The Male Latex Condom - UNAIDS

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WHOThe Male Latex CondomFamily Planning and PopulationReproductive Health Technical SupportProgrammingFact Sheets10 Condom ProgrammingFact Sheets

The Male Latex Condom Fact SheetsWHO/RHT/FPP/98.15UNAIDS/98.12Photo: PSIFact SheetsIntroduction1

The Male Latex Condom Fact Sheets2

The Male Latex Condom Fact SheetsIntroductionFact Sheets on the Male Natural Rubber Latex CondomOne of the most practical and effectivemeans of preventing unwanted pregnancies andthe transmission of sexually transmitted diseases(STDs) is the familiar male natural rubber latexcondom. The evidence suggests that, if used consistently and correctly, the latex male condom is:lan effective contraceptive which does nothave systemic side-effects;lan effective means of protection againstSTDs, including the human immunedeficiency virus (HIV), that causesAIDS.Therefore, natural rubber latex condomsare of prime importance in the fight to stop thespread of AIDS.The dissemination of evidence regardingthe efficacy of condoms can be used to promotethe use of condoms both as a contraceptive methodand as a barrier against the transmission of STDs,including HIV.WHO and UNAIDS have developed thisseries of fact sheets to summarize the latestscientific evidence, basic concepts and bestpractices in key areas of condom programming.programming and provide references tosources of further and more detailedinformation;lThe fact sheets can be used as a basis for:lgenerating a higher level of confidence inpromoting condom use;ldeveloping higher levels of competence inthe major areas of condom programming;lgaining commitment to and financialresources for condom programming amongpolicy-makers and donors;limproving ongoing condom programmes;lincreasing public awareness of theeffectiveness of condoms when used toprevent unwanted pregnancy and thetransmission of STDs/HIV.The fact sheets cover:1 Scientific facts on the male natural rubberlatex condom2 Condom programming3 Condom quality assurance4 Condom promotion5 Logistics management6 Research7 Improving staff performance8 Social marketing of condoms9 Male and female synthetic condoms10 Bibliography and further rescourcesFor more detailed information on allaspects of condom quality, research,specifications, procurement, distribution andprogramming, refer to:lWHO Specification and Guidelines forCondom Procurement.lMonograph: The Latex Condom.lFact Sheets, Bibliography and furtherresources.lThe three Best Practice documents ofUNAIDS.The fact sheets:laddress the major areas of condomprovide a source of basic information onthe key elements of condom programmingfor reproductive health, family planningand STD/HIV prevention for policymakers, programme managers and serviceproviders in both governmental andnongovernmental programmes.3

The Male Latex Condom Fact Sheets4

The Male Latex Condom Fact Sheet 1WHO/RHT/FPP/98.15UNAIDS/98.12Fact Sheet 1Scientific Facts on the Male NaturalRubber Latex CondomPhoto: WHOLearning about condoms1

The Male Latex Condom Fact Sheet 12

The Male Latex Condom Fact Sheet 11. Scientific Facts on the Male NaturalRubber Latex CondomThe condomCarefully monitored studies havedemonstrated that consistent andcorrect use of condoms is an effectivemeans of protecting users and theirpartners against unplanned pregnancyand STDs, including the humanimmunedeficiency virus (HIV), thevirus that causes AIDS.A male condom is a sheath worn on theerect penis to prevent the exchange of body fluidsduring sexual intercourse. The use of a sheath toprevent pregnancy has been an establishedpractice for many years and reference to the useof condoms for pregnancy prevention dates backto the 16th century.With the emergence of the AIDS pandemicin the last decade, the use of condoms has takenon a new significance. It is a fact that:llAnyone who engages in sexual activity isat risk of contracting the humanimmunedeficiency virus (HIV), thatcauses AIDS, except when one is in amonogamous relationship with anuninfected partner.Throughout the world 75 80% of HIVinfections in adults have been transmittedthrough unprotected sexual intercourse.lHIV is more likely to be transmitted wheneither or both partners have, or have had,a sexually transmitted disease (STD).lThe World Health Organization (WHO)estimates that 340 million new casesof curable STDs occur annually.lThe Joint United Nations Programme onHIV/AIDS (UNAIDS) estimates that bythe year 2000 approximately 40 millionpeople worldwide will be infected withHIV, the virus that causes AIDS.A substantial body of evidence exists tosupport the claim that natural rubber latexcondoms, when used consistently and correctly,can protect against unwanted pregnancy andSTDs, including HIV.What types of condoms are available?Until recently, latex rubber condoms andthe less popular lambskin condoms were the onlytypes of condom on the market.However, in the last three years thedevelopment and marketing of non-latex syntheticmale and female condoms have marked thebeginning of a new generation of condoms.At present many of these new products arestill at the design stage and it will be a number ofyears before synthetic condoms are marketed at aprice that is competitive with that of latex rubbercondoms. (For more information on syntheticcondoms, refer to Fact Sheet 9).The male natural rubber latex condomThe modern natural rubber latex condomis based on technology developed in the 1930s. Thefundamentals of the technology have changedlittle, but latex condoms now being produced bymost reputable manufacturers are generally ofvery high quality. Apart from technologicaladvances in the manufacturing process,manufacturers have continued to improve theirproduct in order to increase acceptability by:ldeveloping a wide range of designmodifications;3

