Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests

BMC Infectious Diseases

Rebecca Guy⁴  John M Kaldor⁴  Basil Donovan⁶  Suzanne M Garland⁵  William Rawlinson¹  Marion Saville³  Handan Wand⁴  Sepehr N Tabrizi⁵  Catriona S Bradshaw²  Phillip Read⁶  Anna McNulty⁸  Christopher K Fairley²  Marcus Chen²  Jane S Hocking⁷  Kirsty S Smith⁴ 

[1] Virology Division, SEALS Microbiology, Prince of Wales Hospital, Randwick, NSW, Australia;Melbourne Sexual Health Centre, Carlton, Victoria, Australia;VCS Pathology, Carlton, Victoria, Australia;Kirby Institute, University of New South Wales, Sydney, NSW, Australia;Department of Microbiology and Infectious Diseases, Royal Women’s Hospital, Parkville, Victoria, Australia;Sydney Sexual Health Centre, Sydney, NSW, Australia;Melbourne School of Population and Global Health, University of Melbourne, Carlton, Victoria, Australia;School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia

关键词: Home-collection;    Reinfection;    Positivity;    Retesting;    Chlamydia;   

Others  :  1134033
DOI  :  10.1186/1471-2334-14-223

 received in 2013-11-13, accepted in 2014-04-09,  发布年份 2014

【 摘 要 】

Background

Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men (MSM). Despite guidelines recommending chlamydia retesting three months after treatment, retesting rates are low. We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service (SMS) reminders on chlamydia retesting and reinfection rates in three risk groups.

Methods/Design

The REACT (retest after Chlamydia trachomatis) trial involves 600 patients diagnosed with chlamydia: 200 MSM, 200 women and 200 heterosexual men recruited from two Australian sexual health clinics where SMS reminders for retesting are routine practice. Participants will be randomised to the home group (3-month SMS reminder and home-collection) or the clinic group (3-month SMS reminder to return to the clinic). Participants in the home group will be given the choice of attending the clinic if they prefer. The mailed home-collection kit includes a self-collected vaginal swab (women), UriSWAB (Copan) for urine collection (heterosexual men), and UriSWAB plus rectal swab (MSM). The primary outcome is the retest rate at 1-4 months after a chlamydia diagnosis, and the secondary outcomes are: the repeat positive test rate; the reinfection rate; the acceptability of home testing with SMS reminders; and the cost effectiveness of home testing. Sexual behaviour data collected via an online survey at 4-5 months, and genotyping of repeat infections, will be used to discriminate reinfections from treatment failures. The trial will be conducted over two years. An intention to treat analysis will be conducted.

Discussion

This study will provide evidence about the effectiveness of home-collection combined with SMS reminders on chlamydia retesting, repeat infection and reinfection rates in three risk groups. The trial will determine client acceptability and cost effectiveness of this strategy.

Trial registration

Australian and New Zealand Clinical Trials Registry ACTRN12611000968976.

