Control of Bleeding on Nexplanon in Latinx Patients

Study Overview
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Brief Summary
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In this study, researchers want to find out more about how the Etonogestrel (ENG) contraceptive implant device (also known as Nexplanon) changes people's periods. Study subjects will self select into an exposure group- starting combined hormonal contraceptive pills (COC) on the same day as Nexplanon placement or a delayed initiation of COC when/if bleeding concerns develop. Patients will be followed for 12 months.

Detailed Description
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The study will be conducted at University of Arizona. Investigators will recruit people seeking Nexplanon placement and willing to enroll. We aim to enroll 144 patients. Visit 1: All patients ages 14-24 presenting for contraception services will be screened for potential inclusion. A trained research assistant will conduct a brief patient-centered contraceptive counseling session focusing on patient preferences. If interested in participating, the patient will be given a card to present to their clinician. During the visit, patient and provider will discuss further method selection including risks, benefits, and alternatives. The clinician will assess for contraindications per the CDC MEC for use of COC or the implant. Screening for pregnancy, sexually transmitted infections, and cervical cancer screening will follow as clinically indicated. If pregnancy test is negative and clinician can be reasonably certain that patient is not pregnant using the CDC Selected Practice Recommendations, the ENG implant will be placed. After a clinician encounter, the research assistant will consent those interested in participating. Patients will be assigned a unique identification number once they self-select into their exposure group of choice: ENG implant with initiation of concurrent COC use for bleeding control at time of insertion ENG implant alone with option for delayed initiation of COC if bleeding concerns develop Enrolled patients will complete Demographic Questionnaire and Bleeding Preference Questionnaire. Enrolled patients in exposure group 1 will receive 6 months COC pills (150 mcg levonorgestrel/30 mcg ethinyl estradiol) and condoms for the first week of back-up method. After 6 months, they will be offered a prescription to continue COC pills. Patients in exposure group 2 will be receive handouts describing how to contact the research team should bleeding concerns develop. A telehealth or in-person visit will be arranged with the research clinicians, during which the patient may opt to start COC pills. A 6 month supply will be provided. Follow-Up: Follow-up contact will be weekly for the first 6 months. There will also be 9 and 12 month contact. Each contact will be a brief text-message survey inquiring about bleeding patterns, pill usage and side effects. The ENG implant will be removed upon request at any time during the study. Study participation will be completed after the 12 month follow-up survey. No blood draws will occur during this study. There is little data available on the adverse effects of ENG implant use and combined COC. This is a common clinical practice to combine use for bothersome bleeding and this study will collect long-term data regarding this practice.

Official Title
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Control of Bleeding on Nexplanon in Latinx Patients

Conditions
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Contraception

Intervention / Treatment
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* Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fluent in English or Spanish Access to a cellular phone with text messaging and internet capabilities Capable of and willing to receive cellular phone text message Interest in preventing pregnancy for at least 12 months with the ENG implant Interest in use of COC pills with concurrent with ENG implant use Negative urine pregnancy test Exclusion Criteria: Contraindication to COC pills or ENG implant as determined by the Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use (CDC MEC) Less than 4 weeks postpartum

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Same day initiation option<br>1) ENG implant with initiation of concurrent COC use for bleeding control at time of insertion | Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol<br>* concurrent use of COC with Nexplanon<br>* Other names: combined oral contraceptive (COC);|
| Group 2: Delayed initiation option<br>2) ENG implant alone with option for delayed initiation of COC if bleeding concerns develop | Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol<br>* concurrent use of COC with Nexplanon<br>* Other names: combined oral contraceptive (COC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding pattern preferences (measurement: questionnaire) | Evaluate the bleeding pattern preferences of people prior to contraception initiation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability (measurement: questionnaire and follow-up surveys) | willingness to initiate concurrent use of COC pills with ENG implant | 12 months | 
| continuation (measurement: follow-up surveys) | duration of concurrent use of COC pills with ENG implant; continuation of implant | 12 months | 
| bleeding patterns (measurement: follow-up surveys) | bleeding patterns with concurrent use of COC pills with ENG implant | 12 months | 
| side effects (measurement: follow-up surveys) | side effects with concurrent use of COC pills with ENG implant | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etonogestrel implant; irregular bleeding