Vox Sanguinis (2014) 106, 14–22 © 2013 International Society of Blood Transfusion DOI: 10.1111/vox.12093
ORIGINAL PAPER
Compliance with the current 12-month deferral for male-to-male sex in Australia C. R. Seed,1 T. T. Lucky,2 D. Waller,3 H. Wand,2 J. F. Lee,1 S. Wroth,1 A. McDonald,2 J. Pink,4 D. P. Wilson2 & A. J. Keller1 1
Australian Red Cross Blood Service, Perth, WA, Australia The Kirby Institute, University of New South Wales, Sydney, NSW, Australia 3 Australian Red Cross Blood Service, Sydney, NSW, Australia 4 Australian Red Cross Blood Service, Brisbane, Qld, Australia 2
Background and Objectives In Australia since 2000, donors are deferred for 12 months since last male-to-male sexual contact. There is no estimate of the prevalence of non-compliance (i.e. failure to disclose a risk during the predonation interview which would lead to deferral) with the policy in Australia; however, published studies elsewhere indicate a range of 08–11%. We investigated the rate of, timing and motivation for non-compliance. Materials and Methods A nationally representative sample of donors who had made a recent donation negative for transfusion-transmissible infection testing was surveyed using an anonymous, online instrument. Non-compliance was considered as a ‘yes’ response to the current screening question. Non-compliers were requested to define the timing of the last sexual contact relevant to their most recent donation. Univariate and multivariate regression analyses were used to define factors associated with non-compliance. Results Of 14 476 responses from male donors, 34 (023%, 95% CI: 016–033%) were non-compliant of whom 24 (017%, 95% CI: 011–025%) had contact within 6 months of donation. Factors significantly associated with non-compliance included: multiple sexual partners, history of injecting drug use, perception of a lack of privacy during interview and preference for a computer-based questionnaire.
Received: 8 July 2013, revised 1 September 2013, accepted 3 September 2013, published online 10 October 2013
Conclusion Our study confirms high compliance (>997%) to the 12-month deferral for male-to-male sex in Australia providing reassuring evidence for the efficacy of the screening question. Issues of ‘privacy’ and ‘discomfort’ associated with disclosure suggest the use of validated audio computer-assisted structured interview as a possible option for improving compliance with the donor questionnaire. Key words: donors, epidemiology, transfusion-transmissible infection.
Introduction Deferral of men who have sex with men (MSM) has been the subject of ongoing debate since first application in the early 1980s in response to the observation that HIV disproportionately affected MSM [1–6]. More recently, especially with the improvement in the variety and sensiCorrespondence: Clive R. Seed, Australian Red Cross Blood Service, Level 1, 69 Walters Dr. Osborne Park, Western Australia 6017, Australia E-mail:
[email protected]
14
tivity of screening tests for infectious disease, opponents cite permanent deferral for male-to-male sex – which is currently based on risk behaviour, but not sexual orientation as discriminatory against gay and bi-sexual men [7,8]. The majority of blood services worldwide continue to defer donors for male-to-male sexual contact on safety grounds for a period ranging from 6 months to permanent [9]. In Australia, MSM are currently deferred for 12 months since last sexual contact, and this policy has applied nationwide since 2000 [10]. The policy remains
Compliance with the 12-month MSM deferral in Australia 15
controversial and has been the subject of several unsuccessful legal challenges, the most recent in 2009 [11]. The rationale for ongoing deferral for male-to-male sex relates to the limitation of tests for transfusion-transmissible infections (TTI) including HIV and HBV which are unable to detect donors with very recently acquired infection [known as the testing ‘window period’ (WP)]. However, screening questions targeting high-risk behaviours for TTIs (e.g. intravenous drug use or recent high-risk sexual contact) can potentially identify such donors and their deferral prevents TTIs. The efficacy of this strategy is directly dependent on the donor’s full and frank disclosure (termed ‘compliance’) when answering the relevant screening question on the predonation questionnaire. Non-compliance is detrimental to blood safety, and understanding the motivations for and rate of non-compliance among donors provides an important safety metric. Anonymous donor surveys investigating compliance to permanent deferral policies for male-to-male sex have been conducted in a number of countries including the USA [12], UK [13] and Canada [14] with non-compliance ranging from 08 to 106%. Follow-up interviews with HIVinfected (i.e. test-positive) donors in Australia for