【 授权许可】

   
2014 Smith et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Kirby Institute: HIV, viral hepatitis and sexually transmitted infections in Australia Annual Surveillance Report 2012. Sydney: Kirby Institute, University of New South Wales; 2012.
• [2]Health Protection Agency HIV Sexually Transmitted Infections Department Centre for Infections: Sexually Transmitted Infections and Young People in the United Kingdom. London: Health Protection Agency HIV and Sexually Transmitted Infections Department Centre for Infections; 2008.
• [3]Centers for Disease Control and Prevention (CDC): Sexually Transmitted Disease Surveillance 2011. Atlanta: United States Department of Health and Human Services; 2012.
• [4]Hocking JS, Willis J, Tabrizi S, Fairley CK, Garland SM, Hellard M: A chlamydia prevalence survey of young women living in Melbourne, Victoria. Sex Health 2006, 3(4):235-240.
• [5]Goulet V, de Barbeyrac B, Raherison S, Prudhomme M, Semaille C, Warszawski J: Prevalence of Chlamydia trachomatis: results from the first national population-based survey in France. Sex Transm Infect 2010, 86(4):263-270.
• [6]Datta SD, Torrone E, Kruszon-Moran D, Berman S, Johnson R, Satterwhite CL, Papp J, Weinstock H: Chlamydia trachomatis trends in the United States among persons 14 to 39 years of age, 1999-2008. Sex Transm Dis 2012, 39(2):92-96.
• [7]Eggleston E, Rogers SM, Turner CF, Miller WC, Roman AM, Hobbs MM, Erbelding E, Tan S, Villarroel MA, Ganapathi L: Chlamydia trachomatis infection among 15- to 35-year-olds in Baltimore, MD. Sex Transm Dis 2011, 38(8):743-749.
• [8]Vodstrcil LA, Fairley CK, Fehler G, Leslie D, Walker J, Bradshaw CS, Hocking JS: Trends in chlamydia and gonorrhea positivity among heterosexual men and men who have sex with men attending a large urban sexual health service in Australia, 2002-2009. BMC Infect Dis 2011, 11:158. BioMed Central Full Text
• [9]Annan NT, Sullivan AK, Nori A, Naydenova P, Alexander S, McKenna A, Azadian B, Mandalia S, Rossi M, Ward H, Nwokolo N: Rectal chlamydia–a reservoir of undiagnosed infection in men who have sex with men. Sex Transm Infect 2009, 85(3):176-179.
• [10]Kent CK, Chaw JK, Wong W, Liska S, Gibson S, Hubbard G, Klausner JD: Prevalence of rectal, urethral, and pharyngeal chlamydia and gonorrhea detected in 2 clinical settings among men who have sex with men: San Francisco, California, 2003. Clin Infect Dis 2005, 41(1):67-74.
• [11]Centers for Disease Control and Prevention (CDC): Clinic-based testing for rectal and pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections by community-based organizations-five cities, United States, 2007. MMWR Morb Mortal Wkly Rep 2009, 58(26):716-719.
• [12]Scott LaMontagne D, Baster K, Emmett L, Nichols T, Randall S, McLean L, Meredith P, Harindra V, Tobin JM, Underhill GS, Graham Hewitt W, Hopwood J, Gleave T, Ghosh AK, Mallinson H, Davies AR, Hughes G, Fenton KA: Incidence and reinfection rates of genital chlamydial infection among women aged 16–24 years attending general practice, family planning and genitourinary medicine clinics in England: a prospective cohort study by the Chlamydia Recall Study Advisory Group. Sex Transm Infect 2007, 83(4):292-303.
• [13]Walker J, Tabrizi SN, Fairley CK, Chen MY, Bradshaw CS, Twin J, Taylor N, Donovan B, Kaldor JM, McNamee K, Urban E, Walker S, Currie M, Birden H, Bowden F, Gunn J, Pirotta M, Gurrin L, Harindra V, Garland SM, Hocking JS: Chlamydia trachomatis incidence and re-infection among young women–behavioural and microbiological characteristics. PLoS One 2012, 7(5):e37778.
• [14]Fung M, Scott KC, Kent CK, Klausner JD: Chlamydial and gonococcal reinfection among men: a systematic review of data to evaluate the need for retesting. Sex Transm Infect 2007, 83(4):304-309.
• [15]Harte D, Mercey D, Jarman J, Benn P: Is the recall of men who have sex with men (MSM) diagnosed as having bacterial sexually transmitted infections (STIs) for re-screening a feasible and effective strategy? Sex Transm Infect 2011, 87(7):577-582.
• [16]Haggerty CL, Gottlieb SL, Taylor BD, Low N, Xu F, Ness RB: Risk of Sequelae after Chlamydia trachomatis Genital Infection in Women. J Infect Dis 2010, 201(Suppl 2):S134-S155.
• [17]Bernstein KT, Marcus JL, Nieri G, Philip SS, Klausner JD: Rectal gonorrhea and chlamydia reinfection is associated with increased risk of HIV seroconversion. J Acquir Immune Defic Syndr 2010, 53(4):537-543.
