HER Salt Lake Initiative

Study Overview
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Brief Summary
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This study aims to understand the long-term health, social, and economic impacts of transitioning a community to Highly Effective Reversible Contraception (HER-C).

Detailed Description
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The persistently high rate of unintended pregnancy in the US suggests an inadequacy of current prevention models and a need for new approaches to contraceptive acceptability and promotion. Although popularity of Highly Effective Reversible Contraception (HER-C) in the US is steadily increasing, less than 10% of contracepting women use intrauterine devices (IUDs) or subdermal contraceptive implants, which are the most effective methods for avoiding unintended pregnancy. Poverty is an important predictor of unintended pregnancy where women with incomes below the Federal Poverty Level (FPL) have over a five-fold increased risk of unintended pregnancy relative to women with higher incomes. Because of limited public funds for family planning, low-income women in Salt Lake County have limited access to HER-C, which has high initiation cost but significant cost-saving potential over time. Additionally, contraceptive research has inadequately measured the social impact of HER-C. The first aim of the HER Salt Lake Initiative is to evaluate the increase in HER-C methods with three strategies: 1) Client centered contraceptive counseling; 2) Removal of financial barriers; and 3) Targeted media campaigns. The second aim of the HER Salt Lake Initiative is to assess changes in earnings and education among women initiating HER-C compared to other methods of contraception and model the projected lifetime earning potential of women based on their contraceptive method choices.

Official Title
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Highly Effective Reversible Contraceptive Initiative-Salt Lake (HER-SL)

Conditions
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Contraception, Birth Control

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 16-45 years of age Seeking contraceptive counseling and services at four participating Planned Parenthood clinics in Salt Lake County Desire to prevent pregnancy for at least one year Fluent in English or Spanish Their current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment Exclusion Criteria: Currently pregnant and planning to continue the pregnancy, or trying to get pregnant Relying on female or male sterilization as contraceptive method

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrollment Period 1 Cohort<br>Cohort 1 includes approximately 650 participants who receive a standardized client centered contraceptive counseling session with a clinical assistant. Contraceptive access will be the same as it was prior to the study beginning, meaning participants either have to use insurance or self-pay for their method of choice. | |
| Enrollment Period 2 Cohort<br>Cohort 2 includes approximately 1000 participants who receive a standardized client centered contraceptive counseling session with a clinical assistant. Financial barriers are removed for Period 2 participants and they can initiate which ever contraceptive method they want at no cost to them for three years. | |
| Enrollment Period 3 Cohort<br>Cohort 3 includes approximately 1350 participants who receive a standardized client centered contraceptive counseling session with a clinical assistant. Financial barriers are removed for Period 3 participants and they can initiate which ever contraceptive method they want at no cost to them for three years. During enrollment period 3, a community-wide, media driven intervention will be implemented and population level changes in HER-C initiation will be examined. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive method choice and continuation per participant report and medical record documentation | Assess contraceptive method choice and use in relation to participant demographic and socioeconomic characteristics at enrollment, 12 months, 24 months, and 36 months. | at enrollment through 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Federal Poverty Level (FPL) status by participant reported income | Assess Federal Poverty Level (FPL) at enrollment and 36 months | at enrollment through 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth Control, Contraception, IUD