Contraceptive uptake among gender-expansive individuals in the HER Salt Lake Contraceptive Initiative.

OBJECTIVES: We examined differences in contraceptive uptake and discontinuation between gender-expansive individuals and cis-women in the HER Salt Lake Contraceptive Initiative. STUDY DESIGN: We used self-reported survey data to assess associations between gender identity, contraceptive uptake, and discontinuation. RESULTS: Of participants (n = 4289), 178/4289 (4%) identified as gender-expansive with 157/178 (88%) reporting recent sexual activity with men. Selection of IUD or Implant was most common, with 109/178 (61%) of gender-expansive individuals choosing these options. We observed similar methods selected (p = 0.2) and discontinuation rates at three years between participants (OR: 0.93, p = 0.8). CONCLUSION: Gender-expansive individuals had similar method selection and discontinuation rates as cis-women. IMPLICATIONS: Our finding of no difference in the uptake of contraception between cis-women and gender-expansive individuals should empower providers to openly discuss contraception with patients regardless of gender identity.

Frequency of same-day contraceptive initiation, recent unprotected intercourse, and pregnancy risk: a prospective cohort study of multiple contraceptive methods.

BACKGROUND: Same-day start removes barriers to contraceptive initiation and may reduce the risk of unintended pregnancy. It may be appropriate for all contraceptive methods, but we lack data comparing methods. OBJECTIVE: This study aimed to assess the frequency of same-day start with 6 contraceptive methods among new contraceptive users and describe the efficacy of same-day start in terms of first-cycle pregnancy risk overall and by each method. STUDY DESIGN: Using prospective data from the HER Salt Lake Contraceptive Initiative, we identified and assessed outcomes for participants initiating a new method of contraception beyond the first 7 days of their menstrual cycle (same-day start). Enrolled participants at 4 family planning clinics in Salt Lake County, Utah between September 2015 and March 2017 received their method of choice regardless of their cycle day or recent unprotected intercourse. All participants self-reported last menstrual period data and unprotected intercourse events in the previous 2 weeks. We excluded participants who received care immediately after or within 2 weeks of abortion care. Clinical electronic health records provided information on contraceptive method initiation and use of oral emergency contraception. Participants reported pregnancy outcomes in 1-, 3-, and 6-month follow-up surveys with clinic verification to identify any pregnancy resulting from same-day initiation. The primary outcomes report the frequency of same-day start use and first-cycle pregnancy risk among same-day start users of all contraceptive methods. The secondary outcomes include frequency of and pregnancy risk in the first cycle of use among same-day start contraception users by method. We also report the frequency of unprotected intercourse within 5 days and 6 to 14 days of contraception initiation, frequency of concomitant receipt of oral emergency contraception with initiation of ongoing contraception, and pregnancy risk with these exposures. We analyzed pregnancy risk for each contraceptive method initiated on the same day and assessed the simultaneous use of oral emergency contraception. RESULTS: Of the 3568 individuals enrolled, we identified most as same-day start users (n=2575/3568; 72.2%), with 1 in 8 of those reporting unprotected intercourse in the previous 5 days (n=322/2575; 12.5%) and 1 in 10 reporting unprotected intercourse 6 to 14 days before contraceptive method initiation (n=254/2575; 9.9%). We identified 11 pregnancies among same-day start users (0.4%; 95% confidence interval, 0.2-0.7), as opposed to 1 (0.1%; 95% confidence interval, 0.002-0.6) among those who initiated contraception within 7 days from the last menstrual period. Users of oral hormonal contraception and vaginal hormonal methods reported the highest first-cycle pregnancy rates (1.0-1.2). Among same-day start users, 174 (6.8%) received oral emergency contraception at enrollment in conjunction with another method. Among the same-day start users who received emergency contraception at initiation, 4 (2.3%) pregnancies were reported. CONCLUSION: Same-day start is common and associated with a low pregnancy risk. Using the "any method, any-time" approach better meets contraceptive clients' needs and maintains a low risk of pregnancy.

Factors associated with a negative Patient Acceptable Symptom State (PASS) response with intrauterine device placement: A retrospective survey of HER Salt Lake participants.

