The most effective method to prevent HIV acquisition and transmission, the condom, is worn by men. Many women do not have relationships of equality with the men they have sex with, and they can experience difficulties 'persuading' men to use condoms. This can be particularly difficult in situations where HIV is not the primary concern (for example, when the woman experiences violence). However, it is also problematic for women in more equal relationships, since many men find condoms unpleasant, and as women are more vulnerable to HIV than men from vaginal intercourse, they may not afford the same priority to condom use.

The female condom is the first product which has been developed to offer women more control over HIV prevention methods. However, it is not a method entirely within women's control. Although, in general, the woman inserts the device, it requires compliance and consent from the man for it to be used. It is extremely visible – many would say unattractive – as it extends beyond the labia. It is also possible for the man to avoid it and penetrate between the female condom and the vaginal wall, and it is unlikely that the woman would be aware if he was doing this.

Since there are no methods entirely within women's control, and as the vulnerability to HIV from vaginal sex increases for women, the need for new prevention methods is urgent. Microbicides (previously known as virucides) have been spoken about for several years, and are now receiving a fair degree of attention from some policy makers (such as WHO) and sectors of the research community. No proven safe and effective microbicides are currently available, but research is underway. Microbicides are also beneficial because they offer the potential to protect against sexually transmitted infections, which are a significant contributor to death, illness and infertility around the world.

For more information on the development of microbicides see Microbicides in Emergent prevention technologies.

Trials in the United States and Britain show a pregnancy failure rate of 2.4 per cent when the female condom is used properly, and 12.2 per cent when not used properly and consistently (source: Chartex). That compares to a 2 per cent pregnancy failure rate for properly used `kitemark' condoms, rising to up to 15 per cent for improperly used condoms (source: Durex).

Advantages

Since it does not fit the penis snugly like a male condom, several men report that it is more pleasurable because it is not constricting. The female condom can be inserted before sexual activity begins and so it may be less of an interference than the male condom. Because it is made of polyurethane, the female condom can be used with oil–based or water–based lubricants.

It has been suggested that some women (for example, sex workers) would find the female condoms an easier way of practising safer sex, by keeping it in for a period of time. However, women who have tried this report that it can be uncomfortable, and it is also important to check the female condom at regular intervals for tears in the plastic. Using a female condom on a number of occasions may present few problems with a single sexual partner, but it is clearly different if used for multiple partners (e.g. for a sex worker). There would be risks to multiple partners who came into contact with infected semen in the female condom deposited by previous men.

The manufacturers also warn against taking out the female condom, washing it and then re–inserting it, since this doesn't guarantee hygiene, and the product would need re–lubricating. They advise using a new female condom on each occasion. There are plans to develop the product so that it can be used on several occasions, like the diaphragm.

The female condom is expensive, although it is increasingly available for free from outlets, such as health clinics, which also provide free male condoms. You may need to ask for the female condom if you don't see it on display at some clinics, since they may prefer to give out male condoms, which are cheaper.

There are some reported problems with using the female condom. Some women report losing the inner ring inside their vagina whilst others fear that, because the female condom is seamed, it may be more liable to tearing. Some cases of tearing have been noted.

Trials not sponsored by the company have tended to show a lower rate of acceptability. The female condom is very visible, and many women find it unattractive (and comic) because the appliance hangs down beyond the labia. Some women experience irritation to the vulval area because of the outer ring, which fits over the labia to hold the device in place.

The sound of trapped air in the female condom has irritated some users. Other activities, in particular oral sex, are not feasible with it in place. Some men have found the inner ring uncomfortable as they thrust into it – this problem can be solved by either removing the inner ring, or inserting the female condom on the penis (rather than the woman inserting it like a diaphragm).

Use of the female condom in the developing world

Studies conducted in Africa, Asia, Latin America, Europe and North America have found good initial acceptability of the device. A recent review by the World Health Organization of 41 acceptability studies indicated that the degree of acceptance varies widely, from 41 per cent to 95 per cent of study participants. Research indicates that counselling helps overcome women's initial difficulties in using the device, that directing promotion campaigns to men and providing women with negotiation skills are important to overcome men's resistance to use, and that over time, use tends to become concentrated among a subset of women or couples with high motivation to use it.

