Comparison of unintended pregnancy at 12 months between two contraceptive care programs; a controlled time-trend design.

OBJECTIVES: To compare unintended pregnancy rates at 12 months between women receiving structured contraceptive counseling plus usual contraceptive care and women receiving structured contraceptive counseling, healthcare provider education and cost support for long-acting reversible contraceptive (LARC) methods. STUDY DESIGN: Using a controlled time-trend study design, we first enrolled 502 women receiving structured contraceptive counseling in addition to usual care ("Enhanced Care") and subsequently enrolled 506 women receiving counseling plus healthcare provider education and cost support for LARC methods ("Complete CHOICE") at three federally qualified health centers (FQHCs). Cost support included funds to health centers for "on-the-shelf" LARC methods and no-cost LARC methods for uninsured women. Participants completed in-person baseline surveys and follow-up surveys by telephone at 3, 6 and 12 months. We used Kaplan-Meier survival function to estimate 12-month unintended pregnancy rates and Cox proportional-hazards regression to compare unintended pregnancy rates between the two groups. We imputed pregnancy outcomes for women lost to follow-up (9%) prior to 12 months. RESULTS: "Complete CHOICE" participants were less likely to report an unintended pregnancy at 12 months compared to "Enhanced Care"; 5.3 vs. 9.8 pregnancies per 100 women-years (p=.01). After adjusting for confounders (recruitment site, race, age and federal poverty level), women in "Complete CHOICE" had a 40% lower risk of unintended pregnancy at 12 months (adjusted hazard ratio 0.60; 95% confidence interval 0.37-0.99). CONCLUSIONS: Contraceptive provision that includes cost support and healthcare provider education in addition to patient counseling reduced unintended pregnancy at 12 months compared to counseling plus usual contraceptive care. IMPLICATIONS: A program of contraceptive care that includes comprehensive counseling; healthcare provider education; cost support; and on-the-shelf, long-acting reversible contraception can reduce unintended pregnancy compared to contraceptive counseling in addition to usual health center care in the FQHC setting.

Effect of staff training and cost support on provision of long-acting reversible contraception in community health centers.

OBJECTIVE: To compare the proportion of women receiving same-day long-acting reversible contraception (LARC) between two different models of contraceptive provision adapted from the Contraceptive CHOICE Project. STUDY DESIGN: We used a controlled time-trend study design to compare 502 women receiving structured contraceptive counseling in addition to usual care ("Enhanced Care") to 506 women receiving counseling plus healthcare provider education and cost support for LARC ("Complete CHOICE") at three federally qualified health centers. We provided funds to health centers to ensure an "on-the-shelf" supply and no-cost LARC for uninsured women. We recorded the contraceptive method chosen after contraceptive counseling and the healthcare provider appointment as well as the contraceptive method received that day. Among women choosing LARC, we calculated proportions and performed Poisson regression with robust error variance to estimate relative risks for same-day insertion. RESULTS: Participant demographics reflected the health center populations; 69% were black, 66% had a high school diploma or less, 57% were publicly insured, and 75% reported household income less than 101% federal poverty line. There were 153 (30.5%) women in "Enhanced Care" and 273 (54.0%) in "Complete CHOICE" who chose LARC (p<0.01). Among women who chose LARC (n=426), those in "Complete CHOICE" were more likely to receive a same-day insertion, 53.8% vs. 13.7% (RRadj 4.73; 95%CI 3.20-6.98) compared to "Enhanced Care." CONCLUSIONS: A contraceptive care model that included healthcare provider education and cost support for LARC in addition to structured contraceptive counseling resulted in higher rates of same-day LARC insertion compared to contraceptive counseling and usual care alone. IMPLICATIONS: Contraceptive care provision which includes contraceptive counseling, healthcare provider education, and "on-the-shelf", long-acting reversible contraception facilitate same-day initiation of these methods. Interventions that focus solely on contraceptive counseling do not address other structural barriers to same-day contraceptive provision of all methods including cost and provider practice.

From research to practice: dissemination of the Contraceptive CHOICE Project.

