Assessing Adolescent Use of Nexplanon Over Time

Contraception Clinical Trial

Official title:

Assessing Adolescent Use of Nexplanon Over Time: a Prospective, Longitudinal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04889079
• Other study ID #: IRB_00142231
• Status: Active, not recruiting
• Start date: June 6, 2021
• Est. completion date: May 30, 2025

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Data from this study will provide valuable information for clinical and public health offerings, counseling and support for Nexplanon use across stages of adolescence.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 255
• Est. completion date: May 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 24 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• Contraceptive use (continuation/switching/discontinuation)
Assessing contraceptive continuation/switching/discontinuation over 12-months

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12-months
Secondary	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.	12-months