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ObjectiveTo evaluate the effectiveness of Health-E You/Salud iTu, a mobile health application (app), on increasing knowledge, self-efficacy and contraception use among Latina adolescents, its impact on visit quality, and app satisfaction.Study designThis study used cluster-randomized controlled trial (CRCT) of 18 school-based health centers (SBHCs). Prior to the visit, intervention participants received the patient-centered contraceptive decision-making support app and controls answered sexual health questions on iPads. Participants completed a previsit questionnaire and 3 follow-up surveys (48 hours, 3-, and 6-months) after the recruitment visit (where intervention participants completed the app). Differences in adolescents' contraceptive knowledge, self-efficacy, and use over the 6-month follow-up were assessed by generalized mixed effects regression models.ResultsA total of 1,360 Latina adolescents participated; 57.2% responded to the 48-hour survey, 50.1% to the 3-month, 49.7% to the 6-month, and 42.3% to both the 3- and 6-month surveys. Health-E You users' demonstrated significant increases in pre-post knowledge (p < 0.001). Intervention participants who completed the follow-up survey reported greater increases in mean self-efficacy from baseline (23.2 intervention vs. 22.5 controls) to 6 months (26.1 vs. 23.4; b = 1.58, 95% CI 0.38-2.77, p = 0.01), and greater increases in non-barrier contraceptive use from baseline (29% intervention vs. 30% controls) to 3 months (63% vs. 45%; OR = 3.29, 95% CI 1.04-10.36, p = 0.04) and 6 months (63% vs. 44%; OR = 5.54, 95% CI 1.70-18.06, p = 0.005). Providers and adolescents reported high app satisfaction and stated it improved visit quality.ConclusionsWhile data suggest that Health-E You improved outcomes, findings must be interpreted cautiously. Intervention participants had higher baseline sexual activity rates, more recruitment visits for pregnancy testing, emergency contraception or birth control, and lower completion rates of follow-up surveys than controls.ImplicationsDespite declines in adolescent pregnancy in the United States, Latinas continue to have disproportionately high rates compared to white females. The Health-E You app may be an effective support tool for both adolescents and providers in SBHCs, and possibly other clinical settings, across the country to increase contraceptive use and thereby decrease unintended pregnancies. It could potentially reduce disparities in adolescent pregnancies and create more efficient visit time spent between clients and their providers.

ObjectivesWomen may differ by whether they rely on health providers and/or social ties for seeking information and advice about family planning. It is unknown whether these differences matter for contraceptive outcomes. This study assessed the association between women's family planning (FP) network (social and/or provider ties) and contraceptive use.Study designThis cross-sectional, egocentric network study was conducted among reproductive-age women (n = 193) in rural Madagascar. Data included socio-demographics and contraceptive use. Respondents listed who they relied on for contraceptive information, advice or guidance and provided ties' gender, age, relationship, and perceived support of contraceptive use. The primary outcome was current contraceptive use. Predictors included having a FP network (0/1) and FP network composition (no network, social ties only, provider ties only, both provider and social ties), respectively. Analyses were conducted using a generalized linear model specifying a Poisson distribution, with covariate adjustment and cluster robust standard errors.ResultsHaving a network of individuals to turn to for contraceptive information compared to having no FP network was positively associated with contraceptive use (adjusted relative risk [aRR] 4.4, 95% confidence interval [CI] 2.00-9.87). Having a social network, a provider network, or a combination of social and provider network were all positively associated with contraceptive use (aRR 4.30 [CI 1.92-9.66], aRR 4.46 [CI 2.04-9.75], aRR 4.72 [CI 1.93-11.50], respectively), compared to having no FP network.ConclusionsContraceptive use was higher among women who relied on social ties, provider ties or both for contraceptive information and advice, compared to women with no FP network. These findings suggest that FP interventions should use a multicomponent approach taking into account both social and provider networks.ImplicationsIt is unknown whether differences in whether women rely on social ties (friends, partner, family members) vs. providers for contraceptive information and advice affect contraceptive outcomes. Women are just as likely to use contraception whether they rely on social ties, provider ties, or both for contraceptive information and advice.

ObjectiveTo understand how the COVID-19 pandemic affected women of reproductive age, specifically their economic conditions, desire for pregnancy, and access to contraceptive services during the pandemic.Study designsA total of 554 women respondents age 18 to 49 and reside in the United States were recruited using social media between May 16, 2020 and June 16, 2020. Logistic regression models assessed predictors of reporting pandemic-related changes in economic conditions, desire for pregnancy, and contraceptive access.ResultsCompared to White/Caucasian respondents, Hispanics/Latinx and Black/African Americans have 4 times the odds of experiencing inability to afford food, transportation, and/or housing (p < 0.01) during the pandemic; Hispanics/Latinx have twice the odds of experiencing food insecurity (p < 0.05). Inability to afford food, transportation, and/or housing was associated with drop in desire to be pregnant (p < 0.01). Despite the 25% of participants who reported a drop in desire for pregnancy, 1 in 6 reported difficulty accessing contraceptives, particularly those who experienced reduced income (p < 0.01).ConclusionsIn our sample, the pandemic unevenly affected people from different socioeconomic groups. Many simultaneously experienced reduced income, difficulties in accessing contraception, and a greater desire to avoid a pregnancy. This combination of factors increases the chance that people will experience unintended pregnancies.ImplicationsThe pandemic caused economic hardship and an increased desire to postpone or prevent pregnancy at the same time that it created new barriers to contraceptive services. This pattern may lead to a potential net effect of an increase in unintended pregnancy, particularly among people who had difficulty affording food, transportation, and/or housing during the pandemic.

ObjectiveAssess the relationship between parity and prior route of delivery to levonorgestrel 52 mg intrauterine system (IUS) expulsion during the first 72 months of use.Study designWe evaluated women enrolled in the ACCESS IUS multicenter, Phase 3, open-label clinical trial of the Liletta levonorgestrel 52 mg IUS. Investigators evaluated IUS presence at 3 and 6 months after placement and then every 6 months and during unscheduled visits. We included women with successful placement and at least one follow-up assessment. We evaluated expulsion rates based on obstetric history; for prior delivery method subanalyses, we excluded 12 participants with missing delivery data. We determined predictors of expulsion using multivariable regression analyses.ResultsOf 1714 women with IUS placement, 1710 had at least one follow-up assessment. The total population included 986 (57.7%) nulliparous women. Sixty-five (3.8%) women experienced expulsion within 72 months, 50 (76.9%) within the first 12 months. Expulsion rates among nulliparous women (22/986 [2.2%]) or parous women with any pregnancy ending with a Cesarean delivery (6/195 [3.1%]) differed from parous women who only experienced vaginal deliveries (37/517 [7.2%]) (p < 0.001). In multivariable regression, obesity (adjusted odds ratio [aOR] 2.2, 95% confidence interval [CI] 1.3-3.7), parity (aOR 2.2, 95% CI 1.2-4.1), and non-white race (aOR 1.8, 95% CI 1.1-3.2) predicted expulsion. Among parous women, obesity (aOR 2.2, 95% CI 1.2-4.2) increased the odds and having ever had a cesarean delivery (aOR 0.4, 95% CI 0.1-0.9) decreased the odds of expulsion.ConclusionIUS expulsion occurs in less than 4% of users over the first 6 years of use and occurs mostly during the first year. Expulsion is more likely among obese and parous women.ImplicationsLevonorgestrel 52 mg intrauterine system expulsion occured more commonly in parous than nulliparous women; the increase in parous women is primarily in women who had vaginal deliveries only. The association between obesity, delivery route, and IUS expulsion needs further elucidation.

