A Web-Based Sexual Violence, Alcohol Misuse, and Bystander Intervention Program for College Women (RealConsent): Randomized Controlled Trial

Background Sexual violence (SV) incidence among college women has been invariant for the past 20 years. Innovative prevention strategies that are low resource and technology driven but demonstrate efficacy are greatly needed. Objective The aim of this study was to determine the efficacy of a novel theoretically driven internet-based intervention for first-year college students who identify as women (RealConsent) in reducing their risk of exposure to SV and alcohol misuse as well as increasing alcohol protective and bystander behaviors. Methods This randomized controlled trial involved first-year college students who identified as women (n=881) attending 1 of 3 universities in the southeastern United States. Participants aged 18 to 20 years were randomized to RealConsent (444/881, 50.4%) or to an attention-matched placebo control (437/881, 49.6%). RealConsent is fully automated and consists of four 45-minute modules that incorporate entertainment-education media and proven behavior change techniques. The primary outcome was exposure to SV; the secondary outcomes were alcohol protective behaviors, dating risk behaviors, alcohol misuse, and bystander behavior. Study outcomes were assessed at baseline and 6-month follow-up. Results Among participants with some exposure to SV, those in the RealConsent group experienced less exposure to SV than the placebo group (adjusted incidence rate ratio 0.48, 95% CI 0.33-0.69; P=.002). Furthermore, participants in the RealConsent group engaged in more alcohol protective behaviors (adjusted odds ratio 1.17, 95% CI 0.12-2.22; P=.03) and were less likely to binge drink (adjusted incidence rate ratio 0.81, 95% CI 0.67-0.97; P=.003). Finally, participants in the RealConsent group who had 100% dosage were more likely to engage in bystander behavior than those with <100% dosage plus placebo group (adjusted odds ratio 1.72, 95% CI 1.17-2.55; P=.006). Conclusions A comprehensive exposure to SV, alcohol use, and bystander educational program was successful in decreasing the occurrence of exposure to SV among those most at risk and in increasing alcohol protective behaviors. Because of its web-based and mobile technologies, RealConsent can be easily disseminated and holds potential for reducing campus SV. Trial Registration ClinicalTrials.gov NCT03726437; https://clinicaltrials.gov/ct2/show/NCT03726437

