When cases of AIDS began to appear in North America in the late 1970s and early 1980s, men who had sex with men (MSM) were considered a high-risk group, as were hemophiliacs and Haitians.1,2 This was primarily due to the disease's high prevalence in these population at a time when little was known about the virus and its transmission routes. The first case of HIV transmission through blood transfusion was recorded in 1981; in 1984 it was confirmed that it could be transmitted through this route. Screening blood donors for sexual behaviors considered high-risk became mandatory at this point.3,4

In 1983, the North American Food and Drug Administration (FDA) began its attempts to minimize the transmission of HIV through blood donation, developing awareness and information strategies about the virus and about risk behaviors that could expose donors to infection. However, the FDA recognized the need to intervene more directly in hemotherapy processes. As a result, the first policy prohibiting MSM from donating blood indefinitely was implemented in September 1985.1,5

In Brazil, the policy of excluding MSM from donating blood emerged in May 1985 with ordinance no 236 of the Ministry of Health. Even though its resolution did not explicitly include the exclusion of MSMs, it mentioned members of risk groups.6 Since then, there have been notable improvements in HIV treatment, although the infection still has important health consequences.7

Over the subsequent decades, remarkable advances in HIV testing and treatment, including the most sensitive diagnostic technology, nucleic acid amplification testing, have allowed progressive reductions in deferral periods in many countries, moving from a definitive deferral to a temporary deferral of five years, 12 months or three months. 8-14 A significant drawback of this approach is that, even for a brief period of deferral, all sexually active MSM - including those in committed monogamous relationships - are effectively barred from giving blood. It also does not identify heterosexual donors who engage in potentially risky sexual behaviors such as multiple partners or unprotected sex, which may affect the residual risk of transfusion-transmitted HIV depending on the epidemiology of transmission in a given country.15-19

Some researchers and advocates for the rights of the lesbian, gay, bisexual, transgender, intersex, queer/questioning, asexual etc. (LGBTQIA+) community have long argued that the ban of MSM is discriminatory and that different strategies for assessing high-risk behaviors already exist. Groups such as the Human Rights Campaign advocated for the US FDA to review donation eligibility in order to assess the risk of sexual behaviors equally, without regard to sexual orientation or gender identity. The UK group For the Assessment of Individualized Risk (FAIR)20 has conducted studies to determine whether it is possible to adopt a more individualized risk assessment approach to blood donor selection policy while also ensuring safe blood supply to patients. According to the group, there is no single way to ensure the safety of the blood supply. Nonetheless, the literature generally agrees that the two primary steps required to guarantee safety are (a) serological testing of all potential donors and (b) precise identification of safe donors through behavioral and clinical screening.21,22

The findings of the studies conducted by the FAIR group recommend several adjustments to guarantee a safe and equitable screening process that treats all individuals equally, irrespective of their gender identity or sexual orientation. These adjustments have been dubbed as a ‘neutral approach’ or ‘individualized risk assessment’.20 The advantage of this sex-neutral approach is that it does not stigmatize gay men by classifying all sexually active MSM as high-risk. However, regardless of the sexual orientation of donor candidates, this requires asking all donors a new set of personal questions and personalizing the pre-donation clinical interview by addressing high-risk behaviors that may affect transfusion risk.20-23

In Brazil, the rules that temporarily excluded MSM from blood donation were changed by a decision of the Supreme Court in 2020. The Supreme Court deemed that the regulations of the National Health Surveillance Agency (Anvisa) and the veto of the act by the Ministry of Health were discriminatory.6 Consequently, a project in the Brazilian house of Senate that called for the outlawing of discrimination against blood donors based on sexual orientation was approved at the end of 2021. Nevertheless, no novel methods of behavioral screening have been introduced despite modifications. Moreover, no research has been done to restructure the behavioral and clinical screening interview and suggest a neutral strategy that takes transfusion risk into account, in contrast to other nations like the United Kingdom and Canada.21,23-25

Thus, this study aims to propose a Portuguese version of the FAIR screening criteria that has been adapted for use in studies on the implementation of a neutral approach based on individual risk in healthcare services in Brazil.

The original version of the FAIR screening criteria was translated and went through all planned stages of cross-cultural adaptation until the proposal of a final version suitable for its application in the Brazilian population. A better description of some steps are provided in the results section so that the process can be better understood.

The cross-cultural adaptation stages began with an expert panel. This stage was attended by five professionals: two specialists in adapting scales on human behavior, a nurse involved in the blood donation process, and two researchers in the area of sexual risk behaviors of vulnerable populations. All experts (nurse and researchers) had previous experience with scale adaptation. As a result, all items were categorized as ‘totally equivalent sentences’ based on the expert's evaluation of the equivalency of the translated items with no additional major modifications or reviews being required. Only a few suggestions for capitalizing or highlighting certain words were made by the experts which the authors deemed relevant. These changes were made to the final version of the instrument.