ObjectivesTo assess referral center outcomes with removal of difficult or nonpalpable contraceptive implants using high-frequency point-of-care ultrasonography.Study designWe present a case series examining patients referred to our specialty center from January 2019 through September 2020 for difficult or nonpalpable implant removal.ResultsOf the 54 referrals, 6 had palpable implants and 48 required ultrasonography. We localized 46 (96%) implants in-office, including 13 located subfascially; 2 Implanon implants could not be localized. We successfully completed 50 (96%) of 52 attempted in-office removals, including 12 (92%) subfascial implants.ConclusionHigh-frequency point-of-care ultrasonography can effectively localize nonpalpable contraceptive implants leading to successful in-office removal.ImplicationsSpecialists can use high-frequency point-of-care ultrasonography to localize nonpalpable implants without formal radiology scans and skilled technologists, optimizing patient time and convenience. However, the probe is expensive, and providers may need to consider this cost in the context of reimbursement for these highly specialized procedures.

ObjectiveEvaluate reproductive function in nulligravid and gravid women after levonorgestrel 52 mg intrauterine system (IUS) discontinuation based on time to pregnancy.Study designWe evaluated women participating in the ACCESS IUS multicenter, Phase 3, open-label clinical trial of the Liletta(®) levonorgestrel 52 mg IUS who discontinued the IUS within 60 months of use and desired pregnancy. Study staff contacted participants every three months after IUS discontinuation for up to 12 months to determine whether pregnancy occurred. We excluded women who opted to stop attempting to conceive before 12 months. We evaluated 12-month conception rates in participants 16-35 years at IUS placement, comparing dichotomous outcomes using Fisher's exact test. We performed a multivariable analysis to assess the association of baseline characteristics, age at discontinuation, duration of IUS use, and positive sexually transmitted infection testing during IUS use with conception.ResultsAmong 165 women who attempted to conceive, 142 (86.1%) did so within 12 months with a median time to conception of 92 days. The 12-month conception rates did not differ between nulligravid (66/76 [86.8%]) and gravid (76/89 [85.4%]) women (p = 0.83) and nulliparous (78/90 [86.7%]) and parous (64/75 [85.3%]) women (p = 0.83). In multivariable analysis, only obesity (aOR 0.3 [95% CI 0.1-0.8]) was associated with ability to conceive.ConclusionsAfter levonorgestrel 52 mg IUS discontinuation, women have rapid return of fertility in the year post-removal. Fertility rates after IUS removal do not vary based on gravidity, parity, age at discontinuation, or duration of IUS use.ImplicationsThis contemporary IUS study included a large population of nulligravid and nulliparous women. IUS use over many years does not effect spontaneous fertility after IUS discontinuation, regardless of gravidity or parity. Providers and patients should have no concern about the impact of IUS use on future fertility.

IntroductionEx vivo fusion assays offer an efficient method for studying HIV-1 entry associated with contraceptive use and pregnancy outside of cohort studies of HIV-1 incidence.MethodsWe measured ex vivo HIV-1 fusion to cervical or endometrial immune cells from three groups of women: pregnant, non-pregnant not using hormonal or intrauterine contraception, and using depot medroxyprogesterone acetate (DMPA).Results and conclusionsThere was no excess susceptibility to HIV-1 fusion of cells from pregnant women or DMPA users compared to controls. Although the number of target cells in endometrium was higher in DMPA users compared to controls, HIV-1 fusion was lower.ImplicationsIn ex vivo assays, HIV-1 showed no enhanced fusion to cervical immune cells from pregnant women or DMPA users compared to controls, and lower fusion to endometrial immune cells from DMPA users. This assay is useful for studying hormonal and contraceptive effects on HIV-1 entry into reproductive tract immune cells.

ObjectiveTo evaluate the proportion of 12-month contraceptive pill, patch, and ring prescriptions before and after an institution-wide change of default electronic medical record facility orders to dispensing 12-month supply.Study designThis retrospective pre-post study compares outpatient contraception prescriptions from August 10, 2019 through April 9, 2020 obtained from our institutional electronic medical record prescription database. On December 10, 2019, we facilitated a change in the default orders for dispensing self-administered hormonal contraceptives from one-month to 12-months. We evaluated the primary outcome of 12-month supply prescriptions during the four months before and after the change. We also compared 12-month supply prescriptions for pills, patch, and ring by prescriber specialty and location.ResultsThe dataset included 4897 distinct evaluable prescriptions for the pill, patch, or ring, with an overall increase in 12-month prescriptions from 260/2437 (10.7%) to 669/2460 (27.2%) after the order change (p

ObjectiveWe longitudinally assess associations between changes in expectation of relationship permanence-a measure that incorporates both relationship duration and commitment-pregnancy desire and acceptability, and highly effective contraception use among young U.S. Latino/as.Study designWe used multivariable logistic regression to analyze associations between changes in relationship factors, pregnancy acceptability and desire, and contraceptive method use over 6 months among 299 U.S. Latino/a women and men (ages 18-34) in relationships in a longitudinal study (retention rate: 32.4%).ResultsRespondents who found a pregnancy less acceptable at endline than at baseline were more likely to use highly effective contraception at endline (OR 2.97, 95% CI 1.09, 8.08). Respondents estimating an increase in relationship permanence more than one standard deviation of the mean were 4.90 (95% CI 1.17, 20.55) times more likely to use highly effective contraception at endline, compared to those without a change in estimation of relationship permanence.ConclusionIn this longitudinal study of young adult Latino/as in relationships, we found associations between changes in respondents' perceptions of the acceptability of a pregnancy and expectation of the permanence of their relationship and highly effective contraceptive use. Our findings reiterate the complicated, intertwined links between relationship dynamics, pregnancy orientation, contraception, and time.ImplicationsThe significance of decreased pregnancy acceptability (but not desire) for using highly effective contraception suggests the importance of acknowledging pregnancy acceptability in contraceptive counseling, particularly because providers are more likely to direct Latino/a young adults towards methods that may not fulfill their contraceptive desires. Including discussion of young people's expectations of relationship permanence may also be meaningful in counseling.

