{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T23:19:08Z","timestamp":1775776748238,"version":"3.50.1"},"reference-count":20,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MRC_UU_12023\/23"],"award-info":[{"award-number":["MRC_UU_12023\/23"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]},{"name":"UK NIHR Clinical Research Network"},{"DOI":"10.13039\/501100002141","name":"Public Health England","doi-asserted-by":"publisher","award":["Innovation Grant"],"award-info":[{"award-number":["Innovation Grant"]}],"id":[{"id":"10.13039\/501100002141","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Sex Transm Infect"],"accepted":{"date-parts":[[2019,1,3]]},"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>Pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention for men who have sex with men (MSM). However, uncertainty remains around the optimal eligibility criteria for PrEP, specifically whether there are subgroups at low risk of HIV for whom PrEP might not be warranted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>PROUD was an open-label waitlist trial design that randomised MSM attending participating sexual health centres in England to receive PrEP immediately (IMM) or after a deferral period of 1\u2009year (DEF). This analysis is based on participants who were randomised to the deferred arm, when they did not have access to PrEP. HIV incidence was compared between subgroups defined by baseline characteristics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 21 participants acquired HIV infection over 239.3 person-years (PY) follow-up, yielding an incidence rate of 8.8\/100 PY (95%\u2009CI 5.4 to 13.4). Two highly significant predictors for HIV acquisition were identified. Men with a self-reported diagnosis of syphilis, rectal chlamydia (CT) or rectal gonorrhoea (GC) in the previous 12 months had an incidence of 17.2\/100 PY (95%\u2009CI 9.7 to 28.5); those reporting receptive anal intercourse without a condom (ncRAI) with two or more partners in the previous 3 months had an incidence of 13.6\/100 PY (95%\u2009CI 7.9 to 21.7). The incidence rate among participants lacking both of these risk factors was 1.1\/100 PY (1\/87.6, 95%\u2009CI 0.03 to 6.4).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The high HIV incidence in PROUD suggests that most participants appropriately judged their need for PrEP. Eligibility criteria for a PrEP programme can therefore be broad, as in the current guidelines. However, a recent history of syphilis or rectal CT\/GC, or multiple ncRAI partners indicates a high imminent risk of HIV infection. MSM with any of these characteristics should be offered PrEP as a matter of urgency.<\/jats:p><\/jats:sec>","DOI":"10.1136\/sextrans-2018-053808","type":"journal-article","created":{"date-parts":[[2019,3,28]],"date-time":"2019-03-28T10:53:29Z","timestamp":1553770409000},"page":"449-454","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":17,"title":["Predictive factors for HIV infection among men who have sex with men and who are seeking PrEP: a secondary analysis of the PROUD trial"],"prefix":"10.1136","volume":"95","author":[{"given":"Ellen","family":"White","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David T","family":"Dunn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monica","family":"Desai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitzy","family":"Gafos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Kirwan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann K","family":"Sullivan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Clarke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sheena","family":"McCormack","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,3,27]]},"reference":[{"key":"2024092304500593000_95.6.449.1","doi-asserted-by":"crossref","first-page":"2587","DOI":"10.1056\/NEJMoa1011205","article-title":"Preexposure chemoprophylaxis for HIV prevention in men who have sex with men","volume":"363","author":"Grant","year":"2010","journal-title":"N Engl J Med Overseas Ed"},{"key":"2024092304500593000_95.6.449.2","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1016\/S0140-6736(15)00056-2","article-title":"Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial","volume":"387","author":"McCormack","year":"2016","journal-title":"The Lancet"},{"key":"2024092304500593000_95.6.449.3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1506273"},{"key":"2024092304500593000_95.6.449.4","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiw223"},{"key":"2024092304500593000_95.6.449.5","unstructured":"Nash S , Desai S , Croxford S , et al . Progress towards ending the HIV epidemic in the United Kingdom: 2018 report. London: Public Health England, 2018."},{"key":"2024092304500593000_95.6.449.6","doi-asserted-by":"crossref","unstructured":"Brown AE , Mohammed H , Ogaz D , et al . Fall in new HIV diagnoses among men who have sex with men (MSM) at selected London sexual health clinics since early 2015: testing or treatment or pre-exposure prophylaxis (PreP)? Euro Surveill. 2017;22.doi:10.2807\/1560-7917.ES.2017.22.25.30553","DOI":"10.2807\/1560-7917.ES.2017.22.25.30553"},{"key":"2024092304500593000_95.6.449.7","unstructured":"World Health Organization . Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection 2016. Available: http:\/\/www.who.int\/hiv\/pub\/arv\/arv-2016\/en\/"},{"key":"2024092304500593000_95.6.449.8","unstructured":"Centers for Disease Control and Prevention . Preexposure prophylaxis for the prevention of HIV infection in the United States, 2017. Available: https:\/\/www.cdc.gov\/hiv\/pdf\/risk\/prep\/cdc-hiv-prep-guidelines-2017.pdf"},{"key":"2024092304500593000_95.6.449.9","unstructured":"British HIV Organisation . BHIVA\/BASHH guidelines on the use of HIV pre-exposure prophylaxis (PreP), 2018. Available: https:\/\/www.bhiva.org\/PrEP-guidelines"},{"key":"2024092304500593000_95.6.449.10","unstructured":"European AIDS Clinical Society (EACS) . EACS guidelines 9.0, 2017. Available: http:\/\/www.eacsociety.org\/guidelines\/eacs-guidelines\/eacs-guidelines.html."},{"key":"2024092304500593000_95.6.449.11","doi-asserted-by":"crossref","unstructured":"Dolling DI , Desai M , McOwan A , et al . An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis. 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HIV moments and pre-exposure prophylaxis \u2013 authors' reply. The Lancet 2016;387.doi:10.1016\/S0140-6736(16)00695-4","DOI":"10.1016\/S0140-6736(16)00695-4"},{"key":"2024092304500593000_95.6.449.16","doi-asserted-by":"crossref","unstructured":"Cambiano V , Miners A , Dunn D , et al . Cost-effectiveness of pre-exposure prophylaxis for HIV prevention in men who have sex with men in the UK: a modelling study and health economic evaluation. Lancet Infect Dis 2018;18.doi:10.1016\/S1473-3099(17)30540-6","DOI":"10.1016\/S1473-3099(17)30540-6"},{"key":"2024092304500593000_95.6.449.17","doi-asserted-by":"crossref","unstructured":"Ong KJ , Desai S , Field N , et al . Economic evaluation of HIV pre-exposure prophylaxis among men-who-have-sex-with-men in England in 2016. 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