Ethical Considerations In HIV Preventive Vaccine Research
Ethicalconsiderationsin HIV preventivevaccine researchUNAIDS guidance document21441 Ethical cover.pmd126.04.2004, 18:43
UNAIDS/04.07E (English original, May 2000)ISBN 92-9173-166-8Third reprint April 2004UNAIDS, 20 avenue Appia, 1211 Geneva 27, SwitzerlandTel. ( 41) 22 791 36 66 – Fax ( 41) 22 791 41 87E-mail: unaids@unaids.org – Internet: http://www.unaids.org21441 Ethical cover.pmd226.04.2004, 18:45
Ethical considerationsin HIV preventivevaccine researchUNAIDS guidance documentMay 2000
UNAIDS guidance documentIntroduction3Context6Suggested guidance11Guidance Point1: HIV vaccines development11Guidance Point2: Vaccine availability13Guidance Point3: Capacity building15Guidance Point4: Research protocols andstudy populations17Guidance Point5: Community participation19Guidance Point6: Scientific and ethical review21Guidance Point7: Vulnerable populations22Guidance Point8: Clinical trial phases24Guidance Point9: Potential harms27Guidance Point 10: Benefits30Guidance Point 11: Control group31Guidance Point 12: Informed consent32Guidance Point 13: Informed consent special measures36Guidance Point 14: Risk-reduction interventions38Guidance Point 15: Monitoring informedconsent and interventions39Guidance Point 16: Care and treatment41Guidance Point 17: Women45Guidance Point 18: Children462
Ethical considerations in HIV preventive vaccine researchIntroductionAs we enter the third decade of the AIDS pandemic,there still remains no effective HIV preventive vaccine.As the numbers of those infected by HIV and dyingfrom AIDS increase dramatically, the need for such avaccine becomes ever more urgent. Several HIVcandidate vaccines are at various stages of development.However, the successful development of effective HIVpreventive vaccines is likely to require that many differentcandidate vaccines be studied simultaneously in differentpopulations around the world. This in turn will require alarge international cooperative effort drawing on partners from various health sectors, intergovernmentalorganizations, government, research institutions,industry, and affected populations. It will also requirethat these partners be able and willing to address thedifficult ethical concerns that arise during the development of HIV vaccines.In an effort to elucidate these ethical concerns, and tocreate forums where they could be discussed in full bythose presently involved in, or considering, HIV vaccinedevelopment activities, the UNAIDS Secretariatconvened meetings in Geneva (twice), Brazil, Thailand,Uganda and Washington during 1997-1999. Thesemeetings included lawyers, activists, social scientists,ethicists, vaccine scientists, epidemiologists,representatives of NGOs, people living with HIV/AIDS,and people working in health policy. In the regionalmeetings, efforts were made to include people from anumber of countries from that particular region. Theentire process involved people from a total of3
UNAIDS guidance document33 countries.1 The goals were to : (1) identify anddiscuss ethical elements specific to development of HIVpreventive vaccines; (2) reach consensus when possible,and elucidate different positions, when not; (3) progressin ability to address these matters during pending orproposed HIV vaccine research.In the present document, UNAIDS seeks to offer guidance emanating from this process. This document doesnot purport to capture the extensive discussion, debate,consensus, and disagreement which occurred at thesemeetings. Rather it highlights, from UNAIDS’ perspective, some of the critical elements that must be considered in HIV vaccine development activities. Wherethese are adequately addressed, in UNAIDS’ view, byother existing texts, there is no attempt to duplicate orreplace these texts, which should be consulted extensively throughout HIV vaccine development activities.Such texts include : the Nuremberg Code (1947); theDeclaration of Helsinki, first adopted by the WorldMedical Association in 1964 and subsequentlyamended in 1975, 1983, 1989 and 1996; the BelmontReport - Ethical Principles and Guidelines for the Protection of Human Subjects of Research, issued in 1979 bythe US National Commission for the Protection ofHuman Subjects of Biomedical and Behavioral Research;the International Ethical Guidelines for BiomedicalResearch Involving Human Subjects, issued by theCouncil for International Organizations of Medical1For a full description of the process and participants, see “Final Report, UNAIDSSponsored Regional Workshops to discuss Ethical Issues in Preventive HIV Vaccine Trials”, available from UNAIDS. See also Guenter, Esparza, and Macklin:Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS(UNAIDS. Journal of Medical Ethics (February 2000), vol. 26, No. 1: 37-43.4
