Assessing Adolescent Use of Nexplanon Over Time

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception
• Intervention / Treatment: Behavioral: Contraceptive use (continuation/switching/discontinuation)

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 Type: Observational
• Enrollment (Estimated): 255

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adolescents living in Utah seeking a contraceptive implant at a participating clinic.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescent females, aged 15-18; Adolescents females aged 15-18, who selected a contraceptive implant to prevent pregnancy.	Behavioral: Contraceptive use (continuation/switching/discontinuation); 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.	Behavioral: Contraceptive use (continuation/switching/discontinuation); Assessing contraceptive continuation/switching/discontinuation over 12-months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: contraception; adolescents; contraceptive implant
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: IRB_00142231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No