J. Peipert

Sexually transmitted diseases and infertility

&NA; Female infertility, including tubal factor infertility, is a major public health concern worldwide. Most cases of tubal factor infertility are attributable to untreated sexually transmitted diseases that ascend along the reproductive tract and are capable of causing tubal inflammation, damage, and scarring. Evidence has consistently demonstrated the effects of Chlamydia trachomatis and Neisseria gonorrhoeae as pathogenic bacteria involved in reproductive tract morbidities including tubal factor infertility and pelvic inflammatory disease. There is limited evidence in the medical literature that other sexually transmitted organisms, including Mycoplasma genitalium, Trichomonas vaginalis, and other microorganisms within the vaginal microbiome, may be important factors involved in the pathology of infertility. Further investigation into the vaginal microbiome and other potential pathogens is necessary to identify preventable causes of tubal factor infertility. Improved clinical screening and prevention of ascending infection may provide a solution to the persistent burden of infertility.

Long-acting reversible contraception in adolescents: a systematic review and meta-analysis

BACKGROUND: Among adolescent pregnancies, 75% are unintended. Greater use of highly‐effective contraception can reduce unintended pregnancy. Although multiple studies discuss adolescent contraceptive use, there is no consensus regarding the use of long‐acting reversible contraception as a first‐line contraception option. OBJECTIVE: We performed a systematic review of the medical literature to assess the continuation of long‐acting reversible contraceptives among adolescents. STUDY DESIGN: Ovid‐MEDLINE, Cochrane databases, and Embase databases were searched using key words relevant to the provision of long‐acting contraception to adolescents. Articles published from January 2002 through August 2016 were selected for inclusion based on specific key word searches and detailed review of bibliographies. For inclusion, articles must have provided data on method continuation, effectiveness, or satisfaction of at least 1 long‐acting reversible contraceptive method in participants <25 years of age. Duration of follow‐up had to be ≥6 months. Long‐acting reversible contraceptive methods included intrauterine devices and the etonogestrel implant. Only studies in the English language were included. Guidelines, systematic reviews, and clinical reviews were examined for additional citations and relevant points for discussion. Of 1677 articles initially identified, 90 were selected for full review. Of these, 12 articles met criteria for inclusion. All studies selected for full review were extracted by multiple reviewers; inclusion was determined by consensus among authors. For studies with similar outcomes, forest plots of combined effect estimates were created using the random effects model. The meta‐analysis of observational studies in epidemiology guidelines were followed. Primary outcomes measured were continuation of method at 12 months, and expulsion rates for intrauterine devices. RESULTS: This review included 12 studies, including 6 retrospective cohort studies, 5 prospective observational studies, and 1 randomized controlled trial. The 12 studies included 4886 women age <25 years: 4131 intrauterine device users and 755 implant users. The 12‐month continuation of any long‐acting reversible contraceptive device was 84.0% (95% confidence interval, 79.0–89.0%). Intrauterine device continuation was 74.0% (95% confidence interval, 61.0–87.0%) and implant continuation was 84% (95% confidence interval, 77.0–91.0%). Among postpartum adolescents, the 12‐month long‐acting reversible contraceptive continuation rate was 84.0% (95% confidence interval, 71.0–97.0%). The pooled intrauterine device expulsion rate was 8.0% (95% confidence interval, 4.0–11.0%). CONCLUSION: Adolescents and young women have high 12‐month continuation of long‐acting reversible contraceptive methods. Intrauterine devices and implants should be offered to all adolescents as first‐line contraceptive options.

Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device: 2 years beyond Food and Drug Administration–approved duration

