Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex with Men (DaDHS)
Summary
Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual and other men who have sex with men (gbMSM), with the potential for significant sequelae - particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of this STI have prompted a search for novel prevention solutions. A recent pilot study of daily doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other infections. The overarching goal of this project is to determine whether the daily use of doxycycline is an efficacious and acceptable intervention for syphilis prevention in high-risk, HIV-positive gbMSM.
Timeline
- Start
- 2019-08-15
- Primary completion
- 2024-04-05
- Completion
- 2024-12-31
Publications
- Background Ontario Agency for Health Protection and Promotion (Public Health Ontario). Reportable Disease Trends in Ontario, 2013. Toronto, ON: Queen's Printer for Ontario; 2015.
- Background Burchell AN, Allen VG, Gardner SL, Moravan V, Tan DH, Grewal R, Raboud J, Bayoumi AM, Kaul R, Mazzulli T, McGee F, Rourke SB; OHTN Cohort Study Team. High incidence of diagnosis with syphilis co-infection among men who have sex with men in an HIV cohort in Ontario, Canada. BMC Infect Dis. 2015 Aug 20;15:356. doi: 10.1186/s12879-015-1098-2.
- Background Bolan RK, Beymer MR, Weiss RE, Flynn RP, Leibowitz AA, Klausner JD. Doxycycline prophylaxis to reduce incident syphilis among HIV-infected men who have sex with men who continue to engage in high-risk sex: a randomized, controlled pilot study. Sex Transm Dis. 2015 Feb;42(2):98-103. doi: 10.1097/OLQ.0000000000000216.
- Background Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
- Background Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, Hosek S, Mosquera C, Casapia M, Montoya O, Buchbinder S, Veloso VG, Mayer K, Chariyalertsak S, Bekker LG, Kallas EG, Schechter M, Guanira J, Bushman L, Burns DN, Rooney JF, Glidden DV; iPrEx study team. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014 Sep;14(9):820-9. doi: 10.1016/S1473-3099(14)70847-3. Epub 2014 Jul 22.
- Background Pang LW, Limsomwong N, Boudreau EF, Singharaj P. Doxycycline prophylaxis for falciparum malaria. Lancet. 1987 May 23;1(8543):1161-4. doi: 10.1016/s0140-6736(87)92141-6.
- Background Sehgal SC, Sugunan AP, Murhekar MV, Sharma S, Vijayachari P. Randomized controlled trial of doxycycline prophylaxis against leptospirosis in an endemic area. Int J Antimicrob Agents. 2000 Feb;13(4):249-55. doi: 10.1016/s0924-8579(99)00134-x.
- Background Patton ME, Su JR, Nelson R, Weinstock H; Centers for Disease Control and Prevention (CDC). Primary and secondary syphilis--United States, 2005-2013. MMWR Morb Mortal Wkly Rep. 2014 May 9;63(18):402-6.
- Background Jin F, Prestage GP, Zablotska I, Rawstorne P, Imrie J, Kippax SC, Donovan B, Templeton DJ, Kaldor JM, Grulich AE. High incidence of syphilis in HIV-positive homosexual men: data from two community-based cohort studies. Sex Health. 2009 Dec;6(4):281-4. doi: 10.1071/SH09060.
- Background Ling DI, Janjua NZ, Wong S, Krajden M, Hoang L, Morshed M, Achen M, Murti M, Lester RT, Wong J, Ogilvie G, Gilbert M. Sexually transmitted infection trends among gay or bisexual men from a clinic-based sentinel surveillance system in British Columbia, Canada. Sex Transm Dis. 2015 Mar;42(3):153-9. doi: 10.1097/OLQ.0000000000000250.
- Background Ogilvie GS, Taylor DL, Moniruzzaman A, Knowles L, Jones H, Kim PH, Rekart ML. A population-based study of infectious syphilis rediagnosis in British Columbia, 1995-2005. Clin Infect Dis. 2009 Jun 1;48(11):1554-8. doi: 10.1086/598997.
- Background Jarzebowski W, Caumes E, Dupin N, Farhi D, Lascaux AS, Piketty C, de Truchis P, Bouldouyre MA, Derradji O, Pacanowski J, Costagliola D, Grabar S; FHDH-ANRS CO4 Study Team. Effect of early syphilis infection on plasma viral load and CD4 cell count in human immunodeficiency virus-infected men: results from the FHDH-ANRS CO4 cohort. Arch Intern Med. 2012 Sep 10;172(16):1237-43. doi: 10.1001/archinternmed.2012.2706.