The Male Latex Condom Fact Sheet 1lresponding to the growing body of researchon a wide range of issues related to thequality of condom production.Currently, condoms that are manufacturedin accordance with international standards, andare packaged and stored correctly, will if usedconsistently and correctly substantially reduce therisk of unwanted pregnancy and/or thetransmission of STDs/HIV.Laboratory studies confirm that intactlatex condoms form an effective impermeablebarrier to spermatozoa and pathogens, includingHIV, herpes virus, hepatitis B virus,cytomeglalovirus, gonorrhoea, and chlamydiatrachomatis.The technology to produce high-qualitycondoms exists, but there can be dramaticvariations in the quality of condoms produced bydifferent manufacturers. To avoid buying poorquality condoms, WHO recommends that thepurchaser follows the quality assurance measuresdetailed in the WHO Specification andGuidelines for Condom Procurement.How effective is the male latex rubbercondom?Numerous epidemiological and clinicalstudies have been conducted on the risk of STDtransmission in condom users. Most are conclusivethat consistent use reduces considerably the riskof STD/HIV transmission.For example, in Thailand, the promotionby the government of 100% condom use bycommercial sex workers led to a dramatic increasein the use of condoms from 14% in 1989 to 94% in1994, and an equally dramatic decline in thenationwide numbers of bacterial STD cases (from410,406 cases in 1987 to 29,362 cases in 1994).4The most convincing data on theeffectiveness of condoms in preventing HIVinfection has been generated by prospective studiesundertaken on serodiscordant couples, when onepartner is infected with HIV and the other is not.With regular sexual intercourse over a period oftwo years, partners who consistently used condomshad a near zero risk of HIV, whilst inconsistentuse carried considerable risk averaging 14 21%(an incidence of 4.8 5.4 per 100 person years).Studies have also confirmed that consistentand correct use of condoms is the most importantfactor in preventing pregnancy.In general, the failure rate for perfect use (i.e.a condom used correctly at every act ofintercourse) is approximately 3%, and for typicaluse (condoms not used for every act of intercourse)the failure rate is 12%.Carefully monitored studies havedemonstrated conclusively that:lconsistent and correct condom use preventsSTD/HIV infections.llatex condoms which have beenappropriately tested are effective barriersto spermatozoa and pathogens.