Ethical considerations in HIV preventive vaccine researchSciences (CIOMS) in 1993 (and developed in closecooperation with WHO); the World HealthOrganization’s Good Clinical Practice (WHO GCP)Guideline (1995); and the International Conference onHarmonisation’s Good Clinical Practice (ICH GCP)Guideline (1996).It is hoped that this document will be of use to potential research participants, investigators, communitymembers, government representatives, pharmaceuticalcompanies, and ethical and scientific review committees involved in HIV preventive vaccine development.It suggests standards, as well as processes for arrivingat standards, and can be used as a frame of referencefrom which to conduct further discussion at the international, national, and local levels.5
UNAIDS guidance documentContextThe HIV/AIDS pandemic is characterized by uniquebiological, social and geographical factors that, amongother things, affect the balance of risks and benefits forindividuals and communities who participate in HIVvaccine development activities. These factors mayrequire that additional efforts are made to address theneeds of participating individuals and communities,including their urgent need for a HIV vaccine, theirneed to have their rights protected and their welfarepromoted in the context of HIV vaccine developmentactivities, and their need to be able to be full and equalparticipants . These factors include the following :The global burden of disease and death relatedto HIV is increasing at a rate unmatched by anyother pathogen. For many countries, it is alreadythe leading cause of death. Currently availabletreatments are inadequate because they do notlead to cure, but at best slow the progression ofdisease. The most effective treatment for slowingHIV-related disease progression, antiretroviralmedication, is complicated to administer, requiresclose medical monitoring, is extremely costly, andcan cause significant adverse effects. Because ofthis, antiretroviral medication is not readilyavailable to the vast majority of people affectedby HIV/AIDS. These are people living in developing countries and in marginalized communities in6
Ethical considerations in HIV preventive vaccine researchdeveloped countries. There is therefore anethical imperative to seek, as urgently as possible, a globally effective and accessible vaccine,to complement other prevention strategies.Furthermore, this ethical imperative demandsthat HIV preventive vaccines be developed toaddress the situation of those people and populations most vulnerable to infection.Genetically distinct subtypes of HIV have beendescribed, and different HIV subtypes are predominant in different regions and countries. Yetthe relevance of these subtypes to potentialvaccine-induced protection is not clearly understood. Thus, it is not known whether a vaccinetargeted at one subtype will protect againstinfection from another subtype; and it is likelythat a vaccine directed at a particular subtype willneed to be tested in a population in which thatsubtype is prevalent. Therefore, developing avaccine that is effective in the populations withthe greatest incidence of HIV is likely to requireexperimental vaccines be tested in those populations, even though these populations may for avariety of reasons be relatively vulnerable toexploitation and harm in the context of HIVvaccine development. Additional efforts mayneed to be made to overcome this vulnerability.Some candidate vaccines may be conceived andmanufactured in laboratories of one country(sponsor country or countries), usually in thedeveloped world, and tested in human populations in another country (host country or countries), often in the developing world.7
UNAIDS guidance document[The term ‘sponsor’ has usually referred to theindividual or institution who either owns the candidate vaccine or provides the material resourcesnecessary to carry out the vaccine developmentprogramme. Traditionally, the sponsor has beenthought of as a single corporate entity, such as apharmaceutical company. In modern vaccinedevelopment programmes there are commonlymultiple sponsors including one or more corporations, one or more national governments and one ormore international agencies.] The potential imbalance of such a situation demands particular attention to factors that will address the differing perspectives, interests and capacities of sponsors andhosts with the goal of encouraging the urgentdevelopment of effective vaccines, in ethicallyacceptable manners, and their early distribution topopulations most in need. In this regard, potentialhost countries and communities should be encouraged and given the capacity to make decisions forthemselves regarding their participation in HIVvaccine development, based on their own healthand human development priorities, in a context ofequal collaboration with sponsors.HIV/AIDS is a condition that is both highly fearedand stigmatized. This is in large part because it isassociated with blood, death, sex, and activitieswhich are often not legally sanctioned, such ascommercial sex, men having sex with men, andsubstance abuse. These are issues which aredifficult to address openly - at a societal andindividual level. As a result, people affected byHIV/AIDS can experience stigma, discrimination,8