• [18]Batteiger BE, Tu W, Ofner S, Van Der Pol B, Stothard DR, Orr DP, Katz BP, Fortenberry JD: Repeated Chlamydia trachomatis Genital Infections in Adolescent Women. J Infect Dis 2010, 201(1):42-51.
• [19]Golden MR, Whittington WLH, Handsfield HH, Hughes JP, Stamm WE, Hogben M, Clark A, Malinski C, Helmers JRL, Thomas KK, Holmes KK: Effect of expedited treatment of sex partners on recurrent or persistent gonorrhea or chlamydial infection. N Engl J Med 2005, 352(7):676-685.
• [20]Schwebke JR, Rompalo A, Taylor S, Seña AC, Martin DH, Lopez LM, Lensing S, Lee JY: Re-Evaluating the Treatment of Nongonococcal Urethritis: Emphasizing Emerging Pathogens–A Randomized Clinical Trial. Clin Infect Dis 2011, 52(2):163-170.
• [21]Handsfield HH: Questioning azithromycin for chlamydial infection. Sex Transm Dis 2011, 38(11):1028-1029.
• [22]Horner PJ: Azithromycin antimicrobial resistance and genital Chlamydia trachomatis infection: duration of therapy may be the key to improving efficacy. Sex Transm Infect 2012, 88(3):154-156.
• [23]Chlamydia Trachomatis UK Testing Guidelines http://www.bashh.org/documents/3352.pdf webcite
• [24]Centers for Disease Control and Prevention (CDC): Sexually Transmitted Diseases Treatment Guidelines, 2010. MMWR Morb Mortal Wkly Rep 2010, 59(No. RR-12):46.
• [25]Australasian Chapter of Sexual Health Medicine: National management guidelines for sexually transmissible infections. Melbourne: Royal Australasian College of Physicians; 2008.
• [26]Bourne C, Edwards B, Shaw M, Gowers A, Rodgers C, Ferson M: Sexually transmissible infection testing guidelines for men who have sex with men. Sex Health 2008, 5(2):189-191.
• [27]Lanjouw E, Ossewaarde JM, Stary A, Boag F, van der Meijden WI: 2010 European guideline for the management of Chlamydia trachomatis infections. Int J STD AIDS 2010, 21(11):729-737.
• [28]Hoover KW, Tao G, Nye MB, Body BA: Suboptimal adherence to repeat testing recommendations for men and women with positive Chlamydia tests in the United States, 2008-2010. Clin Infect Dis 2013, 56(1):51-57.
• [29]Guy R, Wand H, Franklin N, Fairley CK, Chen MY, O’Connor CC, Marshall L, Grulich AE, Kaldor JM, Hellard M, Donovan B: Re-testing for chlamydia at sexual health services in Australia, 2004-08. Sex Health 2011, 8(2):242-247.
• [30]Woodhall SC, Atkins JL, Soldan K, Hughes G, Bone A, Gill ON: Repeat genital Chlamydia trachomatis testing rates in young adults in England, 2010. Sex Transm Infect 2013, 89(1):51-56.
• [31]Cook RL, Ostergaard L, Hillier SL, Murray PJ, Chang CC, Comer DM, Ness RB: Home screening for sexually transmitted diseases in high-risk young women: randomised controlled trial. Sex Transm Infect 2007, 83(4):286-291.
• [32]Paneth-Pollak R, Klingler EJ, Blank S, Schillinger JA: The elephant never forgets; piloting a chlamydia and gonorrhea retesting reminder postcard in an STD clinic setting. Sex Transm Dis 2010, 37(6):365-368.
• [33]Xu F, Stoner BP, Taylor SN, Mena L, Tian LH, Papp J, Hutchins K, Martin DH, Markowitz LE: Use of home-obtained vaginal swabs to facilitate rescreening for Chlamydia trachomatis infections: two randomized controlled trials. Obstet Gynecol 2011, 118(2 Pt 1):231-239.
• [34]Gotz HM, van den Broek IV, Hoebe CJ, Brouwers EE, Pars LL, Fennema JS, Koekenbier RH, van Ravesteijn S, Op De Coul EL, van Bergen J: High yield of reinfections by home-based automatic rescreening of Chlamydia positives in a large-scale register-based screening programme and determinants of repeat infections. Sex Transm Infect 2013, 89(1):63-69.
• [35]Zou H, Fairley CK, Guy R, Bilardi J, Bradshaw CS, Garland SM, Sze JK, Afrizal A, Chen MY: Automated, computer generated reminders and increased detection of gonorrhoea, chlamydia and syphilis in men who have sex with men. PLoS One 2013, 8(4):e61972.
• [36]Kohn R, Reynolds A, Snell A, Kohn RP, Reynolds A, Snell A, Marcus JL, Philip SS: New Reminder System Does Not Improve Chlamydia Re-Screening Rate In: National STD Prevention Conference. GA: Atlanta; 2010.
• [37]Gotz HM, Wolfers ME, Luijendijk A, van den Broek IV: Retesting for genital Chlamydia trachomatis among visitors of a sexually transmitted infections clinic: randomized intervention trial of home- versus clinic-based recall. BMC Infect Dis 2013, 13(1):239. BioMed Central Full Text
• [38]Masek BJ, Arora N, Quinn N, Aumakhan B, Holden J, Hardick A, Agreda P, Barnes M, Gaydos CA: Performance of Three Nucleic Acid Amplification Tests for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Use of Self-Collected Vaginal Swabs Obtained via an Internet-Based Screening Program. J Clin Microbiol 2009, 47(6):1663-1667.