Among the many acceptability studies, recent UNAIDS-supported research in Costa Rica, Indonesia, Mexico and Senegal found that women who introduced the female condom into a relationship reported it allowed them to communicate more successfully about safer sex. In a study involving 377 women in the Dominican Republic, Mexico and United States, about four of every five women liked the device and said they would recommend it to others.

In Zambia and Zimbabwe, mass marketing campaigns and some educational support have made the female condom available in urban areas. A year after the Zimbabwe campaign began, a survey of more than 1,600 people at retail outlets concluded that single women and men with partners outside of marriage seemed to benefit most from the female condom introduction. After six months in the Zambia campaign, a random sample of 1,570 persons at 52 retail outlets found that those who had already discussed the female condom with a partner were more likely to use it in the future.

Nine hundred women were provided with both male and female condoms at STI clinics in the US After six months, eight percent had used only the female condom. Another 73 per cent had used both the male and female condom. About a third of those used ten or more female condoms. The researchers concluded that women at risk of STIs find the female condom acceptable, with many using either the male or female condom consistently over time.

Two studies among women at high risk of HIV infection indicated successful sustained use. A study in Zambia found that the devices were used in one quarter of coital acts at three, six and twelve months. In a study among sex workers in Thailand, some 250 women offered both male and female condoms used female condoms in 12 per cent of all sexual acts, a level that continued for the entire six-month study period.

Instructions for use

1 - Find a comfortable position, for example, lying down, sitting with your knees apart, or standing with one foot up on a chair

2 - Open the female condom packet by tearing down from the notch, and remove the product. You will see that the female condom is pre–lubricated. Make sure that the flexible inner ring is at the closed end of the female condom

3 - Squeeze the lower half of the inner ring between your thumb, index and middle fingers. This should give you a confident grip and narrows the inner ring to ease insertion

4 - With the other hand, spread the labia (folds of skin around your vaginal opening). Insert the squeezed ring of the female condom into the vagina, and push inside as far as you can

5 - Then put your finger inside the female condom until you can feel the bottom of the inner ring. Push the ring up into the vagina

6 - You can tell if it is in place when the inner ring is up past the pubic bone. You can feel your pubic bone by curving your finger (towards the front) when it is a couple of inches inside your vagina

7 - The outer ring and a small part of the female condom will stay outside your vagina. This is quite normal so don't worry

8 - Another method is to use the female condom as a penile (male) condom. It may be best to leave the inner ring at the far end of the Female condom, as this will hold it around the cervix. Since the ring helps to guide the device when it is inserted first into the vagina, and it can cause discomfort, another option is to remove the inner ring. This method could also be used for anal sex

9 - Add extra lubricant during sex if one of you needs it. If the outer ring is being drawn into the vagina, or if the penis starts to enter between the vagina and the female condom, then stop. The man should withdraw and add extra lube to the inside of the female condom

10 - Removing the female condom: because the female condom lines the inside of the vagina the man doesn't have to withdraw immediately after coming. You can remove the sheath when it suits you, making sure that no semen is spilt. Twist the outer ring to keep the semen inside, then pull gently. Throw away the used female condom. Do not throw it down the toilet as it may cause a blockage.

It is also possible to use the female condom like a baggy penile condom (see below). Although it would make sense for this method to be as safe as the one described, trials have not been conducted to assess the efficacy of using it in this way.

Female condoms and anal sex

Like condoms, it appears that, although not designed for the purpose, female condoms do work as an effective barrier during anal sex. A study in the United States of 14 male couples using the equivalent of the female condoms found that, although no leaks or tears were found in any of the sheaths used, all of the men found design and usage difficulties, 'which were primarily due to lack of experience and knowledge' of the product.

Provisional guidelines for anal sex with female condoms

1 - The easiest way to use the female condom for anal sex is to wear it like a `male' (penile) condom. Put lubricant in the female condom and then place it over the penis (or a dildo). Use plenty of lubricant on the outside of the female condom or around your partner's anus before sex.

2 - Alternatively, you could try to insert the female condom in the rectum first, as for vaginal intercourse. Use plenty of lubricant around the anus, and loosen it with a finger in readiness for the female condom. Make sure your fingernails are cut short.

3 - After removing the female condom from its wrapper, hold the inner ring between your thumb, index and forefinger, and squeeze it so that it forms an oval. Don't remove the inner ring, as this will lead the female condom to become tangled, and could lead to breakage.

