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No-Commodity, No-Cost Family
        Planning:
            TwoDay Method®
         Presented by Arsene Binanga, MD
 2011 International Conference on Family Planning
                  Dakar, Senegal




                                             PROCODI
Study Team/Contributors

Co-Authors
Donald Cruz, Kimberly Aumack Yee, Justine Kavle

IRH Study Team/Contributors
Melissa Adams, Jeannette Cachan, N. Kate Cho,
Mame Thierno Faye, Begoña Fernandez, Rebecka
Lundgren, Elizabeth Salazar, Jen Schulz
Background
•   While there are significant regional differences in family planning use, in
    about half the countries in sub-Saharan Africa the majority of women have
    never used a method, and Guatemala has one of the lowest contraceptive
    prevalence rates in Central America

•   Contraceptive commodities and distribution can be costly and stock-outs
    common

•   Method-related reasons for not using family planning include concern
    about side effects or health consequences of methods

•   Although women typically notice their cervical secretions, most do not
    know they are a reliable fertility indicator

•   Intra-vaginal practices to remove healthy, naturally occurring secretions can
    be harmful
Fertility Awareness-Based Methods
• Identify days of the menstrual cycle when intercourse can
  result in pregnancy (fertile window)

• Users of these methods:
   – determine the beginning and end of the fertile window by
     monitoring indicators of fertility (typically cervical
     secretions or cycle length calculations)

   – avoid unprotected intercourse on fertile days

• Users who select these methods often are new to family
  planning, have concerns about side effects and health
  consequences of other methods, and cost considerations
TwoDay Method®
• Uses cervical secretions
  as the indicator of fertility

• A women pays attention
  each day to the presence
  or absence of secretions

• If she notices any
  secretions today or
  yesterday, she considers
  herself fertile today; to
  prevent pregnancy she
  avoids unprotected
  intercourse today
TwoDay Method

                        YES
     Did I note any              I can get pregnant today.
      secretions
        today?



               NO



                        YES
     Did I note any              I can get pregnant today.
      secretions
      yesterday?



                NO

Pregnancy is not likely today.
Function of Secretions

In addition to being a
reliable indicator of fertility,
cervical secretions:
• Protect sperm from the
  acidic environment in the
  vagina
• Transport sperm (prevent
  or enhance motility)
• Provide an energy source
  for sperm
Cervical Secretions during the Menstrual
                  Cycle

  Pre-ovulatory days             Peri-ovulatory                   Postovulatory days
                                      days
  -Less water
  -Less fluid                -More water                          -Less water
                             -More fluid                          -Less fluid

                             Yes, notices any secretions
  No noticeable secretions   (until there are two days in a row     No noticeable secretions
                             with no secretions)
TwoDay Method Efficacy Study

• Prospective, multi-site study
  5 culturally diverse sites in Guatemala, Peru and the Philippines

• 450 clients followed for up to 13 cycles
• Results: more than 96% effective preventing
  pregnancy
   – with correct use 3.5 (using abstinence on fertile days)
   – with typical use 13.7
                                                      (Fertility and Sterility, 2004)
Who Can Use TwoDay Method

• Women with healthy
  secretions




                              http://forefugees.com
• Couples who can use
  condoms or abstain
  for several consecutive
  days each cycle

Women with cycles of any
length can use this method
How TwoDay Method Is Offered
              • Screen for method eligibility

              • Explain secretions and the
                menstrual cycle

              • Teach how to observe secretions
                and keep track of observations

              • Discuss the couple’s ability to
                manage fertile days

              • Describe when to return to a
                provider
A Woman Using TwoDay Method:


         1                      2                         3




Identifies whether   Asks herself if she had any   Determines whether
she has secretions   secretions, and notes her     today is a day she can
each day             observation                   get pregnant, and
                                                   communicates this
                                                   with her partner
Previous Secretion Reminder
        Approaches
Study Purpose
Phase 1:
To develop and test a further-simplified reminder
approach for offering the TwoDay Method to lower-
literacy women at the community level

Phase 2:
To test the feasibility and effect of offering the
TwoDay Method using this new approach
through community agents
Partners

 Study direction                          IRH/Georgetown
                                             University




Research, training
  and technical      IRH/Democratic Republic of            IRH/Guatemala
   assistance              Congo (DRC)



                       Community Project for
 Local community-     Integrated Development
                                                            Association BPD
based and research           (PROCODI)
                                                                 and
   organizations                and
                                                           The Manoff Group
                     Health Action Development
                                (ASD)
Study Methods
Phase 1
Formative research to design a few simplified
reminder approaches, tailored to the local context
•   In-depth interviews with local women and men (N=5-10 women
    and 5-10 men)
•   Focus groups with local women
•   Interviews with TwoDay Method providers in the region

