Counseling and provision of long-acting reversible contraception in the US: national survey of nurse practitioners.

OBJECTIVE: Nurse practitioners (NPs) provide frontline care in women's health, including contraception, an essential preventive service. Their importance for contraceptive care will grow, with healthcare reforms focused on affordable primary care. This study assessed practice and training needs to prepare NPs to offer high-efficacy contraceptives - intrauterine devices (IUDs) and implants. METHOD: A US nationally representative sample of nurse practitioners in primary care and women's health was surveyed in 2009 (response rate 69%, n=586) to assess clinician knowledge and practices, guided by the CDC US Medical Eligibility Criteria for Contraceptive Use. RESULTS: Two-thirds of women's health NPs (66%) were trained in IUD insertions, compared to 12% of primary care NPs. Contraceptive counseling that routinely included IUDs was low overall (43%). Nurse practitioners used overly restrictive patient eligibility criteria, inconsistent with CDC guidelines. Insertion training (aOR=2.4, 95%CI: 1.10 5.33) and knowledge of patient eligibility (aOR=2.9, 95%CI: 1.91 4.32) were associated with IUD provision. Contraceptive implant provision was low: 42% of NPs in women's health and 10% in primary care. Half of NPs desired training in these methods. CONCLUSION: Nurse practitioners have an increasingly important position in addressing high unintended pregnancy in the US, but require specific training in long-acting reversible contraceptives.

Contraceptive decision-making in sexual relationships: young men's experiences, attitudes and values.

Much attention has been focused on efforts to reduce unintended pregnancy by improving contraceptive use among high-risk women; however, there is limited information to guide interventions to engage young men in contraceptive decision-making. We conducted focus groups of young men, aged 19-26, from diverse racial backgrounds from low-income communities in the San Francisco Bay Area to examine social norms about sexual relationships and how they impact on contraceptive use. The data were analysed using content analysis. A range of relationships were described, however casual relationships predominated. While young men expressed strong desires to avoid pregnancy in casual relationships, the unpredictable nature of relationships, together with low communication and regard for the women involved, made stressing consistent contraceptive use among partners unlikely. The themes expressed by these young men about sex and behaviour in different relationships illustrate a spectrum of decision-making dilemmas and illustrate the inherent difficulty in fully engaging young men in contraceptive decision-making. A strategy is needed to address relationship values, dynamics and condom use beyond STI-prevention frameworks and young women's ability to make appropriate contraceptive choices in light of the inherent difficulties and uncertainty associated with casual relationships.

Beyond access: acceptability, use and nonuse of emergency contraception among young women.

OBJECTIVE: This study was undertaken to assess the acceptability of levonorgestrel emergency contraception (EC). STUDY DESIGN: We examined attitudes and use patterns among 1950 women in a randomized trial evaluating access to EC through advance provision, pharmacies, or clinics. RESULTS: Most women considered EC to be safe (92%) and effective (98%). Compared with women with clinic access, women with direct pharmacy access were no more likely to use EC within 24 hours (odds ratio [OR] = 1.65, 95% CI = 0.82-3.30) or to report it very convenient (OR = 1.41, 95% CI = 0.77-2.56). However, women with advance provisions were more likely to use EC promptly (OR = 2.43, 95% CI = 1.24-4.80) and report high convenience (OR = 4.25, 95% CI = 2.32-7.76). Advance provision increased use by all women, whereas pharmacy access increased use only among condom users. Inconvenience and fear of side effects were common reasons for nonuse. CONCLUSION: Women viewed EC favorably. Advance provision improved promptness and convenience of use overall, while pharmacy access benefited specific populations.

Adolescent and young women's experience with the vaginal ring and oral contraceptive pills.

STUDY OBJECTIVE: To compare acceptability of the vaginal contraceptive ring to that of oral contraceptive pills. DESIGN: Randomized, cross-over, 6-month study. SETTING: Urban family planning clinic for young low-income patients. PARTICIPANTS: Sexually active females aged 15-21 years (n = 130). INTERVENTIONS: Participants were randomly assigned to use the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method. MAIN OUTCOME MEASURES: Participants completed surveys about method use, acceptability, and side effects at baseline, after three cycles, and after six cycles. We analyzed study data using ANOVA models for cross-over designs. RESULTS: We did not detect higher compliance with the ring as compared to oral contraceptive pills (P = 0.176), although overall approval of the ring was significantly higher on several items measured, including liked using method (P = 0.015), would recommend it to friends (P = 0.012), and not as hard to remember to use method correctly (P < or = 0.000). Participants were less worried about health risks while using the ring (P = 0.006), but reported that the ring was more likely to interfere with sex than the pill (P < or = 0.001) and that sex partners liked the pill (P = 0.034). Most women did not report bothersome side effects with either method. CONCLUSIONS: Adolescent and young women showed favorable acceptability of the vaginal contraceptive ring compared to oral contraceptive pills.

Pharmacokinetics of single-dose levonorgestrel in adolescents.

PURPOSE: The purpose of this study is to compare the pharmacokinetics of levonorgestrel, a drug used for emergency contraception between female adolescents and adults. METHODS: Twenty-two female subjects, aged 13-16 years, received a single 0.75-mg dose of the drug. Serial blood samples were collected for 72 h and used to measure plasma levonorgestrel concentrations. Previously published data from 16 adults, aged 18-45 years, served as comparison. RESULTS: There was a statistically significant higher total plasma clearance divided by the bioavailability (CL/F) of levonorgestrel in adolescents compared to adults, resulting in lower maximum and average total plasma concentrations. There was a trend for a larger volume of distribution divided by bioavailability (V/F), but there was no significant difference in the half-life of levonorgestrel in adolescents relative to adults (p=.098). CONCLUSION: The differences between adolescents and adults are unlikely to be clinically significant because specific changes in total concentrations suggest that unbound concentrations are probably not affected. Furthermore, empirically high doses of levonorgestrel are given for emergency contraception.

The effect of increased access to emergency contraception among young adolescents.

OBJECTIVES: The United States Food and Drug Administration cited an absence of data on young adolescents as the reason the emergency contraceptive, Plan B, could not be moved over-the-counter. This study analyzed data on young adolescents with increased access to emergency contraception. METHODS: We conducted an age-stratified analysis with previously published data from a randomized, controlled trial of Plan B with a sample size of 2,117, including 964 adolescents, 90 of whom were aged younger than 16 years. Participants were randomly assigned to nonprescription pharmacy access, advance provision of 3 packs, or clinic access (control). We measured contraceptive and sexual risk behaviors at baseline and 6-month follow-up and tested for pregnancy and sexually transmitted infections. We used contingency table and logistic regression analysis to measure the effect of the intervention on risk behaviors in young adolescents (< 16 years), compared with middle adolescents (16-17 years), older adolescents (18-19 years), and adults (20-24 years). RESULTS: Adolescents aged younger than 16 years behaved no differently in response to increased access to emergency contraception (EC) from the other age groups. As with adults, EC use was greater among adolescents in advance provision than in clinic access (44% compared with 29%; P < or = .001), and other behaviors were unchanged by study arm, including unprotected intercourse, condom use, sexually transmitted infection acquisition, or pregnancy. Additionally, adolescents with increased access to EC did not become more vulnerable to unwanted sexual activity. CONCLUSION: Young adolescents with improved access to EC used the method more frequently when needed, but did not compromise their use of routine contraception nor increase their sexual risk behavior. LEVEL OF EVIDENCE: I.

Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial.

CONTEXT: It is estimated that half of unintended pregnancies could be averted if emergency contraception (EC) were easily accessible and used. OBJECTIVE: To evaluate the effect of direct access to EC through pharmacies and advance provision on reproductive health outcomes. DESIGN, SETTING, AND PARTICIPANTS: A randomized, single-blind, controlled trial (July 2001-June 2003) of 2117 women, ages 15 to 24 years, attending 4 California clinics providing family planning services, who were not desiring pregnancy, using long-term hormonal contraception or requesting EC. INTERVENTION: Participants were assigned to 1 of the following groups: (1) pharmacy access to EC; (2) advance provision of 3 packs of levonorgestrel EC; or (3) clinic access (control). MAIN OUTCOME MEASURES: Primary outcomes were use of EC, pregnancies, and sexually transmitted infections (STIs) assessed at 6 months; secondary outcomes were changes in contraceptive and condom use and sexual behavior. RESULTS: Women in the pharmacy access group were no more likely to use EC (24.2%) than controls (21.0%) (P = .25). Women in the advance provision group (37.4%) were almost twice as likely to use EC than controls (21.0%) (P<.001) even though the frequency of unprotected intercourse was similar (39.8% vs 41.0%, respectively, P = .46). Only half (46.7%) of study participants who had unprotected intercourse used EC over the study period. Eight percent of participants became pregnant and 12% acquired an STI; compared with controls, women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate (pharmacy access group: adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.58-1.64; P = .93; advance provision group: OR, 1.10; 95% CI, 0.66-1.84, P = .71) or increase in STIs (pharmacy access group: adjusted OR, 1.08, 95% CI, 0.71-1.63, P = .73; advance provision group: OR, 0.94, 95% CI, 0.62-1.44, P = .79). There were no differences in patterns of contraceptive or condom use or sexual behaviors by study group. CONCLUSIONS: While removing the requirement to go through pharmacists or clinics to obtain EC increases use, the public health impact may be negligible because of high rates of unprotected intercourse and relative underutilization of the method. Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.

With pills, patches, rings, and shots: who still uses condoms? A longitudinal cohort study.

PURPOSE: To describe women's condom use patterns over time and assess predictors of dual method use 12 months after initiating hormonal contraceptives. METHODS: We conducted a prospective cohort study among women aged 15-24 years initiating oral contraceptive pills, patch, ring, or depot medroxyprogesterone and attending public family planning clinics. Participants completed questionnaires at baseline and 3, 6, and 12 months after enrollment. We used multivariable logistic regression to assess baseline factors associated with dual method use at 12 months among 1,194 women who were sexually active in the past 30 days. RESULTS: At baseline, 36% were condom users, and only 5% were dual method users. After initiation of a hormonal method, condom use decreased to 27% and remained relatively unchanged thereafter. Dual method use increased to a peak of 20% at 3 months but decreased over time. Women who were condom users at baseline had nearly twice the odds of being a dual method user at 12 months compared with nonusers (adjusted odds ratio [AOR] = 2.01, 95% CI: 1.28-3.14). Women who believed their main partner thought condoms were "very important," regardless of perceived sexually transmitted infection risk or participant's own views of condoms, had higher odds of dual method use (AOR = 2.89, 95% CI: 1.47-5.71). CONCLUSIONS: These results highlight a potential missed opportunity for family planning providers. Providers focus on helping women initiate hormonal methods, however, they may improve outcomes by giving greater attention to method continuation and contingency planning in the event of method discontinuation and to the role of the partner in family planning.

Evaluation of e-mail contact to conduct follow-up among adolescent women participating in a longitudinal cohort study of contraceptive use.

BACKGROUND: The purpose of this study was to determine whether e-mail contact is a viable method for gathering information from adolescent women about contraceptive use. STUDY DESIGN: Adolescent women initiating contraception followed in a prospective longitudinal cohort study and who had access to the Internet were randomized to the control or intervention arm and were contacted at 3, 6 and 12 months after enrollment. The control arm completed follow-up surveys in-person or by telephone. The intervention arm received Web-based surveys via e-mail. RESULTS: There were 46 women in each group. Women in both groups were approximately 20 years old, were sexually active minority women, and were in school or employed. While participants in the intervention group initially had lower response rates than those in the control group (59% vs. 91%, respectively), with the addition of traditional follow-up methods, the overall response rates were comparable (94% vs. 91%, respectively). CONCLUSIONS: E-mail follow-up with Web-based surveys was effective amongst adolescent women at risk for unintended pregnancy. This indicates that e-mail contact could be used as a preliminary follow-up strategy to capture a substantial proportion of participants and that standard follow-up can be used as a second-line approach. A two-pronged approach with initial e-mail contact and traditional follow-up for participants who do not respond may be a viable method when evaluating sensitive areas such as contraceptive use.

Access to levonorgestrel emergency contraception: science versus federal politics.

Past US FDA decisions about emergency contraception (EC) have been subject to undue political influence, and last year's barring of over-the-counter access to Plan B One-Step(®) for those under the age of 17 years is no exception. The US Department of Health and Human Services cited insufficient data on EC use for females aged 11-12 years. These youngest adolescents, however, rarely need EC: data from California (USA) show that in 2009, fewer than one in 10,000 females under the age of 13 years received EC. Maintaining barriers to safe and effective EC is not medically necessary and conflicts with national goals to decrease teenage and unintended pregnancies.

Contraceptive discontinuation and repeat unintended pregnancy within 1 year after an abortion.

BACKGROUND: We examined 12-month hormonal contraceptive continuation and pregnancy rates by abortion history. STUDY DESIGN: Women who wanted to avoid pregnancy for at least 1 year were recruited at four San Francisco Bay area family planning clinics on regular service days and on abortion care days. Participants completed baseline and follow-up questionnaires. Multivariable Cox models assessed the factors associated with method discontinuation and pregnancy. RESULTS: Women who were enrolled into the study on the day of their abortion were 20% more likely to discontinue their contraceptive method than women who never had an abortion [adjusted hazard ratio (AHR)=1.21, 95% confidence interval (CI)=1.03-1.42]. Women who had a recent abortion or previous abortion were 60% more likely to have a pregnancy during follow-up than women who never had an abortion (AHR=1.63, 95% CI =1.21-2.20, and AHR=1.66, 95% CI=1.18-2.33, respectively). CONCLUSION: The experience of having an unintended pregnancy and abortion does not lead to behavioral changes that protect against another unintended pregnancy.

An over-the-counter simulation study of a single-tablet emergency contraceptive in young females.

OBJECTIVES: To evaluate use of a single-tablet (levonorgestrel 1.5 mg) emergency contraceptive administered to young females under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS: Females aged 11-17 years requesting emergency contraception at teen reproductive health clinics in five cities were eligible to participate. Participants read the study product label and determined whether and how to use the product without interacting with providers. Study product was dispensed to participants who appropriately selected to use it; participants were contacted 1, 4, and 8 weeks later to assess use, pregnancy, and adverse events. The incidences of outcomes were calculated and regression analysis was used to assess the effect of age and use status (ever used or no previous use) on primary outcomes. RESULTS: Of the 345 females enrolled, 279 were younger than age 17 years. Among the 340 participants included in the selection analysis, 311 (91.5%) (97.5% confidence interval 87.5- 94.5%) participants appropriately selected to use or not use product. Among the 298 participants who used product, 274 (92.9%) (97.5% confidence interval 88.8-95.8%) correctly used it as labeled. Selection and correct use were not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period and seven (2.3%) participants who used product became pregnant; there were no unusual adverse events. CONCLUSION: Restricting young females' use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access. LEVEL OF EVIDENCE: II.

Evidence-based IUD practice: family physicians and obstetrician-gynecologists.

BACKGROUND AND OBJECTIVES: Family physicians and obstetrician-gynecologists provide much of contraceptive care in the United States and have a shared goal in preventing unintended pregnancy among patients. We assessed their competency to offer women contraceptives of the highest efficacy levels. METHODS: We conducted a national probability survey of family physicians and obstetrician-gynecologists (n=1,192). We measured counseling and provision practices of intrauterine contraception and used multivariable regression analysis to evaluate the importance of evidence-based knowledge to contraceptive care. RESULTS: Family physicians reported seeing fewer contraceptive patients per week than did obstetrician-gynecologists and were less likely to report sufficient time for counseling. While 95% of family physicians believed patients were receptive to learning about intrauterine contraception, fewer than half offered counseling or the method. Only half were trained to competence to offer intrauterine contraception, while virtually all obstetrician-gynecologists were. Both family physicians and obstetrician-gynecologists were unlikely to have adequate knowledge of the women who would be good candidates for intrauterine contraception-as gauged by the Centers for Disease Control and Prevention Medical Eligibility Criteria for contraception-and consequently did not offer the method to a wide range of eligible patients. CONCLUSIONS: Most family physicians providing contraceptive care were not offering methods with top-tier effectiveness, although they reported interest in updating contraceptive skills through training. Obstetrician-gynecologists had technical skills to offer intrauterine contraception but still required education on patient selection. Greater hands-on training opportunities for family physicians, and complementary education on eligible method candidates for obstetrician-gynecologists, can increase access to intrauterine contraception by women seeking contraceptive care.

