The Contraceptive CHOICE Project

Background 

  • Title: The Contraceptive CHOICE Project: Reducing Barriers to Long-Acting Reversible Contraception 

  • Publishing Info:

    • Done by a group at the department of Ob/Gyn at Washington St. Louis School of Medicine (first author was a PhD!) 

    • Published in AJOG in 2010 (first 2500 patients) 

    • Follow up was published in Clinical Ob/Gyn 2014 - 9256 women 

  • Who funded this study 

    • Funded by an anonymous foundation + also Midcareer Investigator Award in women’s Health Research, Clinical Translational Science Award, and NCRR 

  • Why was this study done? 

    • About half of the pregnancies that occur in the US are unintended 

    • A lot of pregnancies results from incorrect or inconsistent use of birth control methods 

    • At the time, LARC use was low, <3% of women in the US used a LARC 

    • CHOICE was done to promote use of LARCs in the St. Louis region 

  • Goal: 

    • Objective: provide no-cost contraception to a large number of women in that region 

      • Secondary: reduce unintended pregnancy at the population level 

    • In order to accomplish, had to overcome two barriers: 

      • Financial obstacles 

      • Lack of patient awareness of LARC method safety and efficacy 

Methods 

  • Type of study

    • Prospective cohort study of 10,000 women in St. Louis region

  • Intervention

    • Provided each participant with the contraceptive of her choice at no cost for three years  

  • Subject recruitment

    • Convenience sample - meaning no randomization, etc. Just chose women at specific clinic locations and via general awareness of CHOICE through medical providers 

      • Clinics were university-affiliated clinics, two facilities providing abortion services, community clinics, etc. 

    • Eligibility: 

      • Age 14-45

      • Reside in or seek clinical services at recruitment sites in St. Louis region 

      • Sexually active with male partner in last 6 months or anticipate sexual activity with male partner in next 6 months 

      • No tubal or hysterectomy 

      • Does not desire pregnancy in next year 

      • Not currently using contraceptive method or interested in starting a new reversible contraceptive method 

    • Recruitment and screening was done by person on site or by telephone 

      • Person was trained with scripted intro to LARC methods if LNG-IUD, copper IUD, and subdermal implant

      • Enrollment occurs in 1.5-2 hr in person process

        • Rule out pregnancy

        • Due to staff constraints, not everyone got the same counseling - so at the community sites, patients received routine family planning counseling 

      • Informed consent 

    • LARC method

      • If they wanted a LARC method, then they had insertion by trained professional 

      • Emergency contraception was provided if needed  

    • Follow up: phone follow up at 3, 6, 12, 18, 24, 30, 36 months post enrollment 

      • Given $10 for each completed survey 

      • Also screened for gonorrhea and chlamydia at 12, 24, and 36 month contacts 

      • Huge undertaking to follow people for 3 years! 

      • Collected info on baseline demographics, OB and gyn history, etc. 

Results 

  • Findings for first 2500 women (2010 study) 

    • Population

      • Between August 2007 - December 2008, screened 4107 women, 3522 met eligibility criteria, 2500 enrolled 

      • 74% (1845/2500) of enrollments occurred at university-based recruitment site  

      • Average age: 25 (range 14-45), majority were 25 or younger (only 36.9% >25)  

      • 49% white, 44% black 

      • 42% no insurance, more than half reported difficulty paying for transportation food, housing, or medications 

      • 63.7% single or never married

      • 41% nulliparous, 54% of parous women reported having 2 or more children 

      • 67.1% chose a LARC, and 32.9% chose other methods 

        • Of those that chose LARCs: 46.8% LNG-IUD, 9.3% Copper IUD, 11.0% subdermal implant 

        • LARC users more likely to be recruited at an abnortion clinic (RR 1.2, 95% CI 1.1-1.2), report greater parity, or history of abrotion 

        • Those who reported black or other race, single or never married, one or no lifetime partners were less likely to choose LARC 

  • Findings for all the patients 

    • Demographics were overall pretty similar 

    • At the end of the study:

      • LARC users were more likely than non-LARC users to continue at the 12 and 24 months with method (86% vs. 55% at 12 months, 77% vs 41% at 24 months)  

      • At 12 months, the IUDs had highest continuation rates (88% for LNG-IUD, 84% for copper iUD), same at 24 months (79% for LNG-IUD and 77% copper) 

  • Some people voiced concern that with increased LARC use, there may be increase in high risk sexual behavior — no evidence to suggest that there was increased sexual risk-taking 

    • 71% reported no change in their number of sexual partners at 6 and 12 months; only 16% report increase, and of those, 80% experienced a change from 0 to 1 partners 

    • Percent of women reporting multiple partners at baseline was significantly reduced at 6 and 12 months (5.2%, 3.5%, 3.3% respectively) 

  • Reduction of unintended pregnancies! 