- Background Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999 Feb;75(1):3-17. doi: 10.1136/sti.75.1.3.
- Background Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.
- Background Lohse N, Hansen AB, Pedersen G, Kronborg G, Gerstoft J, Sorensen HT, Vaeth M, Obel N. Survival of persons with and without HIV infection in Denmark, 1995-2005. Ann Intern Med. 2007 Jan 16;146(2):87-95. doi: 10.7326/0003-4819-146-2-200701160-00003.
- Background Samji H, Cescon A, Hogg RS, Modur SP, Althoff KN, Buchacz K, Burchell AN, Cohen M, Gebo KA, Gill MJ, Justice A, Kirk G, Klein MB, Korthuis PT, Martin J, Napravnik S, Rourke SB, Sterling TR, Silverberg MJ, Deeks S, Jacobson LP, Bosch RJ, Kitahata MM, Goedert JJ, Moore R, Gange SJ; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of IeDEA. Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One. 2013 Dec 18;8(12):e81355. doi: 10.1371/journal.pone.0081355. eCollection 2013.
- Background Bogowicz P, Moore D, Kanters S, Michelow W, Robert W, Hogg R, Gustafson R, Gilbert M; ManCount Study Team. HIV testing behaviour and use of risk reduction strategies by HIV risk category among MSM in Vancouver. Int J STD AIDS. 2016 Mar;27(4):281-7. doi: 10.1177/0956462415575424. Epub 2015 Mar 2.
- Background Vallabhaneni S, McConnell JJ, Loeb L, Hartogensis W, Hecht FM, Grant RM, Pilcher CD. Changes in seroadaptive practices from before to after diagnosis of recent HIV infection among men who have sex with men. PLoS One. 2013;8(2):e55397. doi: 10.1371/journal.pone.0055397. Epub 2013 Feb 6.
- Background Hart G. Syphilis tests in diagnostic and therapeutic decision making. Ann Intern Med. 1986 Mar;104(3):368-76. doi: 10.7326/0003-4819-104-3-368.
- Background Romney MG, Hull MW, Gustafson R, Sandhu J, Champagne S, Wong T, Nematallah A, Forsting S, Daly P. Large community outbreak of Streptococcus pneumoniae serotype 5 invasive infection in an impoverished, urban population. Clin Infect Dis. 2008 Sep 15;47(6):768-74. doi: 10.1086/591128.
- Background Lloyd-Smith E, Hull MW, Hawkins D, Champagne S, Kerr T, Romney MG. Screening for methicillin-resistant Staphylococcus aureus (MRSA) in community-recruited injection drug users: are throat swabs necessary? Epidemiol Infect. 2012 Sep;140(9):1721-4. doi: 10.1017/S0950268811002421. Epub 2011 Dec 13.
- Background Kuehnert MJ, Kruszon-Moran D, Hill HA, McQuillan G, McAllister SK, Fosheim G, McDougal LK, Chaitram J, Jensen B, Fridkin SK, Killgore G, Tenover FC. Prevalence of Staphylococcus aureus nasal colonization in the United States, 2001-2002. J Infect Dis. 2006 Jan 15;193(2):172-9. doi: 10.1086/499632. Epub 2005 Dec 15.
- Background Abudu L, Blair I, Fraise A, Cheng KK. Methicillin-resistant Staphylococcus aureus (MRSA): a community-based prevalence survey. Epidemiol Infect. 2001 Jun;126(3):351-6. doi: 10.1017/s0950268801005416.
- Background Fedson DS, Scott JA. The burden of pneumococcal disease among adults in developed and developing countries: what is and is not known. Vaccine. 1999 Jul 30;17 Suppl 1:S11-8. doi: 10.1016/s0264-410x(99)00122-x.
- Background Aral SO, Blanchard JF. The Program Science initiative: improving the planning, implementation and evaluation of HIV/STI prevention programs. Sex Transm Infect. 2012 Apr;88(3):157-9. doi: 10.1136/sextrans-2011-050389. Epub 2012 Feb 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxycycline | Small molecule | 100 mg | Oral |