ObjectiveTo describe the implementation and results of a proactive patient outreach project to offer self-administered, depot medroxyprogesterone (DMPA) subcutaneous (SC) to interested patients at a California safety-net clinic following expanded state Medicaid coverage.Study designWe contacted non-pregnant patients at an urban, safety-net hospital-based primary care clinic who had been prescribed DMPA intramuscular (IM) in the past year to gauge interest in self-administered DMPA-SC. Interested patients received a prescription for DMPA-SC and a telehealth appointment with a clinic provider to learn self-injection. We recorded patient interest in DMPA-SC, completed appointments, and completed first injections. We conducted initial outreach in May, 2020 and recorded appointment attendance and completed injections through August, 2020.ResultsOf 90 eligible patients (age 17-54), we successfully contacted and discussed DMPA-SC with 70 (78%). Twenty-six (37%) patients expressed interest in DMPA-SC and scheduled telehealth appointments to learn to self-administer the medication. Fifteen (58%) of those interested (21% of the total) successfully self-injected DMPA-SC. Of the 44 (63%) patients not interested in DMPA-SC, the three most common reasons were fear of self-injection (n = 23 [52%]), wanting to stop DMPA (n = 11 [25%]), and satisfaction with DMPA-IM (n = 6 [14%]).ConclusionThere is interest in and successful initiation of self-administered DMPA-SC among patients at an urban safety net hospital-based primary care clinic who have used DMPA-IM in the last year.ImplicationsOur data provide evidence for the interest and successful first injection rate after offering self-administered DMPA-SC to patients on DMPA-IM. Expanding coverage of self-administered DMPA-SC could increase patient-centeredness and accessibility of contraception as well as reduce patient anxiety around COVID-19 transmission without losing contraceptive access.

ObjectiveTo evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism.Study designWe conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.ResultsSixty-five participants enrolled in E2 75 (n = 22), 100 (n = 21), and 200 (n = 22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were 40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days.ConclusionsEstradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use.ImplicationsA 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.

ObjectiveTo determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days.Study designAfter a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception.ResultsFifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal.ConclusionMost participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability.ImplicationsMost participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.

ObjectiveWe sought to test whether participation in an online group including IUD users influenced IUD-related knowledge, attitudes, and behavior among IUD non-users, as a proof-of-concept evaluation of information dissemination for less commonly used or novel contraceptives.Study designWe conducted a blinded, randomized controlled trial on the effect of online communication with IUD users within an online program called Birth Control Connect. Participants were women age 18-45 living in the United States who had never used an IUD. We invited participants randomized to the intervention to join two-week, nine-member discussion groups including four satisfied IUD users and five IUD non-users; we invited control participants to groups including nine IUD non-users. We performed chi-squared tests on IUD knowledge, information-seeking, informational support and use in immediate post-surveys, and t-tests comparing change in IUD attitudes and frequency of logins to discussion groups.ResultsWe invited 488 IUD non-users and enrolled them into 70 groups between October 2015 and April 2016. We found increased positive attitudes towards the IUD in the intervention arm (0.65-point increase between pre- and post-surveys, versus 0.05 mean change for control arm, p = 0.03 for hormonal IUD, with a trend in the same direction for the non-hormonal IUD). Informational support also increased, with 70.3% of intervention arm participants self-reporting that they gained a better idea of what the IUD would be like, compared to 51.3% in control arm (p

ObjectiveTo assess 6-year contraceptive efficacy and safety of a levonorgestrel 52 mg intrauterine system (IUS).Study designWe assessed pregnancy rates through 72 months in women aged 16-35 years at enrollment and safety in all participants (aged 16-45 years, n = 1751) in an ongoing 10-year phase-3 trial.ResultsOver six years, nine pregnancies occurred (none in year 6) for a life-table pregnancy rate of 0.87 (95% CI 0.44-1.70). Adverse event rates remain low through 6 or more years of use. Two expulsions occurred in year 6.ConclusionThis levonorgestrel 52 mg IUS is a highly effective and safe contraceptive over 6 years of use.ImplicationsThe levonorgestrel 52 mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.

ObjectiveOur objective was to evaluate if increasing body mass index (BMI) or weight influences the association between efavirenz-based antiretroviral therapy (ART) and implant effectiveness.Study designWe conducted a secondary cohort analysis of HIV-positive women aged 15 to 45 years enrolled in HIV care in western Kenya using an implant from January 2011 to December 2015. Implant use, ART regimen and weight were documented at each clinic visit and height at enrollment. We categorized BMI as underweight, normal weight, overweight or obese, and weight as

ObjectivesTo evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use.Study designWe reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as "favorable" (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or "unfavorable' (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively.ResultsWe evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75-85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%-50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001).ConclusionImplant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.

ObjectiveIn this study we aimed to investigate the content and process of contraceptive counseling surrounding combined hormonal contraceptive (CHC) methods (combined oral contraceptives, the ring, and the patch).Study designWe performed a mixed methods analysis of data collected as part of the Patient-Provider Communication about Contraception study, in which reproductive age women and their providers were recruited at several San Francisco Bay Area clinics from 2009-2012. Participants completed pre- and post-visit surveys, and had their visits audio recorded and transcribed. We performed descriptive and bivariate analyses of the entire cohort to examine associations between demographic characteristics and pre-existing method preferences with method selection and counseling content, and coded transcripts of a subset of the sample for salient themes related to content and process of counseling about combined hormonal contraceptive methods using a directed content analysis approach.ResultsThe overall sample included 342 women, with 152 women (44%) having a preference for a specific CHC prior to their visit, 127 women (37%) had a preference for a non-CHC method, and 63 (18%) having no existing method preference. Of the women who reported preferring a CHC in their pre-visit survey, the majority (72%) chose that method. We found that women were inconsistently counseled about the range of CHC methods. For example, women who had no pre-visit method preference (52%) or who preferred the ring (54%) or the patch (73%) were more likely to receive comprehensive counseling about the three CHC methods than were women who preferred combined oral contraceptives (35%) or non-CHC methods (33%). Providers mentioned the patch the least often, and in qualitative analysis indicated discomfort with prescribing this method. Side effects and benefits of methods, as well as strategies to enhance successful use of the chosen method, were inconsistently discussed. In only 73% of visits in which a woman chose a CHC did the provider assess the patient's ability to use the chosen method correctly, and in 66% of all visits in which women chose a CHC method, providers discussed what to do if she was dissatisfied with the method.ConclusionsCounseling about combined hormonal contraceptive methods often does not include information about all available methods, or comprehensive information about side effects, benefits, or logistics of use. As this counseling can impact patient's satisfaction with and continuation of their chosen method of contraception, future work should focus on designing interventions to improve providers' ability to meet patients' needs.ImplicationsShort acting hormonal contraception is widely used, but counseling for these methods often neglects key features. Comprehensive counseling about all methods and their individual features can improve contraceptive selection and use.

