HER Salt Lake Initiative

Contraception Clinical Trial

— HER-SL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734199
• Other study ID #: 67378
• Status: Completed
• Start date: November 2014
• Est. completion date: March 2020

Study information

• Verified date: April 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4430
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Control
• Contraception

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Society of Family Planning, William and Flora Hewlett Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Federal Poverty Level (FPL) status by participant reported income	Assess Federal Poverty Level (FPL) at enrollment and 36 months	at enrollment through 36 months