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HER Salt Lake Initiative (HER-SL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734199
Recruitment Status : Active, not recruiting
First Posted : April 12, 2016
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
William and Flora Hewlett Foundation
Society of Family Planning
Information provided by (Responsible Party):
David Turok, University of Utah

Brief 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).

Condition or disease
Birth Control Contraception

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Highly Effective Reversible Contraceptive Initiative—Salt Lake (HER-SL)
Study Start Date : November 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734199


Locations
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United States, Utah
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102
Sponsors and Collaborators
University of Utah
William and Flora Hewlett Foundation
Society of Family Planning
Investigators
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Principal Investigator: David K Turok, MD University of Utah, Department of Obstetrics & Gynecology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Turok, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT02734199    
Other Study ID Numbers: 67378
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Turok, University of Utah:
Birth Control
Contraception
IUD
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs