Training contraceptive providers to offer intrauterine devices and implants in contraceptive care: a cluster randomized trial.

BACKGROUND: US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. OBJECTIVE: We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. STUDY DESIGN: We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. RESULTS: Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60%) (adjusted odds ratio, 1.89; 95% confidence interval, 1.04-3.44), and for the implant increased more in intervention (41-62%) compared to control sites (48-50%) (adjusted odds ratio, 2.30; 95% confidence interval, 1.28-4.12). Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113). Knowledge scores of eligibility for intrauterine device and implant use with common medical conditions increased 15% more in intervention (0.65-0.79) compared to control sites (0.67-0.66) (adjusted coefficient, 0.15; 95% confidence interval, 0.09-0.21). Routine discussion of intrauterine devices and implants by providers in intervention sites increased significantly, 71-87%, compared to in control sites, 76-82% (adjusted odds ratio, 1.97; 95% confidence interval, 1.02-3.80). CONCLUSION: Professional guidelines encourage intrauterine device and implant competency for all contraceptive care providers. Integrating these methods into routine care is important for access. This replicable training intervention translating evidence into care had a sustained impact on provider attitudes, knowledge, and counseling practices, demonstrating significant changes in clinical care a full year after the training intervention.

Reductions in pregnancy rates in the USA with long-acting reversible contraception: a cluster randomised trial.

BACKGROUND: Unintended pregnancy remains a serious public health challenge in the USA. We assessed the effects of an intervention to increase patients' access to long-acting reversible contraceptives (LARCs) on pregnancy rates. METHODS: We did a cluster randomised trial in 40 reproductive health clinics across the USA in 2011-13. 20 clinics were randomly assigned to receive evidence-based training on providing counselling and insertion of intrauterine devices (IUDs) or progestin implants and 20 to provide standard care. Usual costs for contraception were maintained at all sites. We recruited women aged 18-25 years attending family planning or abortion care visits and not desiring pregnancy in the next 12 months. The primary outcome was selection of an IUD or implant at the clinic visit and secondary outcome was pregnancy within 12 months. We used generalised estimating equations for clustered data to measure the intervention effect on contraceptive selection, and used survival analysis to assess pregnancy rates. FINDINGS: Of 1500 women enrolled, more at intervention than control sites reported receiving counselling on IUDs or implants (565 [71%] of 797 vs 271 [39%] of 693, odds ratio 3·8, 95% CI 2·8-5·2) and more selected LARCs during the clinic visit (224 [28%] vs 117 [17%], 1·9, 1·3-2·8). The pregnancy rate was lower in intervention group than in the control group after family planning visits (7·9 vs 15·4 per 100 person-years), but not after abortion visits (26·5 vs 22·3 per 100 person-years). We found a significant intervention effect on pregnancy rates in women attending family planning visits (hazard ratio 0·54, 95% CI 0·34-0·85). INTERPRETATION: The pregnancy rate can be reduced by provision of counselling on long-term reversible contraception and access to devices during family planning counselling visits. FUNDING: William and Flora Hewlett Foundation.

Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood.

OBJECTIVES: Self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-sc) is feasible, acceptable, and effective. Our objective was to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration. STUDY DESIGN: We randomized 401 females ages 15-44 requesting DMPA at clinics in Texas and New Jersey to self-administration or clinic administration in a 1:1 allocation. Clinic staff taught participants randomized to self-administration to self-inject and observed the first injection; participants received instructions, a sharps container, and three doses for home use. Participants randomized to clinic administration received usual care. All participants received DMPA-sc at no cost and injection reminders via text message or email. We conducted follow-up surveys at six and 12 months. RESULTS: Three hundred thirty-six participants (84%) completed the 12-month survey; 316 completed both follow-up surveys (an 80% response rate excluding eight withdrawals). Participants ranged in age from 16-44. One-year DMPA continuous use was 69% in the self-administration group and 54% in the clinic group (p=.005). There were three self-reported pregnancies during the study period, all occurred in the clinic group; all three women had discontinued DMPA and one reported her pregnancy as intended. Among the self-administration group, 97% reported that self-administration was very or somewhat easy; 87% would recommend self-administration of DMPA-sc to a friend. Among the clinic group, 52% reported interest in self-administration in the future. Satisfaction was similar between groups. No serious adverse events were reported. CONCLUSIONS: DMPA self-administration improves contraceptive continuation and is a feasible and acceptable option for women and adolescents. IMPLICATIONS: Self-administration of subcutaneous DMPA can improve contraceptive access, autonomy, and continuation, and is a feasible and acceptable option for women and adolescents. It should be made widely available as an option for women and adolescents.

Treatment of external genital warts at Planned Parenthood Federation of America centers.

OBJECTIVE: To compare patterns and cost of treating external genital warts (EGW) at 5 major Planned Parenthood Federation of America (PPFA) affiliates. STUDY DESIGN: Charts of 422 women and 78 men treated for EGW were reviewed. Treatment must have been successful and occurred at a single clinic. Data included anatomic site, number and dates of office visits, treatment modality and cost. RESULTS: Women required average of 3.01 visits and average cost of $291.36 to reach clearance and males 2.35 visits and $301.81. Monotherapy TCA required 3.2 visits and $263.65 while cryotherapy alone required 3.3 visits and $481.97. Initial imiquimod monotherapy required 2.3 visits and $217.62. Combination therapy of imiquimod and trichloroacetic acid averaged 1.5 visits and $236.53. The largest reduction in visits and cost occurred in patients with multiple or recurrent EGW and those requiring >3 visits. From these data an EGW treatment algorithm was developed allowing more effective management and better utilization of health care resources. CONCLUSION: In the PPFA clinic setting, imiquimod alone or in combination should be initial treatment for patients with multiple or recurrent EGW or for those who do not experience complete clearance by the third clinic visit when nonimiquimod therapy is first employed.

Adequacy and safety of buccal misoprostol for cervical preparation prior to termination of second-trimester pregnancy.

OBJECTIVE: The objective of this retrospective, descriptive study is to assess the adequacy and safety of buccal misoprostol with and without laminaria for cervical preparation prior to second-trimester abortion. METHODS: We analyzed Planned Parenthood Federation of America data from 2,218 elective dilation and evacuation (D&E) procedures conducted on women at 12 to 23 6/7 weeks of gestation from April 2002 to March 2003. Each woman received 400, 600 or 800 microg of buccal misoprostol with or without laminaria for preprocedural cervical preparation. RESULTS: Of the patients, 62% received 400 mug, 32% received 600 microg and 6% received 800 microg of buccal misoprostol; 42.8% had laminaria inserted for phased cervical preparation. The adequacy of cervical dilation was 88.7%. The D&E procedure was completed during a single surgical procedure for 99.8%. The overall adverse event rate was 19.39 per 1,000 women, with a rate of 4.51 per 1,000 women for serious adverse events. CONCLUSIONS: This descriptive study suggests that use of buccal misoprostol with or without laminaria is effective and safe. If buccal misoprostol eliminates or reduces the need for phased, multiday laminaria 1-3 days prior to the surgical procedure, then its use may offer service advantages such as reduced number of clinic visits and fewer pelvic examinations per woman.

Differences in contraceptive use between family planning providers and the U.S. population: results of a nationwide survey.

OBJECTIVES: To describe contraceptive use among U.S. female family planning providers and to compare their contraceptive choices to the general population. STUDY DESIGN: We surveyed a convenience sample of female family planning providers ages 25-44 years, including physicians and advanced practice clinicians, via an internet-based survey from April to May 2013. Family planning providers were compared to female respondents ages 25-44 years from the 2011-2013 National Survey of Family Growth. RESULTS: A total of 488 responses were eligible for analysis; 331 respondents (67.8%) were using a contraceptive method. Providers' contraceptive use differed markedly from that of the general population, with providers significantly more likely to use intrauterine contraception, an implant, and the vaginal ring. Providers were significantly less likely to use female sterilization and condoms. There were no significant differences between providers and the general population in use of partner vasectomy or the pill. Long-acting reversible contraception (LARC) use was significantly higher among providers than in the general population (41.7% vs. 12.1%, p<.001). These results were consistent when stratifying by variables including self-identified race/ethnicity and educational level. CONCLUSIONS: The contraceptive choices of this sample of female family planning providers differed significantly from the general population. These findings have implications for clinical practice, patient education, and health policy. IMPLICATIONS: Family planning providers report higher use of LARC than the general population. This may reflect differences in preferences and access. Providers might consider sharing these findings with patients, while maintaining patient choice and autonomy.

Staying on track: a cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion.

OBJECTIVES: To evaluate whether automated reminders increase on-time completion of the three-dose human papillomavirus (HPV) vaccine series. METHODS: Ten reproductive health centers enrolled 365 women aged 19-26 to receive dose one of the HPV vaccine. Health centers were matched and randomized so that participants received either routine follow-up (control) or automated reminder messages for vaccine doses two and three (intervention). Intervention participants selected their preferred method of reminders - text, e-mail, phone, private Facebook message, or standard mail. We compared vaccine completion rates between groups over a period of 32 weeks. RESULTS: The reminder system did not increase completion rates, which overall were low at 17.2% in the intervention group and 18.9% in the control group (p=0.881). Exploratory analyses revealed that participants who completed the series on-time were more likely to be older (OR=1.15, 95% CI 1.01-1.31), report having completed a four-year college degree or more (age-adjusted OR=2.51, 95% CI 1.29-4.90), and report three or more lifetime sexual partners (age-adjusted OR=3.45, 95% CI 1.20-9.92). CONCLUSIONS: The study intervention did not increase HPV vaccine series completion. Despite great public health interest in HPV vaccine completion and reminder technologies, completion rates remain low.

Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception.

OBJECTIVE: To evaluate the efficacy and safety of ulipristal acetate as emergency contraception in women presenting 48-120 hours after receiving ulipristal acetate for unprotected intercourse. METHODS: Women aged 18 years or older with regular cycles who presented for emergency contraception 48 to 120 hours after unprotected intercourse were enrolled in 45 Planned Parenthood clinics and treated with a single dose of 30 mg ulipristal acetate. Pregnancy status was determined by high-sensitivity urinary human chorionic gonadotropin testing and return of menses. RESULTS: A total of 1,241 women were evaluated for efficacy. Twenty-six were pregnant at follow-up, for a pregnancy rate of 2.1% (95% confidence interval 1.4-3.1%). These results satisfy the protocol-defined statistical criteria for success because the pregnancy rate was lower than both the estimated expected pregnancy rate and a predefined clinical irrelevance threshold. In addition, efficacy did not decrease over time: pregnancy rates were 2.3% (1.4-3.8%), 2.1% (1.0-4.1%), and 1.3% (0.1-4.8%) for intervals of 48 to 72 hours, more than 72 to 96 hours, and more than 96 to 120 hours, respectively. Adverse events were mainly mild or moderate, the most frequent being headache, nausea, and abdominal pain. Cycle length increased a mean of 2.8 days, whereas the duration of menstrual bleeding did not change. CONCLUSION: Ulipristal acetate is effective and well-tolerated for emergency contraception 48-120 hours after unprotected intercourse. LEVEL OF EVIDENCE: II.