- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214848
Evaluation of an Intervention to Increase Post-abortion LARC Uptake.
Evaluation of an Intervention to Increase Post-abortion LARC Uptake: A Randomized Controlled Trial of Educational and Financial Counseling Prior to Clinical Presentation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As repeat unintended pregnancy and abortion remain public health challenges, increasing long-acting reversible contraceptive (LARC), specifically intrauterine device (IUD) and contraceptive implant, use among women presenting for abortion care is a priority. Despite its efficacy and safety, LARC methods remain underutilized in the abortion setting.
This is a randomized prospective study evaluating the impact of a brief contraceptive education intervention with optional referral for financial counseling on post abortion long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post abortion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30297
- Atlanta Women's Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women calling to schedule an appointment for an abortion and/or those who receive abortion services at the Atlanta Women's Center with fluency in English and able to provide informed consent
- 16 years and older
Exclusion Criteria:
-Younger than 16 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standart of Care
Standard of care at the clinic is to discuss the abortion procedure without specific contraceptive counseling given prior to the day of abortion procedure.
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Experimental: Contraceptive education prior to abortion
Addition (to the standard or care) of a brief phone contraceptive education with optional financial counseling referral prior to abortion visit.
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Contraceptive education script will be delivered over the phone prior to abortion visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Long-Acting Reversible Contraception (LARC) methods inserted immediately post abortion in the intervention and standard of care arms.
Time Frame: Immidiately post abortion (day of the procedure).
|
Proportion of LARC methods inserted immediately post abortion in the intervention and standard of care arms will be calculated based on data abstracted from patients' medical records.
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Immidiately post abortion (day of the procedure).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Long-Acting Reversible Contraception (LARC) methods used in the intervention and standard of care arms three months post abortion.
Time Frame: Three months post abortion.
|
This outcome is inclusive of immediate initiators and those who initiate by three months.
Proportion of LARC methods used in the intervention and standard of care arms will be calculated based on the 3-month follow-up phone interview.
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Three months post abortion.
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Cost-effectiveness analysis of the study intervention.
Time Frame: Three months post abortion.
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The cost-effectiveness analysis will involve multiple parts.
The study team will initially complete a cost description of the interventions involving time spent in developing the scripts for LARC education and financial counseling, and additional time spent making contact with women and providing the augmented counseling compared to the initial pre-communication session.Incremental cost-effectiveness ratios for the intervention overall will be calculated compared to a 'base-case' of standard of care in the primary analysis.
This value will provide cost per additional women using LARC.
In a secondary analysis, the study team will compare differences between women receiving the educational component only versus 'base-case', and also women receiving the educational and financial counseling component versus 'base-case'.
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Three months post abortion.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00094882
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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