Study participants with VISR may experience social harms associated with the misunderstanding of their HIV status.Area of daily lifePotential social harmsCommentsPersonal relationships and XL147 in the societyFamily members, loved ones, and co-workers may have negative reactions to trial participation or misinterpret VISR as true HIV infection.The stigma of being associated with HIV ‘positivity’ was reported as a major concern for potential trial volunteers [23] and [24] and was the main social harm in the CAB consultations conducted by the Enterprise.EmploymentEmployers may discriminate against a potential employee perceived as being HIV positive.Reported cases have been rare, but the potential impact is serious [25] and [26].Insurance (medical/dental, disability, or life)In some countries, insurance companies may request an HIV test from an applicant to check for pre-existing conditions and could deny insurance or charge a higher premium from a person perceived to be HIV-infected.Trial sponsors can intervene by providing confirmation of participation and true HIV status; however, companies are not legally compelled to accept test results from CRSs.The insurance industry of the Republic of South Africa has implemented guidelines for HIV testing of individuals applying for insurance who identify as HIV vaccine study participants. These testing guidelines are incorporated into laboratory test requisitions [27].Travel – immigrationA volunteer with VISR may be denied a visa as a result of an HIV test during the medical exam portion of a visa application [28] and [29].For a small number of countries that require an HIV test for entry, visa applicants with VISR should contact the embassy of the destination country and inquire if an HIV test result from a specific laboratory is acceptable or if they need to contact the trial sponsor for assistance in providing comprehensive documentation of their true HIV status.International travelers may also benefit from alerting their own country\'s consulate in the event that further assistance is needed once abroad.Military career, blood banking within military, and deploymentFor some countries with high prevalence, HIV infection is not exclusionary to military service.In the US, individuals with VISR are ineligible to join the military. If already enrolled, they cannot be deployed because they cannot be blood donors in the field [30] and [31].Potential trial volunteers in the US need to be clearly informed that development of VISR may make them ineligible to serve in the US military and eliminate military service as a career option for the foreseeable future.Keefer et al. reported a case that was resolved after the trial sponsor established HIV-negative status [32].US soldiers are excluded from enrollment in the military\'s own HIV vaccine trials [33].Blood, organ, stem cell, and sperm donationsA person with VISR may be rejected on the basis of testing uncertainty. The inability to donate may be considered a social harm by volunteers and may also prevent lifesaving medical procedures for loved ones and patients in critical conditions.In France and the USA, volunteers with VISR are not allowed to donate blood.In Thailand, trial volunteers must produce proof that they were enrolled in the placebo arm of an HIV vaccine trial to be able to donate blood.Confirmation of HIV-negative status of a participant with VISR may not change the exclusion from blood donation per Red Cross guidelines [34].Newborn HIV prophylaxis in the context of PMTCTA newborn in the clinic or hospital may be given antiretroviral drugs as prophylaxis if the mother has VISR and is tested with a rapid test during labor.One case is known in the US wherein a newborn was placed on ART due to the mother\'s VISR. ART was discontinued after the mother self-identified as a vaccine volunteer, the trial site confirmed study participation, and confirmatory tests were conducted [35]. There was another case in the US where a newborn was about to be placed on ART due to the mother\'s VISR status despite the mother self-identifying as a vaccine trial volunteer; initiation of ART was avoided after the trial site was contacted, and confirmatory tests were conducted [36].Full-size tableTable optionsView in workspaceDownload as CSV
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