Contraception, Unintended Pregnancy
Conditions
Keywords
intrauterine device, subdermal implant, contraceptive counseling
Brief 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.
Detailed description
This project involves comparing two models of contraceptive care; 'enhanced care' which is usual care plus the CHOICE structured contraceptive counseling, and the 'complete CHOICE' group which includes the structured contraceptive counseling as well as provider training and cost support for IUDs and implants. Participants will be enrolled at three partner community clinics by a staff member (site coordinator) dedicated to the research study. All participants will undergo contraceptive counseling as well as a baseline survey with the coordinator. Participants will complete telephone surveys at 3, 6, and 12 months post-enrollment and will be asked about contraceptive method chosen, satisfaction and continuation of the method, and any pregnancies experienced since enrollment.
Interventions
BEHAVIORALCHOICE Project Structured Contraceptive Counseling
Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
BEHAVIORALContraceptive Education Session
Prior to Phase 2, health care providers at the recruitment sites will undergo a contraceptive education session with a focus on evidence-based provision of contraception including LARC (IUDs and implant) and same-day insertion.
DEVICECost Support for IUDs and implants
Women in Phase 2 of the study who desire an IUD or implant can receive one through the study at no cost if they do not have insurance coverage. If women have insurance that covers the device, her insurance will be billed for the cost of the device.
Sponsors
Family Care Health Centers
Memphis Health Center
A Step Ahead Foundation
Patient-Centered Outcomes Research Institute
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Due to the controlled time-trend design and, therefore, the different time periods for enrollment and follow up for each group, we were unable to mask the research and clinical staff who administered surveys to the study group assignment when collecting data regarding the study outcomes.
Intervention model description
We used a prospective, controlled time-trend study design, a non-randomized design where outcomes are compared before and after a change in the healthcare setting.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 14-45 years of age 2. Does not desire pregnancy during the next 12 months 3. Desires reversible contraception 4. Sexually active with a man within the past 6 months or intend to have sex with a man in the next 3 months 5. Willing and able to undergo informed consent 6. Willing to comply with study protocol and 1-year follow-up schedule 7. Not currently pregnant 8. Current patient at Family Care Carondelet, Family Care Forest Park Southeast, Memphis Health Center
Exclusion criteria
1. Has undergone a female sterilization procedure such as tubal ligation or hysterectomy 2. Has one sexual partner who has undergone a vasectomy procedure 3. Speaks language other than English or Spanish 4. Currently using an IUD or implant as her contraceptive method
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unintended Pregnancy | 12 months | The number of self-reported unintended pregnancies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Method Use Upon Enrollment Completion | On the day of enrollment | This measure indicates the contraceptive method that the patient left with after the clinical visit on the day of enrollment. Patients could have received desired new method, received a bridge method, stayed on current method, or received no method. |
| Desired Contraceptive Method at Enrollment Visit | On the day of enrollment | This could be a new method, an existing method, or nothing if participant did not choose a method |
| Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit | On the day of enrollment | Number of women choosing an IUD or implant as their preferred contraceptive method |
| Same Day LARC Insertion | On the day of enrollment | Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: Enhanced Care Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs. | 502 |
| Phase 2: Complete CHOICE Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage. | 506 |
| Total | 1,008 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 37 | 49 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Phase 2: Complete CHOICE | Total | Phase 1: Enhanced Care |
|---|---|---|---|
| Age, Continuous | 26.8 years STANDARD_DEVIATION 7.4 | 26.1 years STANDARD_DEVIATION 7 | 25.3 years STANDARD_DEVIATION 6.5 |
| Age, Customized Age <20 years old | 92 Participants | 180 Participants | 88 Participants |
| Age, Customized Age >=20 years old | 414 Participants | 828 Participants | 414 Participants |
| Contraceptive method used immediately prior to enrollment visit Condoms | 77 Participants | 123 Participants | 46 Participants |
| Contraceptive method used immediately prior to enrollment visit Contraceptive Pills/Patch/Ring | 37 Participants | 104 Participants | 67 Participants |
| Contraceptive method used immediately prior to enrollment visit Depot Medroxyprogesterone Acetate (DMPA) | 125 Participants | 310 Participants | 185 Participants |
| Contraceptive method used immediately prior to enrollment visit IUD/Implant | 46 Participants | 65 Participants | 19 Participants |
| Contraceptive method used immediately prior to enrollment visit Nothing | 206 Participants | 372 Participants | 166 Participants |
| Contraceptive method used immediately prior to enrollment visit Other | 15 Participants | 34 Participants | 19 Participants |
| Education =>College Degree | 38 Participants | 70 Participants | 32 Participants |
| Education =<High School | 345 Participants | 662 Participants | 317 Participants |
| Education Some College | 123 Participants | 276 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 66 Participants | 105 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 439 Participants | 899 Participants | 460 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Federal Poverty Level <=100% FPL | 384 Participants | 766 Participants | 382 Participants |
| Federal Poverty Level 101%-200% FPL | 95 Participants | 197 Participants | 102 Participants |
| Federal Poverty Level >=201% FPL | 24 Participants | 40 Participants | 16 Participants |
| Federal Poverty Level Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Insurance Status Commercial | 82 Participants | 152 Participants | 70 Participants |
