Condom Future Directions Editors Erin T. McNeill Caroline E. Gilmore William R. Finger JoAnn H. Lewis William P. Schellstede FAMILY HEALTH INTERNATIONAL Condom Future Directions Editors Erin T. McNeill Caroline E. Gilmore William R. Finger JoAnn H. Lewis William P. Schellstede FAMILY HEALTH INTERNATIONAL Editors and Authors Erin T. McNeill joined Family Health International (FHI) in 1997 as a research scientist. She previously worked at the U.S. Agency for International Development (USAID). Caroline E. Gilmore, at FHI from 1993 to 1997, was a senior research analyst. William R. Finger is a senior wr.iter/editor at FHI. JoAnn H. Lewis is FHI's 9'l;,:",ici.e~p,re;3id,~nt for reproductive health programs. ellstede is FHI's executive vice-president n programs. In addition to writing one or , the five editors conceptualized and edited h. r chapter authors, all FHI employees, are: irector of the product quality and vision; Paul 1. Feldblum, deputy director of tive use and epidemiology division; Alan B. research analyst; and Markus 1. Steiner, iate. ents e especially grateful to Mark Rilling of USAID, who assisted with this project from its concep­ tion through final editing. We would also lil,e to thank: Pete Anderson, Steve Coulter, Gina Dallabetta, Jeff Grant, Jorge Haider, David Mayer, Joan MacNeil, Bill Potter, Bradley Pugh and Tom Wilson for providing technical information during the preparation of this monograph; Gaston Farr, Michael Free, Ron Frezieres, Sarah Harbison, Carol Joanis, Ted King, Don Marlowe, Doug Nichols, Thomas Pendle, Herbert Peterson, Juliet Richters, Robert Spirtas, James Trussell, Margaret Usher, Kirsten Vogelsong, Terri Walsh and Mitchell Warren for reviewing this monograph and making important suggestions to its final content; Nash Herndon for editorial assistance; and Karen Dickerson, who located much of the graphic material and coordinated production. This work, and much of the research cited in it. was supported by USAID, although the views expressed in this document do not necessarily reflect those of USAID. The World Health Organization (WHO) provided partial support for printing and distribution, although the contents do not necessarily reflect WHO policy. FHI is an international not-for-profit organization that conducts research and provides technical assistance in reproduc­ tive health, family planning, maternal!child health, sexually transmitted diseases and AIDS. It is based in Research Triangle Park, North Carolina, USA. Library of Congress Catalog Card Number: 97-78005 ISBN: 0-939704-43-9 Copyright 1998 by Family Health International. All rights reserved. Introduction 2 Why a Monograph on Latex Condoms? JoAnn H. Lewis Chapter 1 5 Pregnancy and STD Prevention Paul J. Feldblum Chapter 2 12 Acceptability of Condoms - User Behaviors and Product Attributes Alan B. Spruyt and William R. Finger Acceptability and Product Development 18 Caroline E. Gilmore t~'7l "',~ I I" {!Hn '\ I I"" ", I"'"' :01 ~"' Tables and Figures 24 Chapter 3 l#mkfillilliilit±m~-li%%~I,"~! \J:fr'''i;''liif"I~}4lJ\'~ t;;1:~~11dIT'f~,t, "i:~ '~11, ';;Jr' I ,tv. ti'\'hl~ ~ ~ ./1 luli, i ~I, :j0~ltti I User Behaviors and Characteristics Related to Condom Failure Figure I-I. Pregnancy Probability, Consistent 6 Alan B. Spruyt and Inconsistent Condom Use Using a Condom Correctly 29 Table I-I. RN Infection in Prospective Studies 8 of Serodiscordant Couples Defining "Condom Failure" 32 Table 3-1. Selected Studies of Distribution of 25 Chapter 4 36 Condom Failure among Study Participants Recent Advances in the Research, Development and Manufacture Table 3-2. Selected Studies of User Characteristics 26 of Latex Rubber Condoms Associated with Condom Failure Caroline E. Gilmore Table 3-3. Selected Studies of User Behaviors 28 How a Latex Condom is Made 39 Associated with Condom Failure Chapter 5 44 Table 4-1. Stress, Strain and Modulus 37 Standards, Specifications and Tests William P. Schellstede, Eli]. Carter Table 5-1. Comparison of International Latex 47 and William R. Finger Condom Standards/Specifications, 1997 .\fajor Laboratory Tests for Condom Quality 50 Table 5-2. Laboratory Tests for Determining 49 Condom Quality New Tests for Product Development 52 Table 6-1. All Studies Published in Peer­ Chapter 6 56 Journals 1980-1997 Comparing Ruman Use Comparing Laboratory Tests with Human Use Brealatge Rates and Laboratory Performance of Eli J. Carter and Markus J. Steiner Latex Condoms Methodological Challenges in Studying 62 Table 7-1. Natural and Synthetic Condoms 67 Condoms Chapter 7 65 The Development of 'lion-latex Condoms Caroline E. Gilmore Chapter 8 72 Conclusion - What We Know and Research Priorities Erin T. McNeill Ten Reasons Wily We Should Have 74 Confidence in Condoms Recommended Research Priorities 78 Acronyms and Abbreviations 80 '?tI e ~~ !~: Introduction f!