Nondisclosure of HIV status is behavior with powerful implications for clinical trial enrollment. Could it happen in clinical care? Do we need to be wary? The question remains open.
Accurate diagnosis of HIV status is as important for enrollment in clinical trials as it is for clinical care. Identification of individuals with newly diagnosed HIV infection is usually based on data obtained directly from patients regarding their prior HIV testing (self-reporting). However, self-reporting may prove both erroneous and unreliable; in fact some patients who report newly diagnosed HIV infection are already receiving treatment.
In a widely publicized study, published in late 2013 in the Journal Clinical Infectious Diseases,1 investigators analyzed samples from patients enrolled in the HIV Prevention Trials Network (HPTN) 061 study.2 HPTN 061 evaluated the feasibility of multiple interventions to reduce HIV incidence among black men who have sex with men (MSM) in the United States. Individuals were eligible for the HPTN trial if they were not on treatment per self-report. Participants were enrolled from the community or as sexual partners of index participants. Index participants were HIV-uninfected men, HIV-infected men who were aware of their infection but not on treatment (previously diagnosed), or HIV-infected men who reported no prior HIV diagnosis. Antiretroviral (ARV) drug testing was performed on HIV-infected men who reported no prior HIV diagnosis and had viral loads <1000 copies/mL. Testing was by qualitative assay that detects 15 ARV drugs, including non-nucleoside reverse transcriptase inhibitors, nucleoside/nucleotide reverse transcriptase inhibitors, and protease inhibitors.
Among the 155 HPTN participants who reported a new diagnosis (no prior or current treatment), 83 were found to have viral loads <1000 copies/mL. These 83 underwent drug testing and 71 (85.5%) of them were positive for at least one ARV at enrollment. Of the 68 participants with viral loads <400 copies/mL, 63 (92.6%) had such drugs detected.
Findings were similar for another HPTN study (#052): approximately half the “treatment-naÃ¯ve” participants with HIV infection who had undetectable viral loads were actually receiving ARV.
It is not clear whether this level of nondisclosure would occur in clinical practice but the studies do support a certain level of caution. In routine care settings self-report of HIV status may be unreliable for identifying newly diagnosed cases and an objective laboratory test should be used to confirm.