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RHO archives : Topics : Contraceptive Methods

Annotated Bibliography

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Male condoms

Davis, K.R. and Weller, S.C. The effectiveness of condoms in reducing heterosexual transmission of HIV. Family Planning Perspectives 31(6):272-279 (1999).
This meta-analysis evaluated 25 published studies of serodiscordant heterosexual couples, organized by study design, direction of transmission, and condom usage (always, sometimes, or never). The authors calculated condom efficacy from the rates of HIV transmission among always-users and never-users. For always-users (12 cohort samples), HIV incidence was 0.9 per 100 person-years (95 percent CI, 0.4-1.8). For never-users (11 cohort samples), HIV incidence was estimated to be 6.8 per 100 person-years (95 percent CI, 4.4-10.1) for male-to-female transmission, 5.9 per 100 (95 percent CI, 1.5-15.1) for female-to-male transmission, and 6.7 per 100 (95 CI, 4.5-9.6) in samples that specified the direction of transmission. The authors concluded that condoms are approximately 87 percent effective at preventing HIV transmission, with a range of 60 to 96 percent depending on the incidence among never-users.

de Vincenzi, I. A longitudinal study of human immunodeficiency virus transmission by heterosexual partners. New England School of Medicine 331(6) (August 11, 1994).
This prospective multi-country European collaborative study evaluated HIV-negative subjects whose only risk of HIV infection was a stable heterosexual relationship with an HIV-infected partner. Every six months the couples were interviewed, tested for HIV, and counseled about safe sex practices. Couples were followed for up to 20 months. Of the 256 couples who continued to have vaginal or anal intercourse for at least three months after enrollment, only 124 used condoms consistently for vaginal and anal intercourse. Among these couples, none of the sero-negative partners became infected with HIV, despite a total of about 15,000 episodes of intercourse. Among the 121 couples who used condoms inconsistently, the rate of infection was 4.8 per 100 person-years (95% CI = 2.5-8.4). The authors conclude that consistent use of condoms for heterosexual intercourse is highly effective in preventing transmission of HIV.

Family Health International (FHI). The Latex Condom—Recent Advances, Future Directions. Research Triangle Park: FHI. (1998). Available at: www.fhi.org/en/fp/fpother/conom/index.html.
This monograph summarizes information on various issues related to condoms, including latex condom manufacturing, quality assurance, performance in human use, acceptability and user behavior, and the interrelationships among these issues. Recent advances in condom design and technology are discussed, including development of several nonlatex alternatives for men and women. This information will be particularly helpful for researchers, manufacturers, regulatory officials and public health officials, and anyone who helps to promote or provide condoms. Chapter 7, "The Development of Non-latex Condoms," (www.fhi.org/en/RH/Pubs/booksReports/latexcondom/nonlatexcon.htm) is a section of particular interest.

Gallo, M.F. et al. Nonlatex vs. latex male condoms for contraception: a systematic review of randomized controlled trials. Contraception 68(5):319-326 (November 2003).
This review evaluated non-latex male condoms compared to latex condoms in terms of contraceptive efficacy, breakage, slippage, safety, and user preferences. Ten randomized controlled trials of non-latex vs. latex male condoms were included in the review. While one product (eZ.on) was found not to protect as well against pregnancy, the other studies found no significant difference between typical-use efficacies for the two other non-latex products (Avanti and the Standard Tactylon) when compared to latex male condoms. Non-latex condoms were associated with higher rates of breakage than latex condoms; however, substantial proportions of participants still reported preferring the non-latex condom. The authors suggest that the contraceptive efficacy of non-latex condoms deserves additional attention.

Gardner, R. et al. Closing the condom gap. Population Reports Series H, Number 9 (April 1999). Available at: www.jhuccp.org/pr/h9edsum.stm.
As HIV/AIDS and other sexually transmitted infections spread, the need for condoms is growing. This issue of Population Reports addresses the gap between the estimated need for condoms worldwide and actual use. Making condoms more accessible, lowering their cost, promoting them more intensively, and helping individuals overcome social and personal obstacles to their use would save many lives and reduce the cost and consequence of STIs and unwanted pregnancy. This issue provides an update on current knowledge about male and female condoms as well as program issues important when providing and promoting condoms.

Lisken, L. et al. Condoms now more than ever. Population Reports Series H, Number 8 (September 1990).
This publication provides an extensive review of condom use and effectiveness for pregnancy and disease prevention in both developed and developing countries. Reviews of studies concerning condom failure are described. Strategies for how to promote condoms more widely are discussed, and program examples are provided. A practical guide for how to counsel condom users also is provided. This issue of Population Reports is useful for policy makers, family planning and STI program managers, and public health officials interested in increase correct and consistent condom use.

National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS). Scientific Evidence on Condom Effectiveness for Sexually Transmitted Disease (STD) Prevention: Summary of Workshop Held June 12-13, 2000. (July 2001). Available at: www.niaid.nih.gov/dmid/stds/condomreport.pdf.
This 48-page report from a National Institutes of Health and Centers for Disease Control study panel presents a summary of current research about condom effectiveness in preventing sexually transmitted infections, including HIV. After reviewing 138 peer-reviewed studies on properties and user patterns of the male latex condom during penile-vaginal intercourse, the NIH report concluded that correct and consistent use of male latex condoms effectively reduces transmission of HIV/AIDS in women and men and gonorrhea in men, and prevents pregnancy. The report also found that, because of limitations in study design, there was insufficient evidence to determine the effectiveness of condoms in preventing the six other sexually transmitted infections that were reviewed. The authors caution that the absence of "definitive conclusions" reflects the inadequacy of the available data and should not be misinterpreted as proof or lack of proof regarding condom effectiveness to prevent these infections.

