Clinical trial NCT02734199: HER Salt Lake Initiative
Official title: Highly Effective Reversible Contraceptive Initiative-Salt Lake (HER-SL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Control
Contraception
Keywords: Birth Control
Contraception
IUD
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: William and Flora Hewlett Foundation
name: Society of Family Planning
First posted: 2016-04-12
Enrollment: 4430
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Contraceptive method choice and continuation per participant report and medical record documentation
timeFrame: at enrollment through 36 months
Secondary outcomes:
measure: Federal Poverty Level (FPL) status by participant reported income
timeFrame: at enrollment through 36 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
Study officials:
affiliation: University of Utah, Department of Obstetrics & Gynecology
name: David K Turok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.