N/A
N=1,008
Innovative Model of Patient-Centered ConTraception
Contraception · Unintended Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02364037 ↗Enrolled (actual)
1,008
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Unintended Pregnancy — 46; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHOICE Project Structured Contraceptive Counseling (Behavioral); Contraceptive Education Session (Behavioral); Cost Support for IUDs and implants (Device)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unintended Pregnancy |
46; 25 | — |
| SECONDARY Contraceptive Method Use Upon Enrollment Completion |
10; 40; 2; 11; 17; 110 | — |
| SECONDARY Desired Contraceptive Method at Enrollment Visit |
41; 85; 27; 26; 85; 162 | — |
| SECONDARY Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit |
153; 273 | — |
| SECONDARY Same Day LARC Insertion |
21; 147 | — |
Summary
This study is testing models of contraceptive care that were developed as part of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women designed to: 1) promote the use of long-acting reversible contraceptive (LARC) methods which include interuterine devices (IUD) and subdermal implants; 2) remove financial barriers to contraception; 3) evaluate continuation of and satisfaction with reversible methods; and 4) reduce unintended pregnancies in the St. Louis region. CHOICE demonstrated that interventions such as comprehensive contraceptive counseling, increased access, and removal of financial barriers increase the uptake of LARC methods and reduce unintended pregnancy. The investigators objective is to determine whether the CHOICE model of contraceptive care can be equally successful in the real world of community clinics.
Eligibility Criteria
Inclusion Criteria
- 14-45 years of age
- Does not desire pregnancy during the next 12 months
- Desires reversible contraception
- Sexually active with a man within the past 6 months or intend to have sex with a man in the next 3 months
- Willing and able to undergo informed consent
- Willing to comply with study protocol and 1-year follow-up schedule
- Not currently pregnant
- Current patient at Family Care Carondelet, Family Care Forest Park Southeast, Memphis Health Center
Exclusion Criteria
- Has undergone a female sterilization procedure such as tubal ligation or hysterectomy
- Has one sexual partner who has undergone a vasectomy procedure
- Speaks language other than English or Spanish
- Currently using an IUD or implant as her contraceptive method
Data sourced from ClinicalTrials.gov (NCT02364037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.