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Introducing CycleBeads® in Title X Clinics


  Preliminary findings of an OPA-funded NFP study

                    Presented by Katherine L. Cain
                        NFP Breakout Session
  National Title X Family Planning Confrence, Miami, August 2011
Study team / contributors
Courtney Benedict, Jeannette Cachan, Lise Ching, Deborah
Dean, Marsha Gelt, Jennifer Grant, Victoria Jennings, David
Klemm, Renee LaForce, Gretchen Latowsky, Rebecka
Lundgren, Renee Marshall, Meredith Puleio, Beatriz Reyes,
Johanna Rosenthal, Irit Sinai, and the staff of all our
participating clinics.
Background
• Half of pregnancies in U.S. each year are
  unintended
• 7% of women 15-44 are at risk of unwanted
  pregnancy but not using contraceptives
• Fertility awareness-based methods (FAM) are safe,
  effective and included in Title X’s mandate, yet
  underutilized
   – Rhythm/calendar, Standard Days Method®, Basal Body
     Temperature, Cervical Mucus, Symptothermal Methods
   – Less than 1% of Title X family planning clients use FAM
Study purpose
• To test provision of SDM/CycleBeads in Title X
  programs through regional training centers
   o Identify factors which constrain and facilitate FAM
     availability and use
   o Develop and test a process to introduce the SDM
     within a framework of expanded choice
   o Assess acceptance, correct use, and satisfaction
Standard Days Method® (SDM)

• Identifies days 8-19 of the cycle
  as fertile
• Is appropriate for women with
  menstrual cycles between 26
  and 32 days long
• Typical use effectiveness = 88%
  (perfect use = 95%)
• Is used with CycleBeads®
Partners
World Health Organization’s
  Strategic Approach to
Contraceptive Introduction
Methods
Phase 1: Needs assessment
Implications of needs assessment
• There is need for more non-hormonal options
  and interest in the SDM among potential clients
• Providers are open to offering it to expand choice
• There are no barriers to method integration from
  a systems perspective
• Considerations for training: method
  effectiveness, how to support correct use,
  cultural factors/ machismo
Moving to phase 2…
SDM Integration: 1) Systems

• Modifications made to:
   – Billing/reporting forms
   – Charting
   – Protocols
• No major changes required in supervision
  systems or clinic flow
• CycleBeads supplied
• Counseling aids and client materials
SDM Integration:
      2) Staff Training and Support
• Provider trainings conducted at each site
• Trainings consisted of 2 hours on
  SDM/CycleBeads counseling, and 1.5-2 hours on
  use of educational materials and study
  procedures
• Follow up visits to sites throughout the year
SDM Integration:
3) Awareness-raising
 • Posters & fliers around town
 • Health fairs
 • Newspaper articles
 • Newsletters, Facebook, etc.
 • Promotoras in Lawrence, MA
Outcome evaluation
• Post-integration staff interviews
• Service statistics
• Follow up of CycleBeads users
Staff interviews
• 25 staff (clinicians & MAs/counselors) interviewed
  after 9 months of offering CycleBeads
• All found the method easy to teach & wanted to
  continue offering it
• Barriers to offering CycleBeads include the high
  proportion of clients who:
   – Have irregular or unknown cycle length
   – Cannot avoid unprotected sex on fertile days due to
     their partner
CycleBeads users from service statistics
Clinic              # of CycleBeads   Reporting period     Avg # of female
name/location       users reported                         FP visits/year
Health Quarters –           9         Oct ‘09-Aug ‘11            900
Beverly, MA                           (23 months)
Health Quarters –          32         Oct ’09-Aug ‘11           1,200
Lawrence, MA                          (23 months)
PPMM-Modesto,              27         Sept ’09-April ‘11       12,000
CA                                    (20 months)
MCC – San Rafael,          41         Aug ‘10-June ’11         10,800
CA                                    (11 months)
MCC – Novato, CA           28         May ‘10-June ‘11          6,000
                                      (14 months)
MCC – Novato               61         Mar ‘10-June ’11          1,200
Wellness Center                       (18 months)

TOTAL                      198
CycleBeads client interviews*

   • 37 reached after receiving method (15+
     additional recruited but could not be reached)
       • 31 using CycleBeads to prevent pregnancy AND met
         eligibility criteria
   • 17 reached for follow-up at 3 months
       – 12 still using CycleBeads to prevent pregnancy
       – Dropouts due to: out-of-range cycles (3), pregnancy
         (1), break up with partner (1)