Unintended pregnancy is a public health problem with societal consequences. The Contraceptive CHOICE Project (CHOICE) demonstrated a reduction in teen pregnancy and abortion by removing barriers to effective contraception. The purpose of the study was to describe the dissemination approach used to create awareness of and promote desire to adopt the CHOICE model among selected audiences. We used a 4-stage approach and detail the work completed in the first 2 stages. We describe stakeholder involvement in the first stage and the process of undertaking core strategies in the second stage. We examine insights gained throughout the process. Through our dissemination approach, we reached an estimated 300,000 targeted individuals, not including the population reached through media. We were contacted by 141 entities for technical assistance. The completion and reporting of dissemination processes is an important component of research. There is a need to fully document and disseminate strategies that can help facilitate practice change.

Barriers and facilitators to implementing a patient-centered model of contraceptive provision in community health centers.

BACKGROUND: The Contraceptive CHOICE Project developed a patient-centered model for contraceptive provision including: (1) structured, evidence-based counseling; (2) staff and health care provider education; and (3) removal of barriers such as cost and multiple appointments to initiate contraception. In preparation for conducting a research study of the CHOICE model in three community health settings, we sought to identify potential barriers and facilitators to implementation. METHODS: Using a semi-structured interview guide guided by a framework of implementation research, we conducted 31 qualitative interviews with female patients, staff, and health care providers assessing attitudes, beliefs, and barriers to receiving contraception. We also asked about current contraceptive provision and explored organizational practices relevant to implementing the CHOICE model. We used a grounded theory approach to identify major themes. RESULTS: Many participants felt that current contraceptive provision could be improved by the CHOICE model. Potential facilitators included agreement about the necessity for improved contraceptive knowledge among patients and staff; importance of patient-centered contraceptive counseling; and benefits to same-day insertion of long-acting reversible contraception (LARC). Potential barriers included misconceptions about contraception held by staff and providers; resistance to new practices; costs associated with LARC; and scheduling challenges required for same-day insertion of LARC. CONCLUSIONS: In addition to staff and provider training, implementing a patient-centered model of contraceptive provision needs to be supplemented by strategies to manage patient and system-level barriers. Community health center staff, providers, and patients support patient-centered contraceptive counseling to improve contraception provision if organizations can address these barriers.

Performance of a checklist to exclude pregnancy at the time of contraceptive initiation among women with a negative urine pregnancy test.

OBJECTIVE: Our objective was to measure the sensitivity and specificity of a six-item "pregnancy checklist" at excluding early- or luteal-phase pregnancy among women with a negative urine pregnancy test who were initiating contraception. STUDY DESIGN: This was a secondary analysis of the Contraceptive CHOICE Project, a prospective cohort study of 9256 women in the St. Louis region. Women who had a negative urine pregnancy test on the day of enrollment were included in this analysis. Women with a positive urine pregnancy test or without urine pregnancy testing were excluded. We identified all luteal-phase pregnancies that occurred among women with a negative urine pregnancy test. We calculated the sensitivity, specificity, positive predictive value and negative predictive value (NPV) and likelihood ratios of the pregnancy checklist for excluding luteal-phase pregnancies. RESULTS: There were 6929 women included in this analysis; 69% of these women met at least one checklist criterion to exclude pregnancy ("negative screen"). There were 36 luteal-phase pregnancies (0.5%) subsequently diagnosed among women with a negative urine pregnancy test. The sensitivity and specificity of the checklist were 77.7% and 69.1%, respectively. The NPV of the checklist was 99.8% and the positive predictive value was 1.3%. CONCLUSION: Among women with a negative urine pregnancy test, the pregnancy checklist can be used to safely exclude more than 99% of early pregnancies at the time of contraceptive initiation. IMPLICATIONS: In patients with a negative urine pregnancy test, a pregnancy checklist using six criteria based on patient history has high NPV in excluding early pregnancy. This checklist can be used to facilitate same-day initiation of contraceptive methods, including long-acting reversible contraception. Although the checklist had a high false positive rate, initiation of contraception should not be delayed in women with a "positive screen." Rather women who desire an intrauterine device or implant can be "bridged" with a shorter-acting method until pregnancy can be excluded.