The Male Latex Condom Fact Sheet 1Effectiveness the Clinical EvidenceThe reasons for the technologicalimprovement in manufacturing condoms areseveral, but clearly the most prominent is thethreat of AIDS. As a contraceptive, the condomdid not command a great deal of scientificattention. In the past. the condom has generallybeen relegated to a secondary role in most familyplanning programmes despite documentation ofa high level of efficacy among experienced users.When it became clear that HIV was transmittedsexually, and public recommendations of condomuse for protection were being widely made, thescientific community renewed its interest incondoms.Condom breakageA large number of studies on condombreakage report rates that vary from less than 1%to more than 10%. The wide variation in breakagerates is attributable to variations across studieswith respect to both condom characteristics (e.g.old condoms are more likely to break than newones) and user characteristics (e.g. less experiencedusers break condoms more frequently).One serious problem with many suchstudies is that they too often studied either thecharacteristics of the condoms used or thecharacteristics of the population using them.Rarely were both factors studied simultaneously.More recently, studies have addressed both factorsand demonstrate conclusively that thecharacteristics of the population using thecondom affect significantly the rate of breakagereported.It is a fact that:lpoor-quality condoms break morefrequently than condoms that passrecognized standards of manufacture;lyounger and less experienced users breakcondoms more frequently than do thosewho have learned to use condoms properly.There seems to be no single answer for therate of condom breakage: it depends on who isusing which condoms.Condom slippageThe choice of width of condoms isimportant because this is one of the main factorsin determining whether the condom is easy to puton, stays on during use, and is comfortable to theuser. The dimensions of the condom need toconform to the intended population of users.There are considerable variations betweenindividuals and, generally, there is no establishedmarket of differently sized condoms even indeveloped countries. The sizes most commonlymarketed are 49 mm and 53 mm.In general terms, condom sizes areclassified as either wide or narrow. Thisclassification is based on studies in Australia,Thailand and the USA, and on the experience ofmajor agencies. The wider condoms (flat width51 54 mm) will be preferred in Africa, Europe,Latin America, the Middle East and NorthAmerica, and the narrower condoms (47 50 mm)are preferred in several Asian countries.In recent years, condom manufacturershave learned how to make condoms thinner toincrease sensation and comfort without increasingthe risk of breakage. The general principle is,however, the thinner the condom, the smaller theforce required to break it.It is important for programmes todetermine and monitor consumer designpreferences since a condom of the wrong size andthickness will not be acceptable. This willcontribute to both method failure and user failure.5

The Male Latex Condom Fact Sheet 1Human behaviourCondoms lubricated with spermicidesOne finding from several studies carriedout by Family Health International (FHI), andother studies on social marketing programmes, isthat breakage is not randomly distributed througha study population. That is, some couples accountfor a disproportionately large fraction of thebreakage reported. The implication of this findingis that what risk there may be in using condomsis greatest for a relatively few breakers .There is evidence to suggest that the use ofspermicidal lubricants in condoms isinappropriate for the following reasons:Further, in the various studies it has beenpossible to isolate these couples and interviewthem to identify certain behavioural patterns thatare linked to condom breakage. For example, menwho have experienced problems with condoms aretwice as likely to experience similar problems inthe future, and the more inexperienced the userthe higher the probability of improper use suchas:-using the same condom twice;unrolling the condom before puttingit on;withdrawing to put the condom onafter starting intercourse;using a condom inside out;using oil-based lubricants;opening the packet with sharp nailsor scissors.Given the difficulty in communicatingcomplex or lengthy messages to the public, it islikely that messages directed at factors identifiedas leading to breakage, such as these, will be moreeffective than detailed instructions aimed at allfactors that might lead to failure.6lThere is no evidence that currentsurfactant spermicides improve theeffectiveness of condoms.lSpermicides can cause irritation of mucousmembranes, which may reduceacceptability and increase the risk ofinfection.lMost spermicidal lubricants will dry upwhen exposed to air. Therefore, they areexceptionally dependent upon packageintegrity.lShelf-life of condoms with spermicidallubricant is limited by the shelf-life of thespermicide.lEvidence suggests that surfactantspermicides weaken the integrity ofcondom package seals.

The Male Latex Condom Fact Sheet 1LubricantsThe lubricant applied to lubricatedcondoms during manufacture is sufficient formost users. Some people, especially thoseparticipating in prolonged vaginal intercourse orin anal sex, require additional lubricant whichcan be applied as needed.If the user applies lubricants to thecondom, the choice of substance used is of criticalconcern. There have been many cases of ordinaryhousehold products being used as lubricants, andthe majority of these have a highly damagingeffect on the condom. Indeed, most of them causedeterioration in the properties of the latex withinminutes. Even some products that are marketedfor use in the vagina such as medication for yeastinfections have a deleterious effect on latex andshould be avoided, if possible.A number of water-based lubricants, suchas KY jelly, are completely harmless to condoms.These are available on the market and it isstrongly recommended that only these specialisedproducts be used when separate or additionallubricant is required.The following household products have been used as sexual lubricants. They have a highlydeleterious effect on latex and should on no account be used in conjunction with a condom:mineral oilssuntan oilsmargarinecoconut butterburn ointmentsbaby oilsedible (cooking) oilcoconut oilfish oilhaemorrhoid ointmentpetroleum jellypalm oildairy butterinsect repellentsrubbing alcoholDO NOT USE THESE PRODUCTS TO LUBRICATE CONDOMS7