PATH (Program for Appropriate Technology in Health). Condoms protect against STDs and HIV: correct and consistent use is key. Outlook 12(4) (December 1994).
This article discusses issues related to the protective effect that latex condoms have against sexually transmitted diseases, especially HIV. Concerns about condom effectiveness, such as permeability, breakage, and slippage, are discussed. The importance of ensuring condom quality and the importance of correct and consistent use for reducing STD risk are emphasized.

Phillips, D. et al. Nonoxynol-9 causes rapid exfoliation of sheets of rectal epithelium. Contraception 62(3):149-154 (2001). (A review of this article is presented in Population Briefs 7(1):3 (March 2001), which is available online at www.popcouncil.org/publications/popbriefs/pb7(1)_3.html.
Findings by Population Council scientists suggest that products containing nonoxynol-9 may increase the risk of HIV infection when used during rectal intercourse. Rectal lavage specimens collected 15 minutes after the application of two over-the-counter gels containing N-9 (K-Y Plus and ForPlay) contained dramatically different results from specimens collected after use of two gel products that do not contain N-9. Lavage specimens after N-9 use contained sheets of epithelial cells containing hundreds of cells. Removal of the rectal epithelium may enhance HIV infection because primary target cells are located directly below the epithelium. These findings challenge conclusions of other scientists who studied the effect of a product containing 3.5 percent N-9. Rectal tissue biopsies taken 12 hours after the application of the product did not reveal the same findings. The Population Council scientists suggest that since the epithelium repairs rapidly, tissue samples after 12 hours would not show the immediate damage. The authors conclude that additional research is needed to determine the length of time needed for rectal epithelial repair.

POPLINE Digital Services. Condoms Web Site. (http://condoms.jhuccp.org/). Accessed March 2003.
The Condoms Web Site provides a comprehensive collection of information, education, communication, and reference materials related to condoms. This site is an updated continuation of the Condoms CD-ROM, published in 1999 by Popline Digital Services, a division of John Hopkins Population Information Program. Users can browse by subject, country, or media type, in addition to performing searches.

Richters, J. et al. Why do condoms break or slip off in use? An exploratory study. International Journal of STD and AIDS (6) (January-February 1995)
This study reports on condom experience in 108 men (age 18-62 years) attending three sexually transmitted disease clinics in Australia. The overall breakage rate was 4.9 percent, and 3.1 percent reported a condom slipping off while in use. On multivariate analysis, condom breakage was related to: (1) having a male sexual partner, (2) infrequent condom use, and (3) method of putting on a condom. Factors associated with slippage included: (1) young age, (2) being circumcised, and (3) having less lifetime experience with condoms. Few men used inappropriate lubricants and no association was found between lubricant type and breakage. Almost half the men reported deliberately removing a condom after the beginning of intercourse; nearly 20 percent had done so three times or more. Condom counseling protocols should be strengthened to reflect the real life user issues related to successful condom use.

Steiner, M.J. et al. Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial. Obstetrics & Gynecology 101(3):539-547 (March 2003).
This randomized controlled trial among 901 couples evaluated the contraceptive effectiveness of a polyurethane condom and a standard latex condom. Couples were tested for pregnancy at enrollment and at 4, 10, 16, 22, and 30 weeks. The six- month typical-use pregnancy rates were 9.0 percent for the polyurethane and 5.4 percent for the latex condom. Both condoms were judged favorably by participants in terms of acceptability (willingness to purchase, willingness to recommend, confidence in the method, and general comfort). While the polyurethane condom was not shown to be as effective as the latex condom in preventing pregnancy, the risk of pregnancy for the polyurethane condom fell within established range for other barrier methods. There was no significant difference between the risks of discontinuation between the two study groups.

WHO. Effectiveness of male latex condoms in protecting against pregnancy and sexually transmitted infections. World Health Organization Fact Sheet No. 243. Geneva: WHO (June 2000). Available at: www.who.int/reproductive-health/rtis/male_condom.html.
This fact sheet from WHO provides an overview of current knowledge about latex allergies and the implications for use of latex condoms. Latex allergies are very rare among the general population, and the reactions tend to be very mild. Sexually active people who are at risk of pregnancy and sexually transmitted infections should not allow concerns about latex allergies to prevent them from using condoms. The risks associated with unprotected sexual contact far exceed those from exposure to latex.

WHO/UNAIDS. Effectiveness of condoms in preventing sexually transmitted infections including HIV. WHO/UNAIDS Information Note (August 2001).
An extensive review of available studies on the effectiveness of condoms as a means to prevent sexually transmitted infections was conducted in June 2000 by a panel convened by the U.S. National Institutes of Health and the Centers for Disease Control and Prevention. The review concluded that condoms, when used correctly and consistently, are effective for preventing HIV infection in women and men as well as gonorrhea in men. For other STIs, however, the available data are less complete. Additional studies are under way to address these gaps in currently available evidence. The authors emphasize that prevention is the first line of defense against HIV/AIDS, and condoms should remain the mainstay of HIV prevention programs.