One-year contraceptive continuation and pregnancy in adolescent girls and women initiating hormonal contraceptives.

OBJECTIVE: To assess contraceptive discontinuation, switching, factors associated with method discontinuation, and pregnancy among women initiating hormonal contraceptives. METHODS: This was a 12-month longitudinal cohort study of adolescent girls and women (n=1,387) aged 15 to 24 years attending public family planning clinics who did not desire pregnancy for at least 1 year and selected to initiate the patch, ring, depot medroxyprogesterone acetate, or pills. Participants completed follow-up assessments at 3, 6, and 12 months after baseline. Life table analysis was used to estimate survival rates for contraceptive continuation. Cox proportional hazards models were used to estimate factors associated with method discontinuation. RESULTS: The continuation rate (per 100 person-years) at 12 months was low for all methods; however, it was lowest for patch and depot medroxyprogesterone acetate initiators, 10.9 and 12.1 per 100 person years, respectively (P≤.003); continuation among ring initiators was comparable to pill initiators, 29.4 and 32.7 per 100 person-years, respectively (P=.06). Discontinuation was independently associated with method initiated and younger age. The only factors associated with lower risk of discontinuation were greater intent to use the method and being in school or working. The pregnancy rate (per 100 person-years) was highest for patch and ring initiators (30.1 and 30.5) and comparable for pill and depot medroxyprogesterone acetate initiators (16.5 and 16.1; P<.001). CONCLUSION: The patch and the ring may not be better options than the pill or depot medroxyprogesterone acetate for women at high risk for unintended pregnancy. This study highlights the need for counseling interventions to improve contraceptive continuation, education about longer-acting methods, and developing new contraceptives that women may be more likely to continue. LEVEL OF EVIDENCE: II.

Attitudes and beliefs about the intrauterine device among teenagers and young women.

BACKGROUND: Little is known about attitudes and beliefs among teenagers and young women about the intrauterine device (IUD). STUDY DESIGN: We surveyed 252 women, ages 14-27 years, presenting for appointments at an urban family planning clinic about demographics, sexual and birth control history, and opinions about the IUD. RESULTS: Fifty-five percent had not heard of the IUD. Participants who were parous were 4.4 times more likely to be interested in the IUD than nulliparous participants. Independent of parity, participants who had heard of the IUD from a health care provider were 2.7 times more likely to be interested in using the method. The study population was at high risk for sexually transmitted infections (STIs); however, 82% of participants predicted that they would increase or experience no change in their condom use with an IUD in place. CONCLUSIONS: Health care providers should be encouraged to talk to teenagers and young women who are at high risk for unintended pregnancy, both parous and nulliparous, about using the IUD.

Hormonal contraceptive method choice among young, low-income women: how important is the provider?

OBJECTIVES: Several new methods are available, but we know little about successful integration of contraceptive technologies into services. We investigated provider factors associated with the initiation of new hormonal methods among women at high risk of unintended pregnancy. METHODS: This cohort study enrolled 1387 women aged 15-24 starting hormonal contraception (vaginal ring, transdermal patch, oral contraceptive, or injectable) at four family planning clinics in low-income communities. We measured provider factors associated with method choice, using multinomial logistic regression. RESULTS: Ring and patch initiators were more likely than women starting oral contraceptives to report that they chose their method due to provider counseling (p<0.001). Contraceptive knowledge in general was low, but initiation of a new method, the ring, was associated with higher knowledge about all methods after seeing the provider (p<0.001). Method initiated varied with provider site (p<0.001). These associations remained significant, controlling for demographics and factors describing the provider-patient relationship, including trust in provider and continuity of care. CONCLUSION: Women's reports of provider counseling and of their own contraceptive knowledge after the visit was significantly associated with hormonal method initiated. PRACTICE IMPLICATIONS: More extensive counseling and patient education should be expected for successful integration of new hormonal methods into clinical practice.