OBJECTIVES: In an established cohort of HER Salt Lake Contraceptive Initiative participants with a prior intrauterine device (IUD) placement, we sought to (1) define the proportion of participants who reported a negative Patient Acceptable Symptom State (PASS) response, (2) explore factors associated with an unacceptable PASS response, and (3) identify pain management preferences for IUD placement. STUDY DESIGN: A retrospective survey was sent to 1440 HER Salt Lake IUD users. A PASS question queried IUD placement pain experience acceptability. We explored associations between an unacceptable PASS response and sociodemographic, reproductive and other individual characteristics using t-tests, chi-square tests, and multivariable logistic regression. RESULTS: Of those surveyed, 620 responded (43%), and 41.6% reported an unacceptable PASS response. Those with an unacceptable PASS response reported a significantly higher experienced pain level (79.2 mm vs 51.8 mm; p < 0.01) than those with an acceptable response, were more likely to have an anxiety diagnosis (47.7% vs 37.1%; p < 0.01), and have a trauma history (33.7% vs 25.1%; p = 0.02). Most patients were not offered pain control options, but 29.4% used ibuprofen and 25.3% had a support person. Regardless of PASS response, if offered, 59.0% desired numbing medication, 56.8% ibuprofen, 51% heating pad, 33.2% support person, and 31.8% anti-anxiety medication, among others. In our multivariable logistic regression model, higher pain was associated with unacceptable PASS response (OR 1.07, 95% CI 1.05-1.08; p < 0.01). CONCLUSIONS: The common finding of unacceptable pain experiences with IUD placement may cause negative perceptions of an otherwise desirable method. Incorporation of the PASS response into IUD pain management studies could expand our pain experience understanding. IMPLICATIONS: IUD placement resulted in unacceptable pain experiences for 41.6% of respondents. Screening for anxiety and trauma history could identify at-risk patients to individualize pain management strategies. Incorporation of the PASS into future IUD pain management studies could result in a more comprehensive, patient-centered measure of patient experiences.

Pharmacodynamic evaluation of the etonogestrel contraceptive implant initiated midcycle with and without ulipristal acetate: An exploratory study.

OBJECTIVE: To estimate the incidence of ovulation suppression within five days of etonogestrel 68 mg implant insertion in the presence of a dominant follicle with and without same-day ulipristal acetate. STUDY DESIGN: This single site non-masked, exploratory randomized trial recruited people age 18-35 years with regular menstrual cycles, no pregnancy risk, and confirmed ovulatory function. We initiated transvaginal ultrasound examinations on menstrual day 7-9 and randomized participants 1:1 to etonogestrel implant alone or with concomitant ulipristal acetate 30 mg oral when a dominant follicle reached ≥14 mm in diameter. We completed daily sonography and serum hormone levels for up to seven days or transitioned to labs alone if sonographic follicular rupture occurred. We defined ovulation as follicular rupture followed by progesterone >3 ng/mL. We calculated point estimates, risk ratios and 95% confidence intervals for ovulation for each group. Ovulation suppression of ≥44% in either group (the follicular rupture suppression rate with oral levonorgestrel emergency contraception), would prompt future method testing. RESULTS: From October 2020 to October 2022, we enrolled 40 people and 39 completed primary outcome assessments: 20 with etonogestrel implant alone (mean follicular size at randomization: 15.2 mm ± 0.9 mm) and 19 with etonogestrel implant + ulipristal acetate (mean follicular size at randomization: 15.4 mm ± 1.2 mm, p = 0.6). Ovulation suppression occurred in 13 (65%) of etonogestrel implant-alone participants (Risk ratio 0.6 (95% CI: 0.3, 1.1), p = 0.08) and seven (37%) of implant + ulipristal acetate participants. CONCLUSIONS: Ovulation suppression of the etonogestrel implant alone exceeds threshold testing for future research while the implant + ulipristal acetate does not. IMPLICATIONS: Data are lacking on midcycle ovulation suppression for the etonogestrel implant with and without oral ulipristal acetate. In this exploratory study, ovulation suppression occurred in 65% of implant participants and 37% of implant + ulipristal acetate participants. Ovulation suppression of the implant alone exceeds threshold testing for future emergency contraception research.

Building an implementation framework to address unmet contraceptive care needs in a carceral setting: a systematic review.

