The Contraceptive CHOICE Project

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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%)