Provision of no-cost, long-acting contraception and teenage pregnancy.

BACKGROUND: The rate of teenage pregnancy in the United States is higher than in other developed nations. Teenage births result in substantial costs, including public assistance, health care costs, and income losses due to lower educational attainment and reduced earning potential. METHODS: The Contraceptive CHOICE Project was a large prospective cohort study designed to promote the use of long-acting, reversible contraceptive (LARC) methods to reduce unintended pregnancy in the St. Louis region. Participants were educated about reversible contraception, with an emphasis on the benefits of LARC methods, were provided with their choice of reversible contraception at no cost, and were followed for 2 to 3 years. We analyzed pregnancy, birth, and induced-abortion rates among teenage girls and women 15 to 19 years of age in this cohort and compared them with those observed nationally among U.S. teens in the same age group. RESULTS: Of the 1404 teenage girls and women enrolled in CHOICE, 72% chose an intrauterine device or implant (LARC methods); the remaining 28% chose another method. During the 2008-2013 period, the mean annual rates of pregnancy, birth, and abortion among CHOICE participants were 34.0, 19.4, and 9.7 per 1000 teens, respectively. In comparison, rates of pregnancy, birth, and abortion among sexually experienced U.S. teens in 2008 were 158.5, 94.0, and 41.5 per 1000, respectively. CONCLUSIONS: Teenage girls and women who were provided contraception at no cost and educated about reversible contraception and the benefits of LARC methods had rates of pregnancy, birth, and abortion that were much lower than the national rates for sexually experienced teens. (Funded by the Susan Thompson Buffett Foundation and others.).

Change in sexual behavior with provision of no-cost contraception.

OBJECTIVE: To estimate whether providing no-cost contraception is associated with the number of sexual partners and frequency of intercourse over time. METHODS: This was an analysis of the Contraceptive CHOICE Project, a prospective cohort study of 9,256 adolescents and women at risk for unintended pregnancy. Participants were provided reversible contraception of their choice at no cost and were followed-up with telephone interviews at 6 and 12 months. We examined the number of male sexual partners and coital frequency reported during the previous 30 days at baseline compared with 6-month and 12-month time points. RESULTS: From our total cohort, 7,751 (84%) women and adolescents completed both 6-month and 12-month surveys and were included in this analysis. We observed a statistically significant decrease in the fraction of women and adolescents who reported more than one sexual partner during the past 30 days from baseline to 12 months (5.2% to 3.3%; P<.01). Most participants (70-71%) reported no change in their number of sexual partners at 6 and 12 months, whereas 13% reported a decrease and 16% reported an increase (P<.01). More than 80% of participants who reported an increase in the number of partners experienced an increase from zero to one partner. Frequency of intercourse increased during the past 30 days from baseline (median, 4) to 6 and 12 months (median, 6; P<.01). However, greater coital frequency did not result in greater sexually transmitted infection incidence at 12 months. CONCLUSION: We found little evidence to support concerns of increased sexual risk-taking behavior subsequent to greater access to no-cost contraception.

Continuation of the etonogestrel implant in women undergoing immediate postabortion placement.

OBJECTIVE: To estimate whether women who receive an immediate postabortion etonogestrel subdermal implant have higher discontinuation rates than women who undergo an interval insertion (insertion not associated with a recent pregnancy). METHODS: This was a secondary analysis of the Contraceptive CHOICE Project. We compared 12-month continuation rates for the subdermal implant between women undergoing immediate postabortion placement and women who underwent an interval placement. Continuation rates were compared using Kaplan-Meier estimator of survival function and Cox proportional hazard models. RESULTS: Over the study period, 141 women received the implant immediately postabortion and 935 women underwent an interval placement. The 12-month continuation rates were similar: 81.5% among women undergoing immediate postabortion placement and 82.8% among women undergoing interval placement (P=.54). In the survival analysis, women who received an immediate postabortion implant were no more likely to discontinue their method than women who had an interval placement (adjusted hazard ratio 1.04, 95% confidence interval 0.68-1.60). The most common reason given for discontinuation was frequent or irregular bleeding, which was reported by 65.4% of women discontinuing in the immediate postabortion group and 56.7% in the interval group. CONCLUSION: Women who undergo immediate postabortion placement of the subdermal implant have high rates of continuation that are equivalent to women undergoing interval insertion. Immediate postabortion long-acting reversible contraceptives should be available to women undergoing induced abortion to decrease the risk of repeat unplanned pregnancy. LEVEL OF EVIDENCE: II.