The Male Latex Condom Fact Sheet 1ReliabilityResearch into condom qualityA wide research programme was initiatedin the mid-1980s, much of it funded by WHO,and US Agency for International Development(USAID).Standards organizations, the bodies thatprovide technical definitions of productsmanufactured or distributed within theirjurisdictions, such as the InternationalOrganization for Standardization (ISO), WHOand the American Society for Testing andMaterials (ASTM), became the centres of hotlydebated ideas about more stringent quality controldemands on the condom as a life-saving medicaldevice.For the first time, research institutes beganstudying the relationship between the laboratorytesting of condoms and their performance in useand behavioural research to determine barriersand inhibitions in use.Product stabilityThe Program for Appropriate Technologyin Health (PATH) examined the physicalproperties of latex condoms and demonstrated,among other things, that the product wasmeasurably weakened by oxidation over time butthat silicone lubrication provides some protectionagainst this process.Moreover, if the condom is isolated fromthe air by means of impermeable, hermeticallysealed aluminium foil packaging and furtherprotected against possible package damage bysilicone lubricant and antioxidant propertieswithin the formulated latex, the well madecondom will withstand all likely environmentalextremes for many years.8Heat was also shown to degrade latexproperties, probably through the propagation ofvulcanizing cross-links among the latexmolecules, leading to a more brittle and breakableproduct. PATH has, however, demonstrated thatthe accumulated heat, or the caloric load, requiredto generate this process is comfortably beyond thatgenerated by the average temperatures ordinarilyfound even in tropical countries.It would be difficult to overstate thesignificance of this carefully executed and widelyreviewed research. It continues to be the case thatexpiration dates for newly manufactured condomsare not easily determined.This study, however, has raised the levelof confidence to the point that routine testing ofstored condoms, even in the tropics, is no longerrecommended as a critical component of qualityassurance. It should still be undertaken at periodicintervals, particularly if there is any sign ofdeterioration in the packaging or when condomshave been stored for over three years.Shelf-life and expiry dateThis edition of the WHO Specification isthe first to include a requirement for shelf-lifeand expiry date. Eventually, a claimed shelf-lifewill have to be supported by real-time stabilitystudies conducted under temperatures thatrepresent the severest average conditions likelyto be encountered during storage and distribution.While some manufacturers already havesuch data, it is not yet universal, and allmanufacturers are encouraged to commence realtime stability testing on their products. Thisinvolves storing several lots of condoms at 35o Cover the full intended shelf-life, and periodicallydoing inflation tests on a suitable sub-sample. For

The Male Latex Condom Fact Sheet 1example, 30 to 50 condoms could be tested every 6months. In this way the rate of deterioration ofphysical properties can be established.Compliance with the inflation requirements fornew condoms at the end of the shelf-life is alsorequired.As an interim measure, WHO will acceptaccelerated ageing tests conducted at highertemperatures for shorter times, as an indicationof shelf-life. The manufacturer may present anysuitable data available, plus the rationale used toinfer the claimed shelf-life.Condom leakageThe fact remains that condoms are notperfect and that failures do occur. At the sametime, more has been learned about the problemof leakage, and even here confidence aboutcondoms has risen.Multiple studies have demonstrated thatproperly manufactured and appropriately testedlatex condoms are impermeable to semen and toall pathogens of relevant size.It is a fact that if condoms are tested in accordancewith the criteria established by the majorstandards organizations and WHO there will belittle if any threat of unwanted pregnancy orinfection through leakage.Latex allergiesLatex protein sensitization became an issuein the early 1990s, mainly in connection with theincreased use of rubber latex gloves and latexmedical devices. Latex allergies are consideredvery rare among the general population (0.08%)and tend in the majority of cases to be rather mild.Allergies generally occur in children andadults repeatedly and continuously exposed tolatex products such as, gloves, multiple operationsand medical procedures. Persons who are awarethat they have a latex allergy should use non-latexcondoms.Quality managementTo achieve high quality, condoms must bewell designed and formulated, and carefully made.To maintain that quality until the condom issupplied to the user, storage and distributionsystems need to be effective. Both themanufacturer and the large-volume purchasershould develop and maintain a qualitymanagement programme to establish theprocedures, structures and record-keepingnecessary for effective and sustainable qualitymanagement. A well designed factory and product,together with an effective top-down qualitymanagement system, form the foundation forconsistent quality over the long term.International Organization forStandardization (ISO)The ISO has created a number of modelstandards for quality management. Perhaps thebest known is the internationally recognized ISO9000 series of standards which prescribes in greatdetail the documentation, procedures andstructures to be followed in factories to facilitatethe production of a consistent standard in theoutput of services and products.The systems of quality management,generally known as good manufacturing practice (GMP) can be used by most factories regardlessof the product and are audited by regulatorybodies. Other ISO quality management guidelinesare ISO 13485 and ISO 13488 are intended to beversions of ISO 9001 and ISO 9002 appliedspecifically to medical devices. Europe uses EN9

