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Completed

NCT Number: NCT02734199

HER Salt Lake Initiative

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

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Key information

Age range

16 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Contraceptive method choice and continuation per participant report and medical record documentation

    Time frame: at enrollment through 36 months

    Assess contraceptive method choice and use in relation to participant demographic and socioeconomic characteristics at enrollment, 12 months, 24 months, and 36 months.

Secondary outcomes

  1. Federal Poverty Level (FPL) status by participant reported income

    Time frame: at enrollment through 36 months

    Assess Federal Poverty Level (FPL) at enrollment and 36 months

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Society of Family Planning
  • William and Flora Hewlett Foundation

Registry information

Official study title

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

Acronym: HER-SL

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2016
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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