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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Clinician Counseling | No Intervention | ||
| Additional Standardized Counseling | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional Standardized Counseling | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Cis-gendered females; Assigned female at birth and not using hormone therapy
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| Name | Affiliation | Role |
|---|---|---|
| Colleen P McNicholas, DO, MSCI | Planned Parenthood of the St. Louis Region and Southwest Missouri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of the St. Louis Region and Southwest Missouri | St Louis | Missouri | 63108 | United States |
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1:1 fashion with block sizes of 8 using a computer-generated random allocation
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All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.
| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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