HER Salt Lake Initiative (HER-SL)

April 26, 2021 updated by: David Turok, University of Utah

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

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

4430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Planned Parenthood Association of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females 16-45 years of age, who desire to prevent pregnancy for at least one year and are seeking contraceptive counseling and long term contraception services in Salt Lake County.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Enrollment Period 1 Cohort
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
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
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at enrollment through 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at enrollment through 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Society of Family Planning
William and Flora Hewlett Foundation

Investigators

  • Principal Investigator: David K Turok, MD, University of Utah, Department of Obstetrics & Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 67378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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