4 - Push the female condom up into your rectum as far as you can, using the inner ring as a guide, whilst spreading your anus with your other hand. You may find this easier if you raise one leg onto the side of the bath, or a stool.

5 - Then put your index finger inside the female condom, until you feel the bottom of the inner ring. Push up as far as you can, but do not insert the outer ring.

6 - You will find that the outer ring, and perhaps a small part of the female condom, are on the outside of your anus. That's meant to happen, and should stop the female condom from slipping inside.

7 - Use more lubricant inside the female condom, to keep it moist, and add it whenever you need it during intercourse.

8 - Check every now and again during sex that the outer ring of the female condom hasn't slipped inside your anus, or that his penis hasn't slipped between the female condom and your anus. If it has, stop, remove the female condom, and use a new one before starting again.

9 - Don't re–use the female condom. Some gay men are reported to have used a female condom as a semi–permanent barrier to HIV during sex with multiple partners. The female condom is designed for vaginal sex and for single use. If you use it more than once for anal sex, we don't know the strains that it could put on the sides of the sheath, which might easily tear. And if you get a lot of semen in the female condom, we don't know how effective it is in holding it in, or whether any seepage into your rectum could take place.

10 - Removing the female condom. Because the female condom lines the inside of the rectum, your partner doesn't have to withdraw immediately after coming. You can remove the sheath when it suits you, making sure that no semen is spilt. Twist the outer ring to keep the semen inside, then pull gently. Throw away the used female condom.

Gay men's use of female condoms

Female condoms were the first product developed to offer women more control over HIV prevention methods. The Reality condom was approved in the USA in 1992 for vaginal contraceptive use. Latex male condoms have been associated with usage problems including, breakage, slippage, latex allergies and lack of control by receptive partners. Although female condoms are essentially not designed for the purpose, some gay men have used them and it seems they do provide an effective barrier during anal sex.

A 1999 study (Renzi 2001) among gay men in San Francisco gave Reality condoms to 100 men attending an STI clinic. Eighty-six men said they would use the Reality condom again and 54 said they preferred it to penile condoms. Acceptability was greatest among HIV-positive men and men in serodiscordant relationships or non-monogamous ones. Problems cited included difficulty inserting (33%), irritation (17%), bunching up (12%), unpleasant texture (10%), and noise (9%). Breakage was reported three times in 334 episodes of use.

Research published in the March 2003 edition of the journal AIDS has assessed the safety and acceptability of a brand of female condom called Reality for anal sex among gay men. The study enrolled 56 monogamous seroconcordant gay male couples who had not used condoms in the past three months were randomised to use latex male condoms or the Reality female condom for anal sex. On study entry the men were given ten Reality or lubricated male condoms to use with lubricant during the following six weeks. In the second six weeks the couples crossed over and began using the other condom type.

The Reality condom has two polyurethane rings and a thin, loose-fitting polyurethane sheath which in laboratory studies has been shown to be impermeable to viruses and less likely to rupture than latex condoms. Since it is made of polyurethane it can be used with both water-based and other kinds of lubricant. In this study couples were advised to remove the inner ring to reduce potential rectal trauma and bleeding.

Receptive partners were more likely to report pain or discomfort with the Reality rather than the male condom. Both partners were significantly more likely to report Reality condom slippage during use or withdrawal. Rates of condom breakage were similar for Reality and male condoms.

After using both sets of condoms, both active and passive partners were significantly less likely to be willing to use Reality condoms in the future with partners of unknown HIV status than they were to be willing to use male latex condoms (21 per cent of receptive and 26 per cent of insertive partners would be willing to use Reality condoms, compared to 61 per cent of both receptive and insertive partners who were willing to use latex condoms). The main reason reported by those who would be willing to use the Reality condom with future partners of unknown HIV status were that the Reality condom was more comfortable, easier to use, and perceived to be stronger and safer.

The researchers suggested that gay men who are considering using the Reality condom might require training relating to slippage and methods for avoiding semen spillage that might expose the anal mucosa. They added "further work is warranted on design modifications, safety and acceptability of the Reality condom in HIV-negative gay men".

References

Agence-France Presse. THAI TEENAGERS SHUNNING CONDOMS, HEALTH MINISTRY WARNS. 16 November 2003.