Trials for Improved Practices (TIPS) interviews to
test new reminder approaches with women during
actual use
•   Bi-weekly in-depth interviews with new users and their partners
    (N=10-15 women and 10-15 men) for four to six months
Formative Research: Preliminary
                 Results
     In-depth interviews with TwoDay Method providers
•   Prior to TwoDay Method use some women:
                                     N=8
        -perceived their secretions as unhealthy, bad, not normal
        -consulted traditional healers or used herbal compounds

•   After learning the purpose of secretions:
        -reported no longer being bothered by the presence of secretions
        -stopped drying up their secretions

•   Providers suggested using a found object, like different colored beans, to help
    users remember the fertile window

•   Had stock outs of client cards, and used paper and pencil to record secretions

•   Suggested more pictorial representation of messages for women with lower
    literacy

•   Indicated breastfeeding women could use this method sooner than other fertility
    awareness methods
Formative Research: Preliminary
             Results
Focus group with women in DRC to test visual
images/drawings of TwoDay Method messages

• Suggested changes to better represent the
  local community
    -Families with significant resource constraints
    -Engaged in activities like helping their child with
    homework
    -Couples of similar age (not an older man with a
    younger wife)
    -Use a latrine or hole in the ground to represent
    where a woman would check secretions

• Suggested local words for describing
  secretions
    -At first women did not admit seeing secretions,
    then shared experiences with the group
    -Interested in learning more about the method
Next Steps: Trials for Improved Practices
                               (TIPS)
  Qualitative research on behavior change with “in-use” testing
  of new, simplified approaches for remembering fertile days

  • Community members test health practices in their daily lives

  • Interviewer/researcher and community member:
         -analyze together current practices
         -discuss what could be improved
         -reach an agreement on what the participant will do for a trial
         period

  • Results help determine which behaviors are doable, motivating
    factors and barriers to healthy practices, and guidance for tailoring
    a TwoDay Method reminder approach to the needs and reality of
    the local community
Phase 2
•   Collaborate with community-based partners: PROCODI in DRC and
    Association BPD in Guatemala

        -Determine the program-specific process for offering the TwoDay
        Method with the new approach that was tailored to the local
        context in phase 1

        -Train community agents and begin the intervention

        -Evaluate the outcome through interviews with clients, community
        agents and other staff, and stakeholders in the area

•   Determine the feasibility and effect of offering the TwoDay Method with
    the new, tested approach through community agents who have not
    previously offered family planning
Conclusion
Potential health and human rights
benefits of community-based delivery of
family planning that is effective AND:

  • Raises awareness and personal power to
    control one’s fertility

  • Fosters gender equity

  • Supports vaginal health and alerts the
    woman to signs of possible reproductive
    tract infection

TwoDay Method is always available
  • No commodity
  • No distribution
  • No cost, and
           eventually may be offered
           direct-to-consumers
For more information
    www.irh.org

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No-commodity, no-cost family planning: the TwoDay Method

