The Opposites Attract Study of viral load, HIV treatment and HIV transmission in serodiscordant homosexual male couples: design and methods

BMC Public Health

Andrew E Grulich²  Kathy Triffitt²  Anthony Kelleher³  Christopher Fairley⁵  David A Cooper⁷  Beatriz Grinsztejn⁶  Nittaya Phanuphak¹  Kersten K Koelsch⁷  Iryna Zablotska²  Garrett Prestage⁴  Fengyi Jin²  Benjamin R Bavinton² 

[1]Thai Red Cross AIDS Research Centre, 10330 Phathumwan, Bangkok, Thailand

[2]The Kirby Institute, University of New South Wales, 2052 Sydney, NSW, Australia

[3]St. Vincent’s Centre for Applied Medical Research, St. Vincent’s Hospital, 2010 Darlinghurst, NSW, Australia

[4]Australian Research Centre in Sex, Health and Society, La Trobe University, 3000 Melbourne, Victoria, Australia

[5]Monash University, 3800 Clayton, Victoria, Australia

[6]Instituto de Pesquisa Clínica Evandro Chagas, Manguinhos, 21040-360 Rio de Janeiro, Brazil

[7]St. Vincent’s Hospital, Sydney, 2010 Darlinghurst, NSW, Australia

关键词: Antiretroviral therapy;    HIV transmission;    Homosexual;    Serodiscordant;    HIV treatment as prevention;   

Others  :  1128028
DOI  :  10.1186/1471-2458-14-917

 received in 2014-08-07, accepted in 2014-08-27,  发布年份 2014

【 摘 要 】

Background

Studies in heterosexual HIV serodiscordant couples have provided critical evidence on the role of HIV treatments and undetectable viral load in reducing the risk of HIV transmission. There is very limited data on the risk of transmission from anal sex in homosexual male serodiscordant couples.

Methods/Design

The Opposites Attract Study is an observational prospective longitudinal cohort study of male homosexual serodiscordant partnerships running from 2012 to 2015 and conducted in clinics throughout Australia, Brazil and Thailand. Couples attend two or more clinic visits per year. The HIV-positive partner’s viral load is tested and the HIV-negative partner is tested for HIV antibodies at every clinic visit. Results from any tests for sexually transmitted infections are also collected. Detailed behavioural questionnaires are completed by both partners at the time of each visit. The primary research question is whether HIV incidence is lower in those couples where the HIV-positive partner is receiving HIV treatment compared to couples where he is not receiving treatment. A voluntary semen sub-study will examine semen plasma viral load in a subsample of HIV-positive partners in Sydney, Rio de Janeiro and Bangkok. In cases of seroconversion of the initially HIV-negative partner, phylogenetic analysis will be conducted at the end of the study on virus from stored blood samples from both partners to determine if the infection came from the HIV-positive study partner. Men in new serodiscordant relationships will specifically be targeted for recruitment.

Discussion

This study will provide critical data on the reduction in HIV transmission risk associated with being on HIV treatment in homosexual male serodiscordant couples in different regions of the world. Data from men in new relationships will be particularly valuable given that the highest transmission risk is in the first year of serodiscordant relationships. Furthermore, the detailed behavioural and attitudinal data from the participant questionnaires will allow exploration of many contextual factors associated with HIV risk, condom use and the negotiation of sexual practice within couples.