ObjectiveThis study assessed whether immediate postpartum insertion of levonorgestrel contraceptive implants is associated with a difference in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 and 6 months postpartum compared to delayed insertion at 6 to 8 weeks postpartum.Study designWe conducted a randomized trial of women in Uganda who desired contraceptive implants postpartum. We randomly assigned participants to receive either immediate (within 5 days of delivery) or delayed (6 to 8 weeks postpartum) insertion of a two-rod levonorgestrel contraceptive implant system. This is a prespecified secondary analysis evaluating breastfeeding outcomes. The primary outcome of this secondary analysis was change in infant weight; infants were weighed and measured at birth and 6 months. We used a validated questionnaire to assess onset of lactogenesis daily in person while participants were in the hospital, and then daily by phone after they left the hospital, until lactogenesis was documented. We used interviewer-administered questionnaires to assess breastfeeding continuation and concerns at 3 months and 6 months postpartum.ResultsAmong the 96 women randomized to the immediate group and the 87 women to the delayed group, the mean change in infant weight from birth to 6 months was similar between groups: 4632 g in the immediate group and 4407 g in the delayed group (p=.26). Among the 97 women who had not experienced lactogenesis prior to randomization, the median time to onset of lactogenesis did not differ significantly between the immediate and delayed groups (65 h versus 63 h; p=.84). Similar proportions of women in the immediate and delayed groups reported exclusive breastfeeding at 3 months (74% versus 71%; p=.74) and 6 months (48% versus 52%; p=.58).ConclusionWe found no association between the timing of postpartum initiation of levonorgestrel contraceptive implants and change in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 or 6 months postpartum.ImplicationsThis study provides evidence that immediate postpartum initiation of contraception implants does not have a deleterious effect on infant growth or initiation or continuation of breastfeeding.

OBJECTIVE:To investigate if women desire talking to a counselor or physician about contraception when seeking first-trimester medical or surgical abortion. STUDY DESIGN:We conducted a cross-sectional study by distributing self-administered anonymous surveys to women at three clinics in Sacramento, California; Chicago, Illinois; and Cleveland, Ohio, from October 2014 to February 2015. Participants completed surveys after registration and before any in-office counseling. We asked whether women want to discuss contraception, specific topics they want to discuss, reasons why they may not want to talk about contraception and whether they want to receive contraception services as part of their abortion care. We conducted regression analyses to assess associations between patient characteristics and the desire for counseling. RESULTS:Among 3041 eligible women, 1959 (64.4%) completed surveys. Overall, 1208 (61.7%) did not want to discuss contraception prior to having an abortion, primarily citing that they already know which method they want. We found no association between the desire to discuss contraception and age, race, planned abortion method, clinic site and number of unplanned pregnancies. Among those who desired to talk about contraception, subjects preferred to discuss which contraceptive methods are easier to use and more effective as compared to previously used methods. Regardless of their desire for a discussion about contraception, 1386 (70.8%) of subjects wanted to leave the clinic with a specific method, including a long-acting reversible method [intrauterine device or implant (190, 13.7%)] or other hormonal method [pills, patch, ring or injectable (680, 49.1%)]. CONCLUSIONS:The majority of women seeking first-trimester abortion do not come to the clinic wanting to discuss contraception, most commonly because they have a preferred method in mind. IMPLICATIONS:Providers should ask women presenting for abortion if they want to discuss contraception and not assume that they need or desire such information. Focused discussions, starting with the preferred method if known, may better satisfy women's preferences. Providers should account for such desires when allocating resources for contraception services during abortion care.

ObjectivesThe subcutaneous depot medroxyprogesterone acetate (DMPA-SC) injectable contraceptive was introduced in South West Nigeria in 2015 through private sector channels. The introduction included community-based distribution and was supported by a social marketing approach. From program monitoring and evaluation, aimed at understanding performance, market reach and other process measures, we identify lessons learned to inform future scale-up efforts.MethodsWe synthesized the findings from a core set of key performance indicators collected through different methods: (1) implementer performance indicators, (2) phone survey of DMPA-SC users (n=541) with a follow-up after 3 months (n=342) and (3) in-depth interviews with 57 providers and 42 users of DMPA-SC.ResultsDistribution of DMPA-SC to private providers was concentrated in states with large urban populations. A shift toward focusing on high-volume family planning facilities coincided with a rapid increase in distribution in late 2016. Users reached in the phone survey were generally older and married with children; few were under age 25. Users and providers reported favorable opinions of DMPA-SC. Many users reported choosing DMPA-SC due to recommendations from providers and friends, and the hope of experiencing reduced side effects compared to other methods. While users reported positive experiences interacting with community-based distributors, the delivery model encountered a number of challenges - high turnover, low motivation, lack of an appropriate compensation package and logistical costs - and was ultimately disbanded.ConclusionsIn the DMPA-SC introductory program in Nigeria, distribution was amplified when focused on high-volume contraceptive providers. Although community-based distribution can be one effective service delivery model for reaching underserved populations, more consideration for balancing cost recovery and public health goals through private sector approaches are needed in the context of South West Nigeria. Additional communications and outreach efforts are needed to reach younger, unmarried users with contraceptive services.

OBJECTIVES:In 2015, private healthcare providers in Nigeria introduced DMPA-SC (depot medroxyprogesterone acetate administered subcutaneously) into the method mix. We aimed to [1] examine the sociodemographic predictors of continued DMPA-SC use after 3 months, and [2] characterize the additional influences of contraceptive counseling quality and experiences of side effects on continuation. STUDY DESIGN:From March to August, 2016, we conducted phone interviews with a convenience sample of women obtaining DMPA-SC from selected providers to survey them about their experience obtaining an initial dose of DMPA-SC. Study coordinators contacted women again about 3 months later after when they were due for reinjection. We used logistic regressions to examine the likelihood of having obtained a subsequent dose of DMPA-SC at follow-up as predicted by sociodemographic characteristics, a quality of counseling indicator based on responses to a 14-item scale, and reports of side effects experienced. RESULTS:Of the 541 DMPA-SC users who completed the first survey, 311 were reached again via phone after 3 months to conduct a second survey. Multivariate results for sociodemographic predictors of continued DMPA-SC use show that those with some college education or more (OR=2.79; 95% CI: 1.09-7.14), and those with four or more children (OR=2.89; 95% CI: 1.09 0 7.67) were more likely to obtain another dose. Our summary quality measure showed that women overall rated the quality of their initial counseling session high. Logistic regressions indicated that higher quality during the initial counseling session is related to the likelihood of getting another dose of DMPA-SC (OR=2.04; 95% CI: 1.12-3.47) whereas experiencing more bleeding reduced the likelihood of continuation after 3 months (OR=0.15; 95% CI: 0.07-0.34). CONCLUSIONS:Among urban Nigerian women, both counseling quality and experiencing side effects were important factors in predicting continued use of DMPA-SC after 3 months. These findings are consistent with previous studies of DMPA and injectable contraception continuation. IMPLICATIONS:New contraceptive methods that are designed for increased access and ease of use, combined with high quality provision, have potential to increase contraceptive use in settings with low levels of contraceptive prevalence. Higher quality counseling can help encourage women's continuation of a new injectable contraceptive method at 3 months.