BACKGROUND: The provision of contraceptive care for incarcerated individuals has been largely inconsistent and has contributed to, at best, inadequate care, and at worst reproductive abuses, violence, and coercion. While previous research has identified strategies to remedy known issues, to date, very few recommendations have been implemented across the carceral system. To address this, we conducted a systematic review of policy and practice recommendations to improve contraceptive care to reproductive-aged, incarcerated individuals in the United States. METHODS: We conducted this systematic review utilizing the Joanna Briggs Institute methodology and framed it within the National Implementation Research Network's (NIRN) Exploration stage. We searched PubMed, PSYCInfo, SCOPUS, ProQuest, Web of Science, MedLine, Social Science Citation Index and reference sections of included materials. Basic study information, explicitly stated policy and practice recommendations, and discussions and conclusions that subtly provide recommendations were extracted in full text. We utilized a thematic analysis approach to analyze the extracted text. RESULTS: A total of 45 materials met the inclusion criteria. Seven overarching themes were identified: 1) policy changes needed to implement care; 2) need for contraceptive care in carceral systems; 3) justice agency barriers regarding contraceptive care provision; 4) policy barriers to contraceptive access; 5) funding strategies to improve care; 6) patient preferences for contraceptive care delivery; and 7) healthcare provider knowledge regarding contraceptive care. The seven themes identified shed light on the need for, gaps, barriers, and facilitators of current contraceptive care provision to incarcerated individuals. CONCLUSION: This systematic review accomplished two goals of NIRN's Exploration stage. First, the compiled evidence identified a clear need for change regarding policies and practices pertaining to contraceptive care provision to incarcerated individuals in the United States. Second, our findings identified several evidence-based solutions supported both by research and professional healthcare organizations to address the identified need for change. This study provides an initial blueprint for correctional agencies to implement the necessary changes for improving contraceptive care provision to incarcerated populations. The correctional system is in a unique position to deliver much-needed care, which would result in many potential benefits to the individuals, correctional system, and community at large.

Catalyzing Collaboration Among Interprofessional Birth Transfer Teams Through Simulation.

INTRODUCTION: Planned home or birth center births sometimes require emergency transfers to a hospital. Poor communication among members of the birth care team during a transfer can lead to unfavorable outcomes for the birthing person and newborn. To improve the quality of birth transfers in Utah, the Utah Women and Newborns Quality Collaborative partnered with the LIFT Simulation Design Lab to develop and pilot an interprofessional birth transfer simulation training. METHODS: We engaged community stakeholders to identify learning objectives and co-design the simulation trainings using principles of participatory design. We conducted 5 simulation trainings featuring birth transfers during a postpartum hemorrhage. The LIFT Lab evaluated the trainings to determine if they were feasible, acceptable, and effective. Measures included a post-training form asking participants to evaluate the quality of the training and a 9-question pre- and post-training survey measuring changes in participants' self-efficacy regarding components of birth transfer. The changes were assessed for significance using a paired t test. RESULTS: A total of 102 participants attended the 5 trainings; all health care provider groups were well represented. Most participants felt the simulations were similar to real situations and would benefit others in their professions. All participants said the trainings were a good use of their time. Following the training, participants had significantly higher levels of self-efficacy regarding their ability to manage birth transfers. DISCUSSION: Birth transfer simulation trainings are an acceptable, feasible, and effective method for training interprofessional birth care teams.

Point-of-Care Testing in Chronic Kidney Disease of Non-Traditional Origin: Considerations for Clinical, Epidemiological, and Health Surveillance Research and Practice.

Purpose: As the prevalence of chronic kidney disease of non-traditional origin (CKDnt) rises in low-resource settings, there is a need for reliable point-of-care creatinine testing. The purpose of this analysis was to assess the accuracy of two commonly used point-of-care creatinine devices, the i-STAT handheld (Abbott, Princeton, NJ, USA) and the StatSensor Creatinine (Nova Biomedical, Waltham, MA, USA) in comparison to venipuncture serum creatinine measures. The affordability, sensitivity, specificity, ease of use, and other considerations for each device are also presented. Methods: Three paired data sets were compared. We collected 213 paired i-STAT and venipuncture samples from a community study in Nicaragua in 2015-2016. We also collected 267 paired StatSensor Creatinine and venipuncture samples, including 158 from a community setting in Nicaragua in 2014-2015 and 109 from a Guatemala sugarcane worker cohort in 2017-2018. Pearson correlation coefficients, Bland-Altman plots, and no intercept linear regression models were used to assess agreement between point-of-care devices and blood samples. Results: The i-STAT performed the most accurately, overestimating creatinine by 0.07 mg/dL (95% CI: 0.02, 0.12) with no evidence of proportional bias. The StatSensor Creatinine performed well at low levels of creatinine (Mean (SD): 0.87 (0.19)). Due to proportional bias, the StatSensor Creatinine performed worse in the Nicaragua community setting where creatinine values ranged from 0.31 to 7.04 mg/dL. Discussion: Both devices provide acceptable sensitivity and specificity. Although adequate for routine surveillance, StatSensor Creatinine is less accurate as the values of measured creatinine increase, a consideration when using the point-of-care device for screening individuals at risk for CKDnt. Research, clinical, and screening objectives, cost, ease of use, and background prevalence of disease must all be carefully considered when selecting a point-of-care creatinine device. Conclusion: POC testing can be more accessible in resource-limited settings. The selection of the appropriate device will depend on the use-case.