【 授权许可】

   
2014 Bavinton et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Attia S, Egger M, Müller M, Zwahlen M, Low N: Sexual transmission of HIV according to viral load and antiretroviral therapy: systematic review and meta-analysis. AIDS 2009, 23(11):1397-1404.
• [2]Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Millis LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, et al.: Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011, 365(6):493-505.
• [3]Montaner JSG: Treatment as prevention—a double hat-trick. Lancet 2011, 378(9787):208-209.
• [4]Smith K, Powers KA, Kashuba ADM, Cohen MS: HIV-1 treatment as prevention: the good, the bad, and the challenges. Curr Opin HIV AIDS 2011, 6(4):315.
• [5]Hammer SM: Antiretroviral Treatment as Prevention. N Engl J Med 2011, 365(6):561-562.
• [6]Muessig KE, Smith MK, Powers KA, Lo Y-R, Burns DN, Grulich AE, Phillips AN, Cohen MS: Does ART prevent HIV transmission among MSM? AIDS 2012, 26(18):2267-2273.
• [7]Rodger A, Bruun T, Weait M, Vernazza P, Collins S, Estrada V, Van Lunzen J, Corbelli GM, Lampe F, Phillips A: Partners of people on ART- a New Evaluation of the Risks (The PARTNER study): Design and methods. BMC Public Health 2012, 12(1):1-6. BioMed Central Full Text
• [8]Vittinghoff E, Douglas J, Judon F, McKiman D, MacQueen K, Buchinder SP: Per-contact risk of Human Immunodificiency Virus transmission between male sexual partners. Am J Epidemiol 1999, 150(3):306-311.
• [9]Visser RO, Smith A, Rissel CE, Richters J, Grulich AE: Sex in Australia: Heterosexual experience and recent heterosexual encounters among a representative sample of adults. Aust NZ J Publ Heal 2003, 27(2):146-154.
• [10]Rodger A, Bruun T, Cambiano V, Vernazza P, Estrada V, Van Lunzen J, Collins S, Geretti AM, Phillips A, Lundgren J, PARTNER Study Group: HIV transmission risk through condomless sex if HIV+ partner on suppressive ART: PARTNER study. [Abstract 153LB]. In 21st Conference on Retroviruses and Opportunistic Infections. Boston, USA; 2014. http://croi2014.org/sites/default/files/uploads/CROI2014_Final_Abstracts.pdf webcite
• [11]Jin F, Jansson J, Law M, Prestage GP, Zablotska I, Imrie JCG, Kippax SC, Kaldor JM, Grulich AE, Wilson DP: Per-contact probability of HIV transmission in homosexual men in Sydney in the era of HAART. AIDS 2010, 24(6):907.
• [12]Jin F, Prestage GP, McDonald A, Ramacciotti T, Imrie JC, Kippax SC, Kaldor JM, Grulich AE: Trend in HIV incidence in a cohort of homosexual men in Sydney: data from the Health in Men Study. Sex Health 2008, 5(2):109-112.
• [13]Falster K, Gelgor L, Shaik A, Zablotska I, Prestage G, Grierson J, Thorpe R, Pitts M, Anderson J, Chuah J: Trends in antiretroviral treatment use and treatment response in three Australian states in the first decade of combination antiretroviral treatment. Sex Health 2008, 5(2):141-154.
• [14]Jin F, Imrie J, Kippax S, Zablotska I, Kaldor J, Grulich A: HIV negative homosexual men in HIV sero-discordant relationships in the Health In Men Study. In 21st Annual Conference of the Australasian Society for HIV Medicine. Brisbane: Australia; 2009.
• [15]STIs In Gay Men Action Group: STI Testing Guidelines for Men who have Sex with Men (MSM). Sydney, Australia: STIs In Gay Men Action Group; 2010.
• [16]Lam TT-Y, Hon C-C, Tang JW: Use of phylogenetics in the molecular epidemiology and evolutionary studies of viral infections. Crit Rev Cl Lab Sci 2010, 47(1):5-49.
• [17]Bavinton BR, Jin F, Prestage G, Zablotska I, Grulich A, The Opposites Attract Study Group: Evidence of behavioural risk compensation in a cohort study of HIV treatment and transmission in homosexual male serodiscordant couples. Melbourne, Australia: 20th International AIDS Conference (AIDS 2014); 2014. http://pag.aids2014.org/abstracts.aspx?aid=6528 webcite
• [18]Australian National Health and Medical Research Council: National Statement on Ethical Conduct in Human Research. Australian Government: Canberra, ACT; 2007.
• [19]World Medical Association: World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Med Assoc 2013, 310(20):2191.
• [20]Bavinton BR, Jin F, Prestage G, Mao L, Zablotska I, Grulich AE: Exploring gay men's serodiscordant relationships: Implications for future 'treatment as prevention' studies in gay men. In M2012 International Microbicides Conference. Sydney, Australia; 2012. https://secure.ashm.org.au/ei/viewpdf.esp?id=82&file=c%3A%5CCertain%5CEventwin%5Cdocs%5Cpdf%5Cc12micAbstract00736%2Epdf webcite
• [21]De Vincenzi I: A longitudinal study of human immunodeficiency virus transmission by heterosexual partners. N Engl J Med 1994, 331(6):341-346.
• [22]Padian NS, Shiboski SC, Glass SO, Vittinghoff E: Heterosexual transmission of human immunodeficiency virus (HIV) in northern California: Results from a ten-year study. Am J Epidemiol 1997, 146(4):350-357.
• [23]Guthrie BL, de Bruyn G, Farquhar C: HIV-1-discordant couples in sub-Saharan Africa: explanations and implications for high rates of discordancy. Curr HIV Res 2007, 5(4):416-429.
• [24]Fernández-Dávila P, Folch C, Zaragoza Lorca K, Casabona J: Silence and Assumptions: Narratives on the Disclosure of HIV Status to Casual Sexual Partners and Serosorting in a Group of Gay Men in Barcelona. Int J Sex Health 2011, 23(2):139-155.
• [25]Zablotska IB, Grulich AE, De Wit J, Prestage G: Casual sexual encounters among gay men: familiarity, trust and unprotected anal intercourse. AIDS Behav 2011, 15(3):607-612.