Data for the cognitive interviewing step were collected between November 8th and November 25th 2023. A brief characterization of the participants in this stage was obtained. The sample was composed of 15 MSM individuals with a mean age of 23.4 (standard deviation: 2.7) years. Among the participants, 14 classified themselves as men and one as non-binary/queer. Most have incomplete higher education. In terms of monthly income, the majority of participants reported earning between two and four minimum wages, with one participant reporting less than one minimum wage.

The duration of each interview session was from 10 to 15 min. As a result, all participants classified the items as easy to understand and had no doubts regarding the content. One participant admitted discomfort while answering certain items. When asked about the source of his discomfort, the participant stated, as an example, that he felt guilty for not using condoms in his sexual relationships. No other respondent reported feeling uncomfortable while filling out the questionnaire. Additionally, none of the 15 participants considered any of the items or words used in the items of the Portuguese version of the FAIR screening criteria as stigmatizing or inappropriate, nor would they change anything in the questionnaire. In response to the question “What is this questionnaire for?”, ten participants believed it was applied for screening behaviors, sexual health, and sexually transmitted infections (STIs); four believed it was an instrument for collecting data for scientific studies; and one declared he did not know.

After reviewing all of the steps and ensuring that they were completed, the researchers finalized the version of the instrument, as presented in Table 1 along with its original version for comparison.

After all the steps as presented in detail, the present study suggests that the translated and adapted version of the FAIR screening criteria is suitable for application in studies on high-risk sexual behavior in the Brazilian population. As previously stated, the FAIR screening criteria were designed as a neutral approach in the context of clinical screening for blood donation, aiming to reduce transfusion risk.20 However, due to its straightforward, simple language and focus on specific and frequent behaviors in some populations, this instrument may also be helpful both for scientific studies and clinical practice in different contexts in the public health area.

In the official publication of the FAIR steering group's conclusions,20 the authors proposed two versions of the instrument, which were used in different contexts/surveys, namely 1) Reports of individual actual behavior, considering the general population, and 2) Perceptions of normative behavior, considering the population of blood donors. The two versions differ in minor aspects, with the main distinction being the separation of questions about the use of PREP and PEP. Two questions were used in the version intended for the donor population, one for PREP and the other for PEP, yielding a total of 12 items. For the general population, the authors combined these questions into a single question (“In the last three months, have you taken PrEP or PEP?”), yielding an instrument with 11 items. In the current study, we propose an adapted version that addresses PrEP and PEP separately, as this is a more complete version of the instrument. In this regard, we recommend that adaptation needs and the possibility of combining items be evaluated before applying it in subsequent studies, considering its objectives and its contexts of use.

The applied methodology was designed to avoid language that is not inclusive or stigmatizes some population groups. Therefore, no question was recognized as such, a result of the cognitive interviewing stage. Nonetheless, it is well known that certain inquiries concerning sexual behavior frequently cause discomfort, particularly in medical settings.22,33

A study conducted by Haw et al.22 sought to identify strategies to reduce discomfort in answering specific questions about high-risk sexual behavior in blood donation candidates. Several strategies to lessen discomfort were mentioned by participants, both explicitly in their suggestions and implicitly in their discussions about how comfortable they felt answering the presented questions. According to the findings, reducing discomfort may involve providing explanations that go into varying degrees of detail regarding the necessity and purpose of the questions. Participants also suggested that more specific questions would lessen guesswork and that ambiguity in the use of spoken or written language may lead to uncertainty. Finally, it was preferable to answer questions in a self-administered questionnaire, such as a web-based app, rather than in a face-to-face interview.

Still considering the interrogatory interview step, one participant expressed a sense of guilt while filling out the FAIR instrument. According to Thomas et al.,34 the MSM population is more susceptible to internalized homophobia and low self-esteem, which can lead to increased risk-taking and poor decision-making. Given that accessibility in healthcare includes proper language use,35 extra efforts are required to prepare professionals involved in screening processes or medical interviews so that they do not stigmatize the patients/blood donation candidates, thereby avoiding discomfort and feelings of guilt.

As a conclusion, the Portuguese version of the FAIR screening criteria for high-risk sexual behavior screening is available for use in future studies or for implementation in healthcare services. Guidance and information about the instrument's content should be tailored to the unique circumstances of each application, taking into account the discomfort that different population groups may experience. If a personal interview is the preferred method of application, team training and additional employee preparation may be required.

This work was supported by the São Paulo Research Foundation [Grants: #2023/10473-5; #2020/02187-4].