• [39]Smith K, Harrington K, Wingood G, Oh M, Hook IE, DiClemente RJ: Self-obtained vaginal swabs for diagnosis of treatable sexually transmitted diseases in adolescent girls. Arch Pediatr Adolesc Med 2001, 155(6):676-679.
• [40]Wiesenfeld HC, Lowry DL, Heine RP, Krohn MA, Bittner H, Kellinger K, Shultz M, Sweet RL: Self-collection of vaginal swabs for the detection of Chlamydia, gonorrhea, and trichomoniasis: opportunity to encourage sexually transmitted disease testing among adolescents. Sex Transm Dis 2001, 28(6):321-325.
• [41]Bloomfield PJ, Steiner KC, Kent CK, Klausner JD: Repeat chlamydia screening by mail, San Francisco. Sex Transm Infect 2003, 79(1):28-30.
• [42]Graseck AS, Shih SL, Peipert JF: Home versus clinic-based specimen collection for Chlamydia trachomatis and Neisseria gonorrhoeae. Expert Rev Anti Infect Ther 2011, 9(2):183-194.
• [43]Stephenson J, Carder C, Copas A, Robinson A, Ridgway G, Haines A: Home screening for chlamydial genital infection: is it acceptable to young men and women? Sex Transm Infect 2000, 76(1):25-27.
• [44]van der Helm JJ, Hoebe CJ, van Rooijen MS, Brouwers EE, Fennema HS, Thiesbrummel HF, Dukers-Muijrers NH: High performance and acceptability of self-collected rectal swabs for diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in men who have sex with men and women. Sex Transm Dis 2009, 36(8):493-497.
• [45]Soni S, White JA: Self-screening for Neisseria gonorrhoeae and Chlamydia trachomatis in the human immunodeficiency virus clinic–high yields and high acceptability. Sex Transm Dis 2011, 38(12):1107-1109.
• [46]Dodge B, Van Der Pol B, Rosenberger JG, Reece M, Roth AM, Herbenick D, Fortenberry JD: Field collection of rectal samples for sexually transmitted infection diagnostics among men who have sex with men. Int J STD AIDS 2010, 21(4):260-264.
• [47]Costa AM, Fairley CK, Garland SM, Tabrizi SN: Evaluation of self-collected urine dip swab method for detection of Chlamydia trachomatis. Sex Health 2009, 6(3):213-216.
• [48]Guy R, Hocking J, Low N, Ali H, Bauer HM, Walker J, Klausner JD, Donovan B, Kaldor JM: Interventions to increase rescreening for repeat chlamydial infection. Sex Transm Dis 2012, 39(2):136-146.
• [49]Stubbs ND, Geraci SA, Stephenson PL, Jones DB, Sanders S: Methods to reduce outpatient non-attendance. Am J Med Sci 2012, 344(3):211-219.
• [50]Warwick Z, Dean G, Carter P: B safe, B sorted: results of a hepatitis B vaccination outreach programme. Int J STD AIDS 2007, 18(5):335-337.
• [51]Chen ZW, Fang LZ, Chen LY, Dai HL: Comparison of an SMS text messaging and phone reminder to improve attendance at a health promotion center: a randomized controlled trial. J Zhejiang Univ Sci B 2008, 9(1):34-38.
• [52]Bourne C, Knight V, Guy R, Wand H, Lu H, McNulty A: Short message service reminder intervention doubles sexually transmitted infection/HIV re-testing rates among men who have sex with men. Sex Transm Infect 2011, 87(3):229-231.
• [53]Lim MSC, Hocking JS, Hellard ME, Aitken CK: SMS STI: a review of the uses of mobile phone text messaging in sexual health. Int J STD AIDS 2008, 19(5):287-290.
• [54]Cohen CE, Coyne KM, Mandalia S, Waters A-M, Sullivan AK: Time to use text reminders in genitourinary medicine clinics. Int J STD AIDS 2008, 19(1):12-13.
• [55]Guy R, Wand H, Knight V, Kenigsberg A, Read P, McNulty AM: SMS reminders improve re-screening in women and heterosexual men with chlamydia infection at Sydney Sexual Health Centre: a before-and-after study. Sex Transm Infect 2013, 89(1):11-15.
• [56]Stevens MP, Twin J, Fairley CK, Donovan B, Tan SE, Yu J, Garland SM, Tabrizi SN: Development and evaluation of an ompA quantitative real-time PCR assay for Chlamydia trachomatis serovar determination. J Clin Microbiol 2010, 48(6):2060-2065.
• [57]Hocking JS, Vodstrcil L, Huston WM, Timms P, Chen M, Worthington K, McIver R, Tabrizi SN: A cohort study of Chlamydia trachomatis treatment failure in women: a study protocol. BMC Infect Dis 2013, 13(1):379. BioMed Central Full Text
• [58]Sparks R, Helmers JR, Handsfield HH, Totten PA, Holmes KK, Wroblewski JK, Malinski C, Golden MR: Rescreening for gonorrhea and chlamydial infection through the mail: a randomized trial. Sex Transm Dis 2004, 31(2):113-116.
• [59]Sacks-Davis R, Gold J, Aitken CK, Hellard ME: Home-based chlamydia testing of young people attending a music festival–who will pee and post? BMC Public Health 2010, 10:376. BioMed Central Full Text