Women's Health Provider Perspectives on Reproductive Services Provision in the Veterans Health Administration.

OBJECTIVES: Women veterans are a fast-growing population in the Veterans Health Administration (VHA), and ensuring reproductive service availability is a VHA priority. As such, we sought to explore barriers and facilitators to VHA reproductive service provision across a catchment area from women's health providers' perspectives. METHODS: We performed a mixed-methods study, including semistructured, qualitative provider interviews with a quantitative survey on training, comfort, and knowledge of reproductive services. All women's health providers and their support staff from the Salt Lake City Veterans Affairs Medical Center and nine VHA community-based outpatient clinics were asked to participate. We conducted qualitative interviews and knowledge surveys with providers and staff to explore training, care processes, and improvement opportunities in reproductive service provision. We completed descriptive analyses of all of the quantitative data and used an open, iterative process to analyze provider interviews for emergent themes. RESULTS: We interviewed 15 providers (7 advanced practice nurses, 4 registered nurses, and 4 physicians) across nine sites (50% response rate). The commonly identified barriers included provider training and staffing, scheduling/referral processes, inconsistent services/supplies, and lack of veteran awareness of reproductive services. Facilitators included prior non-VHA reproductive health experience among providers, invested support staff, and the integrated VHA health system. CONCLUSIONS: Addressing barriers to VHA reproductive healthcare provision may overcome reproductive service variations related to clinic location and improve reproductive health outcomes for women veterans.

One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial.

BACKGROUND: Recent evidence demonstrates the effectiveness of the levonorgestrel 52-mg intrauterine device for emergency contraception vs the copper T380A intrauterine device. Of note, 1-year pregnancy and continuation rates after intrauterine device placement for emergency contraception remain understudied. OBJECTIVE: This study compared 1-year pregnancy and intrauterine device continuation rates and reasons for discontinuation among emergency contraception users randomized to the levonorgestrel 52-mg intrauterine device or the copper intrauterine device. STUDY DESIGN: This participant-masked, randomized noninferiority trial recruited emergency contraception individuals desiring an intrauterine device from 6 Utah family planning clinics between August 2016 and December 2019. Participants were randomized 1:1 to the levonorgestrel 52-mg intrauterine device group or the copper T380A intrauterine device group. Treatment allocation was revealed to participants at the 1-month follow-up. Trained personnel followed up the participants by phone, text, or e-mail at 5 time points in 1 year and reviewed electronic health records for pregnancy and intrauterine device continuation outcomes for both confirmation and nonresponders. We assessed the reasons for the discontinuation and used Cox proportional-hazard models, Kaplan-Meier estimates, and log-rank tests to assess differences in the continuation and pregnancy rates between the groups. RESULTS: The levonorgestrel and copper intrauterine device groups included 327 and 328 participants, respectively, receiving the respective interventions. By intention-to-treat analysis at 1 year, the pregnancy rates were similar between intrauterine device types (2.8% [9/327] in levonorgestrel 52-mg intrauterine device vs 3.0% [10/328] in copper intrauterine device; risk ratio, 0.9; 95% confidence interval, 0.4-2.2; P=.82). Most pregnancies occurred in participants after intrauterine device removal, with only 1 device failure in each group. Of note, 1-year continuation rates did not differ between groups with 204 of 327 levonorgestrel 52-mg intrauterine device users (62.4%) and 183 of 328 copper T380A intrauterine device users (55.8%) continuing intrauterine device use at 1 year (risk ratio, 1.1; 95% confidence interval, 1.0-1.2; P=.09). There were differences concerning the reasons for discontinuation between intrauterine device types, with more bleeding and cramping cited among copper intrauterine device users. CONCLUSION: The pregnancy rates were low and similar between intrauterine device types. Of note, 6 of 10 intrauterine device emergency contraception users continued use at 1 year. Moreover, 1-year continuation rates were similar between intrauterine device types.

