It is worth reviewing the procedures that ensure the safety of blood donations: donor screening (self-assessment questionnaire and pre-donation interview) and laboratory testing. Donor screening identifies individuals with risk factors (related to sexual behavior, travel, drug use, or medical procedures) for blood-borne diseases. Laboratory tests performed on each donation detect markers of infection and exclude positive donations.

Donor screening is very important because it identifies individuals who have been recently infected and whose biological markers of infection are not yet detectable by laboratory tests. This is referred to as the “silent window,” which poses a “residual risk” of infection transmission through transfusion.

Each year, 20 to 30 donors discover their HIV-positive status during a blood donation, as part of the blood product qualification process. However, the majority of these donors found to be HIV-positive do not meet the selection criteria and should have been rejected during the pre-donation medical interview.

Our objective was therefore, through a qualitative study of blood donors whose HIV-positive status was discovered during a blood donation, to understand the reasons for non-compliance with blood donation exclusion criteria. The objectives were to explore the level of information, perceptions, motivations, the context of the donation, and the mechanisms of “non-compliance” among HIV-positive donors during the selection of donation candidates.

It is also important to note that this study was conducted in the context of a review of blood donor selection criteria, the most controversial aspect of which was the permanent deferral of men who have sex with men (MSM)⁽¹⁾. Assessing understanding of the permanent deferral criterion for MSM was also an important objective. Indeed, according to epidemiological surveillance data, despite the permanent deferral of MSM from blood donation until June 2016 in France, nearly 40% of donors who discovered their HIV-positive status during blood donation were men who have sex with men ⁽MSM)⁽²⁾.

This study is the result of a collaboration between Santé publique France and several partners: the French Blood Establishment (EFS), the Armed Forces Blood Transfusion Center (CTSA), the National Blood Transfusion Institute (INTS), and the Cermes III laboratory (Inserm), with a significant social component whose scientific coordination was led by Marie Jauffret Roustide under an Inserm-Santé publique France interface contract.

Thirty-two blood donors who tested positive for HIV during a blood donation between mid-2011 and 2014 participated in this study, which was conducted in 2015. Questions regarding their experience and motivations for donating blood, their understanding of selection criteria, sexual risk management, and opinions on donor selection were asked during face-to-face interviews.

The most striking finding was the high proportion of participants (more than half) who did not comply with blood donor selection criteria. In other words, more than half did not disclose their risk factors in the questionnaire or during the pre-donation interview. The reasons cited were varied: stigma, concern about HIV status, or a symbolic attachment to blood donation. More specifically, when blood donation is experienced as a powerful individual symbolic act, compliance is perceived as secondary. As for the permanent deferral of MSM that was in effect at the time of the study, it was disapproved of by all participants.

The assessment of risky sexual behaviors is not always well understood by the donors themselves.

Furthermore, neither the epidemiological rationale behind blood donor selection criteria nor the concept of the “silent window” is well understood.

In conclusion, it appears that donor selection criteria should be better explained and supported by strong, consistent, and understandable epidemiological arguments to gain donor acceptance.

This study was conducted to inform decision-making and guide public policy on an issue that has long been controversial. Some of the findings from this study have already been taken into account.

The definition of new criteria for selecting blood donors, as described in the decree of April 5, 2016, was based on epidemiological reasoning better suited to the epidemiological reality of the risk of bloodborne infection transmission, notably including the harmonization of deferral periods according to risk level*.

The pre-donation questionnaire has been revised to be better understood by prospective donors. Drawing on the lessons from this study, it now features more educational and comprehensive content. Finally, training for staff conducting pre-donation interviews has been enhanced.

A year and a half after the changes to blood donation eligibility criteria, Santé publique France, in partnership with the EFS and the CTSA, will launch a national study among blood donors. This time, it is a quantitative study whose primary objective is to assess donor compliance with the new screening measures (particularly those concerning MSM) and the factors associated with non-compliance. The results of this survey, expected by the end of 2018, should make it possible to adjust the deferral period for MSM—which is currently one year—while ensuring maximum transfusion safety.