  • 1. No-Commodity, No-Cost Family Planning: TwoDay Method® Presented by Arsene Binanga, MD 2011 International Conference on Family Planning Dakar, Senegal PROCODI
  • 2. Study Team/Contributors Co-Authors Donald Cruz, Kimberly Aumack Yee, Justine Kavle IRH Study Team/Contributors Melissa Adams, Jeannette Cachan, N. Kate Cho, Mame Thierno Faye, Begoña Fernandez, Rebecka Lundgren, Elizabeth Salazar, Jen Schulz
  • 3. Background • While there are significant regional differences in family planning use, in about half the countries in sub-Saharan Africa the majority of women have never used a method, and Guatemala has one of the lowest contraceptive prevalence rates in Central America • Contraceptive commodities and distribution can be costly and stock-outs common • Method-related reasons for not using family planning include concern about side effects or health consequences of methods • Although women typically notice their cervical secretions, most do not know they are a reliable fertility indicator • Intra-vaginal practices to remove healthy, naturally occurring secretions can be harmful
  • 4. Fertility Awareness-Based Methods • Identify days of the menstrual cycle when intercourse can result in pregnancy (fertile window) • Users of these methods: – determine the beginning and end of the fertile window by monitoring indicators of fertility (typically cervical secretions or cycle length calculations) – avoid unprotected intercourse on fertile days • Users who select these methods often are new to family planning, have concerns about side effects and health consequences of other methods, and cost considerations
  • 5. TwoDay Method® • Uses cervical secretions as the indicator of fertility • A women pays attention each day to the presence or absence of secretions • If she notices any secretions today or yesterday, she considers herself fertile today; to prevent pregnancy she avoids unprotected intercourse today
  • 6. TwoDay Method YES Did I note any I can get pregnant today. secretions today? NO YES Did I note any I can get pregnant today. secretions yesterday? NO Pregnancy is not likely today.
  • 7. Function of Secretions In addition to being a reliable indicator of fertility, cervical secretions: • Protect sperm from the acidic environment in the vagina • Transport sperm (prevent or enhance motility) • Provide an energy source for sperm
  • 8. Cervical Secretions during the Menstrual Cycle Pre-ovulatory days Peri-ovulatory Postovulatory days days -Less water -Less fluid -More water -Less water -More fluid -Less fluid Yes, notices any secretions No noticeable secretions (until there are two days in a row No noticeable secretions with no secretions)
  • 9. TwoDay Method Efficacy Study • Prospective, multi-site study 5 culturally diverse sites in Guatemala, Peru and the Philippines • 450 clients followed for up to 13 cycles • Results: more than 96% effective preventing pregnancy – with correct use 3.5 (using abstinence on fertile days) – with typical use 13.7 (Fertility and Sterility, 2004)
  • 10. Who Can Use TwoDay Method • Women with healthy secretions http://forefugees.com • Couples who can use condoms or abstain for several consecutive days each cycle Women with cycles of any length can use this method
  • 11. How TwoDay Method Is Offered • Screen for method eligibility • Explain secretions and the menstrual cycle • Teach how to observe secretions and keep track of observations • Discuss the couple’s ability to manage fertile days • Describe when to return to a provider
  • 12. A Woman Using TwoDay Method: 1 2 3 Identifies whether Asks herself if she had any Determines whether she has secretions secretions, and notes her today is a day she can each day observation get pregnant, and communicates this with her partner
  • 14. Study Purpose Phase 1: To develop and test a further-simplified reminder approach for offering the TwoDay Method to lower- literacy women at the community level Phase 2: To test the feasibility and effect of offering the TwoDay Method using this new approach through community agents
  • 15. Partners Study direction IRH/Georgetown University Research, training and technical IRH/Democratic Republic of IRH/Guatemala assistance Congo (DRC) Community Project for Local community- Integrated Development Association BPD based and research (PROCODI) and organizations and The Manoff Group Health Action Development (ASD)
  • 16. Study Methods Phase 1 Formative research to design a few simplified reminder approaches, tailored to the local context • In-depth interviews with local women and men (N=5-10 women and 5-10 men) • Focus groups with local women • Interviews with TwoDay Method providers in the region Trials for Improved Practices (TIPS) interviews to test new reminder approaches with women during actual use • Bi-weekly in-depth interviews with new users and their partners (N=10-15 women and 10-15 men) for four to six months
  • 17. Formative Research: Preliminary Results In-depth interviews with TwoDay Method providers • Prior to TwoDay Method use some women: N=8 -perceived their secretions as unhealthy, bad, not normal -consulted traditional healers or used herbal compounds • After learning the purpose of secretions: -reported no longer being bothered by the presence of secretions -stopped drying up their secretions • Providers suggested using a found object, like different colored beans, to help users remember the fertile window • Had stock outs of client cards, and used paper and pencil to record secretions • Suggested more pictorial representation of messages for women with lower literacy • Indicated breastfeeding women could use this method sooner than other fertility awareness methods
  • 18. Formative Research: Preliminary Results Focus group with women in DRC to test visual images/drawings of TwoDay Method messages • Suggested changes to better represent the local community -Families with significant resource constraints -Engaged in activities like helping their child with homework -Couples of similar age (not an older man with a younger wife) -Use a latrine or hole in the ground to represent where a woman would check secretions • Suggested local words for describing secretions -At first women did not admit seeing secretions, then shared experiences with the group -Interested in learning more about the method
  • 19. Next Steps: Trials for Improved Practices (TIPS) Qualitative research on behavior change with “in-use” testing of new, simplified approaches for remembering fertile days • Community members test health practices in their daily lives • Interviewer/researcher and community member: -analyze together current practices -discuss what could be improved -reach an agreement on what the participant will do for a trial period • Results help determine which behaviors are doable, motivating factors and barriers to healthy practices, and guidance for tailoring a TwoDay Method reminder approach to the needs and reality of the local community
  • 20. Phase 2 • Collaborate with community-based partners: PROCODI in DRC and Association BPD in Guatemala -Determine the program-specific process for offering the TwoDay Method with the new approach that was tailored to the local context in phase 1 -Train community agents and begin the intervention -Evaluate the outcome through interviews with clients, community agents and other staff, and stakeholders in the area • Determine the feasibility and effect of offering the TwoDay Method with the new, tested approach through community agents who have not previously offered family planning
  • 21. Conclusion Potential health and human rights benefits of community-based delivery of family planning that is effective AND: • Raises awareness and personal power to control one’s fertility • Fosters gender equity • Supports vaginal health and alerts the woman to signs of possible reproductive tract infection TwoDay Method is always available • No commodity • No distribution • No cost, and eventually may be offered direct-to-consumers
  • 22. For more information www.irh.org

