Validation of participant eligibility for pre-exposure prophylaxis: Baseline data from the <i>PRELUDE</i> demonstration project

<div><p>Background</p><p>In Australia, pre-exposure prophylaxis (PrEP) is targeted to individuals at high risk for HIV infection. We describe the HIV risk profile and characteristics of <i>PRELUDE</i> participants, and evaluate the population validity of the sample in representing high-risk gay and bisexual men (GBM) eligible for PrEP.</p><p>Methods</p><p><i>PRELUDE</i> is an on-going, open-label, single-arm observational study. Participants were identified in clinics and screened for eligibility using a paper-based risk assessment tool which followed the New South Wales (NSW) PrEP guidelines. Selection was validated using an independent online behavioural survey, completed by study participants upon enrolment. Demographic information was analysed using descriptive statistics, and kappa tests were used to determine agreement between reporting of high-risk practices in the risk assessment and behavioural survey.</p><p>Results</p><p>During 2014–15, 471 individuals were targeted for enrolment; 341 were assessed for PrEP eligibility and 313 were enrolled. Of these, 303 (97%) identified as GBM. Overall, 85% of GBM met at least one high-risk criterion; 68% reported receptive intercourse with an HIV-positive or unknown status casual male partner, and 37% reported methamphetamine use in the three months preceding enrolment. The remaining 15% were enrolled based on medium-risk behaviours, or at the clinicians’ discretion. We found an 82% total agreement between self-reported high-risk behaviour and clinicians’ categorisation of GBM as being at high risk for HIV based on PrEP eligibility criteria.</p><p>Conclusions</p><p>Behavioural eligibility criteria used by clinicians successfully identified individuals at high risk for HIV infection. This targeted approach ensures that the greatest public health and HIV prevention benefits can be derived in a setting without universal access to PrEP.</p></div

CONSORT flow diagram.

<p>CONSORT flow diagram.</p

Agreement in reporting high-risk behavioural practices between paper-based risk assessment and online behavioural survey for gay and bisexual men (n = 305).

<p>Agreement in reporting high-risk behavioural practices between paper-based risk assessment and online behavioural survey for gay and bisexual men (n = 305).</p

Comparison of high-risk behaviours reported in the paper-based risk assessment and online behavioural survey (n = 305).

<p>HR1: Had an HIV-positive regular partner with whom condoms were not consistently used; HR2: Had receptive intercourse with a casual male partner of HIV-positive or unknown status; HR3: Been diagnosed rectal chlamydia or gonorrhoea; HR4: Methamphetamine use.</p

New South Wales HIV pre-exposure prophylaxis behavioural eligibility criteria for gay and bisexual men.

<p>New South Wales HIV pre-exposure prophylaxis behavioural eligibility criteria for gay and bisexual men.</p

Sexual partners and practices of gay and bisexual male participants (n = 305) in the three months preceding baseline.

<p>Sexual partners and practices of gay and bisexual male participants (n = 305) in the three months preceding baseline.</p