BACKGROUND: The subdermal contraceptive implant and the 52‐mg levonorgestrel intrauterine device are currently Food and Drug Administration approved for 3 and 5 years of use, respectively. Limited available data suggested both of these methods are effective beyond that time. Demonstration of prolonged effectiveness will improve the cost‐effectiveness of the device, and potentially patient continuation and satisfaction. OBJECTIVE: We sought to evaluate the effectiveness of the contraceptive implant and the 52‐mg hormonal intrauterine device in women using the method for 2 years beyond the current Food and Drug Administration–approved duration. STUDY DESIGN: We initiated this ongoing prospective cohort study in January 2012. We are enrolling women using the contraceptive implant or 52‐mg levonorgestrel intrauterine device for a minimum of 3 and 5 years, respectively (started intrauterine device in ≥2007 or implant in ≥2009). Demographic and reproductive health histories, as well as objective body mass index, were collected. Implant users were offered periodic venipuncture for analysis of serum etonogestrel levels. The primary outcome, unintended pregnancy rate, was calculated per 100 woman‐years. We analyzed baseline demographic characteristics using χ2 test and Fisher exact test, and compared serum etonogestrel levels stratified by body mass index using the Kruskal‐Wallis test. RESULTS: Implant users (n = 291) have contributed 444.0 woman‐years of follow‐up. There have been no documented pregnancies in implant users during the 2 years of postexpiration follow‐up. Calculated failure rates in the fourth and fifth years for the implant are calculated as 0 (1‐sided 97.5% confidence interval, 0–1.48) per 100 woman‐years at 4 years and 0 (1‐sided 97.5% confidence interval, 0–2.65) per 100 woman‐years at 5 years. Among 496 levonorgestrel intrauterine device users, 696.9 woman‐years of follow‐up have been completed. Two pregnancies have been reported. The failure rate in the sixth year of use of the levonorgestrel intrauterine device is calculated as 0.25 (95% confidence interval, 0.04–1.42) per 100 woman‐years; failure rate during the seventh year is 0.43 (95% confidence interval, 0.08–2.39) per 100 woman‐years. Among implant users with serum etonogestrel results, the median etonogestrel level was 207.7 pg/mL (range 63.8‐802.6 pg/mL) at the time of method expiration, 166.1 pg/mL (range 67.9 25.0–470.5 pg/mL) at the end of the fourth year, and 153.0 pg/mL (range 72.1‐538.8 pg/mL) at the end of the fifth year. Median etonogestrel levels were compared by body mass index at each time point and a statistical difference was noted at the end of 4 years of use with overweight women having the highest serum etonogestrel (195.9; range 25.0‐450.5 pg/mL) when compared to normal (178.9; range 87.0‐463.7 pg/mL) and obese (137.9; range 66.0‐470.5 pg/mL) women (P = .04). CONCLUSION: This study indicates that the contraceptive implant and 52‐mg hormonal intrauterine device continue to be highly effective for at least 2 additional years of use. Serum etonogestrel evaluation demonstrates median levels remain above the ovulation threshold of 90 pg/mL for women in all body mass index classes.

Changes in body composition in women using long-acting reversible contraception

OBJECTIVE Users of hormonal long-acting reversible contraception (LARC) report weight gain as a side effect, but few studies have assessed body composition change among LARC users. We evaluated weight and body composition of healthy women using the levonorgestrel intrauterine system (LNG-IUS), copper intrauterine device (copper IUD) or etonogestrel implant (ENG implant). We hypothesized that weight gain and body composition over 12 months would not differ between copper IUD, LNG-IUS and ENG implant users. STUDY DESIGN We performed a prospective cohort study of a subgroup of women enrolled in the Contraceptive CHOICE Project who initiated the LNG-IUS, copper IUD or ENG implant. Inclusion criteria included lack of metabolic and eating disorders or change in body weight of more than 5% in the 6 months before enrollment. We measured changes in weight and body composition (body fat percentage, total body fat mass, total lean mass and total body mass) in women who continued their method for 12 months. RESULTS We analyzed data from 149 participants: 85 LNG-IUS users, 31 copper IUD users and 33 ENG implant users. The mean age was 25.9 years, 56.4% were White, 82.5% had some college education and 67.6% were nulliparous. Although lean body mass increased over 12 months in LNG-IUS and copper IUD users but not in ENG implant users, changes in body weight and body composition did not differ between the groups. In the adjusted model, Black race was associated with change in total body mass (p<.05). CONCLUSIONS Among those who continued the method for 12 months, changes in body weight and composition did not differ between copper IUD, LNG-IUS and ENG implant users. IMPLICATIONS STATEMENT Changes in body weight and composition over 12 months did not differ between copper IUD users and LNG-IUS and ENG implant users among those with 12 months of continuous use.