*These are preliminary results as of August 2011, as not all interviews
have been completed and entered.
CycleBeads user characteristics (n=31)
   •   Age range: 18-45 (mean=27, median=26)
   •   68% English spoken at home
   •   42% have children
   •   29% married
   •   81% have used FP method(s) in the past
   •   92% heard about CycleBeads from health center
CycleBeads user admission
        interviews (n=31)
• Reasons for choosing CycleBeads:
   – 87% no hormones/no side effects
   – 42% easy / convenient
   – 35% “it’s natural”
• Plan to handle the fertile days:
   – 74% condoms all or part of the time
   – 39% abstain all or part of the time
   – 13% spermicide
CycleBeads user 3-month follow-up (n=12)

• 100% correctly identified fertile days
• 83% avoided unprotected sex during white beads
• 50% clearly understood how to use CycleBeads to
  track cycle length
CycleBeads user 3-month follow-up (n=12)
 • 100% are satisfied or very satisfied
 • 92% say CycleBeads are “easy to use”
 • Like most: no side effects / natural (92%), easy to
   use (58%), enjoy tracking cycle (25%), effective
   (17%)
 • Like least: moving the band every day (25%),
   unsure about efficacy (17%), using condoms (8%)
 • 42% relationship changed for the better since
   starting CycleBeads (the rest reported no
   change)
Implications
• CycleBeads can be successfully introduced into
  clinics.
• Clients choose the method and can use it
  successfully and satisfactorily.
• Efforts are needed to raise awareness so that
  clients know to ask for the method, and staff
  remember to offer it.
Phase 3
CycleBeadsToolkit
      .com
For more information:
     www.irh.org
CycleBeadsToolkit.com
   CycleBeads.com
References
•   Gribble, JN., Lundgren, R., Velasquez, C., Anastasi, E., Being Strategic
    about Contraceptive Introduction: the Experience of the Standard Days
    Method. Contraception 2008; 77: 147-154.
•   Making decisions about contraceptive introduction : a guide for
    conducting assessments to broaden contraceptive choice and improve
    quality of care. 2002. WHO: Geneva. Available at
    http://www.who.int/reproductivehealth/publications/family_planning/RH
    R_02_11/en/index.html
•   Simmons, R., Hall, P., Diaz, J., et al. The Strategic Approach to
    Contraceptive Introduction. Studies in Family Planning 1997; 28(2): 79-94.
•   Simmons R, Fajans P, and R Ghiron. 2007. Scaling up health service
    delivery from pilot innovations to policies and programmes. World Health
    Organization, ExpandNet: Switzerland.
•   Guttmacher Institute – Facts in brief. Available at www.guttmacher.org.

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Introducing CycleBeads in Title X Clinics: Preliminary findings of an OPA-funded NFP study

