RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

Study Overview
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Brief Summary
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Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.

Official Title
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Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant

Conditions
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Birth Control, Contraception, Contraceptive Usage, Family Planning

Intervention / Treatment
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* Other: Additional Standardized Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits Ability to consent in English Exclusion Criteria: Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 fashion with block sizes of 8 using a computer-generated random allocation
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Clinician Counseling<br> | |
| Experimental: Additional Standardized Counseling<br> | Other: Additional Standardized Counseling<br>* Research staff will follow a script designed to give unbiased, medically accurate information regarding bleeding changes that may occur with use of a contraceptive ENG implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nexplanon Discontinuation Rates | Based subjects' self-reported ability to cope with various changes in bleeding patterns, and other demographic information, we will analyze whether an association exists between those who discontinue their method use early due to troublesome bleeding and the counseling they received on the day of method insertion. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraceptive implant, Birth control, Nexplanon