HER Salt Lake Initiative

NCT02734199 | Completed

• 1 other identifier: 67378
• Study Type: observational
• Target: 4,430
• Locations: 1 country
• Sites: 1

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).

Conditions

Birth Control; Contraception

Keywords

Birth Control; Contraception; IUD

Outcome Measures

Primary Outcomes (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.

  at enrollment through 36 months

Secondary Outcomes (1)

• Federal Poverty Level (FPL) status by participant reported income

  at enrollment through 36 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Females
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• William and Flora Hewlett Foundation: collaborator
• Society of Family Planning: collaborator

Study Sites (1)

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

Location

Related Publications (8)

• 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.

  PMID: 38781634 DERIVED

• 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.

  PMID: 35918666 DERIVED

• 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.

  PMID: 35220665 DERIVED

• 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.

  PMID: 34864316 DERIVED

• 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.

  PMID: 34656551 DERIVED

• 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.

  PMID: 33757511 DERIVED

• 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.

  PMID: 30576664 DERIVED

• 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.

  PMID: 27741195 DERIVED

Study Officials

• David K Turok, MD

  University of Utah, Department of Obstetrics & Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: April 12, 2016
• Study Start: November 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)