  • 1. Introducing CycleBeads® in Title X Clinics Preliminary findings of an OPA-funded NFP study Presented by Katherine L. Cain NFP Breakout Session National Title X Family Planning Confrence, Miami, August 2011
  • 2. Study team / contributors Courtney Benedict, Jeannette Cachan, Lise Ching, Deborah Dean, Marsha Gelt, Jennifer Grant, Victoria Jennings, David Klemm, Renee LaForce, Gretchen Latowsky, Rebecka Lundgren, Renee Marshall, Meredith Puleio, Beatriz Reyes, Johanna Rosenthal, Irit Sinai, and the staff of all our participating clinics.
  • 3. Background • Half of pregnancies in U.S. each year are unintended • 7% of women 15-44 are at risk of unwanted pregnancy but not using contraceptives • Fertility awareness-based methods (FAM) are safe, effective and included in Title X’s mandate, yet underutilized – Rhythm/calendar, Standard Days Method®, Basal Body Temperature, Cervical Mucus, Symptothermal Methods – Less than 1% of Title X family planning clients use FAM
  • 4. Study purpose • To test provision of SDM/CycleBeads in Title X programs through regional training centers o Identify factors which constrain and facilitate FAM availability and use o Develop and test a process to introduce the SDM within a framework of expanded choice o Assess acceptance, correct use, and satisfaction
  • 5. Standard Days Method® (SDM) • Identifies days 8-19 of the cycle as fertile • Is appropriate for women with menstrual cycles between 26 and 32 days long • Typical use effectiveness = 88% (perfect use = 95%) • Is used with CycleBeads®
  • 7. World Health Organization’s Strategic Approach to Contraceptive Introduction
  • 9. Phase 1: Needs assessment
  • 10. Implications of needs assessment • There is need for more non-hormonal options and interest in the SDM among potential clients • Providers are open to offering it to expand choice • There are no barriers to method integration from a systems perspective • Considerations for training: method effectiveness, how to support correct use, cultural factors/ machismo
  • 12. SDM Integration: 1) Systems • Modifications made to: – Billing/reporting forms – Charting – Protocols • No major changes required in supervision systems or clinic flow • CycleBeads supplied • Counseling aids and client materials
  • 13. SDM Integration: 2) Staff Training and Support • Provider trainings conducted at each site • Trainings consisted of 2 hours on SDM/CycleBeads counseling, and 1.5-2 hours on use of educational materials and study procedures • Follow up visits to sites throughout the year
  • 14. SDM Integration: 3) Awareness-raising • Posters & fliers around town • Health fairs • Newspaper articles • Newsletters, Facebook, etc. • Promotoras in Lawrence, MA
  • 15. Outcome evaluation • Post-integration staff interviews • Service statistics • Follow up of CycleBeads users
  • 16. Staff interviews • 25 staff (clinicians & MAs/counselors) interviewed after 9 months of offering CycleBeads • All found the method easy to teach & wanted to continue offering it • Barriers to offering CycleBeads include the high proportion of clients who: – Have irregular or unknown cycle length – Cannot avoid unprotected sex on fertile days due to their partner
  • 17. CycleBeads users from service statistics Clinic # of CycleBeads Reporting period Avg # of female name/location users reported FP visits/year Health Quarters – 9 Oct ‘09-Aug ‘11 900 Beverly, MA (23 months) Health Quarters – 32 Oct ’09-Aug ‘11 1,200 Lawrence, MA (23 months) PPMM-Modesto, 27 Sept ’09-April ‘11 12,000 CA (20 months) MCC – San Rafael, 41 Aug ‘10-June ’11 10,800 CA (11 months) MCC – Novato, CA 28 May ‘10-June ‘11 6,000 (14 months) MCC – Novato 61 Mar ‘10-June ’11 1,200 Wellness Center (18 months) TOTAL 198
  • 18. CycleBeads client interviews* • 37 reached after receiving method (15+ additional recruited but could not be reached) • 31 using CycleBeads to prevent pregnancy AND met eligibility criteria • 17 reached for follow-up at 3 months – 12 still using CycleBeads to prevent pregnancy – Dropouts due to: out-of-range cycles (3), pregnancy (1), break up with partner (1) *These are preliminary results as of August 2011, as not all interviews have been completed and entered.
  • 19. CycleBeads user characteristics (n=31) • Age range: 18-45 (mean=27, median=26) • 68% English spoken at home • 42% have children • 29% married • 81% have used FP method(s) in the past • 92% heard about CycleBeads from health center
  • 20. CycleBeads user admission interviews (n=31) • Reasons for choosing CycleBeads: – 87% no hormones/no side effects – 42% easy / convenient – 35% “it’s natural” • Plan to handle the fertile days: – 74% condoms all or part of the time – 39% abstain all or part of the time – 13% spermicide
  • 21. CycleBeads user 3-month follow-up (n=12) • 100% correctly identified fertile days • 83% avoided unprotected sex during white beads • 50% clearly understood how to use CycleBeads to track cycle length
  • 22. CycleBeads user 3-month follow-up (n=12) • 100% are satisfied or very satisfied • 92% say CycleBeads are “easy to use” • Like most: no side effects / natural (92%), easy to use (58%), enjoy tracking cycle (25%), effective (17%) • Like least: moving the band every day (25%), unsure about efficacy (17%), using condoms (8%) • 42% relationship changed for the better since starting CycleBeads (the rest reported no change)
  • 23. Implications • CycleBeads can be successfully introduced into clinics. • Clients choose the method and can use it successfully and satisfactorily. • Efforts are needed to raise awareness so that clients know to ask for the method, and staff remember to offer it.
  • 26. For more information: www.irh.org CycleBeadsToolkit.com CycleBeads.com
  • 27. References • Gribble, JN., Lundgren, R., Velasquez, C., Anastasi, E., Being Strategic about Contraceptive Introduction: the Experience of the Standard Days Method. Contraception 2008; 77: 147-154. • Making decisions about contraceptive introduction : a guide for conducting assessments to broaden contraceptive choice and improve quality of care. 2002. WHO: Geneva. Available at http://www.who.int/reproductivehealth/publications/family_planning/RH R_02_11/en/index.html • Simmons, R., Hall, P., Diaz, J., et al. The Strategic Approach to Contraceptive Introduction. Studies in Family Planning 1997; 28(2): 79-94. • Simmons R, Fajans P, and R Ghiron. 2007. Scaling up health service delivery from pilot innovations to policies and programmes. World Health Organization, ExpandNet: Switzerland. • Guttmacher Institute – Facts in brief. Available at www.guttmacher.org.

