title: The Sexunzipped trial: optimizing the design of online randomized controlled trials.
abstract: BACKGROUND
  Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition.
  
  
  OBJECTIVE
  This study addresses the feasibility of several dimensions of online trial design-recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up.
  
  
  METHODS
  Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the "Sexunzipped" online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data.
  
  
  RESULTS
  The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of online self-reported sexual health outcomes and 47.4% (118/249) for return of chlamydia urine samples by post.
  
  
  CONCLUSIONS
  It was quick and efficient to recruit young people to this online trial. Our procedures for obtaining online consent, verifying participant identity, automated randomization, and concealment of allocation worked well. The optimal response rate for the online sexual health outcome measurement was comparable to face-to-face trials. Multiple methods of participant contact, requesting online data only, and higher value compensation increased trial retention at 3-month follow-up.
  
  
  BACKGROUND
  International Standard Randomized Controlled Trial Number (ISRCTN): 55651027; http://www.controlled-trials.com/ISRCTN55651027 (Archived by WebCite at http://www.webcitation.org/6LbkxdPKf).
authors: e-Health Unit, Research Department of Primary Care and Population Health, University College London, London, United Kingdom. julia.bailey@ucl.ac.uk.
authors: Julia V
authors: JV
authors: Bailey
authors: Menelaos
authors: M
authors: Pavlou
authors: Andrew
authors: A
authors: Copas
authors: Ona
authors: O
authors: McCarthy
authors: Ken
authors: K
authors: Carswell
authors: Greta
authors: G
authors: Rait
authors: Graham
authors: G
authors: Hart
authors: Irwin
authors: I
authors: Nazareth
authors: Caroline
authors: C
authors: Free
authors: Rebecca
authors: R
authors: French
authors: Elizabeth
authors: E
authors: Murray
mesh_terms: D000293:Adolescent; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D020407:Internet; D008297:Male; D010355:Patient Identification Systems; D018579:Patient Selection; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D060728:Reproductive Health; D012749:Sexually Transmitted Diseases / Q000517:prevention & control / Q000523:psychology; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000379:methods*; D006113:United Kingdom; D055815:Young Adult
keywords: Internet; behavioral research; outcome assessment (health care); randomized controlled trials as topic; sexual health; sexually transmitted diseases