A public cervix announcement:
CERVICAL BARRIER METHODS
AND HIV/STI PREVENTION
Ibis Reproductive Health
Cervical Barrier Advancement Society
Version 2
© September 2004
Overview
Section 1: What are cervical barriers?
Section 2: About cervical barriers: history,
effectiveness, safety, and acceptability
Section 3: The logic behind testing cervical barriers
for HIV/STI prevention
Section 4: Clinical and acceptability research on
cervical barriers for HIV/STI prevention
Section 5: Female controlled HIV/STI prevention –
expanding options
Section 6: Regulatory issues and N-9
SECTION 1
What are cervical barriers (CBs)?
A Public Cervix Announcement
Diaphragm
What is it?
A latex or silicone cup with a firm flexible rim and
shallow dome that can be coated with gel and
folded for insertion into the vagina
Indications for use as a contraceptive:
• Insert diaphragm with spermicide before
intercourse
• Apply more spermicide before additional
acts of intercourse
• Leave the diaphragm in place for at least
six hours after intercourse
• Do not wear for more than 24 hours
The diaphragm is designed to be held in place by the
vaginal walls, the posterior fornix, and the pubic arch.
Diaphragms in the US

Ortho All-Flex, by OrthoMcNeil Pharmaceutical

Ortho Coil Spring, by
Ortho-McNeil
Pharmaceutical

Wide Seal, by Milex
Products, Inc.
Other diaphragms

Semina, by Semina
Industries and
Commerce, Ltd.

Flat Spring, by
Reflexions
Cervical Cap
What is it?
A small, firm latex or silicone cup designed to
adhere to the cervix by suction and to hold gel
close to the cervix
Indications for use as a contraceptive:
• Insert cap with spermicide before
intercourse
• It is optional to apply more spermicide
before additional acts of intercourse
• Leave the cap in place for at least eight
hours after intercourse
• Cervical caps are approved to be worn up
to 48 hours in the US and up to 72 hours
in Europe
Unlike the diaphragm, the cervical cap is held in
place by suction. It covers the cervix at the top
of the vagina.
Cervical Caps in the US

Prentif cervical cap, by
Lamberts (Dalston), Ltd.

FemCap cervical cap, by
FemCap, Inc.
Other cervical caps

Oves cervical cap, by
Veos UK, Ltd.

Dumas, by Lamberts
(Dalston), Ltd., UK

Vimule, by Lamberts
(Dalston), Ltd., UK
Other cervical barrier methods

Lea’s Shield contraceptive,
by Yama, Inc.
New CBs under development

SILCS diaphragm, by
PATH

BufferGel cup, by
ReProtect, Inc.
SECTION 2
About cervical barriers:
history, effectiveness, safety, and
acceptability
A Public Cervix Announcement
History of cervical barriers

Ancient methods: crocodile dung pessaries, lemon
halves, and beeswax plugs

First CBs developed in Europe in 1842

Rising usage in Europe in the early 20th century

Popularized in the US by Sanger in the 1920s

By 1930, most frequently prescribed contraceptive
Establishing a protocol in the US
Early History – grassroots
birth control
 Medicalization of
contraceptive devices

– Legal constraints (Comstock
Laws)
– Distribution: Physicians vs.
Over the Counter

Fitting requirement?
Current use
Approved for family
planning purposes
 BUT

– Limited distribution
worldwide
– Limited clientele in the
US (client demand,
provider bias)
– Myths and
misconceptions
Diaphragm Usage Rates
(as a percentage of contracepting
women 15-44 in the US)
8%
6%
All
4%
Blacks
2%
Whites
0%
1988
1995
Contraceptive efficacy
•
•
Effectiveness depends on correct and consistent use
Effectiveness of the cervical cap is lower for women who have
already given birth
Diaphragm (plus spermicide) Efficacy Rates
Perfect Use
94%
Typical Use
84%
Cervical Cap (plus spermicide) Efficacy Rates
Perfect Use
Non-parous
Parous
91%
74%
Typical Use
Non-parous
Parous
84%
68%
Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Nelson A, Cates W, Guest F, Kowal
D. Contraceptive Technology: Eighteenth Revised Edition. New York, NY: Ardent Media, 2004.
Safety
In general, CB users report few side effects.
However, users should be aware of
 Urinary Tract Infections (UTI) – some evidence
implicates spermicide (Fihn, Handley)
 Bacterial Vaginosis (BV) – clear association,
causality not established (Hooton, Mauck)
 Toxic Shock Syndrome (TSS) – very rare,
associated with wear >24 hours (Baehler, Hyde)
Acceptability
Acceptability is used to describe both the initial
selection of a method and satisfaction with use
of that method.
 Influences on acceptability