Notas del editor

  1. 7% of 62 million = 4.3 million women Title X authorizes grants “to assist in the establishment and operation of voluntary family planning projects which shall offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents).” Among perfect users of NFP, the percentage of women experiencing an unintended pregnancy during the first year of use ranges from two to five percent, depending on the method. The effectiveness of many of the NFP methods with perfect use is equal to or more effective than many other contraceptives, including the contraceptive sponge, male and female condom, diaphragm, and cervical cap. Although natural family planning (NFP) methods are explicitly referenced in the Title X statute, the utilization of NFP methods remains low among clients seeking services in Title X-funded clinics. Recent data from the Family Planning Annual Report (FPAR) show that in 2006, less than one percent of female Title X clients (9,702 females) relied on fertility awareness methods (also known as NFP) methods as their primary method of pregnancy prevention. Family Planning Annual Report (FPAR) is the only source of annual, uniform reporting by all Title X-funded services grantees. A revised FPAR data collection system was implemented in 2005, and the definition of fertility awareness methods changed at that time. The current FPAR definition stipulates that “fertility awareness method (FAM) refers to family planning methods that rely on identifying potentially fertile days in each menstrual cycle when intercourse is most likely to result in a pregnancy.” Included in this definition are: rhythm/calendar, Standard Days™, Basal Body Temperature, Cervical Mucus, and Symptothermal Methods. The percentage of Title X clients using NFP is consistent with national rates of NFP use reported by the National Center for Health Statistics (NCHS) in the 2002 National Survey of Family Growth (NSFG). The percentage of women 15 – 44 years of age who stated that they currently used NFP as their current contraceptive method was also less than one percent.
  2. To evaluate whether integrating SDM helps to increase FAM availability and use
  3. Mention international experience with SDM; Mention prior US experience with SDM at Planned Parenthood and Tri-City Disadvantage = not everyone can use b/c of criteria Advantages = easy to teach, easy to learn (any educational level), no resupply needed
  4. Phase I: Needs assessment Phase II: SDM integration and evaluation (Research phase) Phase III: Use of research results for policy and planning
  5. Potential clients’ knowledge, needs, and interest in FAM Provider knowledge, attitudes, and practices regarding FAM Service delivery systems and outreach activities Opportunities and challenges to adding SDM to method mix
  6. There is interest in the SDM. It appeals to those who wish to avoid pregnancy but do not wish to use hormones due to side effects or other reasons. Providers are open to offering SDM as it is simple to teach, would expand options, and would meet the needs of their clients – they will need to integrate it into their counseling and offer it to all who come in who don’t know what kind of method they want. The SDM may not be appropriate for clients who desire a highly effective method, who are unable to communicate with their partners about sex, or who cannot remember to move the ring on CycleBeads. There are no barriers to method integration from a systems perspective.
  7. Integration has been completed. The evaluation phase is still ongoing.
  8. We used the results of the needs assessment in phase 2.
  9. The things we learned from providers during the needs assessment enabled us to better tailor the trainings to their needs. For example, The needs assessment results suggested that staff training should address provider concerns about SDM including its effectiveness, how to ensure proper screening of clients, and how to encourage and support correct use and male involvement. The training should also address couple dynamics, taking into account the contextual issues that may inhibit correct use. Since FAM is not part of the counseling routine, it should be stressed that SDM should be incorporated into counseling when all methods are reviewed so that clients can learn about it.
  10. The evaluation phase is still ongoing and will continue until the end of the study.
  11. We still have some interviews remaining to do. Irregular (or unknown) cycles could be due to just coming off a hormonal method. Lots of PCOS reported as well.
  12. When we dug deeper we found that ppl would forget to offer it (wasn’t part of their habit) Ppl don’t know about it
  13. Follow up of SDM/CycleBeads users for 1 year (interviews upon admission, then at 3, 6, and 12 months) We have also reached some 6 and 12-month users but numbers are smaller so will report on those once study is completed. Interviews were conducted over the phone. Women may use CycleBeads without participating in the study.
  14. Education = all over the map FP methods used = mostly condoms (74%) and pills (61%), but many other methods were well-represented, including depo, ring, patch, IUD, spermicides, withdrawal, NFP or rhythm, and Implanon
  15. Multiple answers were allowed. Also mentioned by two or fewer interviewees: religion/moral, effective, liked tracking cycle, complemented what they were already doing, environmentally friendly. For the fertile days, also, 1 person said withdrawal, and 2 people were undecided.
  16. There were two women who did not avoid unprotected sex during the fertile phase of their last cycle; 1 forgot and used EC afterwards; the other one said she knew her body enough to know that she was not fertile on the first couple white beads.
  17. RE Satisfaction: of course, this is a biased sample because we are talking with people who have continued to use CycleBeads and wanted to talk about it. Some of the people whose relationship changed for the better said: “ It’s easier to talk about fertility, and now we share responsibility for sex.” “ When it’s not a white bead day when there is a need to use condoms, it feels more intimate.”
  18. In this project we have learned what areas of counseling need greater emphasis, have taken our lessons learned and including them in scale-up activities and products.