Objective
To introduce and promote the use of long-acting reversible methods of contraception (LARC; intrauterine contraceptives and subdermal implant) by removing financial and knowledge barriers.
Study Design
The Contraceptive CHOICE Project is a prospective cohort study of 10,000 women 14-45 years who want to avoid pregnancy for at least 1 year and are initiating a new form of reversible contraception. Women screened for this study are read a script regarding long-acting reversible methods of contraception to increase awareness of these options. Participants choose their contraceptive method that is provided at no cost. We report the contraceptive choice and baseline characteristics of the first 2500 women enrolled August 2007 through December 2008.
Results
Sixty-seven percent of women enrolled (95% confidence interval, 65.3–69.0) chose long-acting methods. Fifty-six percent selected intrauterine contraception and 11% selected the subdermal implant.
Conclusion
Once financial barriers were removed and long-acting reversible methods of contraception were introduced to all potential participants as a first-line contraceptive option, two-thirds chose long-acting reversible methods of contraception.
Of the 6 million pregnancies that occur each year in the United States, approximately half are unintended. Among women who experience an unintended pregnancy, half report using a contraceptive method in the month when the pregnancy occurred. Because most women use a contraceptive method with adherence requirements, the majority of pregnancies result from incorrect or inconsistent method use rather than from method failure. Despite their proven safety, effectiveness, and cost-effectiveness less than 3% of women in the United States use a long-acting reversible method of contraception (LARC), which includes intrauterine contraception (IUC) and subdermal implants. Reasons for lack of use include women’s knowledge of and attitudes toward the methods, practice patterns among providers, and high initial up-front cost associated with these methods.
In response to the underuse of LARC, the Contraceptive CHOICE Project (CHOICE) was developed to promote the use of long-acting methods in the St. Louis region. Our primary objective is to provide no-cost contraception to a large number of women in our region and to promote the use of long-acting reversible contraception (LARC = IUC and the subdermal implant). To accomplish this objective, we sought to remove 2 major barriers to LARC use: financial obstacles and lack of patient awareness of LARC method safety and efficacy. By increasing the acceptance and use of LARC, CHOICE seeks to reduce unintended pregnancy at the population level in the St. Louis region. In this analysis, we describe baseline contraceptive method choice and the demographic, reproductive, and behavioral characteristics of the first 2500 participants enrolled.
Materials and Methods
The Contraceptive CHOICE Project is a prospective cohort study of 10,000 women in the St. Louis region. Each participant is provided the contraceptive method(s) of her choice at no cost to her for 3 years duration. The CHOICE protocol was approved by the Washington University in St. Louis School of Medicine Human Research Protection Office before initiation of participant recruitment.
CHOICE is a convenience sample of women in the St. Louis region. Participants are recruited at specific clinic locations and via general awareness about CHOICE through their medical providers, newspaper reports, study flyers, and word of mouth. Recruitment sites include university-affiliated clinics and providers, 2 facilities providing abortion services, and community clinics that provide family planning, obstetric, gynecologic, and/or primary care. Women are eligible to participate if they are 14-45 years of age, reside in or seek clinical services in designated recruitment sites in the St. Louis region, have been sexually active with a male partner in the past 6 months or anticipate sexual activity in the next 6 months, have not had a tubal ligation or hysterectomy, do not desire pregnancy in the next year, and are not currently using a contraceptive method or are interested in starting a new reversible contraceptive method.
Women are screened for eligibility in person at a recruitment site or on the telephone by calling the CHOICE telephone number. Every screening encounter is conducted by a trained staff person who provides a brief scripted introduction to LARC methods: levonorgestrel intrauterine contraception (LNG-IUC), copper intrauterine contraception (copper IUC), and the subdermal implant ( Appendix ). The screener asks a series of questions to determine eligibility and, when eligible, offers the opportunity to enroll in CHOICE. Using a standardized data collection form, the screener documents each eligibility criterion, the final eligibility status, and whether the woman enrolls in the project that day or is scheduled to enroll on a future date. For women scheduled to enroll, the screener collects contact information to facilitate reminder calls before the enrollment appointment. Thus, all women screened are introduced to LARC methods, regardless of their initial contraceptive preference or whether they are ultimately enrolled.
Enrollment in CHOICE occurs during a 1.5-2 hour inperson process. Before obtaining informed consent to participate in CHOICE, women undergo pregnancy testing to rule out pregnancy. Those identified with an occult pregnancy are counseled about options and offered the opportunity to participate in CHOICE after resolution of the pregnancy. Approximately 74% (1845/2500) of CHOICE enrollments occur at the university-based recruitment site. At this site, contraceptive counseling is provided by research assistants who are trained contraceptive counselors. Among the remaining 26% (655/2500) of enrollments, clinic staff, and/or health care providers at the clinical facility provide the counseling. Our goal was to promote LARC, but to also offer the CHOICE Project to as many outpatient facilities in our region as possible. All women undergo contraceptive counseling before providing informed consent.
