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Diaphragms Path

This document discusses diaphragms as an underused contraceptive method in India and evaluates the potential for introducing the single-size SILCS diaphragm. It finds that traditional diaphragms provide non-hormonal protection from pregnancy and disease but have challenges due to sizing and insertion difficulties. The SILCS diaphragm addresses these issues as a one-size-fits-most device. Studies show SILCS is safe, acceptable and effective. Introducing SILCS in India could expand family planning options and improve reproductive health by offering a non-hormonal, female-initiated birth spacing method. However, further assessment is needed regarding procurement, training needs, and

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Vaanmathe
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52 views

Diaphragms Path

This document discusses diaphragms as an underused contraceptive method in India and evaluates the potential for introducing the single-size SILCS diaphragm. It finds that traditional diaphragms provide non-hormonal protection from pregnancy and disease but have challenges due to sizing and insertion difficulties. The SILCS diaphragm addresses these issues as a one-size-fits-most device. Studies show SILCS is safe, acceptable and effective. Introducing SILCS in India could expand family planning options and improve reproductive health by offering a non-hormonal, female-initiated birth spacing method. However, further assessment is needed regarding procurement, training needs, and

Uploaded by

Vaanmathe
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 14

Diaphragms—an underused method in India

Evidence and best practices on new & underutilized contraceptives

Sita Shankar Wunnava


Director-MCHN
PATH India
September 6, 2012
What is a diaphragm?

• Soft latex or silicone cup that covers the cervix.


• Flexible rim keeps diaphragm in place.
• Used with spermicide to improve effectiveness.
• Comes in different sizes and requires fitting by a trained
provider.
o A one-size-fits-most device may be available soon that would not
require fitting- SILCS
• Prevents Pregnancy by blocking sperm from entering cervix.
• Protects cervix from infection

Page 2 12/12/2012
Advantages of diaphragms

• Non-hormonal, no systemic side effects.


• User-initiated. Use only when needed.
• Appropriate for almost all women.
• Reusable.
• Discreet—more so than male or female condom.
• Protects from pregnancy and possibly some STIs that infect the
cervix.

Page 3 12/12/2012
Diaphragm - evidence for disease
protection
Design Sample STI Odds ratio 95% C.I. Author
Case STI clinic GC .45 .15-1.3 Austin et
control al
Cross STI clinic GC .8 Madger et
sectional al

Cross STI clinic GC, CT, TV .32* .16-.45 Rosenberg


sectional et al
.24* .05-1.36

.25 .12-.48

Case STI clinic CIN 1,2 .3* .1-.8 Becker et


control al

Case STI clinic PID .3 .09-.75 Wolner-


control Hanssen
et al
Case Hospital PID .4 .2-.7 Kelaghan
control et al
Contraceptive failure rates of barrier methods

Typical use Perfect use Continue at 1 yr


Diaphragm 16 6 57%
with spermicide

Condom
Female 21 5 49%
Male 15 2 53%

Spermicide 29 18 42%

Page 5 Source: Trussell; Contraceptive Technology, 2007. 12/12/2012


Challenges with traditional diaphragms

• Service delivery:
• Provider bias
• Multiple-sized device: requires fitting exam from trained
provider; complicates supply.
• Providers don’t feel confident assessing size; requires
additional time for counseling in method use.
• Need appropriate contraceptive gel (alternative to N-9)
• Assumption that women will be hesitant to insert
• Hygiene issues
• User perspective: Can be difficult to learn to insert/remove.
SILCS has been developed to address these challenges

Page 6 12/12/2012
Diaphragm research in 12 countries

Page 7 12/12/2012
Diaphragm acceptability among low-income
Women, Madras, India*
• Study group: 97 currently married women (15–49 years), from
urban, low income settlements, recruited at 3 family planning
clinics in Madras.
• Collected user perspectives after 6–7 months use on:
o User experience;
o Consistency of use and sexual life;
o Support from partners;
o Positive factors; and
o Service delivery.
• Follow-up after 18 months of diaphragm use, found almost
70% of women contacted were still using diaphragm.
*Ravindran and Rao. In Beyond Acceptability

Page 8 12/12/2012
SILCS Diaphragm: one-size-fits-most

Page 9 12/12/2012
SILCS Diaphragm: status

• Evaluated in 7 studies in 5 countries for safety, acceptability, fit,


and ease of use.
• Contraceptive effectiveness study in United States completed
in 2010. Effectiveness similar to traditional diaphragm.
• In 2010, PATH licensed SILCS to Kessel Marketing , Germany, for
commercialization.
• Regulatory applications underway in Europe and United States.
• PATH working to raise awareness and explore feasibility for
low resource countries.
• PATH and CONRAD evaluating alternative contraceptive gel
product for use with SILCS. Contragel is a lactic-acid based
contraceptive gel with CE Mark approval, available in European
countries.

Page 10 12/12/2012
SILCS Diaphragm: cost
• SILCS is reusable for 2 years. Initial product cost spread over
the use life results in a low-cost contraceptive method.
• Manufacturing cost for public sector in developing countries
not yet determined.
• Kessel Marketing committed to providing product at
affordable price for low resource countries.
• What is a reasonable cost for a reusable contraceptive that
lasts 2+ years?
• Diaphragms recommended for use with a contraceptive gel.
The gel is a recurring cost.

Page 11 12/12/2012
Could diaphragms improve reproductive health
options in India?
• Family planning (FP) in India has a high reliance on sterilization
and low availability of birth spacing methods.
• Lack of female initiated methods
• Lack of methods without systemic side effects
• Will introducing a single-size diaphragm improve women’s RH
options in India?
• Who are the groups of women who would benefit from access
to a non-hormonal barrier method for birth spacing?

Page 12 12/12/2012
Health Systems Assessment for SILCS - India

Ashodaya, a local NGO, is implementing a health systems


assessment in 2012 to identify opportunities and challenges
for future introduction of SILCS in India
Key areas being explored:
- Facility based opportunities
- Procurement logistics
- Community level opportunities
- Communication channels with key target audience
- Training needs for SILCS introduction
- Stakeholder assessment & mapping
Urgent need to expand basket of contraceptive choices in
India

Time to Act!
Thank you!

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