HER Salt Lake Initiative (HER-SL)
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| ClinicalTrials.gov Identifier: NCT02734199 |
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Recruitment Status :
Completed
First Posted : April 12, 2016
Last Update Posted : April 28, 2021
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| Condition or disease |
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| Birth Control Contraception |
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 |
| Actual Enrollment : | 4430 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Highly Effective Reversible Contraceptive Initiative-Salt Lake (HER-SL) |
| Actual Study Start Date : | November 2014 |
| Actual Primary Completion Date : | March 2020 |
| Actual Study Completion Date : | March 2020 |
| Group/Cohort |
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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.
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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.
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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.
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- 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.
- 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
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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 |
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
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
| United States, Utah | |
| Planned Parenthood Association of Utah | |
| Salt Lake City, Utah, United States, 84102 | |
| Principal Investigator: | David K Turok, MD | University of Utah, Department of Obstetrics & Gynecology |
| 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: | April 28, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Birth Control Contraception IUD |