Abstinence and teenagers: prevention counseling practices of health care providers serving high-risk patients in the United States.

CONTEXT: Abstinence-only education has had little demonstrable impact on teenagers' sexual behaviors, despite significant policy and funding efforts. Given the struggle over resources to improve teenagers' reproductive health outcomes, the views of clinicians serving teenagers at high risk for unintended pregnancy and STDs merit particular attention. METHODS: In 2005, a qualitative study with 31 clinicians serving low-income, at-risk patients was conducted. A semistructured interview guide was used to ask clinicians about adolescent pregnancy, HIV and STD prevention counseling, and when they include abstinence. Thematic content analysis was used to examine the content of the counseling and the techniques used in different situations. RESULTS: Providers reported offering comprehensive counseling, presenting abstinence as a choice for teenagers, along with information about contraceptives and condoms. Several providers mentioned that with young, sexually inexperienced teenagers, they discuss delaying sexual activity and suggest other ways to be affectionate, while giving information on condoms. Providers explained how they assess whether teenagers feel ready to be sexually active and try to impart skills for healthy relationships. Some described abstinence as giving teenagers a way to opt out of unwanted sexual activity. Many support abstinence if that is the patient's desire, but routinely dispense condoms and contraceptives. CONCLUSIONS: Overall, providers did not give abstinence counseling as a rigid categorical concept in their preventive practices, but as a health tool to give agency to teenagers within a harm reduction framework. Their approach may be informative for adolescent policies and programs in the future.

Should providers give women advance provision of emergency contraceptive pills? A cost-effectiveness analysis.

PURPOSE: We sought to determine the potential effect and cost-effectiveness of different means of accessing emergency contraceptive pills (ECP) on unintended pregnancy rates in sexually active women. METHODS: We used a computer simulation model to compare the effects of advance provision, on-demand provision, and no use of ECP on unintended pregnancies and costs of care in three hypothetical cohorts of 1 million sexually active women. Data on effectiveness of ECP from the single-use clinical trials, and costs from Medi-Cal, California's Medicaid program were used for the model. FINDINGS: Advance provision of ECP is projected to avert a greater or the same percentage of unintended pregnancies compared with on-demand provision, with the greatest percentage of pregnancies averted (66%) in low-risk women with advance provision. In the simulation model, the percentage of pregnancies averted decreases as the frequency of unprotected intercourse increases and ECP use decreases. In all scenarios, the cost-savings ratio--the number of dollars saved on averted pregnancy expenditures for each dollar spent on advance ECP--is greater than one. CONCLUSION: Advance provision of ECP has the potential to avert unintended pregnancies and reduce medical expenditures. The most likely reason that the advance provision trials fail to demonstrate reductions in pregnancy rates is a result of a combination of small study sizes, the use of ECP in both treatment and control groups, and a failure to take into account a realistic range of rates of unprotected intercourse and imperfect ECP use.

Attitudes toward the vaginal ring and transdermal patch among adolescents and young women.

PURPOSE: The vaginal ring and the transdermal patch offer important contraceptive options for women at high risk for unintended pregnancy. Little is known about what adolescents and young women think about these methods and why use of the ring has been relatively low compared with the patch. We sought to examine young women's attitudes and perceptions about the ring and the patch to better understand the relationship between perceptions of these methods and decisions to use them. METHODS: Sixteen focus groups of young women aged 15-26 years (n=113) from family planning clinics in the San Francisco Bay Area were convened. Data from the focus groups were analyzed using standard content analysis. RESULTS: Although young women expressed apprehension and doubt about both methods, for the most part women expressed more positive attitudes about the patch. Two related themes for the ring and the patch were identified: "lack of trust in effectiveness," and "method use concerns". Two themes unique to the ring ("concerns regarding vaginal insertion" and "sexual partner perceptions") and three themes unique to the patch ("ease of remembering," "visibility issues," and "perceived health risk") were identified. CONCLUSIONS: Increased provider education about apprehensions related to the ring and the patch may lead to increased use of the ring and may counter recent declines in use of the patch. It would be unfortunate if these safe and effective options for young women were to be underused because negative attitudes and perceptions about these methods acted as barriers to adoption.