The Male Latex Condom Fact Sheet 146001 and EN 46002, which are very similar toISO 13485 and 13488. The USA uses its own codeof GMP, with slightly different emphasis fromthe ISO requirements.WHO suggests that purchasers should notrely unduly on certification of GMP to ensurethat condoms supplied are of high quality andmeet the required specification. The proof of thetechnical competence also involves evidence ofappropriate design and the verification ofconsistent compliance with performancerequirements of standards and specifications asdetailed in the WHO Specification andGuidelines for Condom Procurement.The international basis for condomstandards is provided by ISO 4074 - RubberCondoms. This document is drafted by a technicalcommittee (ISO TC 157) and is currently underextensive revision. Many of the product testsprescribed by WHO in the Specification andGuidelines for Condom Procurement are derivedfrom ISO 4074.National regulatory authoritiesNational regulatory authorities such asUnited States Food and Drug Administration(USFDA) and other key agencies control GMPand end-product condom standards in manydeveloped countries.The Medical Device Directive, adopted byall European Union countries and Switzerland,requires conformance with the European CENstandard for condoms, and with EN 46001 or46002, from June 1998. Compliance with theEuropean requirements at factory level is assessedby a series of so-called notified bodies, appointedby each member nation.10Regulatory agencies license drugs andmedical devices for use in the country or region,carry out audits and test products. They may adoptstandards issued by standards authorities andmake them mandatory. They generally have theauthority to recall products and close factories inthe event of continued non-compliance with theirregulations.Drug controllers, AIDS preventionauthorities and ministries of health are beginningto take on a similar role in developing countries.A number of these authorities have based theirstandards on the WHO Specification, and severalare actively participating in the drafting of thenew ISO condom standard 4074.What is meant by a standard?Safety and efficacy standards are publishedby national or international regulatoryauthorities or standards bodies to establish aminimum level of quality for products (e.g.condoms) that are made or imported, and sold,within a particular country or region.A standard is concerned primarily withsafety, security and efficacy and usually coversonly essential performance attributes that shouldnot be compromised. A standard is not concernedwith the special requirements of individual buyersbut with the quality of the product that isproduced.

The Male Latex Condom Fact Sheet 1Design features that are a matter of choiceand discretion (e.g. colour) will not normallyfigure in a standard (except perhaps to stipulatethat any pigment used must be non-toxic and nonirritant). Standards also provide consensus on theprocedures and protocols to use when carryingout basic tests for quality verification.incorporating into the procurement process asystem to pre-qualify suppliers prior to awardinga contract and lot-by-lot compliance testing priorto purchasing a consignment of condoms.The principal international standardsauthority is the ISO, a worldwide federation ofnational standards bodies responsible for draftinginternational standards for manufacturedproducts based on the best available evidence.This ensures that quality assurancemeasures are incorporated into the procurementprocess. Pre-qualification, before or during thetendering process, assesses the capability of themanufacture to produce good quality condoms.Lot by lot compliance testing assesses the qualityof the product before accepting the shipment ofcondoms from the manufacturer.What is a specification?Laboratory testing of condomsA specification is a statement of a buyer srequirements, and will cover all attributes andfeatures of the product, both the essential, generaland performance requirements and thediscretionary design requirements. A specificationmay contain within it some or all of a standardas its essential performance requirement.Third-party test laboratories play animportant role in providing objective testing ofcondoms for pre-qualification of suppliers andfor lot-by-lot compliance testing prior to delivery.Some also provide other quality managementservices, including diagnosis of quality problems,GMP training and review, inter-laboratorycomparison of test equipment, procedures, andstability trials. Other organizations provideindependent sampling services, travelling to themanufacturers factory or warehouse to takerandom samples for testing.The WHO Specification andGuidelines for Condom ProcurementThe WHO Specification and Guidelinesfor Condom Procurement (published jointly byWHO and UNAIDS) translates the scientificevidence used by ISO as the basis for establishingmanufacturing standards into a step-by-step guidefor programme managers and procurementofficers. It describes how to develop a specificationand follow quality assurance procedures toprocure high quality condoms.The WHO Specification and Guidelinesfor Condom Procurement suggests that purchasersshould not rely unduly on GMP certification toensure that condoms supplied are of high qualityand meet specifications. The technical competenceof the manufacturer should always be verified byThe quality of laboratory testingIn choosing a testing laboratory, purchasersshould give due weight to whether or not acandidate laboratory participates in voluntaryinter-laboratory trials.Inter-laboratory comparison of condom testlaboratories is an important service that has comeinto existence in recent years. It helps to ensurethat the measurements made by the manufacturer,regulatory authority and test laboratory arecompatible, and contributes to avoiding disputesdue to measurement differences or errors. The11