OBJECTIVE:We evaluated a novel concept of initiating the etonogestrel implant as a "back-up" method in women who desire using combined oral contraceptives (COC) but want to decrease their risk of unintended pregnancy with a more effective method. STUDY DESIGN:In this prospective cohort study, we planned to include 20 women as a proof-of-concept. We enrolled both new COC starters and continuing COC users and placed an etonogestrel implant. Participants completed daily bleeding diaries and attended follow-up visits at 1, 3, and 6 months. We assessed implant continuation through six months of study participation and side effects with dual hormonal contraceptive use. RESULTS:Between September and December 2016, we enrolled 10 new starters and 10 current COC users. All participants completed 1-month follow-up, and 18 (90%) subjects completed the 3- and 6-month follow-up assessments. Two current COC users had the implant removed for mood changes before 6 months. At the 6-month follow-up visit, 10 women were using both pills and implant, seven relied on the implant only, and one was using a COC only. Three new starters chose implant removal at end of study participation; one for weight gain and acne, another for mood changes, and one for decreased libido. No subjects discontinued the implant for bleeding complaints. CONCLUSION:In this proof-of-concept study, women using COCs were willing to initiate the implant as a "back-up" method to improve pregnancy prevention. Most women continued the implant through 6 months and after completing study participation. IMPLICATIONS:Initiating the etonogestrel implant as a "back-up" method may be an option for women who desire more effective pregnancy prevention while using combined oral contraceptive pills for its bleeding profile or non-contraceptive benefits.

OBJECTIVE:The objective was to evaluate amenorrhea patterns and predictors of amenorrhea during the first year after levonorgestrel 52 mg intrauterine system (IUS) placement. STUDY DESIGN:This cohort analysis includes 1714 nulliparous and parous women who received a Liletta® levonorgestrel 52 mg IUS in a multicenter trial to evaluate efficacy and safety for up to 8 years. Participants maintained a daily diary with bleeding information. We assessed bleeding patterns in 90-day intervals; amenorrhea was defined as no bleeding or spotting in the preceding 90 days. We employed multivariable regression to identify predictors of amenorrhea at 12 months. The predictor analysis only included women not using a levonorgestrel IUS in the month prior to study enrollment. RESULTS:In the month before enrollment, 148 and 1566 women, respectively, had used and not used a levonorgestrel IUS. Prior users averaged 50±19 months of use before IUS placement; 38.4% of these women reported amenorrhea at 12 months. Amenorrhea rates for non-prior-users at 3, 6, 9 and 12 months were 0.2%, 9.1%, 17.2% and 16.9%, respectively. During the first 12 months, 29 (1.7%) women discontinued for bleeding irregularities; no women discontinued for amenorrhea. The only significant predictor of amenorrhea at 12 months was self-reported baseline duration of menstrual flow of fewer than 7 days vs. 7 or more days (18.2% vs. 5.2%, adjusted odds ratio 3.70 [1.69, 8.07]). We found no relationships between 12-month amenorrhea rates and age, parity, race, body mass index, baseline flow intensity or hormonal contraception use immediately prior to IUS placement. CONCLUSIONS:Amenorrhea rates during the first year of levonorgestrel 52 mg IUS use are similar at 9 and 12 months. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow. IMPLICATIONS STATEMENT:This information provides more data for clinicians when counseling women about amenorrhea expectations, especially since women seeking a levonorgestrel 52 mg IUS for contraception are different than women desiring treatment for heavy menstrual bleeding. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow.

ObjectiveThe objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).Study designUS health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.ResultsAmong 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.ConclusionEvents related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.ImplicationsThis report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide.

ObjectiveTo understand the potential duration of action for Liletta®, we conducted this study to estimate levonorgestrel (LNG) release rates over approximately 5½years of product use.MethodsClinical sites in the U.S. Phase 3 study of Liletta collected the LNG intrauterine systems (IUSs) from women who discontinued the study. We randomly selected samples within 90-day intervals after discontinuation of IUS use through 900days (approximately 2.5years) and 180-day intervals for the remaining duration through 5.4years (1980days) to evaluate residual LNG content. We also performed an initial LNG content analysis using 10 randomly selected samples from a single lot. We calculated the average ex vivo release rate using the residual LNG content over the duration of the analysis.ResultsWe analyzed 64 samples within 90-day intervals (range 6-10 samples per interval) through 900days and 36 samples within 180-day intervals (6 samples per interval) for the remaining duration. The initial content analysis averaged 52.0±1.8mg. We calculated an average initial release rate of 19.5mcg/day that decreased to 17.0, 14.8, 12.9, 11.3 and 9.8mcg/day after 1, 2, 3, 4 and 5years, respectively. The 5-year average release rate is 14.7mcg/day.ConclusionThe estimated initial LNG release rate and gradual decay of the estimated release rate are consistent with the target design and function of the product. The calculated LNG content and release rate curves support the continued evaluation of Liletta as a contraceptive for 5 or more years of use.Implications statementLiletta LNG content and release rates are comparable to published data for another LNG 52-mg IUS. The release rate at 5years is more than double the published release rate at 3years with an LNG 13.5-mg IUS, suggesting continued efficacy of Liletta beyond 5years.

OBJECTIVE: To assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial. STUDY DESIGN: This is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition. RESULTS: The analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55). CONCLUSION: In this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organizations recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures. IMPLICATIONS: Among Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.

ObjectiveThe objective was to determine individual and dyadic factors associated with effective contraceptive use among human immunodeficiency virus (HIV)-infected women accessing antiretroviral therapy (ART) in rural Uganda.Study designHIV-infected women enrolled in the Uganda AIDS Rural Treatment Outcomes cohort completed questionnaires (detailing sociobehavioral characteristics, sexual and reproductive history, contraceptive use, fertility desires) and phlebotomy (October 2011-March 2013). We describe prevalence of effective contraceptive use (i.e., consistent condom use and/or oral contraceptives, injectable hormonal contraception, intrauterine device, female sterilization) in the previous 6 months among sexually active, nonpregnant women (18-40 years). We assessed covariates of contraceptive use using multivariable logistic regression.ResultsA total of 362 women (median values: age 30 years, CD4 count 397 cells/mm(3), 4.0 years since ART initiation) were included. Among 284 sexually active women, 50% did not desire a(nother) child, and 51% had a seroconcordant partner. Forty-five percent (n=127) reported effective contraceptive use, of whom 57% (n=72) used condoms, 42% (n=53) injectables, 12% (n=15) oral contraceptives and 11% (n=14) other effective methods. Dual contraception was reported by 6% (n=8). Only "partnership fertility desire" was independently associated with contraceptive use; women who reported that neither partner desired a child had significantly increased odds of contraceptive use (adjusted odds ratio: 2.40, 95% confidence interval: 1.07-5.35) compared with women in partnerships where at least one partner desired a child.ConclusionsLess than half of sexually active HIV-infected women accessing ART used effective contraception, of which 44% (n=56) relied exclusively on male condoms, highlighting a continued need to expand access to a wider range of longer-acting female-controlled contraceptive methods. Association with partnership fertility desire underscores the need to include men in reproductive health programming.Implications statementLess than half of sexually active HIV-infected women accessing ART in rural Uganda reported using effective contraception, of whom 44% relied exclusively on the male condom. These findings highlight the need to expand access to a wider range of longer-acting, female-controlled contraceptive methods for women seeking to limit or space pregnancies. Use of contraception was more likely when both the male and female partner expressed concordant desires to limit future fertility, emphasizing the importance of engaging men in reproductive health programming.