Switching and discontinuation of participant-masked randomization to a copper or levonorgestrel intrauterine device when presenting for emergency contraception.

OBJECTIVES: Examine intrauterine device (IUD) switching or discontinuation up to 6 months after participant-masked randomization to different IUDs. STUDY DESIGN: Participants were randomized 1:1 to the copper T380A or levonorgestrel 52 mg IUD for emergency contraception and informed they could switch IUD type without cost at any time. RESULTS: Of the 327 subjects allocated to the levonorgestrel IUD, 7 (2.1%) switched their IUD type by 6 months versus 18 (5.5%) of the 328 copper IUD users (RR: 0.4 [95% CI: 0.2, 0.9], p = 0.03). Six-month IUD discontinuation occurred in 34 (10.4%) levonorgestrel and 35 (10.7%) copper IUD users. CONCLUSION: Individuals randomly assigned to IUD type at presentation for emergency contraception continue their assigned IUDs at high rates over 6 months. IMPLICATIONS: While many recruited individuals declined enrollment, those who accepted randomization had high continuation rates; the high continuation and low cross-over supports using IUD randomization as a tool for future investigation. Participants' similar rates of and reasons for switching and discontinuation by IUD type over the study period may impact clinical counseling.

Does access to no-cost contraception change method selection among individuals who report difficulty paying for health-related care?

BACKGROUND: Out-of-pocket costs continue to be a barrier to accessing necessary healthcare services, including contraception. We explored how eliminating out-of-pocket cost affects contraceptive method choice among people reporting difficulty paying for healthcare in the previous year, and whether method satisfaction differed by method choice. METHODS: We used data from the HER Salt Lake Contraceptive Initiative. This prospective cohort study provided participants with no-cost contraception (April 2016-March 2017) following a control period that provided no reduction in cost for the contraceptive implant, a reduced price for the hormonal IUD, and a sliding scale that decreased to no-cost for the copper IUD (September 2015-March 2016). We restricted the study population to those who reported difficulty paying for healthcare in the past 12 months. For our primary outcome assessing changes in method selection between intervention and control periods, we ran simultaneous multivariable logistic regression models for each method, applying test corrections for multiple comparisons. Among participants who continued their method for 1 year, we explored differences in method satisfaction using multivariable logistic regression. RESULTS: Of the 1,029 participants reporting difficulty paying for healthcare and controlling for other factors, participants more frequently selected the implant (aOR 6.0, 95% CI 2.7, 13.2) and the hormonal IUD (aOR 3.2, 95% CI 1.7, 5.9) during the intervention than control period. Comparing the same periods, participants less frequently chose the injection (aOR 0.5, 95% CI 0.3, 0.8) and the pill (aOR 0.4, 95% CI 0.3, 0.6). We did not observe a difference in uptake of the copper IUD (aOR 2.0, 95% CI 1.0, 4.1).Contraceptive satisfaction scores differed minimally by contraceptive method used among contraceptive continuers (n = 534). Those who selected LNG IUDs were less likely to report low satisfaction with their method (aOR 0.5, 95% CI 0.3, 0.97). CONCLUSION: With costs removed, participants who reported difficulty paying for healthcare were more likely to select hormonal IUDs and implants and less likely to select the injectable or contraceptive pills. Among continuers, there were few differences in method satisfaction. CLINICALTRIALS: gov Identifier NCT02734199.

Facility-based simulation as a programmatic tool for implementing a statewide contraceptive initiative.