American Social Health Association Press Release: SURVEY SUGGESTS LACK OF AWARENESS HEIGHTENS RISK FOR SEXUALLY TRANSMITTED DISEASES. See http://www.planetout.com/health/hiv/?sernum=2778. 6 April 2004.

Centers for Disease Control and Prevention, Communicable Disease Weekly, January 29, 148(3): 45-48, 1999.

Cove J, Petrak J. Factors associated with sexual problems in HIV-positive gay men. Int J STD AIDS, 15(11): 732-736, 2004.

Dandona L. Sex behaviour of men who have sex with men and risk of HIV in Andhra Pradesh, India. AIDS. 19(6): 611-619, 2005.

Davidovich U et al. Assessing sexual risk behaviour of young gay men in primary relationships: the incorporation of negotiated safety and negotiated safety compliance. AIDS 14(6): 701-706,  2000.

De Vincenzi I. A Longitudinal Study of Human Immunodeficiency virus Transmission by Heterosexual Partners.NEJM331(6): 341-346, 1994.

Elford J et al. HIV positive and negative homosexual men have adopted different strategies for reducing the risk of HIV transmission. Sexually Transmitted Infections 77: 224-225, 2001.

Elford J. High Risk Sexual Behaviour among London gay men: no longer increasing? 11^th Annual BHIVA Conference, Dublin, abstract O14, 2005(a).

Elford J et al. High-risk sexual behaviour among London gay men: no longer increasing. AIDS, 2005 (in press), 2005b.

Erickson P. Prevalence of anal sex among heterosexuals in California and its relationship to other AIDS risk behaviours. AIDS Education & Prevention 7(6): 477-493, 1995

Gay Men’s Sex Surveys 1999-2003: See http://www.sigmaresearch.org/

Golombok S et al. An evaluation of a thicker versus a standard condom with gay men. AIDS, 15: 245-250, 2001.

Guzman, R et al. Negotiated safety relationships and sexual behaviour among a diverse sample of HIV-negative men who have sex with men. JAIDS38(1): 82-86, 2005.

Harding, R et al. A clinical trial of a thicker versus a standard condom for gay men. Thirteenth International AIDS Conference, Durban, abstract WePpC1395, 2000.

Hickson F et al. Out and About: Findings form the UK Gay Men’s Sex Survey 2002. Sigma Research, 2003.

Johnson AM et al. Sexual behaviour in Britain: partnerships, practices, and HIV risk behaviours. Lancet 358(9296): 1835-1842, 2001.

Lightfoot M et al. The Influence of partner type and risk status on the sexual behaviour of young men who have sex with me living with HIV/AIDS. JAIDS 38(1): 61-68, 2005.

Maharaj P and Cleland J. Risk Perception and Condom Use Among Married Or Cohabiting Couples in KwaZulu-Natal, South Africa. International Family Planning Perspectives 31(1), 2005

Najjumba M. Risk Perception and Condom Use in Uganda. African Population Studies 18(1), 2003.

Peltzer K. Factors affecting condom use among senior secondary school pupils in South Africa. Cent Afr J Med. 46(11): 302-308, 2000.

Mechai Viravaidya. Personal communication with author, 2004.

Prabhu R. et al. The bisexual bridge revisited: sexual risk behavior among men who have sex with men and women, San Francisco, 1998-2003. AIDS 18(11): 1604-1606, 2004.

Renzi, C. et al. Safety and acceptability of the Reality^TM condom for anal sex among men who have sex with men. AIDS17(5) 28: 727-731, 2003.

San Francisco Department of Public Health – HIV Epidemiology Annual Report 2004 – see http://www.dph.sf.ca.us/Reports/HlthAssess.htm 2004.

Simoni J M et al. Safer sex among HIV+ women: The role of relationships. Sex Roles 42: 691-708, 2000.

Weller S, Davis K. Condom Effectiveness in Reducing Heterosexual Transmission. The Cohrane Database of Systematic Reviews, issue 1, 2002.

UNAIDS: AIDS Epidemic Update, December 2001

Bradshaw S. Vatican: condoms don't stop Aids, The Guardian, 9 October 2003. See http://www.guardian.co.uk/aids/story/0,7369,1059068,00.html