BackgroundBetween 2006 and 2008, Iowa increased access to family planning services through a Medicaid expansion and a privately funded initiative. During this same time, Iowa expanded access to abortion through telemedicine provision of medical abortion. Despite increased access to abortion services, abortions in Iowa have declined. This study assessed whether increased provision of long-acting reversible contraception (LARC) may have contributed to the abortion decline.Study designWe analyzed abortion data from Iowa vital statistics and LARC use data from 14 family planning agencies' records (N=544,248) for the years 2005 to 2012. Mixed-effects logistic regression analyses assessed whether changes in the percentage of LARC users were associated with subsequent reductions in abortion across the state.ResultsFrom 2005 to 2012, the number of family planning clients using LARC increased from 539 to 8603 (less than 1% to 15%); the number of resident abortions decreased from 5198 to 3887 (8.7 per 1000 women aged 15-44 to 6.7). There were reduced odds of abortion (adjusted odds ratio, 0.96; 95% confidence interval: 0.94-0.97) with increased LARC use.ConclusionsDeclines in abortion followed increases in LARC use in Iowa.

ObjectiveTo assess how a checklist reminding clinicians to deliver a bundled intervention affects contraceptive knowledge and use 3 months after women seek walk-in pregnancy testing.MethodsPre-intervention, an inner-city family planning clinic provided unstructured care; during the intervention period, clinic staff used a checklist to ensure women received needed services. Women seeking walk-in pregnancy testing who wished to avoid pregnancy for at least 6 months were asked to complete surveys about their contraceptive knowledge and use immediately after and 3-months after visiting the study clinic. To assess the significance of changes over time, we used logistic regression models.ResultsBetween January 2011 and May 2013, over 1500 women sought pregnancy testing from the study clinic; 323 completed surveys (95 pre-intervention and 228 during the intervention period). With this checklist intervention, participants were more likely to receive emergency contraception (EC) (22% vs. 5%, [aOR 4.66 (1.76-12.35)], [corrected] have an intrauterine device or implant placed at the time of their clinic visit (5% vs. 0%, p=0.02), or receive a contraceptive prescription (23% vs. 10%, p

BackgroundLittle is known regarding clinicians' attitudes about or the extent to which the recommendation to offer same-day insertions for long-acting reversible contraception (LARC) is applied in practice.Study designSince 2006, 47 family planning agencies in Colorado and Iowa participated in two initiatives to reduce unintended pregnancy by increasing LARC provision. Clinic directors (n = 45) and clinicians (n = 114) participating in these initiatives were interviewed and surveyed regarding their LARC provision practices and attitudes.ResultsAgencies required fewer visits for the contraceptive implant than for the intrauterine device (IUD). Only 18% of agencies typically offered an IUD, and 36% typically offered an implant in one visit. Years of experience and professional title significantly predicted attitudes about the number of visits required to get LARC.DiscussionBarriers must be overcome for full implementation of professional LARC guidelines and for more women to receive chosen methods without the extra burden of multiple visits.

BackgroundContraceptives are among the most commonly prescribed medications used by women of reproductive age, but little is known about women's information-seeking behavior after receiving prescriptions for medication.Study designAll reproductive-age women who visited one of four primary care clinics in Western Pennsylvania between October 2008 and April 2010 were invited to complete a follow-up survey after their visit which included questions regarding medications prescribed, information-seeking after their visit and their perceptions of the quality of the information they found.ResultsOf the 218 women prescribed contraceptives, 49% sought additional information after their visit. In models adjusted for sociodemographic and reproductive characteristics of the respondents, women who received a contraceptive prescription were twice as likely to seek additional information about their medication as women who received noncontraceptive prescriptions [odds ratio (OR)=2.06, 95% confidence interval (CI) 1.47-2.90]. Women who received a contraceptive prescription were more likely to seek information from the Internet (OR=1.84, 95% CI 1.26-2.70) and from the package insert (OR=1.55, 95% CI 1.02-2.36) than women who received noncontraceptive prescriptions.ConclusionsWomen frequently sought additional information on contraceptive prescriptions. Efforts are needed to increase the quantity and improve the quality of contraceptive counseling provided by primary care providers and the quality of the information provided by package inserts and the Internet.

BackgroundWe evaluated whether computerized counseling about contraceptive options and screening for contraindications increased women's subsequent knowledge and use of hormonal contraception.MethodsFor the study 814 women aged 18-45 years were recruited from the waiting rooms of three emergency departments and an urgent care clinic staffed by non-gynecologists and asked to use a randomly selected computer module before seeing a clinician.ResultsWomen in the intervention group were more likely to report receiving a contraceptive prescription when seeking acute care than women in the control group (16% vs. 1%, p=.001). Women who requested contraceptive refills were not less likely than women requesting new prescriptions to have potential contraindications to estrogen (75% of refills vs. 52% new, p=.23). Three months after visiting the clinic, women in the intervention group tended to be more likely to have used contraception at last intercourse (71% vs. 65%, p=.91) and to correctly answer questions about contraceptive effectiveness, but these differences were not statistically significant.ConclusionPatient-facing computers appear to increase access to prescription contraception for women seeking acute care.