Ethical considerations in HIV preventive vaccine researchand even violence; and governments and communities continue to deny the existence andprevalence of HIV/AIDS. Furthermore, vulnerability to HIV infection and to the impact of AIDSis greater where people are marginalized due totheir social, economic and legal status. Thesefactors increase the risk of social and psychological harm for people participating in HIV vaccineresearch. Additional efforts must be made toaddress these increased risks, and to ensure thatthe risks participants take are justified by thebenefits they receive by virtue of their participation in the research. A key means by which toprotect participants and the communities fromwhich they come is to ensure that the communityin which the research is carried out is meaningfully involved in the design, implementation, anddistribution of results of vaccine research, including the involvement of representatives frommarginalized communities from which participants are drawn, where possible and appropriate.921441 Ethical interieur.pmd915.04.2004, 12:49
UNAIDS guidance document1021441 Ethical interieur.pmd1015.04.2004, 12:49
Ethical considerations in HIV preventive vaccine researchSuggested guidanceGiven the globalGuidance Point 1:nature of theHIV vaccines developmentepidemic, thedevastation beingGiven the severity of the HIV/wreaked in someAIDS pandemic in human, pubcountries by it, thelic health, social, and ecofact that vaccine(s)nomic terms, sufficient capacmay be the best longity and incentives should be determ solution by whichveloped to foster the early andto control the epiethical development of effecdemic, especially intive vaccines, both from thedeveloping countries,point of view of countriesand the potentiallywhere HIV vaccine trials mayuniversal benefits ofbe held, and from the point ofeffective HIV vaccines,view of sponsors of HIV vaccinethere is an ethicaltrials. Donor countries andimperative for globalrelevant international orsupport to the effortganizations should join with theseto develop thesestakeholders to promote suchvaccines. This effortvaccine development.will require intenseinternational collaboration and coordination over time, including among countries with scientificexpertise and resources, and among countries wherecandidate vaccines could be tested but whose infrastructure, resource base, and scientific and ethicalcapacities could be insufficient at present. Though HIVvaccines should benefit all those in need, it is imperativethat they benefit the populations at greatest risk of1121441 Ethical interieur.pmd1115.04.2004, 12:49
UNAIDS guidance documentinfection. Thus, HIV vaccine development shouldensure that the vaccines are appropriate for use amongsuch populations, among which it will be necessary toconduct trials; and, when developed, they should bemade available and affordable to such populations.Because HIV vaccine development activities take time,are complex, and require infrastructure, resources andinternational collaboration,potential sponsor countries and host countriesshould immediately include HIV vaccine development in their regional and national AIDS prevention and control plans.potential host countries should assess how theycan and should participate in HIV vaccine development activities either nationally or on a regional basis, including identifying resources,establishing partnerships, conducting nationalinformation campaigns, strengthening theirscientific and ethical sectors, and including avaccine research component to complementother prevention interventions.potential donors and international agenciesshould make early and sustained commitments toallocate sufficient funds to make a vaccine areality, including funds to strengthen ethical andscientific capacity in countries where multipletrials will have to be conducted and to purchaseand distribute future vaccines.potential sponsors should establish partnerships1221441 Ethical interieur.pmd1215.04.2004, 12:49
Ethical considerations in HIV preventive vaccine researchwith potential host countries, and begin discussions regarding community consultations,strengthening necessary scientific and ethicalcomponents, and eventual plans for equitabledistribution of the benefits of research.Guidance Point 2 :Vaccine availabilityAlthough makinga safe andAny HIV preventive vaccineeffectivedemonstrated to be safe andvaccine reasonablyeffective, as well as otheravailable to theknowledge and benefits resultpopulation where iting from HIV vaccine research,was tested is a basicshould be made available asethical requirement,soon as possible to all particisome have arguedpants in the trials in which itthat it could be awas tested, as well as to otherdisincentive forpopulations at high risk of HIVindustry to conductinfection. Plans should be destudies in countriesveloped at the initial stages ofwith large populations,HIV vaccine development toor that it could constiensure such availability.tute an undue inducement for a resourcepoor country orcommunity to “cooperate”. Given the severity of the epidemic, it is imperative that sufficient incentives exist, both through financialrewards in the marketplace and through public subsidies,to foster development of effective vaccines while alsoensuring that vaccines are produced and distributed in afashion that actually makes them available to thepopulations at greatest risk.1321441 Ethical interieur.pmd1315.04.2004, 12:49
