Confused about condoms? It’s the data, not condoms, that may be inadequate

Stay consistent in delivering STD prevention message

While controversy swirls in the wake of a government evaluation of male latex condom research, make sure that your facility is delivering one clear message: Consistent and correct use of latex condoms continues to be an effective tool in the prevention of sexually transmitted diseases (STDs).

The report, released July 20, followed a June 2000 workshop organized by the Bethesda, MD-based National Institutes of Health (NIH), the Atlanta-based Centers for Disease Control and Prevention, the Rockville, MD-based Food and Drug Administration, and the Washington, DC-based U.S. Agency for International Development. The workshop was held at the request of Tom Coburn, a physician and former Republican congressman from Oklahoma who had questioned the role of condoms in prevention of human papillomavirus during public health legislation. (Contraceptive Technology Update offered an overview of the legislation in its "Washington Watch" column, May 2000, p. 61.)

During the June 2000 workshop, 28 expert panel members analyzed 138 peer-reviewed, published studies on the properties and user patterns of the male latex condom during penile-vaginal intercourse.

The NIH workshop summary report confirms that correct and consistent use of condoms can reduce the risk of HIV/AIDS transmission.1 The epidemiological studies reviewed by the experts also show condoms aid in protecting men from acquiring gonorrhea from a female partner, the report states.

"Given that the consequences of HIV are so serious, including lifelong disease and death, and that gonorrhea is one of the most common curable STDs on earth, these are strong reasons for persons who choose to be sexually active to use condoms correctly and consistently," says Edward Hook III, MD, professor of medicine at the University of Alabama at Birmingham and medical director of the Jefferson County STD Control Program. Hook served as a member of the workshop panel.

However, the NIH review panel concluded that due to limitations in study designs, epidemiological evidence is currently insufficient to provide an accurate assessment of condom effectiveness in preventing spread of chlamydial infection, syphilis, chancroid, trichomoniasis, genital herpes, and genital human papillomavirus infection. The panel recommended further well-designed research to help answer questions about those infections.

Make the distinction

 The release of the report has sparked markedly different interpretations of its information. Some conservative groups have pointed to the report as proof that the term "safe sex" is a myth.2

National organizations including the New York City-based Planned Parenthood Federation of America, the Washington, DC-based American College of Obstetricians and Gynecologists, and the Research Triangle Park, NC-based American Social Health Association, have issued statements affirming condoms’ role in STD prevention.

It is important that the public understand the difference between the inadequate data and inadequate condoms, says Hook. "The data simply are not good enough for STDs; other than gonorrhea in men, HIV, and perhaps herpes infections, to really know whether and how well condoms work," states Hook. "This is very, very different from data that might show that condoms do not work; we just can’t tell for most STDs with a high degree of scientific certainty."

Very few studies have been performed in which condom use for STD prevention was the major outcome of the study, states Hook. Thus, other than the instances mentioned above, the data simply are not sufficient to draw conclusions, he notes.

"Deliberate attempts by political groups to misrepresent the evidence as demonstrating ineffectiveness of condoms’ constitute a misunderstanding of what the report states," states Willard Cates Jr., MD, MPH, president of Family Health International, a Research Triangle Park, NC-based research organization that has conducted numerous studies of condoms and other contraceptive methods. "Moreover, by undermining the public’s confidence in condoms, this misrepresentation may lead to public health harm," he says.

Review STD study design

 The studies reviewed by the NIH panel were observational in nature and carry a variety of methodologic limitations well described in the text, states Cates, author of an upcoming over-view of the workshop’s findings.3

"Unfortunately, as the report states, the ideal study design of a prospective randomized controlled trial is not possible to evaluate condom effectiveness," Cates observes. "Ethical concerns do not allow randomization of individuals to a condom nonuse group in populations at high risk for STDs."

While many studies have gathered information on condom use while addressing other topics and specific aims, few studies actually have been designed to study how well condoms protect against STDs, says Hook.

"As a result, questions such as, How often did you use condoms,’ are asked without too much precision," Hook comments. "In addition, to really evaluate how condoms were used by a study participant, a rather large number of questions [must be asked] to delineate the proportion of acts of intercourse in which condoms were used, whether they were used correctly or not, whether slippage or breakage occurred, etc."

Unless a study is designed specifically to answer such questions, the information is not fully covered within the confines of the research paper, says Hook. As a result, the data are not adequate to definitively answer the efficacy question, he explains.

Look at evidence

Evidence that was either not considered by the NIH report or surfaced since the panel met has leaned toward strengthening the already-acknowledged protective effects of condoms against a range of STDs, says Cates.

A just-published study of a randomized, controlled trial which examined condom efficacy in prevention of herpes simplex virus type 2 (HSV-2) transmission in discordant couples, found that condoms offered significant protection against HSV-2 infection in susceptible women.4

"Not only has the adequacy of the data improved since the [NIH] report, but the deliberate attempts by some groups to misrepresent the absence of data with the ineffectiveness of condoms is doing exactly what the report cautioned them not to do," stresses Cates. "This deliberate misrepresentation undermines the reinforcing public health messages and may lead to wider transmission of STDs by encouraging nonuse of condoms, and it’s the nonuse of condoms, not the ineffectiveness of condoms, that is the problem."

References

1. National Institute of Allergy and Infectious Diseases. Workshop Summary: Scientific Evidence on Condom Effectiveness for Sexually Transmitted Disease (STD) Prevention. Bethesda, MD: July 20, 2001.

2. Connolly C. Report questions condoms’ disease prevention ability. Washington Post, July 20, 2001:A01.

3. Cates W. The NIH condom report: The glass is 90% full! Fam Plann Perspect (in press).

4. Wald A, Langenberg AG, Link K, et al. Effect of condoms on reducing the transmission of herpes simplex virus type 2 from men to women. JAMA 2001; 285:3,100-3,106.