– Selection




Provider Bias
Perceived Efficacy
Perceived Safety
Convenience
– Use




Partner Attitude
Service Provision
Side Effects
Ease of use
Research on diaphragm acceptability
– Colombia, Turkey, Philippines
Bulut A et al. Assessing the acceptability, service delivery requirements,
and use-effectiveness of the diaphragm in Colombia, Philippines, and
Turkey. Contraception. 2001 May;63(5):267-75.
– Brazil
do Lago TD et al. Acceptability of the Diaphragm Among Low-Income
Women in Sao Paulo, Brazil. International Family Planning
Perspectives. 1995 Sep:21(3):114-118.
– India
Ravindran TKS and Rao SS, Is the diaphragm a suitable method of
contraception for low-income women: a user perspectives study,
Madras India. Available at http://www.who.int/reproductive-
health/publications/beyond_acceptability_users_perspectives_on_contracepti
on/ravindran.en.pdf
SECTION 3
The logic behind testing cervical
barriers for HIV/STI prevention
A Public Cervix Announcement
Reasons to consider cervical barriers
as potential HIV prevention methods
Woman-initiated, woman-controlled
 Need not interrupt sexual activity
 May be used without partner knowledge
 Durable, reusable
 Good track record
 May be used with a microbicide
 Approved by regulatory authorities

Why cover the cervix?

The cervix is fragile
– Entrance lined with delicate columnar
epithelial cells
– This layer is only 1 cell thick

Preferential site of infection for many STIs
– Bacterial pathogens (gonorrhea, chlamydia)
– Human papilloma virus
Concentration of HIV receptor sites
 Protection of the upper genital tract

Moench T, Chipato T, Padian N. 2001. Preventing disease by protecting the cervix: the
unexplored promise of internal vaginal barrier devices. AIDS, 15(13):1595-1602.
Anderson D. HIV immunology. Oral presentation, Diaphragm Renaissance; Sept 2002.
Potential limitations to using CBs
for HIV/STI prevention

No protection for the vulva, urethra, and
vagina (unless used with a microbicide)

Protection of the cervix alone is likely to
be incomplete
Data supporting the potential for
diaphragms as STI preventives

Observational studies of diaphragm use with
spermicide
– 20-55% reduction in gonorrhea
(Austin, Quinn, Rosenberg)
– Up to 75% reduction in chlamydia and trichomonosis
(McCormick, Magder, Cramer, Rosenberg, Park)
– 60-70% reduction in pelvic inflamatory disease (PID)
(Kelaghan, Wolner-Hanssen)
– 70% reduction in cervical neoplasia (CIN)
(Hildesheim, Becker)
See also: Rosenberg and Gollub, 1992 (Am J Public Health, 82:1473-8)
Observational Studies Reporting the
Association Between Diaphragm Use and STIs
From: Moench T, Chipato T, Padian N. 2001. Preventing disease by protecting the cervix: the
unexplored promise of internal vaginal barrier devices. AIDS, 15(13):1595-1602.
Design
Sample
STI
Case Control
STD Clinic
GC
Cross Sec
STD Clinic
GC
.8
Cross Sec
STD Clinic
GC
Trich
CT
.32*
.24*
.25
.16-.45
.12-.48
.05-1.36
Rosenberg et al
CIN II, III
.3*
.1-.8
Becker et al
Case Control
Odds Ratio
.45
95% Con Limit
Author
.15-1.3
Austin et al
Magder et al
Case Control
STD Clinic
PID
.3
.09-.75
Wolner-Hansen
et al
Case Control
Hospital
PID
.4
.2-.7
Keleghan et al
*Also significantly protective when compared to condom users
SECTION 4
Clinical and acceptability research
on cervical barriers for HIV/STI
prevention
A Public Cervix Announcement
MIRA Trial