| Insurance Status Missing | 1 Participants | 2 Participants | 1 Participants |
| Insurance Status None | 149 Participants | 269 Participants | 120 Participants |
| Insurance Status Public | 274 Participants | 585 Participants | 311 Participants |
| Marital Status Married/Living with Partner | 132 Participants | 217 Participants | 85 Participants |
| Marital Status Never Married | 341 Participants | 735 Participants | 394 Participants |
| Marital Status Separated/Divorced/Widowed | 33 Participants | 56 Participants | 23 Participants |
| Parity 0 | 165 Participants | 326 Participants | 161 Participants |
| Parity 1-2 | 221 Participants | 466 Participants | 245 Participants |
| Parity 3+ | 120 Participants | 216 Participants | 96 Participants |
| Participant feelings about becoming pregnant in next 12 months Neutral | 101 Participants | 203 Participants | 102 Participants |
| Participant feelings about becoming pregnant in next 12 months Pleased | 60 Participants | 109 Participants | 49 Participants |
| Participant feelings about becoming pregnant in next 12 months Unsure | 52 Participants | 81 Participants | 29 Participants |
| Participant feelings about becoming pregnant in next 12 months Upset | 293 Participants | 615 Participants | 322 Participants |
| Race/Ethnicity, Customized Race Black | 320 Participants | 694 Participants | 374 Participants |
| Race/Ethnicity, Customized Race Other | 27 Participants | 59 Participants | 32 Participants |
| Race/Ethnicity, Customized Race White | 159 Participants | 255 Participants | 96 Participants |
| Region of Enrollment United States | 506 Participants | 1008 Participants | 502 Participants |
| Sex: Female, Male Female | 506 Participants | 1008 Participants | 502 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Unintended Pregnancy At least one prior pregnancy was unintended | 222 Participants | 479 Participants | 257 Participants |
| Unintended Pregnancy Missing | 2 Participants | 3 Participants | 1 Participants |
| Unintended Pregnancy Never pregnant | 135 Participants | 278 Participants | 143 Participants |
| Unintended Pregnancy No prior pregnancy was unintended | 147 Participants | 248 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 502 | 0 / 506 |
| serious Total, serious adverse events | 0 / 502 | 0 / 506 |
Outcome results
Primary
Unintended Pregnancy
The number of self-reported unintended pregnancies.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Enhanced Care | Unintended Pregnancy | 46 Participants |
| Phase 2: Complete CHOICE | Unintended Pregnancy | 25 Participants |
Secondary
Contraceptive Method Use Upon Enrollment Completion
This measure indicates the contraceptive method that the patient left with after the clinical visit on the day of enrollment. Patients could have received desired new method, received a bridge method, stayed on current method, or received no method.
Time frame: On the day of enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | Pills/Patch/Ring | 113 Participants |
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | DMPA | 220 Participants |
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | Condoms | 35 Participants |
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | Other | 13 Participants |
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | Nothing | 92 Participants |
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | Hormonal IUD | 10 Participants |
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | Copper IUD | 2 Participants |
| Phase 1: Enhanced Care | Contraceptive Method Use Upon Enrollment Completion | Implant | 17 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | Other | 8 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | Implant | 110 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | Hormonal IUD | 40 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | DMPA | 145 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | Pills/Patch/Ring | 66 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | Nothing | 69 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | Condoms | 57 Participants |
| Phase 2: Complete CHOICE | Contraceptive Method Use Upon Enrollment Completion | Copper IUD | 11 Participants |
Secondary
Desired Contraceptive Method at Enrollment Visit
This could be a new method, an existing method, or nothing if participant did not choose a method
Time frame: On the day of enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | Copper IUD | 27 Participants |
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | Implant | 85 Participants |
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | DMPA | 192 Participants |
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | Pills/Patch/Ring | 104 Participants |
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | Condoms | 13 Participants |
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | Other | 5 Participants |
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | Nothing | 35 Participants |
| Phase 1: Enhanced Care | Desired Contraceptive Method at Enrollment Visit | Hormonal IUD | 41 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | Hormonal IUD | 85 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | Copper IUD | 26 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | Condoms | 16 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | Implant | 162 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | Nothing | 35 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | DMPA | 127 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | Other | 2 Participants |
| Phase 2: Complete CHOICE | Desired Contraceptive Method at Enrollment Visit | Pills/Patch/Ring | 53 Participants |
Secondary
Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit
Number of women choosing an IUD or implant as their preferred contraceptive method
Time frame: On the day of enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Enhanced Care | Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit | 153 Participants |
| Phase 2: Complete CHOICE | Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit | 273 Participants |
Secondary
Same Day LARC Insertion
Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit.
Time frame: On the day of enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Enhanced Care | Same Day LARC Insertion | 21 Participants |
| Phase 2: Complete CHOICE | Same Day LARC Insertion | 147 Participants |