Condom use and incident sexually transmitted infection after initiation of long-acting reversible contraception

Background Use of more effective contraception may lead to less condom use and increased incidence of sexually transmitted infection. Objective The objective of this study was to compare changes in condom use and incidence of sexually transmitted infection acquisition among new initiators of long‐acting reversible contraceptives to those initiating non‐long‐acting reversible contraceptive methods. Study Design This is a secondary analysis of the Contraceptive CHOICE Project. We included 2 sample populations of 12‐month continuous contraceptive users. The first included users with complete condom data (baseline, and 3, 6, and 12 months) (long‐acting reversible contraceptive users: N = 2371; other methods: N = 575). The second included users with 12‐month sexually transmitted infection data (long‐acting reversible contraceptive users: N = 2102; other methods: N = 592). Self‐reported condom use was assessed at baseline and at 3, 6, and 12 months following enrollment. Changes in condom use and incident sexually transmitted infection rates were compared using χ2 tests. Risk factors for sexually transmitted infection acquisition were identified using multivariable logistic regression. Results Few participants in either group reported consistent condom use across all survey time points and with all partners (long‐acting reversible contraceptive users: 5.2%; other methods: 11.3%; P < .001). There was no difference in change of condom use at 3, 6, and 12 months compared to baseline condom use regardless of method type (P = .65). A total of 94 incident sexually transmitted infections were documented, with long‐acting reversible contraceptive users accounting for a higher proportion (3.9% vs 2.0%; P = .03). Initiation of a long‐acting reversible contraceptive method was associated with increased sexually transmitted infection incidence (odds ratio, 2.0; 95% confidence ratio, 1.07–3.72). Conclusion Long‐acting reversible contraceptive initiators reported lower rates of consistent condom use, but did not demonstrate a change in condom use when compared to preinitiation behaviors. Long‐acting reversible contraceptive users were more likely to acquire a sexually transmitted infection in the 12 months following initiation.

Reducing health disparities by removing cost, access, and knowledge barriers

BACKGROUND: While the rate of unintended pregnancy has declined in the United States in recent years, unintended pregnancy among teens in the United States is the highest among industrialized nations, and disproportionately affects minority teens. OBJECTIVE: Our objective of this secondary analysis was to estimate the risk of unintended pregnancy for both Black and White teens age 15‐19 years when barriers to access, cost, and knowledge are removed. Our hypothesis was that the Black‐White disparities would be reduced when access, education, and cost barriers are removed. STUDY DESIGN: We performed an analysis of the Contraceptive CHOICE Project database. CHOICE is a longitudinal cohort study of 9256 sexually active girls and women ages 14‐45 years in the St Louis, MO, region from 2007 through 2013. Two measures of disparities were used to analyze teenage pregnancy rates and pregnancy risk from 2008 through 2013 among teens ages 15‐19 years. These rates were then compared to the rates of pregnancy among all sexually active teens in the United States during the years 2008, 2009, 2010, and 2011. We estimated an absolute measure (rate difference) and a relative measure (rate ratio) to examine Black‐White disparities in the rates of unintended pregnancy. RESULTS: While national rates of unintended pregnancy are decreasing, racial disparities in these rates persist. The Black‐White rate difference dropped from 158.5 per 1000 in 2008 to 120.1 per 1000 in 2011; however, the relative ratio disparity decreased only from 2.6‐2.5, suggesting that Black sexually active teens in the United States have 2.5 times the rate of unintended pregnancy as White teenagers. In the CHOICE Project, there was a decreasing trend in racial disparities in unintended pregnancy rates among sexually active teens (age 15‐19 years): 2008 through 2009 (rate difference, 18.2; rate ratio, 3.7), 2010 through 2011 (rate difference, 4.3; rate ratio, 1.2), and 2012 through 2013 (rate difference, –1.5; rate ratio, 1.0). CONCLUSION: When barriers to cost, access, and knowledge were removed, such as in the Contraceptive CHOICE Project, Black‐White disparities in unintended pregnancy rates among sexually active teens were reduced on both absolute and relative scales. The rate of unintended pregnancy was almost equal between Black and White teens compared to large Black‐White disparities on the national level.

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

BackgroundThe 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.MethodsUsing 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.ResultsMany 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.ConclusionsIn 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.