What is it? A randomized, controlled trial to measure
the effectiveness of the diaphragm used with lubricant
gel in preventing HIV infection
among women

How does it work?
– All participants receive condoms, safe
sex counseling, and STI treatment
– Half also receive a diaphragm and gel and counseling
on use
– We will compare outcomes between these groups
Where is it happening? South Africa and Zimbabwe
 When will we know the results? By 2007

Other research on the diaphragm
for HIV/STI prevention
Kenya: Acceptability of the diaphragm for HIV/STI
prevention among family planning clinic clients and sex
workers (by CDC/International Center for RH)
 Dominican Republic: Study of the diaphragm’s protective
effects against chlamydia and gonorrhea in sex workers
(by Population Council)
 Zimbabwe: Phase I trial to examine the safety of
diaphragm use with cellulose sulfate gel (a candidate
microbicide) (by CONRAD/UZ-UCSF)
 Other planned trials

– Efficacy
– Safety
– Acceptability
UZ-UCSF Diaphragm Acceptability Study
Comfort using the diaphragm




93% were very comfortable putting k-y jelly on the
diaphragm and cleaning the diaphragm
92% were very comfortable inserting and removing the
diaphragm
89% were very
comfortable having the
diaphragm inside them
86% were very
comfortable with leaving
the diaphragm in for 6
hours after sex
Acceptability of the diaphragm for
HIV prevention among US women at risk


N=140 ethnically-diverse women at risk for HIV/STIs.
Findings
– diaphragm has positive attributes
– but messy and difficult to insert/remove.
– disadvantages noted may be overcome by product design or
provider intervention.

About 3/4 of these women would be more likely to use
the diaphragm if
– They were confident about their ability to use the method, and
– If the diaphragm offered protection against HIV.
Harvey SM, Bird ST. A new look at an old method: exploring diaprhagm use among women in two U.S.
samples. Poster presentation. Microbicides 2004, London, March 2004. Harvey SM, et al. Exploring
diaphragm use as a potential HIV prevention strategy among women at risk. Forthcoming.
Recent publications on diaphragm
acceptability in the US
Bird ST, Harvey SM, Maher JE, Beckman LJ.
Women’s Health Issues. 2004 14(3):85-93.
Harvey SM et al. Women’s Health Issues. 2003
Nov; 13:185-93.
Maher JE, Harvey SM, Bird ST, Stevens VJ,
Beckman LJ. Perspectives on Sexual and
Reproductive Health. 2004 36(2):64-71.
Future Directions in Research
Acceptability of CBs in different settings
 Safety and risks of CB use
 Importance of fitting
 Continuous vs. episodic use
 Impact of use with or without chemical
barriers such as spermicide
 Surrogate markers of exposure to semen
to validate research methods

SECTION 5
Female-controlled HIV/STI
prevention – expanding options
A Public Cervix Announcement
HIV/STIs and women
Worldwide, half of all new HIV infections occur in women

Africa (UNAIDS)
– In 2003, 58% of the 26.6 million HIV+ people in SSA were
women.
– Women ages 15-24 are 2.5 times more likely to be HIV+ than
young men.

United States (CDC)
– During 1999-2002, 64% of heterosexually acquired HIV
infections occurred among women.
– 64% of new HIV infections among women occurred in AfricanAmericans and 18% in Latinas.
– Women are expected to experience 50% of all new HIV
infections by 2010.
Why are female-controlled
methods important?



Women are biologically more vulnerable to HIV/AIDS
– Larger exposed mucosal surfaces, high viral
concentration in infected semen, untreated STIs
Some HIV prevention messages may be ineffective for
women who lack power
– Economic need or dependency
– Social and cultural norms
– Gender-based violence
Current methods (abstinence, fidelity, and condom use)
often require male consent, knowledge, or cooperation
Female-controlled methods
Expanding Options:
 Cervical barriers (being researched)
 Female condom (currently available)
 Microbicides (under development)
Female Condom
Reality Female Condom
Female Health Company, USA
www.femalehealth.com
www.femalecondom.org
What is a female condom?