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Female barrier contraceptives

Beksinska, M.E. et al. Structural integrity of the female condom after multiple uses, washing, drying, and re-lubrication. Contraception 63(1):33-36 (January 2001).
Structural integrity of female condoms was tested after multiple acts of vaginal intercourse. Fifty women were recruited for the study. Each woman reused one condom up to eight times and washed, dried, and relubricated the condom with vegetable oil between each use. Standard FDA tests for water leakage, air-burst, and seam strength were used to determine structural integrity of the condoms. Test results showed that the structural integrity for all cycles were above the minimum standards for seam strength and burst tests. Condoms used eight times showed no structural deterioration in these tests when compared to new female condoms. Results of the water leakage tests across all test cycles revealed five holes; three of these had previously been detected by the volunteer. The holes were not associated with increased number of uses. The authors conclude that the structural integrity of the female condom after multiple use is still within FDA minimum standards, although the washing and handling procedures required for reuse may result in development of random holes.

Elias, C.J. et al. Women-controlled HIV prevention methods. In: AIDS in the World II: Global Dimensions, Social Roots, and Responses, The Global AIDS Policy Coalition. Mann, J. and Tarantola, D. (editors), New York: Oxford University Press (1996).
This chapter provides a succinct review of the state of development of female-controlled methods for preventing STI and HIV transmission. It focuses on the need for further development and evaluation of vaginal barrier methods, clarifies the safety and efficacy of currently available spermicides, and describes some of the new microbicidal vaginal products being developed. The authors conclude that while these strategies are important in the short-term effort to reduce the spread of HIV infection, ultimately long-term strategic investments will be needed to increase the status and ability of women in society to define their sexual relationships.

Family Health International (FHI). Female Condom Research Briefs. Triangle Park, NC: FHI; 2001. Available at: www.fhi.org/en/RH/Pubs/Briefs/fcbriefs/index.htm.
To promote dialogue on the role of female condom in reproductive health programs, Family Health International has published a concise series of research updates on female condom issues. This link allows access to updates on the following topics: effectiveness, reuse, acceptability, impact on male condom use, and other key issues.

FHI. Female barrier methods. Network 20(2) (2000). Available online at: www.fhi.org/en/fp/fppubs/network/v20-2/index.html.
This entire issue is devoted to a discussion of female barrier methods. Topics cover both chemical and mechanical female barriers and include a report on recent developments in the area of microbicide research, including a table of experimental microbicides in or nearing human trials; a review of spermicide effectiveness; and a discussion of some of the formidable challenges faced by scientists involved in microbicide research. Descriptions of several new barrier devices that soon may be approved also are included.

Feldblum P. and Joanis C. Modern Barrier Methods: Effective Contraception and Disease Prevention. Family Health International (1994).
This publication provides a thorough review of the safety, effectiveness, and acceptability of male and female barrier methods in an easy-to-use format useful for family planning providers and others interested in these products. Topics covered include: pregnancy prevention, disease prevention, user perspectives, and a review of recent developments in male and female barrier methods.

French, P.P. et al. Use effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sexually Transmitted Diseases 30(5):433-439 (May 2003).
This study among 1,442 female patients at an STD clinic in the United States compared STD rates between women given small group education on, and free supplies of, either female or male condoms. Women participating in this study were followed for a minimum of 6 months and a maximum of 12 months, and they were screened for four STDs under study each time they attended the clinic. Results of this study suggest that women educated about and supplied with female condoms are protected at least as much as women educated and supplied with male condoms alone. This study challenges the view that the female condom should be offered only as a “second-best” option in preventing infection.

International Planned Parenthood Federation (IPPF). IMAP statement on the female condom. IPPF Medical Bulletin 32(3) (June 1998).
This Bulletin presents a clear summary of female condom issues, including what is known about contraceptive efficacy, sexually transmitted infection prevention, and acceptability. Availability, cost, and the issue of female condom reuse also are described. The authors conclude that the female condom is a much needed addition to existing options for pregnancy and disease prevention, and that the currently approved product is safe, effective, acceptable, and increasingly available. They call for more research, however, to understand how people use all methods, both serially and simultaneously, and how they can best be combined to give dual protection under varying circumstances.

IPPF. Re-use of the female condom. IPPF Medical Bulletin 34(4) (August 2000). Available at: www.ippf.org/medical/bulletin/pdf/e0008.pdf.
Page 4 of this bulletin is a news brief on results of the WHO/UNAIDS consultation on reuse of female condoms. In addition to reporting the final recommendation of the consultation, this news brief clarifies the additional concerns regarding possible risk to women during washing and to partners during subsequent reuse, and also concern about possible effect a bleach-soaked and rewashed condom might have on a woman's vaginal flora if the reprocessed condom carries residual chemicals.  

Johns Hopkins Center for Communication Programs. Popline Search: Female Condoms. Available online at http://db.jhuccp.org/popinform/basic.html, search for "female condoms." Accessed April 2004.
The POPLINE site lists the abstracts of more than 200 articles on condom efficacy and use found in the Johns Hopkins University's POPLINE. POPLINE (Population information onLINE) is a database of publications on population, family planning, and related health issues. Comprehensive searches are provided for anyone affiliated with an academic, government, population, or other qualified organization in a developing country. Readers can view article abstracts on the site and order full-text copies of most articles. The POPLINE database is also available on CD-ROM in English, French, or Spanish. The articles, comprehensive searches, and CD-ROM are free to readers in developing countries.

Kuyoh, M.A. et al. Sponge versus diaphragm for contraception (Cochrane Review). In: Cochrane Library, Issue 2. Oxford: Update Software (2003).
This Cochrane review examines two randomized, controlled trials comparing the Today sponge with any diaphragm used with nonoxynol-9 for contraception. The authors conclude that the sponge is less effective than the diaphragm in preventing pregnancy, and has higher discontinuation rates at 12 months. The authors suggest that further study is needed to determine the role of spermicides in preventing STIs or in causing adverse side effects.