UNAIDS guidance documentAs health and research communities build HIV preventivevaccine research programmes, attention needs to be givenimmediately to how a successful vaccine, and other benefitsresulting from the research, will be made readily andaffordably available to the communities and countries wheresuch a vaccine is tested, as well as to other communities andcountries at high risk for HIV infection. This process ofdiscussion and negotiation should start as soon as possibleand should be carried on through the course of the research.At a minimum, the parties directly concerned should beginthis discussion before the trials commence. This discussionshould include representatives from relevant stakeholders inthe host country, such as representatives from the executivebranch, health ministry, local health authorities, and relevantscientific and ethical groups. It should also include representatives from the communities from which participants aredrawn, people living with HIV/AIDS, and NGOs representingaffected communities. The discussions should includedecisions regarding payments, royalties, subsidies, technologyand intellectual property, as well as distribution costs, channels and modalities, including vaccination strategies, targetpopulations, and number of doses.Furthermore, the discussion concerning availability anddistribution of an effective HIV vaccine should engageinternational organizations, donor governments and bilateralagencies, representatives from wider affected communities,international and regional NGOs and the private sector.These should not only consider financial assistance regardingmaking vaccines available, but should also help to build thecapacity of host governments and communities to negotiatefor and implement distribution plans.1421441 Ethical interieur.pmd1415.04.2004, 12:49
Ethical considerations in HIV preventive vaccine researchGuidance Point 3 :Capacity buildingPotential hostcountries andStrategies should be implecommunitiesmented to build capacity inhave the right, andhost countries and communithe responsibility, toties so that they can practisetake decisions remeaningful self-determinationgarding the nature ofin vaccine development, cantheir participation inensure the scientific and ethiHIV vaccine research.cal conduct of vaccine develYet disparities ineconomic wealth,opment, and can function asscientific experience,equal partners with sponsorsand technical capacand others in a collaborativeity among countriesprocess.and communities canlead to undue influence over and possible exploitation of host countries and communities.The development of an HIV vaccine will require international cooperative research, which should transcend,in an ethical manner, such disparities. Real or perceiveddisparities should be resolved in a way that ensuresequality in decision-making and action. The desiredrelationship is one of collaboration among equals. Factorsthat may increase vulnerability to exploitation of hostcountries and communities may include, but are notlimited to, the following:level of the proposed community’s economiccapacity, such as is reflected in the Human Development Index of the UNDPcommunity/cultural experience with, and/orunderstanding of, scientific research1521441 Ethical interieur.pmd1515.04.2004, 12:49
UNAIDS guidance documentlocal political awareness of the importance andprocess of vaccine researchlocal infrastructure, personnel, and technicalcapacity for providing HIV health care and treatment optionsability of individuals in the community to provideinformed consent, including the effect of class,gender, and other social factors on the potentialfor freely given consentlevel of experience and capacity for conductingethical and scientific review, andlocal infrastructure, personnel, and technicalcapacity for conducting the proposed research.Strategies to overcome these disparities could involve:scientific exchange, and knowledge and skillstransfer between sponsor countries and institutions, and host countries and communitiescapacity-building programmes in the science andethics of vaccine development by relevant scientific institutions and international organizationssupport to development of national and localethical review capacity (see Guidance Point 6)support to affected communities and communities from which participants are drawn regardinginformation, education, and capacity and consensus-building on vaccine development, andearly involvement of affected communities in thedesign and implementation of vaccine development plans and protocols (see Guidance Point 5).1621441 Ethical interieur.pmd1615.04.2004, 12:49