Given space constraints and logistical issues, research staff could not provide the counseling at all recruitment sites. Thus, the content of the contraceptive counseling session varies by recruitment site. The clinic staff that provides the counseling at the community clinic sites is not engaged in the research protocol; the counseling is considered part of routine family planning care that she receives during her clinic visit before enrollment in CHOICE. Counseling at the university-affiliated recruitment site includes a nonbiased description of all contraceptive methods available, including method effectiveness, advantages, and disadvantages. To assist the participant in making an informed decision, research staff attempts to dispel misinformation or myths about contraceptive methods and to answer any questions or concerns regarding each method. During this session, the research assistant collects clinical information using a standardized form to identify contraindications or conditions that may influence the use of a particular contraceptive method. Once the woman has chosen her method, the counselor obtains the approval of the clinician for the chosen method, regardless of recruitment location. If a method is medically contraindicated, the clinician consults with the participant to identify a more suitable contraceptive method; otherwise participants receive their initial method of choice.
After contraceptive counseling is completed, informed consent is obtained to participate in CHOICE by engaged research staff at the recruitment location. For women under the age of 18 years, we obtain their assent and the consent of 1 parent or legal guardian. For minors who do not know the whereabouts of their parent or legal guardian or are fearful of their parent or legal guardian’s knowledge of her seeking contraception, we have obtained Human Research Protection Office approval to waive parental consent. Emancipated minors are consented as adults.
After informed consent, research staff administers a standardized survey instrument and collects detailed contact information. Comprehensive contact information (eg, residence address, telephone, cell phone, email) is documented for the participant and 2 additional contacts (eg, partner, relative, or friend) to increase the likelihood of sustained contact with the participant during the 3-year follow-up period. The participant is then screened for sexually transmitted infections (STIs; Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis , and syphilis) and HIV, and the chosen contraceptive method is provided. Participants are compensated for their time with a $15.00 gift card.
Once pregnancy is ruled out, women who choose a LARC method undergo insertion by a trained clinician at the time of enrollment. Emergency contraception is offered to patients who have had recent unprotected intercourse, and “bridge methods” such as oral contraceptive pills (OCPs), vaginal ring, transdermal patch, depo-medroxyprogesterone acetate (DMPA), or condoms are offered to women when pregnancy cannot be excluded. Participants are encouraged to immediately initiate their contraceptive method, and can return in 3-4 weeks for a repeat pregnancy test and LARC insertion, if desired.
After the enrollment session participants are interviewed by phone 3-, 6-, 12-, 18-, 24-, 30-, and 36-months postenrollment using standardized survey instruments. They are compensated with a $10.00 gift card for every completed survey. Participants are initially notified by mail or e-mail 2 weeks before their next follow-up contact, and are then called to schedule the interview. Participants are screened again for C trachomatis and N gonorrhoeae at the 12-, 24-, and 36-month contacts.
The baseline and follow-up survey instruments collect comprehensive information on demographic characteristics, past, and current reproductive history, including contraceptive experience (eg, continuation, side effects, reasons for discontinuation or noncompliance, and satisfaction), menstrual bleeding patterns, sexual behavior with male and female partners, main and casual sex partners, pregnancy, incident STI, and experiences of discrimination and violence. During both scheduled and interim contacts, research staff also collect and record clinically relevant data, including complaints, complications, side effects, method expulsions and removals, pregnancies and outcomes, and STI occurrence and treatment.
CHOICE provides all contraceptive methods at no cost to the participant through 2 processes. Women who choose a LARC method can receive the method at their enrollment site or can request that their regular health care provider insert the method. CHOICE has established a network of private providers who refer patients to CHOICE for enrollment. Research staff travels to these physician offices or recruitment sites with LARC methods and provides the clinician with the method for insertion.
CHOICE has partnered with 2 community affiliates to provide OCPs, vaginal ring, transdermal patch, or DMPA to participants. After enrollment, every participant, regardless of method choice, receives a CHOICE prescription card that documents her participation in CHOICE and allows her to obtain her OCPs, vaginal ring, or transdermal patch on a monthly basis at a local pharmacy chain located throughout the St. Louis region. Participants who are established patients of the local family planning clinic may obtain their monthly refills or DMPA at selected family planning clinics in the St. Louis area. On a monthly basis, the pharmacy chain and local family planning clinic provide CHOICE with claims data documenting the date and methods dispensed for each participant and are subsequently reimbursed.