Mauck C, Lai JJ, Schwartz J, Weiner DH. Diaphragms in clinical trials: Is clinician fitting necessary? Contraception. 2004;24(4):263-266.
Traditional diaphragms come in a wide range of sizes and family planning guidelines state that women need to be individually measured by a clinician to determine their appropriate diaphragm size. The role of the fitting has never been rigorously evaluated, however, and some anatomical evidence draws into question the need for this procedure and fit size assessments can vary depending on clinician training. If sizing is not necessary for method effectiveness and women could successfully use the same size device, diaphragm provision and clinician training could be greatly simplified. Drawing on re-analysis of fitting data from several clinical studies, this article looks at the feasibility of predicting diaphragm size based on several parameters and the feasibility of providing a one-size diaphragm provision. Based on this re-analysis, if all women in the two studies analyzed received a size 70 mm diaphragm, about 33 percent would receive the same size device they would have received if they were measured by a clinician. If the definition of “correct fit” is broadened to include both a one-size smaller and one-size larger device than what the clinician determined, almost 80 percent of women could be correctly fit with a size 70 mm diaphragm. The authors suggest that using a size 70 mm diaphragm in clinical studies would be acceptable as long as safety, effectiveness, and acceptability are closely monitored.

Moench, T. et al. Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barrier devices. AIDS 15(13):1595-1602 (2001).
This article reviews current knowledge on the susceptibility of the cervix to STI and HIV infection. The authors make the case that, in the absence of safe and reliable microbicides, health advocates should look at the protection offered by mechanical cervical barriers. They conclude with a call for more research into this issue. The review of clinical, epidemiological, and biological evidence supports their hypothesis that combining a microbicide with a cervical barrier will enhance protection.

PATH. Re-examining the role of cervical barrier devices. Outlook. 2003;20(2):1-8. Available at: www.path.org/files/eol20_2.pdf.
In addition to offering protection from pregnancy, some researchers believe that diaphragms and cervical caps have the potential to offer protection from sexually transmitted infections, including HIV. This issue of Outlook summarizes the presentations and discussions of the Diaphragm Renaissance meeting, where researchers, policymakers, and reproductive health advocates met to discuss and debate the current thinking about the role of the cervix in acquiring STIs, including HIV.

PATH. The female condom: for men and women. Outlook. 1997;15(4):18.
This article provides a brief summary of the effectiveness of the female condom for pregnancy and STI prevention, user perspectives, availability and cost issues, and program implications. A table of selected acceptability studies from African countries also is included. 

PATH. Vaginal barrier methods: underutilized options? Outlook 11(4) (December 1993).
This article presents current information on the effectiveness, safety, protective effects, and service delivery/use requirements of various vaginal barrier methods. It also describes current efforts to learn more about the effectiveness and acceptability of these methods in developing country settings.

Pettifor, A. et al. In vitro assessment of the structural integrity of the female condom after multiple wash, dry, and re-lubrication cycles. Contraception 61(4):271-276.
This article presents results from one of several studies undertaken to systematically look at the issue of female condom washing and reuse. In this study, devices were evaluated after being washed and dried up to 10 times, according to several washing protocols (for example, different washing agents, water temperature, and lubricant). Results showed that washing, drying, and relubricating of the female condom up to 10 times did affect the structural integrity of the device. Although values for the burst test and seam strength differed significantly from unwashed condoms, they still were above the approved regulatory standards for an unused device. Researchers presumed that the holes detected in the devices may have been caused by the testing process or by the researchers who washed, dried, and relubricated the devices.

World Health Organization (WHO). Barrier Methods: What Health Workers Need to Know. Geneva: WHO (in preparation).
Barrier methods can be an important part of a family planning program's contraceptive method mix. They can help prevent unwanted pregnancy as well as protect against sexually transmitted infections. Barrier methods may be particularly appropriate for women who cannot or do not wish to use hormonal methods or an IUD and for young women. Method effectiveness varies widely, primarily because of user issues. This booklet focuses on the importance of consistent and correct use, the need for careful client counseling, and the support required for sustained use.

WHO. Considerations regarding re-use of the female condom: information update, 10 July 2002. Reproductive Health Matters 10(20):182-186 (2002). Available at: www.reusefemalecondom.org/resources/docs/20who_femdom.pdf. This article provides an overview of the discussion and issues considered at the second WHO consultation on re-use of the female condom, and also provides a one-page summary of the protocol for preparing female condoms for re-use. This protocol is provided for field testing so local authorities can determine the feasibility, benefit, and suitability of its use.

WHO. The Female Condom: A Review. Geneva: World Health Organization, WHO/HRP/WOM/97.1 (1997).
This paper reviews what is known about the safety, effectiveness, and acceptability of the female condom and explores the public health rationale for considering its introduction. The paper proposes a strategy for introducing the female condom, especially in developing countries, and examines questions of cost and availability.

World Health Organization (WHO). Barrier Contraceptives and Spermicides: Their Role in Family Planning Care. Geneva: WHO (1987). Cost: Sw.fr. 15-/US$13.50. Orders from developing countries: Sw.fr. 10.50.
This 80-page book provides practical information on how barrier contraceptives and spermicides can be successfully incorporated into a family planning program. The book outlines the advantages and disadvantages of available barrier methods. Emphasis is placed on information that helps users select the most appropriate and acceptable method, use it correctly and safely; and recognize and address side-effects. Key potential user groups are defined according to factors such as reproductive status, age, current contraceptive method use, and STI risk. Information about sources of supply and quality control also are provided.