Dual method use among long-acting reversible contraceptive users

Abstract Objective: To compare rates of dual method use (concurrent use of condoms and an effective method of contraception) in long-acting reversible contraceptive (LARC) and non-LARC hormonal contraceptive users, and to determine factors associated with dual method use. Methods: We conducted a secondary analysis of the Contraceptive CHOICE Project, an observational, prospective cohort study of 9256 women in St. Louis, MO, USA. Our sample included 6744 women who initiated a contraceptive method within 3 months of enrollment, continued use at 6 months post-enrollment, and responded regarding dual method use. Our primary outcome was the rate of dual method use at 6 months post-enrollment. Results: Dual method use was reported by 32% of LARC and 45% of non-LARC hormonal contraceptive users (p < .01). After adjusting for other covariates and comparing to non-LARC hormonal contraceptive users, LARC users were less likely to report dual method use (RRadj 0.76, 95% CI 0.70–0.83). Factors associated with dual method use in our multivariable analysis were age <25 years, black race, lower education, single relationship status, baseline dual method use, baseline diagnosis of sexually transmitted infection (STI), greater partner willingness to use a condom, and higher condom self-efficacy score. Conclusions: LARC users are less likely to report dual method use compared to non-LARC hormonal contraceptive users, but other factors also impact dual method use. Further studies should be performed to determine whether this lower dual method use increases the risk of STI. Clinical trials registration: Clinicaltrials.gov Identifier NCT01986439.

Comparison of an additional early visit to routine postpartum care on initiation of long-acting reversible contraception: A randomized trial

OBJECTIVE To investigate whether an early 3-week postpartum visit in addition to the standard 6-week visit increases long-acting reversible contraception (LARC) initiation by 8 weeks postpartum compared to the routine 6-week visit alone. STUDY DESIGN We enrolled pregnant and immediate postpartum women into a prospective randomized, non-blinded trial comparing a single 6-week postpartum visit (routine care) to two visits at 3 and 6 weeks postpartum (intervention), with initiation of contraception at the 3-week visit, if desired. All participants received structured contraceptive counseling. Participants completed surveys in-person at baseline and at the time of each postpartum visit. A sample size of 200 total participants was needed to detect a 2-fold difference in LARC initiation (20% vs. 40%). RESULTS Between May 2016 and March 2017, 200 participants enrolled; outcome data are available for 188. The majority of LARC initiation occurred immediately postpartum (25% of the intervention arm and 27% of the routine care arm). By 8 weeks postpartum, 34% of participants in the intervention arm initiated LARC, compared to 41% in the routine care arm (p=.35). Overall contraceptive initiation by 8 weeks was 83% and 84% in the intervention and routine care arms, respectively (p=.79). There was no difference between the arms in the proportion of women who attended at least one postpartum visit (70% vs. 74%, p=.56). CONCLUSION The addition of a 3-week postpartum visit to routine care does not increase LARC initiation by 8 weeks postpartum. The majority of LARC users desired immediate rather than interval postpartum initiation. CLINICAL TRIAL REGISTRATION Clinicaltrials.govNCT02769676 IMPLICATIONS: The addition of a 3-week postpartum visit to routine care does not increase LARC or overall contraceptive initiation by 8 weeks postpartum when the option of immediate postpartum placement is available. The majority of LARC users desired immediate rather than interval postpartum initiation.

Medicaid Savings from the Contraceptive CHOICE Project: a Cost Savings Analysis

BACKGROUND: Forty‐five percent of births in the United States are unintended, and the costs of unintended pregnancy and birth are substantial. Clinical and policy interventions that increase access to the most effective reversible contraceptive methods (intrauterine devices and contraceptive implants) have potential to generate significant cost savings. Evidence of cost savings for these interventions is needed. OBJECTIVE: The purpose of this study was to conduct a cost‐savings analysis of the Contraceptive CHOICE Project, which provided counseling and no‐cost contraception, to demonstrate the value of investment in enhanced contraceptive care to the Missouri Medicaid program. STUDY DESIGN: The Contraceptive CHOICE Project was a prospective cohort study of 9256 reproductive‐age women who were enrolled between 2007 and 2011. Study follow‐up was completed October 2013. This analysis includes 5061 Contraceptive CHOICE Project participants who were current Missouri Medicaid beneficiaries or were uninsured and reported household incomes <201% of the federal poverty line. We created a simulated comparison group of women who were receiving care through the Missouri Title X program and modeled the contraception and pregnancy outcomes that would have occurred in the absence of the Contraceptive CHOICE Project. Data about contraceptive use for the comparison group (N=5061) were obtained from the Missouri Title X program and adjusted based on age, race, ethnicity, and income. To make an accurate comparison that would account for the difference in the 2 populations, we used our simulation model to estimate total Contraceptive CHOICE Project costs and total comparison group costs. We reported all costs in 2013 dollars to account for inflation. RESULTS: Among the Contraceptive CHOICE Project participants who were included, the uptake of intrauterine devices and implants was 76.1% compared with 4.8% among the comparison group. The estimated contraceptive cost for the simulated Contraceptive CHOICE Project group was