Premature Discontinuation of Contraceptive Implants

Study Overview
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Brief Summary
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To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

Detailed Description
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Objective: To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator). Secondary Objectives: To determine if participants initiating the contraceptive implant who are also provided COCR are more likely than participants receiving standard counseling to: report higher levels of satisfaction with their contraceptive implant at one year following initiation require less clinical follow-up and clinical resources in the year following initiation.

Official Title
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Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial

Conditions
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Contraception Behavior

Intervention / Treatment
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* Drug: Ethinyl Estradiol / Norgestimate Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You are between ages of 14 to 22.9 years. Started etonogestrel implant for the first time and have never used the implant before. Exclusion Criteria: There is any contraindication to estrogen containing birth control. Desire of pregnancy in next 12 months. Plans to move from the area in next 12 months and is not able to come to the clinic.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 23 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COCR Arm<br>Participants in the COCR arm will receive three packs of combined oral contraceptive pills (35mcg ethinyl estradiol/norgestimate) and a specific protocol for their use for bothersome bleeding. | Drug: Ethinyl Estradiol / Norgestimate Oral Tablet<br>* Those who desire COCs as an intervention are prescribed (over the phone) or given (in person) 3 packs of COCs. They are told to take one pill per day until the first pack is complete and save the remaining 2 packs for possible future use.<br>|
| No Intervention: SOC Arm<br>Participants in the SC arm will be offered care according to our standardized protocol, which may include STI testing, reassurance and monitoring, prescription of COCs if desired, or removal. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Continuation | We will assess continuation of use of the contraceptive implant. | 12 months post-insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with contraceptive implant | We will assess satisfaction with bleeding profile and overall satisfaction using a Likert scale (very satisfied, somewhat satisfied and not satisfied). | 3, 6, and 12 months post-insertion |