WHO. WHO/UNAIDS Information Update: Consultation on the Re-Use of the Female Condom. (July 2000) Available at: www.who.int/reproductive-health/rtis/consultation_on_re-use_of%20female_condom_Durban.en.html.
In June 2000, WHO and UNAIDS convened a meeting to evaluate the safety and feasibility of reuse of the female condom.  Experts in microbiology, sexually transmitted infections, condom production, and quality assurance testing, and programmatic issues reviewed the relevant female condom reuse data and concluded that there currently is insufficient evidence available to determine whether soap and water wash alone will remove a broad range of STI pathogens. Concerns were raised that disinfecting (soaking in bleach) might affect the structural integrity of the condom. Available evidence suggests that female condoms can withstand several washes in soap and water, drying, relubrication, and reuse, but the studies indicate that such condoms may be more likely to have holes than new condoms.

WHO, UNAIDS, Female Health Company. The Female Condom: A Guide for Planning and Programming. Geneva: WHO/UNAIDS. Available at: www.femalehealth.com/download/JC301-FemCondGuide-E.pdf or at www.unaids.org/publications/documents/care/fcondoms/JC301-FemCondGuide-E.pdf.
This comprehensive guide discusses issues related to the international introduction of the female condom. This 81-page document is based on experiences of projects around the world, and it is intended to help design, implement, and monitor the introduction of female condom in a range of different settings.

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Spermicides  

Also see Female Barrier Methods section above.

Alan Guttmacher Institute (AGI). Nonoxynol-9 spermicide contraception useUnited States, 1999. Morbidity and Mortality Weekly Report 51(18):389-392 (May 10, 2002). Available at: www.cdc.gov/mmwr/PDF/wk/mm5118.pdf.
This article provides background information on the use of nonoxynol-9 containing contraceptives provided by the National Family Planning Program (Title X) in the United States in 1999. Most women in the United States with HIV become infected through sexual transmission. A womans choice of contraception can affect her risk for HIV transmission during sexual contact with an infected partner. This article reviews the recent studies on effect of nonoxynol-9 on STI and HIV transmission.

Family Health International (FHI). How effective are spermicides? Network 20(2):11-15 (2000). Available at: www.fhi.org/en/fp/fppubs/network/v20-2/nt2022.html.
Part of an entire issue dedicated to female barrier methods, this article provides a general introduction to information about spermicide use, with the primary focus on pregnancy prevention. It indicates that women should not expect sizable protection against STIs from use of spermicide, and that recent studies indicate that repeated use can irritate the vaginal lining, possibly increasing susceptibility to HIV and other STIs. The article discusses the effectiveness of spermicde use alone, as well as use with other barrier methods. It also discusses health effects and acceptability.

FHI. Study examines N-9 film effect on STDs; N-9 contraceptive film and the risk of STDs; and Selected research involving N-9 and STDs. Network 17(3):4-8 (Spring 1997). Available at: www.fhi.org/en/fp/fppubs/network/v17-3/nt1731.html)
These three articles from the Adolescent Reproductive Health issue of Network provide an excellent and timely update on the state of knowledge about Nonoxynol-9 (N-9) film and STD prevention. The first article describes the two-year study of condom users (some of whom also used a spermicide) in Cameroon conducted by FHI. The study concluded that vaginal spermicide film was safe but did not confer any additional protection to women from HIV, gonorrhea, or chlamydia infection beyond the protection already provided by condoms. These findings raise doubts about the additional benefits from using N-9 film. The other two articles provide an excellent overview of what is known about N-9.

International Planned Parenthood Federation, Medical Advisory Panel (IMAP). IMAP recommendations on nonoxynol-9. IPPF Medical Bulletin 37(1):2 (February 2003).
This statement was drafted by IMAP at its May 2002 meeting, and outlines its recommendations on use of nonoxynol-9. Because nonoxynol-9 does not protect against HIV, cervical gonohorrhea, or chlamydia infection (and may increase HIV risk), it should not be used for HIV/STI prevention. Nonoxynol-9 's contraceptive effectiveness is low compared to other methods; therefore it should be used only in combination with a female mechanical barrier method. Condoms prelubricated with nonoxynol-9 should be phased out of family planning programs. Women at high risk of HIV should not use any nonoxynol-9 products.

Kreiss, J. et al. Efficacy of nonoxynol-9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. Journal of the American Medical Association (JAMA) 268(4) (1992).
This articles describes a randomized controlled trial of N-9 contraceptive sponge use among sex workers in Nairobi. Sponge use did not appear to protect against HIV, and sponge users had a three-fold increase in incidence of genital ulcers. However, sponge users had a 60 percent reduced risk of gonorrhea.

Niruthisard, S. et al. Use of nonoxynol-9 and reduction in rate of gonococcal and chlamydial cervical infections. Lancet 339 (1992).
This article presents results of a randomized controlled trial in Bangkok, Thailand, on the effects of N-9 film in preventing chlamydia and gonorrhea infection. Infection rates among 186 women who use N-9 film and condoms were compared to rates among 157 women use used condoms and a placebo film. Results indicated that N-9 film use decreased the rate of gonococcal and chlamydial infection by 25 percent. The rate of infection declined by 40 percent among women who used N-9 in more than 75 percent of sexual acts.