Objectives: Ovaprene is a novel, investigational, intravaginal hormone-free monthly ring contraceptive designed for use in women of reproductive age to be worn over multiple weeks (one menstrual cycle). The objective of this work was to evaluate the safety of Ovaprene during a nine-month repeat-dose sheep study., Study Design: In addition to traditional safety endpoints such as histopathological evaluation of the sheep female reproductive tract, vaginal fluids were collected and tested for released iron over time. Also, the amount of iron in the rings was assessed following removal, and serum iron levels were measured. There were four sheep in each group (Ovaprene group and sham group)., Results: There were no macroscopic clinical findings. There was minimal to mild, mixed or mononuclear cell infiltration present in all levels of vagina (cranial, mid, and caudal) from all animals including sham controls based on post-study necropsy. The female reproductive tract from animals treated with the Ovaprene ring was comparable to the sham controls. The concentrations of serum iron in sheep treated with Ovaprene ring were similar compared to a sham treated animal. The average amount of ferrous gluconate released from Ovaprene over the 29-day period of use was 175 mg of the approximately 512 mg nominally loaded into the rings., Conclusions: Overall, the Ovaprene devices were well-tolerated in female sheep., Implications: This study should support a chronic (e.g., one year) contraceptive efficacy study in women., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Evaluate reduction in progressively motile sperm per high power field (HPF) in midcycle cervical mucus after intercourse with Ovaprene: an investigational monthly non-hormonal vaginal contraceptive consisting of a vaginal ring and mechanical barrier, releasing spermiostatic ferrous gluconate., Study Design: Open-label, multicenter study enrolling heterosexually-active women with previous permanent contraception. Participants underwent a baseline postcoital test cycle with no device to confirm the presence of sperm, followed by one diaphragm postcoital test cycle, one Ovaprene safety cycle, and two Ovaprene postcoital test cycles. In each postcoital test cycle, participants underwent a midcycle cervical mucus evaluation to confirm an Insler score ≥10 and absence of sperm, and then returned two to four hours after vaginal intercourse for repeat cervical mucus evaluation. We considered <5 progressively motile sperm/HPF indicative of preliminary contraceptive effectiveness., Results: We enrolled 38 participants; 23 completed the study. All participants had ≥5 progressively motile sperm/HPF in the baseline cycle and <5 progressively motile sperm/HPF in all 49 Ovaprene cycles and all 35 diaphragm cycles, meeting the definition of a successful postcoital test. This was true regardless of examiner blinding, prior vaginal delivery or vaginal ring use, body mass index, or dislodgements noted by the participant or investigator. The mean of 27.2 (±17.9) progressively motile sperm/HPF in baseline postcoital test cycles was reduced to 0.5 (±1.1) and 0.5 (±1.3) progressively motile sperm/HPF in the first and second Ovaprene cycles, respectively. Ovaprene fit all participants and all could insert, position, and remove it., Conclusion: Use of Ovaprene resulted in meeting the prespecified criterion for contraceptive effect by all participants during all postcoital test cycles., Implications: The finding that use of Ovaprene, an investigational monthly non-hormonal vaginal contraceptive, resulted in postcoital testing of cervical mucus that met the pre-specified definition of success (<5 progressively motile sperm/HPF) supports further evaluation of contraceptive efficacy of the device in users at risk for pregnancy., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The study aimed to evaluate the impact of a structured subdermic implant training program on healthcare providers and its effect on the integration of this contraceptive method into patient counselling., Study Design: The study was a longitudinal experiment with an intervention group, assessing changes at three points: before the training, immediately after, and six months later. The training consisted of a four-hour session combining theory and practical application, conducted by experts in contraception., Results: Out of the participants, 376 healthcare professionals (a 34.3% response rate) completed the training and subsequent questionnaires. Post-training, there was an increase in the inclusion of the implant in contraceptive advice and a rise in the monthly number of implants. Knowledge about the implant, including insertion, positioning, removal, and replacement, significantly improved after six months (p<0.05), particularly among general practitioners., Conclusions: The training program successfully enhanced knowledge and handling of the contraceptive implant, leading to its increased recommendation by healthcare providers and selection by patients. Theoretical and practical training in contraception should be compulsory for healthcare providers involved in contraceptive counselling., Implications: A training program that includes lectures, video material, and hands-on demonstrations is effective for developing skills in administering the subdermic implant and its integration into contraceptive counselling. Such training should be regular and required for all healthcare professionals providing contraceptive advice., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: We used the validated Person-Centered Contraceptive Counseling (PCCC) scale to examine experiences with counseling and associations between counseling quality, method satisfaction, and planned method continuation at the population level in two southeastern states., Study Design: We used data from the Statewide Survey of Women, a probability-based sample of reproductive-aged women in Alabama and South Carolina in 2017/18. We included women using a contraceptive method and reporting a contraceptive visit in the past year (n = 1265). Respondents rated their most recent provider experience across four PCCC items. Regression analyses examined relationships between counseling quality and outcomes of interest, and path analysis examined the extent to which method satisfaction mediated the effects of counseling quality on planned continuation., Results: Over half of participants (54%) reported optimal contraceptive counseling. Optimal counseling was associated with method satisfaction (aPR = 1.16; 95% confidence interval (CI) = 1.04-1.29) in adjusted models. Optimal counseling was marginally associated with planned discontinuation in the bivariate analysis but was attenuated in the adjusted model (aPR = 1.07; 95% CI = 0.98-1.18). In the path analysis, counseling quality influenced method satisfaction (0.143 (0.045), p = 0.001) which influenced planned continuation, controlling for PCCC (0.74 (0.07), p < 0.001). The total indirect effect of counseling quality on planned continuation was significant (0.106 (0.03), p = 0.001), and a residual direct effect from counseling quality to planned continuation was noted (0.106 (0.03), p = 0.001)., Conclusions: Counseling quality is independently associated with method satisfaction at the population level. The effect of counseling on planned continuation is partially mediated by method satisfaction., Implications: Interventions to support person-centered contraceptive counseling promise to improve quality of care, patient experience with care, and reproductive outcomes., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Evaluate contraception usage in patients awaiting permanent contraception during COVID-19 pandemic., Study Design: Patients awaiting permanent contraception between March 2020 and July 2022 completed a survey assessing contraceptive usage. Descriptive statistics were analyzed., Results: One hundred and twenty-three patients consented to the survey. Ninety seven percent identified as Black, Indigenous, and people of color. Eighty three percent used alternative forms of contraception, with 31% using long acting, reversible contraceptives. Eighty nine percent still desired surgery., Conclusions: Despite delays, most patients still desired surgery. Patients alternatively chose intrauterine devices and implants., Implications: Hospitals should prioritize permanent contraception to avoid delays in access to desired reproductive healthcare options., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: We aimed to adapt and validate person-centered measures to evaluate various contributors to self-determination in perinatal contraceptive decision-making., Study Design: We developed and administered four scales adapted from existing measures in the context of Self-Determination Theory: the Treatment Self-Regulation Questionnaire (TSRQ), Perceived Competence Scale, modified Health Care Climate Questionnaire, and Important Other Climate Questionnaire. The TSRQ consists of three subscales: autonomous motivation, controlled motivation, and amotivation. We recruited a nonprobability convenience sample of 300 hospitalized postpartum patients in Baltimore, MD, between 2015 and 2016 and administered surveys in English and Spanish. We validated the scales with Cronbach's alpha coefficients, confirmatory factor analysis, and invariance analysis. We examined construct validity by testing correlations between the scales and other person-centered measures, such as satisfaction with counseling., Results: Cronbach's alpha was >0.8 except for the amotivation subscale. Confirmatory factor analysis was adequate for all scales. Autonomous motivation correlated positively and significantly with perceived competence, health care provider autonomy support, important other autonomy support, and other measures of patient satisfaction., Conclusions: We found the four scales to be internally consistent and valid except for the amotivation subscale. We recommend using the autonomous motivation subscale in place of the full TSRQ. The autonomous motivation subscale, Perceived Competence Scale, modified Health Care Climate Questionnaire, and Important Other Climate Questionnaire showed adequate internal consistency, construct validity, and adherence to the expected conceptual structure of the scales., Implications: Autonomous decision-making is central to ethics and quality of care, especially for contraceptive methods that require a provider for initiation or discontinuation and at more vulnerable times, such as postpartum and postabortion. These scales may help tailor person-centered and autonomy-supportive interventions and programs to improve contraceptive counseling and care delivery., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: We assessed contraceptive use changes during the second lockdown due to COVID-19 in Brazil and their associated factors., Study Design: This was a longitudinal web-based study in which 725 non-pregnant Brazilian women aged 18 to 49 completed an online structured survey about their contraceptive practices in two rounds in 2021. Multivariate multinomial logistic regression was used to analyze factors associated with contraceptive use changes during COVID-19., Results: Sixty percent reported they changed their contraceptive use during COVID-19, especially starting to use a method or switching to a more effective one (32%). In adjusted analysis, women who were ambivalent about a future pregnancy were more likely to switch to a more effective method (adjusted odds ratio [aOR] 2.33, 95% CI 1.42-3.83) and to stop using contraceptive (aOR 3.64, 95% CI 1.91-6.91). Women with a partner were less likely to switch to a more effective method (aOR 0.61, 95% CI 0.39-0.93) and to stop using contraceptive (aOR 0.53, 95% CI 0.31-0.93), but more likely to switch to a less effective method (aOR 2.25, 95% CI 1.16-4.34). Age was also associated with contraceptive use changes., Conclusions: Contraceptive use among Brazilian women during COVID-19 depended on their age and partnership status. During the period of the highest peak in the number of cases and deaths in the country, ambivalence towards a future pregnancy increased changes in contraceptive use., Implications: Contraceptive changes were observed during a two-wave web-survey in Brazil depending on women's age and partnership status. Ambivalence towards a future pregnancy increased changes in contraceptive use and should be considered in future studies regarding sexual and reproductive health and COVID-19 as well as in family planning program implementation., (Copyright © 2024 Elsevier Inc. All rights reserved.)

