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Birth ControlHER-SLNCT02734199

HER Salt Lake Initiative

An observational study of Birth Control and Contraception, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 16 to 45 years, women only
Conditions the study is for
Birth Control, Contraception
How many people
4,430 participants
Where
1 siteUnited States
Study dates
Nov 2014to Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

  • Currently pregnant and planning to continue the pregnancy, or trying to get pregnant
  • Relying on female or male sterilization as contraceptive method

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Planned Parenthood Association of Utah

    Salt Lake City, Utah, 84102

Other trials in United States

About this study

Official title: 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).

Read the 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.

Keywords
Birth Control, Contraception, IUD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02734199
Study groupRoleWhat they receive
Enrollment Period 1 CohortCohort 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 CohortCohort 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 CohortCohort 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at enrollment through 36 months

Secondary outcomes (1)

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

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

    Measured: at enrollment through 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study startNov 2014
  3. Primary completionMar 2020
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734199
Sponsor's protocol ID
67378
Acronym
HER-SL
Status last verified
Apr 2021
First submitted
8 Mar 2016
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sanders JN, Carter G, Bullington BW, Gero A, Simmons R, Gawron LM, Kaiser JE, Turok DK. Three-Year Contraceptive Failure Rates During the HER Salt Lake Contraceptive Initiative. JAMA Netw Open. 2026 Jun 1;9(6):e2617273. doi: 10.1001/jamanetworkopen.2026.17273.

    PubMed 42301715

  • Simmons RG, Carter G, Sanders JN, Turok DK. Assessing Contraceptive Switching and Discontinuation Over 3 Years in the HER Salt Lake Study. Obstet Gynecol. 2024 Jul 1;144(1):79-88. doi: 10.1097/AOG.0000000000005621. Epub 2024 May 23.

    PubMed 38781634

  • Gero A, Simmons RG, Sanders JN, Turok DK. Does access to no-cost contraception change method selection among individuals who report difficulty paying for health-related care? BMC Womens Health. 2022 Aug 2;22(1):327. doi: 10.1186/s12905-022-01911-x.

    PubMed 35918666

  • Higgins JA, Kramer R, Senderowicz L, Everett B, Turok DK, Sanders JN. Sex, poverty, and public health: Connections between sexual wellbeing and economic resources among US reproductive health clients. Perspect Sex Reprod Health. 2022 Mar;54(1):25-28. doi: 10.1363/psrh.12189. Epub 2022 Feb 27.

    PubMed 35220665

  • Dalessandro C, Kaiser J, Sanders JN. Reproductive autonomy and feelings of control over pregnancy among emerging adult clients in a Utah (USA) contraceptive initiative study. Sex Reprod Healthc. 2022 Mar;31:100688. doi: 10.1016/j.srhc.2021.100688. Epub 2021 Nov 26.

    PubMed 34864316

  • Kramer RD, Higgins JA, Everett B, Turok DK, Sanders JN. A prospective analysis of the relationship between sexual acceptability and contraceptive satisfaction over time. Am J Obstet Gynecol. 2022 Mar;226(3):396.e1-396.e11. doi: 10.1016/j.ajog.2021.10.008. Epub 2021 Oct 14.

    PubMed 34656551

  • Myers K, Sanders JN, Dalessandro C, Sexsmith CD, Geist C, Turok DK. The HER Salt Lake media campaign: comparing characteristics and outcomes of clients who make appointments online versus standard scheduling. BMC Womens Health. 2021 Mar 23;21(1):121. doi: 10.1186/s12905-021-01256-x.

    PubMed 33757511

  • Simmons RG, Sanders JN, Geist C, Gawron L, Myers K, Turok DK. Predictors of contraceptive switching and discontinuation within the first 6 months of use among Highly Effective Reversible Contraceptive Initiative Salt Lake study participants. Am J Obstet Gynecol. 2019 Apr;220(4):376.e1-376.e12. doi: 10.1016/j.ajog.2018.12.022. Epub 2018 Dec 18.

    PubMed 30576664

  • Higgins JA, Sanders JN, Palta M, Turok DK. Women's Sexual Function, Satisfaction, and Perceptions After Starting Long-Acting Reversible Contraceptives. Obstet Gynecol. 2016 Nov;128(5):1143-1151. doi: 10.1097/AOG.0000000000001655.

    PubMed 27741195

Questions about this trial

What is this clinical trial studying?

An observational study of Birth Control and Contraception, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contraceptive method choice and continuation per participant report and medical record documentation (time frame: at enrollment through 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734199, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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