BACKGROUND: Assessing implementation fidelity is highly recommended, but successful approaches can be challenging. Family Planning Elevated (FPE) is a statewide contraceptive initiative which partnered with 28 health clinics across Utah. To assess implementation fidelity, we developed in-situ high-fidelity simulation training to both determine clinic adherence to FPE and offer education to implementing teams. This study aimed to develop, pilot, and assess the use of simulation as a tool for measuring implementation fidelity. METHODS: We developed two simulation scenarios to determine implementation fidelity: one scenario wherein a client is seeking a new method of contraception and another in which the same client has returned to discontinue the method. Both simulations contained multiple aspects of program implementation (e.g., determining program eligibility). We then offered simulations to all FPE partner organizations. To assess simulation training as a tool for determining implementation fidelity, we developed strategies aligned with each aspect of an adapted RE-AIM framework, including pre-post surveys, acceptability and self-efficacy testing, a checklist for programmatic adherence, field notes, action planning and analysis of monitoring data. RESULTS: Fifteen clinical sites and 71 team members participated in the in-situ simulations. Assessment of the checklist showed that 90% of the clinics successfully demonstrated key program components, including person-centered counseling techniques such as sitting at the patient's level (95.8%); asking open-ended questions (100%); and explaining how to use the contraceptive method selected (91.7%). More than half of clinics fell short in programmatic areas including: confirmation that the FPE program covered same-day intrauterine device insertion (54.2%), and education on health risks associated with the selected contraceptive method (58.3%). After simulation, participants reported improved knowledge of how FPE works (p = < 0.001), increased ability to identify FPE-eligible clients (p = 0.02) and heightened self-efficacy in helping clients select a method (p = 0.03). Participants were satisfied with the simulations, with most (84.1%) reporting that the simulation exceeded their expectations. CONCLUSIONS: Highly-realistic in-situ family planning simulations are acceptable to participants, positively change knowledge and clinical team confidence, and can identify systems gaps in clinical care and program implementation. Simulation offers a reciprocal way of monitoring implementation fidelity of a family planning access initiative. TRIAL REGISTRATION: This project was determined to be exempt by the IRB of the University of Utah, the larger Family Planning Elevated program under which this pilot study was nested is registered at ClinicalTrials.gov Identifier: NCT03877757 .

Implementation and Monitoring of the Family Planning Elevated Contraceptive Access Program, Utah, 2018‒2019.

Family Planning Elevated (FPE) is a contraceptive access initiative in Utah. FPE designed and utilized a comprehensive monitoring system to identify and respond to challenges implementing our initiative as they arose. Here, we describe the components of our monitoring system, and highlight how FPE's monitoring system successfully identified that Utah's Medicaid expansion was not widely adopted by eligible individuals. We then describe how FPE adapted to this challenge. (Am J Public Health. 2022;112(S5):S528-S531. https://doi.org/10.2105/AJPH.2022.306935).

Pregnancy Risk by Frequency and Timing of Unprotected Intercourse Before Intrauterine Device Placement for Emergency Contraception.

OBJECTIVE: To assess pregnancy risk after intrauterine device (IUD) placement by the number and timing of unprotected intercourse episodes in the prior 14 days. METHODS: This was a secondary analysis of a randomized trial that compared the copper T380A IUD and levonorgestrel 52-mg intrauterine system for emergency contraception. At enrollment, participants had a negative urine pregnancy test result and reported the frequency and timing of any unprotected intercourse in the preceding 14 days. We assessed pregnancies 1 month after IUD placement and compared pregnancy risk by single or multiple unprotected intercourse episodes and by timing (5 or fewer days before IUD placement or 6 or more days before). RESULTS: Among the 655 participants, one pregnancy occurred in a patient who reported intercourse once 48 hours before IUD placement. Multiple unprotected intercourse episodes were reported by 286 participants (43.7%), and 95 participants (14.4%) reported at least one unprotected intercourse episode 6 or more days before IUD placement. No pregnancies occurred among those with multiple unprotected intercourse episodes (0%, 97.5% CI 0-1.3%) or with any unprotected intercourse episode 6-14 days before IUD placement (0.0%, 97.5% CI 0.0-3.8%). Pregnancy risk difference did not significantly differ by single compared with multiple unprotected intercourse episodes (0.3%, 95% CI -0.3% to 0.8%), nor by unprotected intercourse 5 or fewer days before IUD placement or 6 or more days before (0.2%, 95% CI -0.2% to 0.5%). CONCLUSION: With a negative urine pregnancy test result at IUD placement, 1-month pregnancy risk remains low, regardless of frequency or timing of unprotected intercourse in the prior 14 days. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02175030.

Rates of pregnancy among levonorgestrel and copper intrauterine emergency contraception initiators: Implications for backup contraception recommendations.

