IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings

Study Overview
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Brief Summary
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Investigators previously developed a guide to help people with IUD self-removal. In this randomized study, the goal is to see if this guide makes it easier for IUD-users to remove their own IUDs. The main question the study aims to answer is: -Does use of the previously developed IUD self-removal guide increase rates of self removal? Participants will: Complete a pre-study survey Be randomized to self-removal with use of the guide or no additional resource Self-select participation at home or in clinic Attempt IUD self-removal either at home or in clinic Complete a post-study survey. Investigators will compare rates of successful self-removal between those randomized to the guide to those randomized to no additional resource to see if increases success.

Official Title
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A Randomized Trial Evaluating the Effectiveness of a Previously Developed Online IUD Self-removal Guide Versus Basic Information Sheet in Clinical and Non-clinical Settings

Conditions
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IUD, Contraception

Intervention / Treatment
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* Other: IUD self-removal guide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 14 and older IUD in place and desiring removal Interest in attempting self-removal English speaking Working cell-phone with camera. Exclusion Criteria: Not meeting above inclusion criteria, no other specific exclusion criteria

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guide<br>Randomized to use of our IUD self-removal guide | Other: IUD self-removal guide<br>* We previously developed an online guide for IUD self-removal through an iterative process including advice from key expert informants, focus groups, interviews, and a pilot clinical study. It includes an online animation, step-by-step guide, troubleshooting tips, and information about pregnancy and contraception.<br>|
| No Intervention: No guide<br>Randomized to use of no additional resource | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of successful IUD self-removal rates | Successful self-removal will be reported by participants on the post-study survey and documented with an uploaded photo of the removed IUD on a study ruler sheet. Rates of successful self-removal will be compared between those randomized to the guide versus no additional resource. | The post study survey will be completed within 48 hours of study participation. Participants schedule their participation on average 1-3 months from study enrollment but up to 1 year (the duration of the study being open). |