Ethical considerations in HIV preventive vaccine researchIGuidance Point 4 :n order to beResearch protocolsethical, clinicaland study populationstrials of vaccinesIn order to conduct HIV vacshould be based oncineresearch in an ethicallyscientifically validacceptable manner, the reresearch protocols,search protocol should be sciand the scientificentifically appropriate, andquestions posedthe desired outcome of theshould be rigorouslyproposed research should poformulated in atentially benefit the popularesearch protocoltion from which research parthat is capable ofticipants are drawn.providing reliableresponses. Validscientific questionsrelevant to HIVvaccine development are those that seek:to gain scientific information on the safety,immunogenicity (ability to induce immune responses against HIV) and efficacy (degree ofprotection) of candidate vaccinesto determine immunological correlates or surrogates in order to identify the protective mechanisms and how they can be elicitedto compare different candidate vaccines; andto test whether vaccines effective in one population are effective in other populations.Furthermore, the selection of the research populationshould be based on the fact that its characteristics arerelevant to the scientific issues raised; and the results of1721441 Ethical interieur.pmd1715.04.2004, 12:50
UNAIDS guidance documentthe research will potentially benefit the selectedpopulation. In this sense, the research protocolshould:justify the selection of the research populationfrom a scientific point of viewoutline how the risks undertaken by the participants of that population are balanced by thepotential benefits to that populationaddress particular needs of the proposed researchpopulationdemonstrate how the candidate vaccine beingtested is expected to be beneficial to the population in which testing occurs, andestablish safeguards for the protection of researchparticipants from potential harm arising from theresearch.These general principles will be further elaborated below.1821441 Ethical interieur.pmd1815.04.2004, 12:50
Ethical considerations in HIV preventive vaccine researchGuidance Point 5 :Community participationInvolvement ofcommunity repreTo ensure the ethical andsentatives shouldscientific quality of pro not be seen as aposed research, its relsingle encounter, norevance to the affected comas one-directional.munity, and its acceptanceThe orientation ofby the affected community,community involvecommunity representativesment should be oneshould be involved in anof partnership early and sustained mannertowards mutualin the design, development,education andimplementation, and districonsensus-buildingbution of results of HIV vacregarding all aspectscine research.of the vaccinedevelopmentprogramme. Thereshould be established a continuing forum for communication and problem-solving on all aspects of the vaccinedevelopment programme from phase I through phase IIIand beyond, to the distribution of a safe, effective,licensed vaccine. All participating parties should definethe nature of this ongoing relationship. It should includeappropriate representation of the community oncommittees charged with the review, approval, andmonitoring of the HIV vaccine research. Like investigators and sponsors, communities should assume appropriate responsibility for assuring the successful completionof the trial and of the programme.Appropriate community representatives should be determined through a process of broad consultation. Membersof the community who may contribute to a vaccine1921441 Ethical interieur.pmd1915.04.2004, 12:50
UNAIDS guidance documentdevelopment process include representatives of theresearch population eligible to serve as research participants, other members of the community who would beamong the intended beneficiaries of the developedvaccine, relevant nongovernmental organizations,persons living with HIV/AIDS, community leaders,public health officials, and those who provide healthcare and other services to people living with and affected by HIV.Participation of the community in the planning andimplementation of a vaccine development strategy canprovide the following benefits:information regarding the health beliefs andunderstanding of the study populationinput into the design of the protocolinput into an appropriate informed consentprocessinsight into the design of risk reduction interventionseffective methods for disseminating informationabout the trial and its outcomesinformation to the community-at-large on theproposed researchtrust between the community and researchersequity in choice of participantsequity in decisions regarding level of standard ofcare and treatment and its duration, andequity in plans for applying results and vaccinedistribution.2021441 Ethical interieur.pmd2015.04.2004, 12:50
