Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection

Michael W. Traeger, Vincent J. Cornelisse, Jason Asselin, Brian Price, Norman J. Roth, Jeff Willcox, Ban Kiem Tee, Christopher K. Fairley, Christina C. Chang, Jude Armishaw, Olga Vujovic, Matthew Penn, Pauline Cundill, George Forgan-Smith, John Gall, Claire Pickett, Luxi Lal, Anne Mak, Tim D. Spelman, Long Nguyen & 12 others Dean A. Murphy, Kathleen E. Ryan, Carol El-Hayek, Michael West, Simon Ruth, Colin Batrouney, John T. Lockwood, Jennifer F. Hoy, Margaret E. Hellard, Mark A. Stoové, Edwina J. Wright, PrEPX study team

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Importance: Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP). Objective: To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement. Design, Setting, and Participants: The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018. Exposures: Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring. Main Outcomes and Measures: The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378). Results: Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]). Conclusions and Relevance: Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

Original languageEnglish
Pages (from-to)1380-1390
Number of pages11
JournalJAMA
Volume321
Issue number14
DOIs
Publication statusPublished - 9 Apr 2019

Cite this

Traeger, Michael W. ; Cornelisse, Vincent J. ; Asselin, Jason ; Price, Brian ; Roth, Norman J. ; Willcox, Jeff ; Tee, Ban Kiem ; Fairley, Christopher K. ; Chang, Christina C. ; Armishaw, Jude ; Vujovic, Olga ; Penn, Matthew ; Cundill, Pauline ; Forgan-Smith, George ; Gall, John ; Pickett, Claire ; Lal, Luxi ; Mak, Anne ; Spelman, Tim D. ; Nguyen, Long ; Murphy, Dean A. ; Ryan, Kathleen E. ; El-Hayek, Carol ; West, Michael ; Ruth, Simon ; Batrouney, Colin ; Lockwood, John T. ; Hoy, Jennifer F. ; Hellard, Margaret E. ; Stoové, Mark A. ; Wright, Edwina J. ; PrEPX study team. / Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection. In: JAMA. 2019 ; Vol. 321, No. 14. pp. 1380-1390.
@article{574e0f51979f4f9eae261336ccdd456a,
title = "Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection",
abstract = "Importance: Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP). Objective: To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement. Design, Setting, and Participants: The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018. Exposures: Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring. Main Outcomes and Measures: The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378). Results: Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5{\%} identified as gay or bisexual males, 29{\%} used PrEP prior to enrollment, 89 (3{\%}) withdrew and were censored at date of withdrawal, leaving 2892 (97.0{\%}) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48{\%}) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25{\%}) accounting for 2237 (76{\%}) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95{\%} CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95{\%} CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95{\%} CI, 1.04-1.33]). Conclusions and Relevance: Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.",
author = "Traeger, {Michael W.} and Cornelisse, {Vincent J.} and Jason Asselin and Brian Price and Roth, {Norman J.} and Jeff Willcox and Tee, {Ban Kiem} and Fairley, {Christopher K.} and Chang, {Christina C.} and Jude Armishaw and Olga Vujovic and Matthew Penn and Pauline Cundill and George Forgan-Smith and John Gall and Claire Pickett and Luxi Lal and Anne Mak and Spelman, {Tim D.} and Long Nguyen and Murphy, {Dean A.} and Ryan, {Kathleen E.} and Carol El-Hayek and Michael West and Simon Ruth and Colin Batrouney and Lockwood, {John T.} and Hoy, {Jennifer F.} and Hellard, {Margaret E.} and Stoov{\'e}, {Mark A.} and Wright, {Edwina J.} and {PrEPX study team}",
year = "2019",
month = "4",
day = "9",
doi = "10.1001/jama.2019.2947",
language = "English",
volume = "321",
pages = "1380--1390",
journal = "JAMA",
issn = "0098-7484",
publisher = "American Medical Association (AMA)",
number = "14",

}

Traeger, MW, Cornelisse, VJ, Asselin, J, Price, B, Roth, NJ, Willcox, J, Tee, BK, Fairley, CK, Chang, CC, Armishaw, J, Vujovic, O, Penn, M, Cundill, P, Forgan-Smith, G, Gall, J, Pickett, C, Lal, L, Mak, A, Spelman, TD, Nguyen, L, Murphy, DA, Ryan, KE, El-Hayek, C, West, M, Ruth, S, Batrouney, C, Lockwood, JT, Hoy, JF, Hellard, ME, Stoové, MA, Wright, EJ & PrEPX study team 2019, 'Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection', JAMA, vol. 321, no. 14, pp. 1380-1390. https://doi.org/10.1001/jama.2019.2947

Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection. / Traeger, Michael W.; Cornelisse, Vincent J.; Asselin, Jason; Price, Brian; Roth, Norman J.; Willcox, Jeff; Tee, Ban Kiem; Fairley, Christopher K.; Chang, Christina C.; Armishaw, Jude; Vujovic, Olga; Penn, Matthew; Cundill, Pauline; Forgan-Smith, George; Gall, John; Pickett, Claire; Lal, Luxi; Mak, Anne; Spelman, Tim D.; Nguyen, Long; Murphy, Dean A.; Ryan, Kathleen E.; El-Hayek, Carol; West, Michael; Ruth, Simon; Batrouney, Colin; Lockwood, John T.; Hoy, Jennifer F.; Hellard, Margaret E.; Stoové, Mark A.; Wright, Edwina J.; PrEPX study team.

In: JAMA, Vol. 321, No. 14, 09.04.2019, p. 1380-1390.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection

AU - Traeger, Michael W.

AU - Cornelisse, Vincent J.

AU - Asselin, Jason

AU - Price, Brian

AU - Roth, Norman J.

AU - Willcox, Jeff

AU - Tee, Ban Kiem

AU - Fairley, Christopher K.

AU - Chang, Christina C.

AU - Armishaw, Jude

AU - Vujovic, Olga

AU - Penn, Matthew

AU - Cundill, Pauline

AU - Forgan-Smith, George

AU - Gall, John

AU - Pickett, Claire

AU - Lal, Luxi

AU - Mak, Anne

AU - Spelman, Tim D.

AU - Nguyen, Long

AU - Murphy, Dean A.

AU - Ryan, Kathleen E.

AU - El-Hayek, Carol

AU - West, Michael

AU - Ruth, Simon

AU - Batrouney, Colin

AU - Lockwood, John T.

AU - Hoy, Jennifer F.

AU - Hellard, Margaret E.

AU - Stoové, Mark A.

AU - Wright, Edwina J.

AU - PrEPX study team

PY - 2019/4/9

Y1 - 2019/4/9

N2 - Importance: Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP). Objective: To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement. Design, Setting, and Participants: The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018. Exposures: Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring. Main Outcomes and Measures: The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378). Results: Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]). Conclusions and Relevance: Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

AB - Importance: Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP). Objective: To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement. Design, Setting, and Participants: The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018. Exposures: Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring. Main Outcomes and Measures: The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378). Results: Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]). Conclusions and Relevance: Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

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DO - 10.1001/jama.2019.2947

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