Raymond EG, Chen PL, Luoto J, Spermicide Trial Group. Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: a randomized trial. Obstetrics & Gynecology. 2004;103(3): 430-439.
Vaginal spermicides containing N-9 have been widely available since the 1950s, but little research has been published on the effect of different formulations and dosages. Findings from this randomized clinical trial involving more than 1,500 women in the United States found that women who used a spermicidal gel that contained a low dose of N-9 (52.5 mg) were more likely to become pregnant than were women used either of two other gels with higher dosages of N-9 (100 mg or 150 mg). Pregnancy rates did not differ significantly among women who used a gel, film, or suppository containing equal dosage of N-9 (100 mg). No significant differences were found in urogenital conditions based on product dose or formulation.

Wilkinson, D. et al. Nonoxynol-9 for preventing vaginal acquisition of sexually ransmitted infections by women from men (Cochrane Review). In: Cochrane Library, Issue 4. Oxford: Update Software (2002).
This Cochrane Review of 10 randomized, controlled trials found broadly consistent results. In this meta-analysis, risks of gonorrhea, cervical infection, trichomoniasis, bacterial vaginosis, chlamydia, and candidiasis were not statistically significantly different in women receiving N-9 compared to placebo users. At the same time, genital lesions were more common among the N-9 users. Because these trials were conducted among high-risk female sex workers working in high STI prevalence areas and with high rates of partner change, these results cannot be generalized to lower risk women who use N-9 occasionally as a spermicide.

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Intrauterine devices

Chi, I-cheng. What we have learned from recent IUD studies: a researchers perspective. Contraception (48):81-107 (August 1993).
This review of research was one of the first to conclude that IUD use is not associated with an increased risk of pelvic inflammatory disease. Other key findings were: (1) IUDs are not abortifacients; (2) newer copper IUDs are highly effective and long-lasting; (3) IUDs can be safely used by most lactating women with lower removal rates for bleeding or pain than for nonlactating women; and (4) immediate post-placental IUD insertion reduces the risk of expulsion often associated with postpartum insertion.

Family Health International (FHI). Copper T IUD: Safe, effective, reversible. Network 20(1):4-8 (2000). Available at: www.fhi.org/en/fp/fppubs/network/v20-1/nt2011.html.
This article is part of an entire issue dedicated to intrauterine contraception. Although the Copper T IUD is a safe and reversible method of contraception, fears about side effects, inaccurate information, and lack of technical training for providers combine to discourage use of IUDs in some countries. This article provides an excellent review of the method and some of the barriers that prevent more widespread use.

FHI. Intrauterine devices. Network 20(1) (2000). Available at: www.fhi.org/en/fp/fppubs/network/v20-1/index.html.
Today's intrauterine devices offer safe and reversible long-term contraception, requiring little effort on the part of users once they are inserted. However, although popular in some countries, IUDs are not widely used in all countries because of reluctance among users and health providers or a lack of supplies and trained staff. Fears about side effects, concerns about infection and infertility, lack of technical training for providers, and the time and costs involved in providing services combine to discourage use. IUDs will continue to be underutilized in many countries until health workers are trained in the latest scientific information on the device, proper insertion methods, and good counseling techniques. Other factors that limit women's access to IUDs include: national policies; restrictive protocols on who may do insertions; required number of follow-up visits; fear among potential users; and, in some areas, maintaining a steady supply of IUDs.

FHI. Intrauterine devices. Network 16(2) (Winter 1996).
Available at: www.fhi.org/en/fp/fppubs/network/v16-2/index.html)
This issue focuses on the safe provision of IUDs in family planning programs in developing countries. Key articles emphasize the importance of proper training (including current scientific knowledge, insertion practice, and counseling techniques), how IUDs work, and key precautions to minimize PID risk. A special counseling section presents short, practical answers to questions commonly asked about Copper IUDs and reviews the current WHO Eligibility Criteria for Use of Copper IUDs.

Farley, T.M.M. et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 339(8796):785-788 (March 28, 1992).
This article reviewed World Health Organization's IUD clinical trial data to explore the incidence and patterns of PID risk with use of an IUD. Twelve studies were included, involving nearly 2,300 IUD users from around the world who used a total of 10 different device types. Overall, the rate of PID among IUD users was very low (1.6 case per 1,000 women-years of use). After adjusting for confounding factors, PID risk was more than six times higher during the 20 days after insertion than during later times (9.7 per 1,000 women-years of use) and low and stable thereafter (1.4 cases per 1,000 women-years of use). After the 20 days following insertion, the risk of PID remained very low, even among users who had an IUD in place for eight years or more. These findings indicate that PID among IUD users is most strongly related to the insertion process and to background risk of STIs. Because of the increased risk with insertion, IUDs should be left in place up to their maximum life span, and not routinely replaced earlier, provided there are not medical reasons to discontinue use and the woman wishes to continue with the device.

Farr, G. et al. Non-physician insertion of IUDs: clinical outcomes among TCu380A insertions in three developing-country clinics. Advances in Contraception 14(1):44-57 (March 1998).
Demand for IUDs and IUD-related services affects family planning service delivery, especially in developing countries, where physicians are spending more time than ever before evaluating IUD candidates and performing insertions. Insertion by trained non-physicians is increasing in several countries. This analysis looked at the experience of 367 IUD acceptors collected at clinics in Nigeria, Turkey, and Mexico. Physicians performed 193 insertions; non-physicians performed 174 insertions. Women having their IUD inserted by a non-physician were more likely to experience a pain-free insertion, but also were more likely to have the IUD removed for bleeding and pain, or to experience an expulsion, than were women who had the IUD inserted by a physician. Discontinuation rates were similar between the two groups. Trained non-physicians can probably insert the TCu380A safely and acceptably, but researchers stress the importance of competency-based training, especially in correct IUD placement, to reduce the number of expulsions.