the 2000–2006 period indicated a non-compliance rate for male-to-male sex of approximately 27% [15], comparable to a recent UK report of 25% [16]. More recently, the overall non-compliance rate for high-risk behaviours among HIV-, HCV-, HBV- and HTLV-infected donors in Australia declined from 244% in 2008 to 129% in 2011 [17], which is comparable to the 11% reported in UK donors during 2011 [16]. However, the non-compliance rate among donors testing TTI negative (which would include any in the WP) has not been assessed in Australia. We previously validated the comparative safety of the current Australian 12-month deferral for male-to-male sex in respect of the risk of HIV transmission [10]. No significant increase in the number of donors with HIV or the proportion with male-to-male sex as a risk was evident when comparing 5-year periods before and after the implementation of the current deferral. The finding from this study that all five HIV-positive donors identified in the 5 years after implementation were non-compliant (i.e. had contact within 12 months and thus should have self-deferred) highlighted that in terms of the risk of collecting an HIV-positive donation, compliance with the deferral policy appears to be more influential than the duration of the deferral itself. This hypothesis has since been supported by other investigators in Sweden [18], France [19] and the UK [20]. The Australian Blood Service nationally applicable donor selection criteria are evidence-based, reviewed annually and approved by the Australian Competent Authority (Australian Therapeutic Goods Administration). © 2013 International Society of Blood Transfusion Vox Sanguinis (2014) 106, 14–22
In response to allegations of discrimination, the Blood Service undertook an independent, expert review of sexual-activity-based deferral policies including those for male-to-male sex, sex with a bi-sexual male, sex work/sex with a sex worker and sex with a resident of, or new partner from a high-HIV-risk county. This expert review committee has since recommended that the current 12-month deferral for all these sexual-activity-based deferrals including male-to-male sex could safely be reduced to 6 months. The selection of a 6-month period was principally based on a review of the testing window periods for HIV, HBV and HCV, the predominant sexually transmissible TTIs in Australia. The window periods for tests currently applied in Australia to screen for these TTIs are all well within 6 months allowing for a comfortable ‘margin for error’ consistent with the public expectation of maintaining a precautionary approach in matters impacting recipient safety. Among additional suggested research by the review committee was an anonymous donor study assessing the rate of compliance with the existing deferral, the results of which should be considered by the Blood Service before any change is implemented [21]. In this report, we describe a subset of data from an online, anonymous survey of volunteer Australian donors who had recently donated a TTI-negative donation. The primary aim of the survey was to provide a reliable estimate of the rate of, and timing in relation to last donation of non-compliance with the current 12-month deferral for male-to-male sex although we also took the opportunity to assess compliance with other sexual-activity-based deferrals and donor attitudes to our current predonation assessment process (to be reported separately).
Materials and methods Study participants The study sample comprised 30 274 (14 476 men and 15 798 women) Australian blood donors who had made at least one successful donation within 6 weeks of invitation to the study. For the purpose of this research, a successful donation was defined as having satisfactorily completed the donor assessment process including completion of the predonation questionnaire, formal interview and signature of a legally binding statutory declaration together with negative mandatory TTI test results (see below). To optimise privacy during donation assessment, formal one-on-one interviews are conducted between the donor and assessor in dedicated interview rooms wherever possible. In a minority of collection sessions where a dedicated room is unavailable, a designated area ensuring ‘auditory privacy’ is required to conduct assessment interviews. This requirement is
16 C. R. Seed et al.
audited by collection site managers prior to the commencement of collection sessions. Donors with positive or incomplete mandatory test results, sample only collections, therapeutic venesections (i.e. patients) and/or autologous collections were excluded from the study. The participant group was a convenience sample stratified against the national blood donor panel on age, gender, donation experience and state of residence to provide a nationally representative sample.