Notas del editor

  1. Public sector facilities remain a main source for family planning methods. Information-based methods, like the Two Day Method, have the potential to expand family planning options through community-based programs as well as explore future possibilities for direct-to-consumer availability.References for background, if needed:Khan, S., Mishra, M., Arnold, F., Abderrahim, N., Contraceptive Trends in Developing Countries. DHS Comparative Reports No. 16. Calverton, Maryland, USA: Macro International Inc. 2007: 62, 69-70.Grace, K., DHS Working Papers Guatemala Regional Fertility Patterns 1987-2002, No. 51. 2008.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.Arévalo, M., Jennings, V., Sinai, I., Efficacy of a New Method of Family Planning: The Standard Days Method. Contraception 2002; 65: 333-338.Klebanoff, M., Nansel, T., Brotman, R., et al., Personal Hygienic Behaviors and Bacterial Vaginosis. Sexually Transmitted Diseases 2010; 37 (2) 94-99.Arévalo, M., Jennings, V., Nikula, M., Sinai, I., Efficacy of the New TwoDay Method of Family Planning. Reproductive Endocrinology 2004; 82 (4): 885-892.
  2. Fertility Awareness Methods (FAM) of family planning,also called “natural methods,” rely on naturally occurring indicators of fertility the woman and/or couple can observe, to determine the days of the menstrual cycle that the woman can become pregnant. The woman and her partner either abstain from intercourse on fertile days, or use a barrier method of family planning (like condoms) to prevent pregnancy on those fertile days.
  3. If a woman has had two days in a row with NO secretions, pregnancy is NOT likely.
  4. In addition to the efficacy study, other studies have been conducted in different settings including a study in Peru that determined TwoDay Method can be offered at any time of the woman’s menstrual cycle. Studies have found that most users find secretion checking to be simple, acceptable and meaningful to them. They describe the method as easy-to-use, and some include couple communication and enhanced couple relationship as non-contraceptive benefits.
  5. Male involvement and partner communication is very important with this method as both the woman and man need to be able to avoid unprotected sex on fertile days for the method to work for them, as individuals and as a couple.Women also need to be willing to check/note their secretions daily
  6. TwoDay Method has been offered in Peru, Guatemala and the Philippines through the efficacy study, in Peru through an introduction study which determined that the method can be offered at any time of a woman’s menstrual cycle, and through faith-based programs with providers in Rwanda and DRC who had previous experience teaching other, more complex secretion-based methods.
  7. FYIIssues that have come up with different reminder approaches:On the versions without a calendar , women forgot which day they were onThe chips/buttons were not self-contained, and chips were lostCombined recording with a standard calendar was too busy for someClient card with many words has challenges for women and couples with lower literacy skills The current project involves the design and testing of reminder approaches that are simple and relevant to the local context
  8. The Georgetown University Institute for Reproductive Health (IRH), addressing global RH & FP issues through a research-to-practice agenda, emphasizes fertility awareness-based methods of family planning; strategies for developing equitable gender norms for youth; and improved quality of HIV/AIDS services by reducing stigma and discrimination. IRH work includes network and system strengthening, scale up of innovations and incorporating gender perspectives in reproductive health. DRCCommunity Project for Integrated Development (PROCODI) is a community-based non-profit organization that conducts microcredit programs and small animal husbandry and gardening initiatives to increase local food production to improve the health of women and families in Kinshasa. Health Action Development (ASD) is a local research organizationGuatemalaBehrhorstPartners for Development , a community-based organization, partnering with indigenous (i.e. Mayan) Guatemalan communities and the Ministry of Health to provide nutrition, water and sanitation, education and family planning information and services to improve maternal and child health in rural Guatemala. The ManoffGroup developed the TIPS methodology utilized by this project and is available to provide TA for study direction as well as local support to research and community-based organizations as they employ this approach.
  9. In many countries women follow intra-vaginal practices to wash away or dry up secretions (for hygiene, curative, preventative, and/or sexual appeal purposes) While some TwoDayMethod providers have reported that women often abandon these practices, and then follow healthier vaginal care practices after learning about the purpose and function of secretions, this has not been studied. The 8 interviews were with TwoDay Method providers in Rwanda, who had previously offered other, more complex secretion-based methods.
  10. The focus group, conducted in Mont Ngafula, neighborhood MassangaMbila, Kinshasa, DRC. Included 6 women ages 30-48, members of PROCODIThe recommended word for talking about secretions was “pertes blanche” for vaginal discharge, mucus, stretchy gooey water.Recommended word for talking about menstruation was “monisanza” which means “I saw the month.”
  11. An effective, no-cost, no-commodity family planning method, based on self-observation of cervical secretions, is available and can easily be used by most women who want to use it….called TwoDayMethod