Assessing Adolescent Use of Nexplanon Over Time

NCT ID: NCT04889079

Last Updated: 2024-05-08

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

ACTIVE_NOT_RECRUITING

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-06

Study Completion Date

2025-05-30

Brief Summary

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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

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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

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adolescent females, aged 15-18

Adolescents females aged 15-18, who selected a contraceptive implant to prevent pregnancy.

Contraceptive use (continuation/switching/discontinuation)

Intervention Type BEHAVIORAL

Assessing contraceptive continuation/switching/discontinuation over 12-months

Adolescent females, aged 19-24

Adolescents females aged 19-24, who selected a contraceptive implant to prevent pregnancy.

Contraceptive use (continuation/switching/discontinuation)

Intervention Type BEHAVIORAL

Assessing contraceptive continuation/switching/discontinuation over 12-months

Interventions

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Contraceptive use (continuation/switching/discontinuation)

Assessing contraceptive continuation/switching/discontinuation over 12-months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\-
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Simmons

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32621879 (View on PubMed)

Sawyer 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.

Reference Type BACKGROUND
PMID: 30169257 (View on PubMed)

Downey 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.

Reference Type BACKGROUND
PMID: 28412049 (View on PubMed)

Diedrich 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.

Reference Type RESULT
PMID: 28038902 (View on PubMed)

Other Identifiers

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IRB_00142231

Identifier Type: -

Identifier Source: org_study_id

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