Mandatory TTI testing All donors in the study were tested for HBsAg, antiHCV, anti-HIV 1 and 2, anti-HTLV I and II using the Abbott PRISM HBsAg, anti-HCV, HIV 1-2 O plus or anti-HTLV I/II chemiluminescent immunoassays (ChLIA) (Abbott Diagnostics, Delkenheim, Germany). Additionally, all donations were tested for HIV-1 RNA, HCV RNA and HBV DNA individually with the PROCLEIX ULTRIO (HIV-1/HCV/HBV multiplex) assay (Ultrio) on the PROCLEIX TIGRIS (Tigris) automated system (GenProbe/Novartis Diagnostics, San Diego/Emeryville, CA, USA) and antibodies to Treponema pallidum using the Beckman Coulter PK automated microplate system (Beckman Coulter, Tokyo, Japan) using the Treponema pallidum microhaemagglutination test (Fujirebio Inc, Tokyo, Japan).
responses from the survey, specifically those relating to male-to-male sex and the assessment of the effectiveness of the screening materials and process (similar to the method of Goldman et al. [14]). The survey instrument was designed using skip logic such that questions appeared individually, with the response driving the subsequent question posed. The maximum number of questions posed to a participant was 32. The survey was designed such that a valid response was required before the next question was presented. The option for participants to track back through the survey was provided so that an erroneous response could be retrospectively corrected by the donor. A link to the secure survey was sent as a component of the email invitation from the Blood Service. The survey link was restricted so that it could only be used once to avoid multiple submissions either from the same invitee or from any others that might be forwarded the invitation email. If a donor experienced problems using a restricted survey link, they were given the option to use a generic link. Researchers monitored the number of responses received from restricted links (total responses from restricted links: 30 443, of which 516 were excluded from analyses including 455 where no matching invitation link existed) vs. generic links (total responses from generic links: 347) and are confident that the overall sample reflects an unbiased estimate of donor compliance that has not been affected by multiple submissions.
Survey method The Blood Service sent a total of 98 044 email invitations to eligible participants inviting them to complete the survey. Among the 98 044 invitations, 16 934 were to first-time donors (7739 men and 9195 women) and 81,110 to repeat donors (39 479 men and 41 631 women). Monthly batches of invites were sent starting from November 2012 concluding April 2013. In addition, an automated reminder email was sent to participants 1–2 weeks after the initial email. These strategies were successful with the study achieving an overall response rate of 314%. The survey instrument was created using Survey Gizmo a secure online research tool. The decision to use an online survey was made in order to reduce project costs and to increase the accuracy of participant responses. Research indicates that validity of responding to sensitive questions is increased when participants feel able to report anonymously [22]. The survey collected information on demographics, perceptions of the current Blood Service interview process and information related to the specific risk factors of interest. In this report, we consider a subset of
Consent Participants were required to read an information statement and had to signal agreement to participation before gaining access to the survey. As the survey was anonymous, the ability to withdraw consent and survey responses was not available. Whilst links to the survey were sent by the Blood Service, responses were collected by the Kirby Institute using Survey Gizmo ensuring anonymity of responses. Statistical analyses of the data were conducted by the Kirby Institute. The survey protocol was approved by both the Australian Red Cross Blood Service and the University of New South Wales Human Research Ethics committees.
MSM survey questions The current Blood Service predonation questionnaire contains a specific question designed to capture male-to-male sexual contact. This question was included verbatim in the survey with ‘yes’ responses (i.e. non-compliers) requested to define within the 12-month period the timing of the contact (see below). © 2013 International Society of Blood Transfusion Vox Sanguinis (2014) 106, 14–22
Compliance with the 12-month MSM deferral in Australia 17
Question
Responses
If participant is male: In the last 12 months, have you had male-to-male sex (that is, oral or anal sex) with or without a condom?
a. Yes b. No If you have answered Yes to the above question, when was the most recent time you had sex with a man prior to your last donation? a. Within 1 month b. Within 6 months, but not within 1 month c. Within 12 months, but not within 6 months
Non-compliance Male donors who reported male-to-male sexual contact (either oral/anal with or without condom) within 12 months prior to their most recent donation are defined as non-compliant with the current deferral for male-tomale sex. The timing of this non-compliance in relation to their most recent donation was requested to allow an analysis of a potential change to the duration of the deferral to 6 months.
Data analysis and statistical methods We derived the prevalence (95% confidence intervals) of non-compliance among male donors who had reported having sex with men overall and by donor status (firsttime vs. repeat donors). Descriptive statistics were used to compare socio-demographic characteristics for compliant donors including age, state/territory of current residence, country of birth (Australian born vs. not), language spoken at home (English vs. others), level of education (high school vs. less than high school) as well as sexual behaviours, with those who were designated as non-compliant. Chi-square and Fisher’s exact (when observed cell counts