~~~ Why a Monograph on Latex Condoms? by JoAnn H. I.ewis ondoms in various forms have been barriers to overall acceptability of condoms. with us for centuries. The use of Many people do not believe they are at risk of barriers covering the penis to STD/HIV. Others do not like the feeling of a Cprotect against disease dates back to condom or worry about their partner's reac­ at least 1350 BC, and for pregnancy preven­ tions to suggesting condom use. Some are tion at least to the 16th century AD. Since the embarrassed by, or lack skills in, adding 1930s, latex condoms have been available to condom use to sexual activity. Communication prevent both pregnancy and sexually transmit­ between sexual partners is minimal in many ted disease (STD), but in most parts of the cases, contributing to non-use and higher STD world they have never been widely used. When rates. Also, cultural and political norms often forms of contraception that were not coitally reinforce negative perceptions of condoms and dependent became available in the 1960s and tend to limit their availability. The most 1970s, the use of condoms declined. Begin­ important obstacle to more widespread and ning in the 1980s, however, the worldwide consistent use of condoms, however, appears epidemic of STDs, including HIVjAIDS, to be that consumers do not like them. prompted a renewed interest in latex condoms, The aim of this monograph is to draw which, to date, remain the most effective together the wealth of information that now method of preventing disease transmission exists on multiple aspects of latex condom during sexual intercourse. manufacturing, quality assurance, perfor­ The rediscovery of condoms for disease mance in human use, acceptability and user prevention has led to an explosion in research behaviors - and the interrelationships among and technical knowledge during the past these issues. The monograph focuses on the decade and the first substantial modifications product, its attributes and how attributes affect in manufacturing of condoms since the 1930s. human use. Providing a comprehensive review Along with the technical improvements in the of all the behavioral and programmatic issues product, research has contributed to a better that relate to condom use is beyond the scope understanding of the behaviors that influence of this monograph. We briefly review the whether and how condoms are used, and the major issues regarding behavior change and extent to which user behaviors and technical condom acceptability, focusing on the interac­ product attributes interact to determine tion between people and product. We explore effectiveness. Sadly, the great improvements in the remaining gaps in knowledge about latex condom design and reliability are not widely condoms, describe several non-latex alterna­ known. Consumers and service providers alike tives for men and women that are in develop­ continue to lack confidence in the condom's ment or have recently become available, and ability to prevent pregnancy and disease. propose research priorities for the future. We While perceived unreliability is often a hope that researchers, manufacturers, regula­ problem, a host of other issues present greater tory officials and public health professionals 2 who promote and provide condoms will find program of research to apply the same scien­ the information in these pages useful. tific rigor to the study of condoms that had The impetus to produce a monograph on been applied to the study of other contracep­ latex condoms came from an experts meeting tive methods. The research carried out by FHI convened by Family Health International (FHI) and other agencies, such as the Program for in May 1996. The meeting brought together Appropriate Technology in Health (PATH), has representatives from research, industry, provided new information on the physical regulatory agencies and the donor community characteristics of the latex condom and on to assess needs and set priorities for future behavioral aspects that influence whether and research on latex condoms. In particular, the how condoms are used. experts scrutinized the issue of whether During the past decade, manufacturers of laboratory measures of condom reliability can latex condoms have continued to make predict condom performance in human use. improvements in the product based on new The consensus of the meeting was that relating insights provided by the growing body of laboratory-based measurements of quality research on a wide range of issues and based assurance with human use remains problem­ on changes in purchase specifications of major atic. Even so, we know a great deal about the buyers. Condoms now on the market are technical merits of latex condoms and an ever­ manufactured more consistently, have better Currently available increasing amount about consumer use formulations of latex, have incorporated a wide behaviors. range of design modifications to improve both condoms, if The experts proposed a publication that acceptability and functionality, and are would summarize state-of-the-art information subjected to pre-marketing quality assurance. packaged and stored from the various disciplines involved in the Improvements in packaging have minimized production, quality assurance, behavioral potential damage to the product prior to use. correctly, will main- research and promotion of latex condoms.