In this article, we provide a baseline descriptive analysis of the first 2500 women enrolled in the CHOICE Project. We also compare the demographic and behavioral characteristics of women who chose a LARC method (IUC or implant) with those of women who chose the DMPA injection, OCPs, vaginal ring, transdermal patch, or diaphragm. We examine whether participants differed by LARC or non-LARC contraceptive method choice. Comparisons were made using χ 2 for categorical variables, Student t test for continuous variables, and logistic regression for multivariable analyses. To analyze the predictors of choosing LARC at enrollment, we used Poisson regression with robust error variance. This regression technique allows for a conservative estimation of the relative risk when the outcome of interest occurs more than 10% of the time, as in the case of LARC acceptance in this analysis. Univariate analysis for each of the 9 categorical covariates that were not correlated was performed; independent predictors, with unadjusted alpha of .05, or confounders, with greater 10% change in related variable’s beta estimate, were included in the final multivariable model to estimate relative risk of choosing a LARC method at enrollment. Statistical analyses were conducted using SAS Software (v.9.1.; SAS Institute, Cary, NC).
Results
From August 2007 through December 2008, we screened 4107 women for eligibility. Eighty-six percent (3522) met the eligibility criteria to participate in the study and were offered the opportunity to enroll. The most common reasons for ineligibility included a desire to continue with their current contraceptive method (84%) or had not been and were not planning on being sexually active with a man (11%). Of the 3522 eligible women, 2500 enrolled. After adjusting for age, eligible women were significantly more likely to enroll if they self-reported their race as white compared with black (relative risk adjusted [RR adj ] , 1.8; 95% confidence interval [CI], 1.5–2.1), or are currently using a contraceptive method and are interested in switching to a new method compared with women not currently using a contraceptive method (RR adj, 1.3; 95% CI, 1.1–1.5).
The demographic and reproductive characteristics of study participants are shown in Table 1 . The average age of participants was 25 years (range, 14–45 years); over 63% were 25 years or less, including 99 (4%) who were minors less than 18 years. Forty-nine percent of participants were white, and 44% were black. Forty-two percent of participants reported no insurance; more than half of all participants reported difficulty paying for transportation, housing, food, or medical care during the past 12 months or currently receive public assistance. Overall, 26% of the study participants were recruited at an abortion clinic or community family planning clinic.
| Total | ||
|---|---|---|
| Characteristics | n | % |
| Recruitment clinic | ||
| University-affiliated | 1845 | 73.8 |
| Abortion | 444 | 17.8 |
| Family planning/community health | 211 | 8.4 |
| PARTICIPANT DEMOGRAPHIC CHARACTERISTICS | ||
| Race | ||
| Black | 1086 | 43.7 |
| White | 1209 | 48.7 |
| Other | 190 | 7.6 |
| Hispanic ethnicity | 114 | 4.6 |
| Age | ||
| <18 | 99 | 4.0 |
| 18-20 | 426 | 17.0 |
| 21-25 | 1053 | 42.1 |
| >25 | 922 | 36.9 |
| Marital status | ||
| Single/never married | 1592 | 63.7 |
| Married/living with a partner | 737 | 29.5 |
| Separated/divorced/widowed | 169 | 6.8 |
| Trouble paying for transportation, housing, medical expenses, or food in past 12 mo | 968 | 39.0 |
| Currently receives food stamps, WIC, welfare, or unemployment | 719 | 28.9 |
| Trouble paying for basic necessities in past 12 mo or currently receives public assistance | 1281 | 51.7 |
| PARTICIPANT BEHAVIORAL CHARACTERISTICS | ||
| Lifetime sexual partners | ||
| 0-1 | 364 | 14.6 |
| 2-4 | 671 | 26.8 |
| 5-9 | 849 | 34.0 |
| 10+ | 616 | 24.6 |
| Gravidity, mean (SD) | 2.0 (2.1) | |
| Parity, mean (SD) | 0.9 (1.2) | |
| History of abortion | 1128 | 45.1 |
| Any STI diagnosis in lifetime a | 702 | 28.4 |
| Any STI at baseline b | 119 | 4.8 |
| CONTRACEPTION | ||
| Method chosen at enrollment | ||
| LARC methods | 1678 | 67.1 |
| Levonorgestrel IUC | 1171 | 46.8 |
| Copper IUC | 233 | 9.3 |
| Subdermal implant | 274 | 11.0 |
| Shorter-acting contraceptive methods | 822 | 32.9 |
| Depo-medroxyprogesterone acetate | 154 | 6.2 |
| Oral contraceptive pills | 306 | 12.2 |
| Vaginal ring | 292 | 11.7 |
| Transdermal patch | 68 | 2.7 |
| Diaphragm | 2 | 0.1 |
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