    • Failure rates for pill, patch, and ring = 4.8%, 7.8%, 9.4% at 1, 2, and 3 years 

    • Failure rate for LARC users remained <1% throughout the 3 year follow up (cumulative was 0.3%, 0.6%, and 0.9% at each year respectively) 

    • Non-LARC users were 22x as likely to experience an unintended pregnancy compared to LARC counterparts 

    • Adolescent users of pill, patch, or ring were twice as likely as older women to experience unintended pregnancies 

Very cool: super decreased rates of pregnancy, birth and abortion among teens! 

National for each: 158/1000, 94/1000, 41/1000

CHOICE: 34/1000, 19.4/1000, 9.7/1000 - Greater than 75% reduction! 

  • Contraception in the overweight and obese populations 

    • BMI was not found to be significant factor associated with increased risk of method failure for pill, patch, or vaginal ring (there were a total of 334 unintended pregnancies, 128 were determined to be contraceptive failure)

    • Weight gain

      • Those who perceived weight gain were more likely to be implant or DMPA users 

      • Objective weight gain on average was 10.3 lbs 

      • Adjusted models only identified black race as having significant association with weight gain in 12 months 

  •  STIs: Prevalence of GC, CT, and trich were higher in the CHOICE cohort than the national average at baseline 

    • 7.9% had one or more 

Conclusions 

  • Huge # of women seeking reversible contraception 

    • When barriers of cost, access, and knowledge are removed, women choose the most effective and least-user dependent methods more often 

      • In general population, LARC use was 3% 

      • In this population, 46% chose LNG IUD, 11.9% chose Copper IUD, and 16.9% chose implant 

    • Continue to use them 

    • Also found they were highly satisfied 

    • Also decrease risk of unintended pregnancies, teen pregnancies 

What do we do now? 

  • Some pretty cool follow up: 

    • Colorado Family Planning Initiative - provides access to long-acting reversible contraception 

    • Teen birth rates cut in half, abortion rates cut in half 

    • Average rate of first birth increased by 1.2 years among all women 

    • Cost avoided: $66.1-69.6 million

  • Per CDC we have definitely increased LARC use now! 

    • 2015-2017: LARC use was up to 10.3% 

    • LARC was highest among women 20-29 (13.1%)

Progestins

Today we welcome Dr. Ben Brown, who is an assistant professor in the Division of Emergency Obstetrics and Gynecology at Women and Infants Hospital and the Warren Alpert Brown School of Medicine. Dr. Brown is also completed a fellowship in Family Planning, and thus shares with us his expertise in progestin-based contraception!

We quickly reviewed initially that progesterone naturally serves as an inhibitory feedback to luteinizing hormone during the menstrual cycle. There were also a number of downstream effects of progesterone, including cervical mucus thickening, stabilizing the endometrial lining, and down-regulating both systemic progesterone and estrogen receptors — you can review all of these again with our episode on the menstrual cycle if you missed it. These mechanisms of action underlie the way progestins work clinically. We do not cover the anti-progestins (mifepristone) and selective progesterone receptor modulators (ulipristal) today.

We then reviewed the generations of progestins. As Dr. Brown states, knowing drosperinone as a 4th generation is probably a good thing, but otherwise some of this is just good to know as a “contraception nerd.” The generations are summarized below in a nice table:

We then spoke about the delivery methods beyond the drugs — pills, injections, IUDs, implants, and more!

Side effects and contraindications are important to know for all forms of contraception. Here are a few that we review:

  • Androgenicity: more apparent in combined-hormonal methods, due to upregulation of SHBG by estrogen. Some progestins (particularly 1st generation) also competitively bind androgenic receptors — even sometimes if given without estrogen, those progestins may actually produce androgenic side effects! That said, this is quite uncommon.

  • Thrombosis: this can be very confusing and controversial:

    • Estrogen-containing methods will raise risk of both venous and arterial clots.

      • Drosperinone and other later-generation progestins has received poor press due to higher risk of thrombosis in combined formulations. The risk is overall still very low: 7-13 events per 10,000 woman years. But compared to pregnancy as a competing outcome, 20-30 events/10k woman years, and postpartum 40-60/10k woman-years!

    • Progestins alone can also raise arterial thrombus risk.

      • These are patients who you consider to have significant endovascular risk factors — longstanding poorly-controlled diabetes, coronary disease, heavy smoking, etc. This is because progestins can shift lipid profiles to a more androgenic appearance - lower HDL, higher LDL and total cholesterol.

    • The CDC’s US MEC guidelines are an excellent tool to cross-reference comorbidities against contraceptive methods.

  • Breast cancer: current or prior is a relative contraindication to hormonal contraception.

  • Severe liver disease: contraindicated due to impaired hepatic processing of steroid hormone.

  • Bariatric malabsorptive procedures: may not be great candidates for progestin-only pills due to need for consistent dosing time.