A highly effective, woman-controlled barrier method that
has been tested and approved by the FDA and WHO

Offers dual protection against pregnancy AND sexually
transmitted infections

Use is not dependent on male erection, does not
constrict the penis, and does not require immediate
withdrawal after ejaculation

Polyurethane is 40% stronger than latex used in male
condoms and can be used with either water or oil-based
lubricants
Facts about the female condom
Estimated reduction of risk of HIV infection 97.1%
Contraceptive failure rate (one year, consistent and
correct use) 5% (compared to 3% male condom, 6%
diaphragm)
 Less breakage and potentially less irritation than male
condoms
 Approved by US FDA; European Union CE Mark for
Quality
 Available through the public sector in 80 countries;
commercially available in 17
 50-93% of male and female study participants around
the world found the female condom acceptable
 Availability of the female condom increases the number
of protected acts of intercourse


Microbicides
Carraguard® Micralax® applicator
For more information on microbicides
Global Campaign for Microbicides
www.global-campaign.org
Alliance for Microbicide Development
www.microbicide.org
International Partnership for Microbicides
www.ipm-microbicides.org
What is a microbicide?

Any substance (i.e. gel, cream, film, suppository,
sponge, etc.) that can substantially reduce
transmission of HIV or other STIs when applied
topically

Could work by disabling pathogens, enhancing
natural defenses, blocking or preventing the
spread of infection

Could be produced in both contraceptive and
non-contraceptive form

A microbicide is NOT yet available to the
public
Facts about microbicides

Although we have lots of laboratory data on many of the
current microbicide candidates, no product has yet been
shown to work in women

A microbicide could be available in about 5-7 years

Research around the world has found that women and
men like the idea of a microbicide and say they would
use it or would support their partner using it

Data from clinical trials confirm that women find
microbicides acceptable—even where “dry sex” is
practiced and many women report improved sexual
pleasure with microbicide use
See for example: Coggins C, Blanchard K, Friedland B. Men’s attitudes toward a potential vaginal
microbicide in Zimbabwe, Mexico and the USA. Reproductive Health Matters 2000;8(15):132-141.; Ellertson
C et al. A randomized, placebo-controlled, triple-blind, expanded safety trial of Carraguard® microbicide gel in
South Africa. Oral presentation. 13th International AIDS Conference, Barcelona, July 2002.
SECTION 6
Regulatory issues
and Nonoxynol-9 (N9)
A Public Cervix Announcement
US Food and Drug Administration –
regulatory status of CBs

Device classification
– I (Low risk; general controls)
– II (Moderate risk; general & special controls)
– III (High risk; general controls & premarket
approval)
Diaphragm and cervical caps are class II
 Classification based on advisory input

Regulatory issues and the diaphragm

Diaphragm fitting requirement
– Based on advisory input
– May be a barrier to access

Labeling for use with spermicide
– HIV/STI vs. contraception vs. dual use
Often easier to increase rather than ease
restrictions
 More research necessary to ensure access
isn’t unnecessarily impeded

N9 use recommendations
CDC and WHO agree on the following:
 N-9 is a safe, effective contraceptive
option for women at low risk for HIV/STIs
who do not use the product more than
once a day
 N-9 should not be used to prevent
HIV/STIs
 N-9 should not be used rectally
N9 policy issues

FDA proposed label change for N-9
products
– Offers no protection from HIV/STIs
– Public comments received, no change yet
Call to discontinue rectal use of N-9
(Global Campaign for Microbicides and
others)
 Need to preserve and expand womancontrolled OTC options for contraception

Summary
Cervical barriers are safe, effective
woman-controlled contraceptives with a
long history of use.
 Cervical barriers are currently being
studied to see if they reduce transmission
of HIV/STIs.
 A range of female-controlled HIV/STI
prevention and contraceptive options is
necessary to meet women’s needs.

More information

Cervical Barrier Advancement Society (CBAS)
– www.cervicalbarriers.org

Ibis Reproductive Health
– www.ibisreproductivehealth.org

Diaphragm Renaissance Conference
– www.rho.org/html/cont_diaphragm_renaissance.htm