As a result of advances in cancer diagnosis and treatment, young women within the reproductive-aged group are now more likely to survive cancer. Reproductive-aged women with cancer may be interested in deferring pregnancy either temporarily or permanently at cancer diagnosis, during therapy or after treatment. Currently, there are limited guidelines to aide clinicians in managing the contraceptive needs in this special population. After reviewing the evidence regarding the safety and efficacy of available methods of contraception for women who have been diagnosed with cancer, the Society of Family Planning recommends that women of childbearing age who are being treated for cancer avoid combined hormonal contraceptive methods (containing estrogen and progestin) when possible because they may further increase the risk of venous thromboembolism (VTE) (Level A). The copper T380A intrauterine device, a highly effective, reversible, long-acting, hormone-free method, should be considered the first-line contraceptive option for women with a history of breast cancer (Level A), although for women being treated with tamoxifen, the levonorgestrel-containing intrauterine system (IUS) which decreases endometrial proliferation may be preferable (Level B). Women who develop anemia may benefit from use of a progestin-containing contraceptive (Level A). Women who develop osteopenia or osteoporosis following chemotherapy should avoid the progestin-only contraceptive injection (Level B). More information is needed in many areas. There are insufficient data to evaluate the risk of VTE when progestin-only contraceptives are used by women at high risk of VTE. Information is also needed on whether the levonorgestrel-containing IUS affects the risk of breast cancer recurrence and whether hormonal contraceptives affect the risk of breast cancer among women who have received chest wall, or "mantle field," radiation. Finally, studies of the safety and effectiveness of IUS use by women who are immunosuppressed and studies of whether progestin-only contraceptives affect the risk of fracture among cancer survivors or, more generally, women with osteopenia would be useful.

BackgroundThe study was conducted to compare 6-month usage of the levonorgestrel-releasing intrauterine device (LNG-IUD) when placed immediately or 3 to 6 weeks after dilation and evacuation (D&E) procedure.Study designWe enrolled women undergoing D&E at 15 to 23 weeks of gestation. After completion of the D&E, subjects without contraindications to immediate IUD insertion were randomized to immediate or delayed (3 to 6 weeks later) LNG-IUD insertion. Subjects in the immediate group had the LNG-IUD placed using ultrasound guidance. All subjects returned at 3 to 6 weeks and 8 to 10 weeks after D&E and were contacted by phone at 6 months.ResultsOf the 93 subjects enrolled, 88 were randomized. All 44 subjects (100%) randomized to immediate insertion had successful IUD placement, while only 20 (45.5%) of the 44 subjects randomized to delayed insertion returned for IUD placement, all of which were successful [difference 54.5%, 95% confidence interval (CI) 39.8%-69.3%]. Seventeen (38.6%) participants in each group were lost to follow-up. Of subjects contacted at the 6-month follow-up phone call, 23 of 27 women (85.2%) and 17 of 27 women (62.9%) were utilizing the LNG-IUD in the immediate and delayed groups, respectively (difference 22.2%, 95% CI -0.4% to 44.8%). Intrauterine device expulsion occurred in three subjects (6.8%) and one subject (5.0%) in whom the IUD was placed in the immediate and delayed groups, respectively (p=1.0). No significant adverse events occurred.ConclusionSignificantly more participants had the LNG-IUD placed in the immediate insertion group compared with the delayed insertion group. Given the low risk of complications, immediate post-D&E insertion of the LNG-IUD should be offered, especially for populations that may have difficulty returning for follow-up.

BackgroundTopical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV.MethodsWe performed a multicenter, Phase I, placebo-controlled, randomized study to evaluate the genital toxicity of CS. Two cohorts of healthy women used 3.5 ml of 6% CS gel or 3.5 ml of K-Y Jelly, vaginally, bid, for 14 days. The first cohort was sexually abstinent, and the second cohort was sexually active.ResultsCS was associated with only a slightly higher odds ratio (OR) of symptoms of minor urogenital irritation compared to the inactive lubricant K-Y Jelly (OR=2.02, 95% confidence interval=0.90-4.53). In addition, there were minor shifts in some genital flora, but there was no evidence of greater inflammation as evidenced by few colposcopic findings, decreased influx of polymorphonuclear cells and minimal changes in proinflammatory cytokines. Moreover, both products appeared acceptable to most women. Product leakage was identified as more of a problem in sexually abstinent women, but less so in women using the product for sexual intercourse, as would be the case in actual practice.ConclusionCS was safe for twice-daily use for 14 days. CS is appropriate for future studies in effectiveness trials.

Although adolescent women are actively acquiring bone, there has been little study of the possible effects of depot medroxyprogesterone acetate (DMPA) injectable contraception use on bone density in adolescents. We conducted a cross-sectional evaluation of the association between DMPA use and bone mineral density in adolescent women, ages 14-18 years. Of 174 study participants, 81 were DMPA users (range, 1-13 injections, median = 3) and 93 were not. Mean bone density at all anatomic sites (hip, spine and whole body) was lower for DMPA users than nonusers, but differences were not statistically significant (e.g., hip, 0.940 vs. 0.970 g/cm2, p = 0.10; spine, 0.970 vs. 0.992 g/cm2, p = 0.19). Duration of DMPA use showed a trend toward lower spine bone density (p-value for trend = 0.06). This study did not find a strong association between DMPA use and bone density. Further prospective evaluation of bone density changes with DMPA use and after DMPA discontinuation are needed in this age group.