OBJECTIVE: This study assessed the timing, frequency, use of backup method and 1-month pregnancy rates among individuals who had an intrauterine device (IUD) placed as emergency contraception and reported intercourse within 7 days post-placement. STUDY DESIGN: In this secondary analysis of a randomized control trial of IUDs for emergency contraception, 518 individuals reporting unprotected intercourse in the preceding 5 days had a 52 mg levonorgestrel intrauterine system (IUS) or 380 mm2 copper IUD placed outside the first week of their menstrual cycle. All participants were advised to use backup contraception for 7 days. We assessed pregnancy status 1 month after placement by urine testing or, when not available, by survey responses and electronic health record review.  Participants reported whether their first sexual activity after device placement occurred within 7 days of their placement, the frequency of intercourse and whether they used backup contraception. RESULTS: Rapid return to sexual activity was common and use of backup contraception was rare, regardless of type of IUD placed. Of participants who resumed penile-vaginal intercourse in the first month, most (286/446, 64.1%) participants reported intercourse within 7 days of IUD placement; only 16.4% (74/446) used condoms or withdrawal. No pregnancies occurred among users of the levonorgestrel IUS who reported intercourse within 7 days of placement (0/138, 0.0%, 95% CI 0.0%, 2.6%) nor among users of the 380mm2 copper IUD (0/148, 0.0%, 95% CI 0.0%, 2.5%). CONCLUSION: Pregnancy rates are low after placement of an IUD for emergency contraception, even among the many who resume intercourse within days following IUD placement without use of backup contraception. IMPLICATIONS: Clinical guidelines should facilitate access to contraception, including elimination of unnecessary recommendations for backup contraception or abstinence in the 7 days following 52 mg levonorgestrel intrauterine system.

Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.

BACKGROUND: In the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose. METHODS: This randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points. RESULTS: Among the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group. CONCLUSIONS: The levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).

Evaluating a Longitudinal Cohort of Clinics Engaging in the Family Planning Elevated Contraceptive Access Program: Study Protocol for a Comparative Interrupted Time Series Analysis.

BACKGROUND: Access to high-quality, comprehensive contraceptive care is an inherent component of reproductive human rights. However, hindrances to specific aspects of contraceptive provision, including availability, accessibility, acceptability, and quality, continue to perpetuate unmet needs. The state of Utah has recently passed a series of contraceptive policies intended to improve contraceptive access. Despite these positive changes to theoretical access, fiscal appropriations to support the implementation of these policies have been minimal, and many individuals still struggle to access contraception. OBJECTIVE: The Family Planning Elevated Contraceptive Access Program (FPE CAP), part of a larger statewide contraceptive initiative, specifically aims to improve contraceptive access within health clinics. This paper describes the study protocol for evaluating the success of FPE CAP. METHODS: Health clinics apply for membership in the FPE CAP. On acceptance in the program, they receive a cash grant for clinical supplies, equipment, and personnel expenses; reimbursement for contraceptive services and methods for eligible clients; technical support, training, and proctoring on counseling and providing all methods of contraception; method stocking of intrauterine devices and implants; and demand generation activities, including local media campaigns, to inform community members about the FPE CAP and possible eligibility. FPE collects monthly service delivery reports from participating clinics for evaluation purposes. The primary outcomes of FPE CAP are level and trend changes in contraceptive service delivery among individuals earning ≤138% federal poverty level (FPL) following membership in FPE CAP and among FPE CAP clients earning between 139% and 250% FPL (including those ineligible for Medicaid) compared with historical data and control clinics. To assess this, we will conduct comparative interrupted time series analyses assessing the level and trend changes in intervention and control clinics 12 months before the intervention, for the 2-year duration of the intervention, and for the subsequent 12 months following the intervention. RESULTS: We found that the study is adequately powered (>80% power) with our planned number of clinics and the number of months of data available in the study. To date, we have successfully completed the recruitment and enrollment of 8 of the expected 9 health organizations and 4 of the control clinics. Completed health organization enrollment for both intervention and control organizations is expected to be completed in December 2020. CONCLUSIONS: The study aims to provide insight into a new approach to contraceptive initiatives by addressing comprehensive aspects of contraceptive care at the health system level. Ongoing state policy changes and implementation components may affect the evaluation outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18308.