ages 19-24, living in Utah. Data from this study will provide valuable information for clinical and public health offerings, counseling and support for Nexplanon use across stages of adolescence.
Read the detailed description
Despite increasing availability of Nexplanon in the United States, only limited resesarch exists on Nexplanon use among adolescents, particularly nulliparous adolescents. A Cochrane systematic review of long-acting contraception use among adolescents in 2017 identified only four studies that had specifically assessed implant use and continuation among adolescents [1]. Of these, the majority of studies assessed use postpartum [1]. The majority of research on adolescent attitudes around and barriers to long-acting reversible contraception has been conducted on intrauterine devices, rather than implants, and further research is needed to understand decision-making and behaviors around implant use [2]. Additionally, no studies have assessed differences in adolescent decision-making by age. While adolescence is considered ages 10-24 [3], this period is one of substantial change, physically, mentally, and in stages of life. Contraceptive use can be influenced by all of these [4] and understanding differences in stages of adolescence could result in meaningful differences in counseling and support approaches.
The purpose of this study is to compare Nexplanon decision-making, uptake, satisfaction and contraceptive outcomes (continuation, switching, discontinuation) over a 12-month period among adolescents ages 15-18 to adolescents ages 19-24, living in Utah. Data from this study will provide valuable information for clinical and public health offerings, counseling and support for Nexplanon use across stages of adolescence.
- Conditions
- Contraception
- Being tested
- Contraceptive use (continuation/switching/discontinuation)
- Keywords
- adolescents, contraception, contraceptive implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive use (continuation/switching/discontinuation)Behavioural
Assessing contraceptive continuation/switching/discontinuation over 12-months
| Study group | Role | What they receive |
|---|---|---|
| Adolescent females, aged 15-18 | Adolescents females aged 15-18, who selected a contraceptive implant to prevent pregnancy. Receives: Behavioral: Contraceptive use (continuation/switching/discontinuation) | |
| Adolescent females, aged 19-24 | Adolescents females aged 19-24, who selected a contraceptive implant to prevent pregnancy. Receives: Behavioral: Contraceptive use (continuation/switching/discontinuation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month contraceptive outcomes
This outcome measures contraceptive use. The question asks "are you still using the Nexplanon implant that you received", and then the outcomes are either: continuation, switching or discontinuation.
Measured: 12-months
Secondary outcomes (1)
Contraceptive satisfaction
The 5-point Likert satisfaction scale asks "how satisfied are you with your Nexplanon implant?" and the scale ranges from 1-Very unsatisfied to 5-Very satisfied.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start6 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Simmons, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889079
- Sponsor's protocol ID
- IRB_00142231
- Status last verified
- May 2024
- First submitted
- 11 May 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berlan ED, Richards MJ, Vieira CS, Creinin MD, Kaunitz AM, Fraser IS, Edelman A, Mansour D. Best Practices for Counseling Adolescents about the Etonogestrel Implant. J Pediatr Adolesc Gynecol. 2020 Oct;33(5):448-454. doi: 10.1016/j.jpag.2020.06.022. Epub 2020 Jul 2.
PubMed 32621879Sawyer SM, Azzopardi PS, Wickremarathne D, Patton GC. The age of adolescence. Lancet Child Adolesc Health. 2018 Mar;2(3):223-228. doi: 10.1016/S2352-4642(18)30022-1. Epub 2018 Jan 30.
PubMed 30169257Downey MM, Arteaga S, Villasenor E, Gomez AM. More Than a Destination: Contraceptive Decision Making as a Journey. Womens Health Issues. 2017 Sep-Oct;27(5):539-545. doi: 10.1016/j.whi.2017.03.004. Epub 2017 Apr 12.
PubMed 28412049Diedrich JT, Klein DA, Peipert JF. Long-acting reversible contraception in adolescents: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Apr;216(4):364.e1-364.e12. doi: 10.1016/j.ajog.2016.12.024. Epub 2016 Dec 28.
PubMed 28038902
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Adolescent Use of Nexplanon Over Time: a Prospective, Longitudinal Study
- ClinicalTrials.gov ID
- NCT04889079
- Acronym / sponsor ID
- IRB_00142231
- Conditions
- Contraception
- Keywords
- adolescents, contraception, contraceptive implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 17 May 2021 (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.