Grimes, D.A. and Schulz, K.F. Antibiotic prophylaxis for intrauterine contraceptive device insertion (Cochrane Review). In: Cochrane Library, Issue 4. Oxford: Update Software (2002).
A recent review of randomized, controlled trials using any antibiotic compared with a placebo found that antibiotic prophylaxis was associated with a small reduction in unscheduled visits to the provider. It had little effect on the likelihood of IUD removal within 90 days of insertion, however. A consistent finding in the reviewed studies was the low risk of IUD-associated infection, with or without use of antibiotic prophylaxis.

Grimes, D.A. and Schultz, K. Prophylactic antibiotics for intrauterine device insertion: a metaanalysis of the randomized controlled trials. Contraception 60(2):57-63 (August 1999).
As part of the Fertility Regulation Review Group of the Cochrane Collaboration, the authors undertook this review of all randomized controlled trials in the world addressing prophylactic antibiotics for IUD insertion. Four trials from developed and developing country settings were included in this review. Analysis compared antibiotic (either doxycycline or azithromycin) versus a placebo or no treatment. In this meta-analysis, the only statistically significant benefit was a small reduction in the frequency of unscheduled return visits. Prophylaxis did not significantly lower the risk of PID or rate of premature IUD discontinuation. The authors conclude that use of prophylactic antibiotics probably would be cost-effective only where sexually transmitted diseases are common. Further study of prophylactic antibiotics for IUD insertion in low-risk populations does not appear warranted; in high-risk settings, further research may be appropriate.

IPPF. IMAP statement on intrauterine devices. IPPF Medical Bulletin 37(2):1-6 (April 2003). Available at: www.ippf.org/medical/bulletin/pdf/vol37no2april2003.pdf. A large body of evidence points to the high efficacy of IUDs, and to their safety in women who are at low risk of STIs. This IPPF IMAP statement provides an summary of the various types of IUDs and the key issues when considering IUD provision

Johns Hopkins Center for Communication Programs, Population Information Program. IUDs. Population Reports 23(5) (December 1995). Available at: www.jhuccp.org/pr/b6edsum.stm.
This issue provides information about the safety and effectiveness of the modern Copper-T IUDs. IUDs are among the best family planning methods for protecting women's lives; they are highly effective at preventing pregnancy, and they avert many maternal deaths. The TCu380A IUD—approved for 10 years use—is the most widely available IUD and one of the most effective methods of contraception ever developed. The newly developed hormone-releasing LNG-20 IUD may be the most effective of all IUDs. Better scientific understanding has enabled experts to recommend updated guidance for providing IUDs. These recommendations eliminate unscientific limits on IUD use and better define who can use IUDs safely. Sections within this issue discuss results of clinical trials, insertion technique, important information for IUD users, and infection prevention practices.

Johns Hopkins Center for Communication Programs. Intrauterine Devices (IUDs). www.jhuccp.org/topics/iuds.shtml. Accessed March 2003).
This page provides links to several Johns Hopkins resources on oral contraceptives, including the Media/Materials Clearinghouse, the POPLINE database of journal articles, Population Reports, and other publications, and relevant articles by Johns Hopkins staff.

Kishen, M. Gynefix. IPPF Medical Bulletin 32(1) (February 1998).
This article reports on experience with the newly approved Gynefix frameless IUD in a family planning clinic in the United Kingdom. Some 56 percent of the 210 Gynefix insertions were in nulliparous women; 25 percent of insertions were for postcoital contraception. The need for proper provider training for insertion is emphasized. The author suggests that despite the higher cost of the new Gynefix IUD (four times the cost of a Copper T 380 in the UK), it should be considered by nulliparous women who have experienced pain or spontaneous expulsion with a framed IUD.

Luukkainen, T. and Toivonen, J. Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception 52(5): 269-276 (November 1995).
This article reviews the performance, safety, and therapeutic use of the the levonorgestrel-releasing IUD. It states that the local release of levonorgestrel results in the strong suppression of endometrial growth, which in turn results in a significant reduction of menstrual blood loss or amenorrhea, and for the disappearance of dysmenorrhea. Although irregular spotting is common during the first 2-3 months of use, blood loss and number of bleeding days per cycle are significantly reduced. The authors state that the levonorgestrel-releasing IUD is an effective and well-tolerated treatment for women with menorrhagia, and that it protects against ectopic pregnancy and pelvic inflammatory disease. In addition, the failure rate (0.0 to 0.2 per 100 women-years) is not dependent on the user's age.

PATH. IUDs: Do new devices reduce bleeding and expulsion rates? Outlook. 1999;17(1):1-8. Available at: www.path.org/files/eol17_1.pdf.
This article reviews three new, modern IUDs specifically designed to reduce the incidence of side effects most troublesome to users (especially young women) bleeding, pain, and expulsion. The results of three studies are used to compare the pregnancy, expulsion, and bleeding/pain rates of a Copper T IUD (the TCu380A) with two modified IUDs (the Cu-Safe 300 and the Cu-Fix). Data presented suggest that the modified devices provide comparable pregnancy protection to the Copper T and may provide an alternative for women who have experienced difficulty with other IUDs.

PATH. IUDs: safe and effective for many women. Outlook 10(2) (September 1992).
This article summarizes presentations and discussions from an international conference held in March 1992 to evaluate the safety, effectiveness, and reversibility of modern IUDs. Key points are that modern devices (Copper T 380A and Multiload 375) are extremely effective and safe when clients are appropriately screened and high-quality insertion procedures are used. Newer devices (levonorgestrel releasing IUD and frameless IUDs) are discussed. Safe and gentle insertion procedures for Copper T380A insertion are detailed.