The Male Latex Condom Fact Sheet 1laboratory should also be part of aninternationally recognized laboratoryaccreditation scheme. This scheme is similar tothe GMP certification offered according to ISO9000, with the additional requirement of atechnical review by an experienced independenttechnical auditor of the competence of thelaboratory staff, and efficacy of the equipmentand procedures.12

The Male Latex Condom Fact Sheet 2WHO/RHT/FPP/98.15UNAIDS/98.12Photo: WHOFact Sheet 2Condom Programming1

The Male Latex Condom Fact Sheet 22

The Male Latex Condom Fact Sheet 22. Condom ProgrammingCondom programming and programmemanagementCondom programming identifies the keyactivities required to ensure successful andeffective procurement, promotion and delivery ofhigh quality condoms.Managers of programmes for reproductivehealth care, family planning, STD/HIVprevention and social marketing can use theprinciple of condom programming to plan andimplement the support activities required to linkcondom supply with demand.AIDS. To gain this support, policy-makers mustbe convinced that condom programming cansuccessfully ensure the equitable distribution ofaccessible, affordable high-quality condoms.If policy-makers are convinced, they will:ladvocate the inclusion of condomprogramming in all planned reproductivehealth care interventions;ladvocate reduction of the impact of lawsand regulations on condom use;lobtain support from political, religious andcommunity leaders to promote the use ofcondoms;linfluence public opinion and overcomepolitical or cultural barriers to promotingcondom use;lallocate sufficient resources to support eachcomponent of condom programming.Strengthening policyCondom programming requires the fullsupport of policy-makers. Policy-makers musthave a proper understanding of the importantreproductive health care benefits provided by goodquality condoms in preventing both unwantedpregnancy and the transmission of STDs/HIV/Diagram 1: The components of condom programming.Condom motion/IECTargeted DistributionSalesPolicyForecasting & ProcurementDistribution SystemsQuality ManagementLogistical Information SystemsManagementStaff Development Monitor and Evaluation3

The Male Latex Condom Fact Sheet 2Programme managersProgramme managers need to use allavailable sources of information to campaignstrongly for the inclusion of condomprogramming activities in all plannedreproductive health care interventions.The programme manager will have overallresponsibility for developing and implementingthe condom programming strategy. This willmean coordinating the development of a workplanthat includes the following components:ResearchIt is important to distinguish betweenresearch that is done to assist the planning of anew or revised programme and the research thatis required to assess the effect of the programmewhen it is running.The research that is carried out as part ofplannin

3 The Male Latex Condom ΠFact Sheet 1 The condom A male condom is a sheath worn on the erect penis to prevent the exchange of body fluids during sexual intercourse.

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The responsibility for the interpretation and use of the material lies with the reader. In no event shall UNAIDS be liable for damages arising from its use. Cover photo: UNAIDS UNAIDS 20 avenue Appia CH-1211 Geneva 27 Switzerland T ( 41) 22 791 36 66 F ( 41) 22 791 48 35 distribution@unaids.org www.unaids.org WHO Library Cataloguing-in .

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