Ethical considerations in HIV preventive vaccine researchPGuidance Point 6 :roposed HIVScientific and ethical reviewvaccine researchHIV preventive vaccine trialsprotocols shouldshould only be carried out inbe reviewed bycountries and communitiesscientific and ethicalthat have the capacity to conreview committeesthat are located in,duct appropriate indepenand include memberdent and competent scienship from, the countrytific and ethical review.and community wherethe research is proposed to take place.This process ensures that the proposed research isanalysed from the scientific and ethical viewpointsby individuals who are familiar with the conditionsprevailing in the potential research population.Some countries do not currently have the capacity toconduct independent, competent and meaningfulscientific and ethical review. If the country’s capacity forscientific and ethical review is inadequate, the sponsorshould be responsible for ensuring that adequate structures are developed in the host country for scientific andethical review prior to the start of the research. Careshould be taken to minimize the potential for conflicts ofinterest, while providing assistance in capacity-buildingfor scientific and ethical review. Capacity-building forscientific and ethical review may also be developed incollaboration with international agencies, organizationswithin the host country, and other relevant parties.2121441 Ethical interieur.pmd2115.04.2004, 12:50
UNAIDS guidance documentSGuidance Point 7 :ome countries orVulnerable populationscommunities,Where relevant, the researchoften described asprotocol should describe the“developing”, have beensocial contexts of a proposedperceived as inappropriresearch population (countryate participants for someor community) that createphases of clinical reconditions for possible exploisearch, due to a real ortation or increased vulnerperceived increased levelability among potential reof vulnerability to exploisearch participants, as well astation or harm. Thethe steps that will be taken tousefulness of the “develovercome these and protectoping/developed”the dignity, safety, and welterminology for assessfare of the participants.ing risk of harm andexploitation, however,is limited. It refersprimarily to economic considerations, which are notthe only relevant factors in HIV vaccine research. Italso establishes two fixed categories, whereas inreality, countries and communities are distributedalong a spectrum, characterized by a variety ofdifferent factors that affect risk. It is more useful toidentify the particular aspects of a social contextthat create conditions for exploitation or increasedvulnerability for the pool of participants that hasbeen selected. These aspects should be described in theprotocol, as should the measures that will be taken toovercome them. In some potential research populations(countries or communities), conditions affecting potentialvulnerability or exploitation may be so severe thatensuring adequate safeguards is not possible. In suchpopulations, HIV preventive vaccine research should notbe conducted.2221441 Ethical interieur.pmd2215.04.2004, 12:50
Ethical considerations in HIV preventive vaccine researchSome factors to be considered are those listed inGuidance Point 3 which influence the disparity in real orperceived power as between sponsors and host countries,as well as the factors listed below that can also increasethe nature and level of risk of harm to participants:governmental, institutional or social stigmatization or discrimination on the basis of HIV statusinadequate ability to protect HIV-related humanrights, and to prevent HIV-related discriminationand stigma, including those arising from participation in an HIV vaccine trialsocial and legal marginalization of groups fromwhich participants might be drawn, e.g. women,injecting drug users, men having sex with men,sex workerslimited availability, accessibility and sustainabilityof health care and treatment optionslimited ability of individuals or groups in thecommunity to understand the research processlimited ability of individuals to understand theinformed consent processlimited ability of individuals to be able to givefreely their informed consent in the light ofprevailing class, gender, and other social and legalfactors, andlack of meaningful national/local scientific andethical review.2321441 Ethical interieur.pmd2315.04.2004, 12:50
UNAIDS guidance documentInitial stages in avaccine development programme entailresearch in laboratories andamong animals. Thetransition from this preclinical phase to a phase Iclinical trial, in whichtesting involves the administration of the candidatevaccine to human subjectsto assess safety and immunogenicity, is a time whenrisks may not be yet welldefined. Furthermore,specific infrastructures areoften required in orde
Introduction 3 Context 6 Suggested guidance 11 Guidance Point 1: HIV vaccines development 11 Guidance Point 2: Vaccine availability 13 Guidance Point 3: Capacity building 15 Guidance Point 4: Research protocols and study populations 17 Guidance Point 5: Community participation 19 Guidance Point 6: Scientific and ethical review 21
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