The purpose of this study is to compare Nexplanon decision-making, uptake, satisfaction and contraceptive outcomes (continuation, switching, discontinuation) over a 12-month period among adolescents ages 15-18 to adolescents ages 19-24, living in Utah. Data from this study will provide valuable information for clinical and public health offerings, counseling and support for Nexplanon use across stages of adolescence.
Detailed description
Despite increasing availability of Nexplanon in the United States, only limited resesarch exists on Nexplanon use among adolescents, particularly nulliparous adolescents. A Cochrane systematic review of long-acting contraception use among adolescents in 2017 identified only four studies that had specifically assessed implant use and continuation among adolescents [1]. Of these, the majority of studies assessed use postpartum [1]. The majority of research on adolescent attitudes around and barriers to long-acting reversible contraception has been conducted on intrauterine devices, rather than implants, and further research is needed to understand decision-making and behaviors around implant use [2]. Additionally, no studies have assessed differences in adolescent decision-making by age. While adolescence is considered ages 10-24 [3], this period is one of substantial change, physically, mentally, and in stages of life. Contraceptive use can be influenced by all of these [4] and understanding differences in stages of adolescence could result in meaningful differences in counseling and support approaches.
The purpose of this study is to compare Nexplanon decision-making, uptake, satisfaction and contraceptive outcomes (continuation, switching, discontinuation) over a 12-month period among adolescents ages 15-18 to adolescents ages 19-24, living in Utah. Data from this study will provide valuable information for clinical and public health offerings, counseling and support for Nexplanon use across stages of adolescence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent females, aged 15-18 | – | Behavioral: Contraceptive use (continuation/switching/discontinuation)Adolescents females aged 15-18, who selected a contraceptive implant to prevent pregnancy. |
| Adolescent females, aged 19-24 | – | Behavioral: Contraceptive use (continuation/switching/discontinuation)Adolescents females aged 19-24, who selected a contraceptive implant to prevent pregnancy. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents living in Utah seeking a contraceptive implant at a participating clinic.
Key inclusion criteria (5 listed)
- Between the ages of 15-24;
- Not currently pregnant;
- Planning to avoid pregnancy for the next 12 months;
- Selecting the contraceptive implant as their contraceptive method of choice;
- Willing to be contacted via email survey 4 times over 12-months
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Contraceptive use (continuation/switching/discontinuation)Assessing contraceptive continuation/switching/discontinuation over 12-months | Behavioural | Adolescent females, aged 15-18, Adolescent females, aged 19-24 |
Primary outcome
12-month contraceptive outcomes
Time frame: 12-months
This outcome measures contraceptive use. The question asks "are you still using the Nexplanon implant that you received", and then the outcomes are either: continuation, switching or discontinuation.
1 secondary outcome
Contraceptive satisfaction
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 32621879Berlan ED, Richards MJ, Vieira CS, Creinin MD, Kaunitz AM, Fraser IS, Edelman A, Mansour D. Best Practices for Counseling Adolescents about the Etonogestrel Implant. J Pediatr Adolesc Gynecol. 2020 Oct;33(5):448-454. doi: 10.1016/j.jpag.2020.06.022. Epub 2020 Jul 2.
- Background: PubMed 30169257Sawyer SM, Azzopardi PS, Wickremarathne D, Patton GC. The age of adolescence. Lancet Child Adolesc Health. 2018 Mar;2(3):223-228. doi: 10.1016/S2352-4642(18)30022-1. Epub 2018 Jan 30.
- Background: PubMed 28412049Downey MM, Arteaga S, Villasenor E, Gomez AM. More Than a Destination: Contraceptive Decision Making as a Journey. Womens Health Issues. 2017 Sep-Oct;27(5):539-545. doi: 10.1016/j.whi.2017.03.004. Epub 2017 Apr 12.
- Results publication: PubMed 28038902Diedrich JT, Klein DA, Peipert JF. Long-acting reversible contraception in adolescents: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Apr;216(4):364.e1-364.e12. doi: 10.1016/j.ajog.2016.12.024. Epub 2016 Dec 28.
- Individual participant dataSharing planned: No
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Contraception
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 Utah 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
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?
12-month contraceptive outcomes (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889079, which also lists 4 linked publications.
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 8 May 2024.