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

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

Clinical Phase

PHASE4

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2025-12-30

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.

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Detailed Description

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Conditions

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Birth Control Contraception Contraceptive Usage Family Planning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 fashion with block sizes of 8 using a computer-generated random allocation

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.

Study Groups

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Standard of Care Clinician Counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Additional Standardized Counseling

Group Type EXPERIMENTAL

Additional Standardized Counseling

Intervention Type OTHER

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.

Interventions

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Additional Standardized Counseling

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.

Intervention Type OTHER

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