Risk of False HIV Diagnoses - Information for healthcare providers
HIV vaccine trial participants can test HIV vaccine-induced seropositive (VISP) even if they are not infected with HIV.
Tests such as EIA, Western Blot and rapid tests detect HIV antibodies, not the virus, resulting in a potentially false diagnosis of HIV infection for some HIV vaccine trial participants.
Incorrect HIV diagnoses of study participants create significant problems and can:
We do not know how long the body will retain these antibodies. Some former study participants have tested VISP even 15 years post-study.
HIV vaccine study participants are instructed to decline HIV tests outside their study site.
- Cause unwarranted distress.
- Result in incorrect HIV infection reporting to public health authorities.
- Compromise a participant's study "blind", which is needed for accurate conclusions about a vaccine's effect on safety, immunogenicity, and efficacy.
Help your patient avoid an incorrect diagnosis:
- Study participants may decline HIV tests due to current or former study participation.
- Free HIV tests are available through the participant's vaccine study site or the HVTN VISP Testing Service.
- Your patient can give the study site permission to send you test results showing recent HIV status.
- With your patient's permission, you may be able to contact the study site directly.
- Inform your patients if HIV testing is indicated for their healthcare.
- Ask patients whether they have participated in an HIV vaccine trial—even if they don't fit your perception of HIV vaccine study participants.
- Familiarize yourself with HIV vaccine trials happening in your area. If you need HIV test results on a patient who is or was an HIV vaccine trial participant, please contact the participant's trial site to coordinate the HIV test.