Population Council/Center for Biomedical Research. Copper T 380A Intrauterine Device: Frequently Asked Questions. Available at: http://www.popcouncil.org/biomed/Cut380.html. Accessed April 2004.
The Copper-T 380A intrauterine device (IUD), developed by the Population Council, is one of the most effective, long-acting, reversible contraceptives available. More than 50 million Copper-T 380A IUDs have been distributed in over 70 countries. The U.S. Food and Drug Administration approved marketing of the Copper-T 380A in the United States in 1984, and the IUD was introduced into the United States in 1988. Manufacturers of the Copper T-380A are based in Finland, India, and the United States; producers for local use are located in China, Indonesia, and Mexico. These pages from the Population Council website provide a information about the Copper-T 380A, including general information (mode of action, effectiveness, shelf-life, copper tarnishing, continuation rates), information about who can and should not use an IUD, insertion and removal, and side effects and complications. 

Sinei, S.K., Morrison, C.S. et al. Complications of use of intrauterine devices among HIV-1-infected women. Lancet 351 (April 25, 1998).
This article investigates whether women infected with HIV-1 have a higher risk of short-term complications with IUD use than women who are not infected with HIV-1. Complications including pelvic inflammatory disease and IUD expulsion are investigated. The study found low rates of overall and infection-related complications among HIV-1 infected women during the four months after insertion. The study concludes that although more information is needed, IUDs may be a safe contraceptive method for appropriately selected women who are infected with HIV-1and have continuing access to medical services.

Van Os, W. and Edelman, D. New Directions in IUD Development. Advances in Contraception 14: 41-44 (March 1998).
This article reports on recent developments to improve IUDs through reducing expulsion and removal for complaints such as bleeding and pain. Special attention is placed on the GyneFix frameless IUD, which recently became available in Europe. This device and its predecessors (the Copper-Fix 390 and FlexiGard) have been studied since 1984. Results of a study of 1,039 GyneFix insertions by experienced practitioners are discussed. The cumulative three-year rates per 100 women were 0.5 for pregnancy, 0.7 for expulsion, and 3.8 for removal for bleeding or pain. No serious complications were reported. Confirmation of these early promising results is needed.

World Health Organization (WHO). The IUD—worth singing about. WHO Progress in Reproductive Health Research 60:1-8 (2002). Available at: www.who.int/reproductive-health/hrp/progress/60/Progress60.pdf.
This issue is outlines the historical development of the latest and most effective versions of the IUD, and presents summary information from WHO/HRP international trials comparing the safety and effectiveness of these devices. Also included is a one-page reference on recommendations for use when providing IUDs.

WHO. Intrauterine Devices, Technical and Managerial Guidelines for Services. World Health Organization (1997). Cost: Sw.fr. 54-/US$48.60, in developing countries: Sw.fr. 37.80.
This 175-page book addressed primarily at managers of clinic-based services provides detailed guidelines for providing IUDs through family planning programs. The book provides information needed to update policies and practices, including counseling and screening of clients, infection prevention, and follow-up care. The newer copper-bearing IUDs, which have been shown in clinical and epidemiological studies to offer advantages in terms of safety, acceptability, and life span, are featured. Annexes provide additional guidance in procurement of IUDs and other supplies, calculation of contraceptive prevalence, insertion and removal procedures, and assessing client satisfaction.

WHO. IUDs: What health workers need to know. Geneva: WHO (1997). Available on request.
This booklet is aimed at health workers and provides an overview of IUDs and the major points important to their safe provision. Topics covered include: IUDs and how they work, effectiveness and safety, client concerns, appropriate screening for IUD use, and basic elements of high quality services. Although IUDs are used by over 100 million women, many women still have questions about the method, particularly about safety. This booklet will help address those concerns.

Wildemeersch, D. et al. GyneFIX. The frameless intrauterine contraceptive implant—an update for interval, emergency and postabortal contraception. British Journal of Family Planning 24(4) (January 1999).
This article reviews the clinical experience with the GyneFix IUD for interval, emergency, and postabortal contraception. The GyneFix IUD is a frameless IUD consisting of six copper sleeves threaded on a length of suture material. Research has found that this specific design minimizes the side effects and discomfort commonly experienced with other conventional IUDs. The article reports that the pregnancy rate with GyneFix is lower than those of the most effective high-load copper devices currently used. Additionally, a properly inserted GyneFix implant is rarely expelled. The article concludes that because of its design and insertion requirements, GyneFix could assist in reducing the number of unintended pregnancies and induced abortions.

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Natural Family Planning

Also see the Contraceptive methods section of the Links page, particularly the Georgetown University Institute for Reproductive Health website.

Jennings V, Lundgren R. Standard Days Method: a simple, effective natural method. Global Health Technical Brief. Washington, D.C.: Georgetown Institute for Reproductive Health; 2004. Available at: www.irh.org/News&Events/media2004/GlobalHealthTechBriefSDMSept04.pdf.
The Standard Days Method is a natural method of family planning developed through analysis of the fertile time in a woman’s menstrual cycle. This news brief outlines the advantages and disadvantages of this simple method, obstacles to use, and program ideas for incorporating this method of natural family planning into your program.

Johns Hopkins Center for Communication Programs. Natural Family Planning. (www.jhuccp.org/topics/nfp.shtml. Accessed March 2003.
This page provides links to several Johns Hopkins resources on oral contraceptives, including the Media/Materials Clearinghouse, the POPLINE database of journal articles, Population Reports and other publications, and relevant articles by Johns Hopkins staff.

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