Effectiveness of long-acting reversible contraception.

BACKGROUND: The rate of unintended pregnancy in the United States is much higher than in other developed nations. Approximately half of unintended pregnancies are due to contraceptive failure, largely owing to inconsistent or incorrect use. METHODS: We designed a large prospective cohort study to promote the use of long-acting reversible contraceptive methods as a means of reducing unintended pregnancies in our region. Participants were provided with reversible contraception of their choice at no cost. We compared the rate of failure of long-acting reversible contraception (intrauterine devices [IUDs] and implants) with other commonly prescribed contraceptive methods (oral contraceptive pills, transdermal patch, contraceptive vaginal ring, and depot medroxyprogesterone acetate [DMPA] injection) in the overall cohort and in groups stratified according to age (less than 21 years of age vs. 21 years or older). RESULTS: Among the 7486 participants included in this analysis, we identified 334 unintended pregnancies. The contraceptive failure rate among participants using pills, patch, or ring was 4.55 per 100 participant-years, as compared with 0.27 among participants using long-acting reversible contraception (hazard ratio after adjustment for age, educational level, and history with respect to unintended pregnancy, 21.8; 95% confidence interval, 13.7 to 34.9). Among participants who used pills, patch, or ring, those who were less than 21 years of age had a risk of unintended pregnancy that was almost twice as high as the risk among older participants. Rates of unintended pregnancy were similarly low among participants using DMPA injection and those using an IUD or implant, regardless of age. CONCLUSIONS: The effectiveness of long-acting reversible contraception is superior to that of contraceptive pills, patch, or ring and is not altered in adolescents and young women. (Funded by the Susan Thompson Buffet Foundation.).

A prospective study of the psychosocial impact of a positive Chlamydia trachomatis laboratory test.

BACKGROUND: Few data exist on potential harms of chlamydia screening. We assessed the psychosocial impact of receiving a positive Chlamydia trachomatis test result. METHODS: We prospectively studied women ≥16 years of age undergoing chlamydia testing in 2 Midwestern family planning clinics. We surveyed women at baseline and about 1 month after receiving test results, using 9 validated psychosocial scales/subscales and chlamydia-specific questions. Changes in scale scores were calculated for each woman. Mean percent changes in scores for chlamydia-positive and -negative women were compared using a t test. RESULTS: We enrolled 1807 women (response rate, 84%). Of the 1688 women with test results, 149 (8.8%) tested positive. At follow-up, chlamydia-positive women (n = 71) had a 75% increase in anxiety about sexual aspects of their life on the Multidimensional Sexual Self-Concept Questionnaire (P < 0.001), significantly greater than the 26% increase among 280 randomly selected chlamydia-negative women (P = 0.02). There were no differences for the other 8 scales/subscales, including general measures of anxiety, depression, and self-esteem. Chlamydia-positive women were more likely than chlamydia-negative women to be "concerned about chlamydia" (80% vs. 40%, P < 0.001) and to report breaking up with a main partner (33% vs. 11%, P < 0.001) at follow-up. Women testing positive reported a range of chlamydia-specific concerns. CONCLUSIONS: Chlamydia-positive women had significant increases in anxiety about sex and concern about chlamydia, but did not have marked changes in more general measures of psychosocial well-being about 1 month after diagnosis. Chlamydia diagnoses were associated with some disruption of relationships with main partners. Chlamydia-specific concerns may guide counseling messages to minimize psychosocial impact.