1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
C l e a r s e l e c t i o n Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
C l e a r s e l e c t i o n Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The intervention does not involve any non-web-based components Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Women aged 18 to 20 years were randomized to RealConsent (n=444) or to an attention-matched placebo control )(n=437)" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 13/82 subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) C l e a r s e l e c t i o n Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "RealConsent is fully automated" Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) C l e a r s e l e c t i o n Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, we report in the abstract the number of women assigned to each group, however, we do not report attrition in the abstract. Attrition by group is reported in the manuscript as per CONSORT.  Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, significant changes in the primary outcome were observed and reported in the Results section; thus, this was not a negative trial. Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "In this study, RealConsent was evaluated for efficacy in reducing SV incidence, in affecting alcohol and dating risk and protective factors, in reducing alcohol misuse and in increasing bystander behavior among college women." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, A randomized controlled trial (RCT) (ClinicalTrials.gov: NCT03726437) was implemented at three universities in the Southeastern United States. Study procedures were approved by the primary investigator's university institutional review board...Potential participants were blinded to study hypotheses and told that the purpose of the study was to "examine the effectiveness of a 3-hour web-based program for incoming female freshmen." Once they provided informed consent, participants were asked to complete an online registration form, where they provided their contact information including their full name, email, address, and phone number. Then, participants were redirected to the baseline survey assessment. Participants received $30 for completing the baseline survey. Once participants completed the baseline survey, they were directed to an online survey that collected data on their email and institution, which was then used to randomize participants to one of the two study conditions. Stratified block randomization was implemented via Redcap to randomly assign participants to either RealConsent® or to an attention-matched placebo condition called Stress and Mood Management (Isagroup.com)." Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Eligible participants were students identifying as women, 18-20 years of age, single, and entering their first year of college."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As participants were first-year college women, recruited from three universities, via email, computer literacy was not an issue.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "An online sample N=881 first-year women college students were recruited using email contact lists provided by each university's Registrar's office. An email was sent to potential participants containing a description of the study with a link to an online survey delivered via Qualtrics to complete an eligibility screener. If individuals met eligibility criteria, they were then redirected to another online survey to complete the informed consent form and electronically provide their consent to participate. Potential participants were blinded to study hypotheses and told that the purpose of the study was to "examine the effectiveness of a 3-hour web-based program for incoming first-year women students."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Potential participants were blinded to study hypotheses and told that the purpose of the study was to "examine the effectiveness of a 3-hour web-based program for incoming first-year women students ." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "A randomized controlled trial (RCT) (ClinicalTrials.gov: NCT03726437) was implemented at three universities in the Southeastern United States. Study procedures were approved by the primary investigator's university institutional review board. Eligible participants were 18-20 years of age, identified as a woman, single, and entering their first year of college." Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Once they provided informed consent, participants were asked to complete an online registration form, where they provided their contact information including their full name, email, address, and phone number. Then, participants were redirected to the baseline survey assessment. Participants received $30 for completing the baseline survey. Once participants completed the baseline survey, they were directed to an online survey that collected data on their email and institution, which was then used to randomize participants to one of the two study conditions. " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
C l e a r s e l e c t i o n Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "In developing RealConsent, extensive formative research with the targeted population was conducted to assess the different contexts in which SV victimization occurs, how men and women express sexual interest and consent, reasons for alcohol use, protective strategies to avoid SV, victim-blaming, barriers to bystander intervention, and stereotypical gender roles. The results were used to inform the content, messaging, language and story lines for each segment and particularly for the serial drama episodes titled "Squad." Once the intervention module content was developed on paper, prior to production, an additional round of focus groups was conducted to assess the acceptability and relevancy of the materials and scripts in terms of literacy, language, realism, presentation and delivery."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
C l e a r s e l e c t i o n Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
C l e a r s e l e c t i o n Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
C l e a r s e l e c t i o n Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
C l e a r s e l e c t i o n

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
C l e a r s e l e c t i o n Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "RealConsent was delivered via a password-protected Web portal that allowed women to access the program either via the web or their mobile phone." Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "RealConsent was delivered via a password-protected Web portal that allowed women to access the program either via the web or their mobile phones. The program contains four 45-minute program modules for a total duration of 3 hours. Each module includes interactivity, didactic activities, and entertainment-education media.
[39,40] Entertainmenteducation is an effective health communication strategy that combines or embeds educational messages into entertainment programs to bring about social and behavior change.
[40] RealConsent® contains eight mini-episodes of a serial drama titled, "Squad" as its entertainment-education. To ensure relevancy and quality of "Squad,", we worked with a professional scriptwriter to ensure that our dialogue was realistic and entertaining. In addition, we contracted with a professional film and video company, who had won several Emmy awards for their documentary films, to film, direct and edit our video segments. Consequently, the "Squad" serial drama garnered four Telly Awards. Telly awards honor excellence in video and television across all platforms. The Squad episodes allow for the modeling of positive behaviors and for illustrating both positive and negative outcome expectations related to alcohol misuse and bystander intervention. RealConsent includes ethnically and racially diverse actors in its filmed segments and in images accompanying didactic segments, and also includes representation of same-sex relationships.
RealConsent® was programmed so that participants could not skip or click-through segments within each module without viewing the entire segment. In addition, the program contained an administrative component that allowed study staff to track participants' completion of the program. Attention-Placebo Control Intervention Stress and Mood Management is a web-based, multi-media health promotion program designed to help manage stress levels, prevent mood problems, and seek early identification and treatment for depression and anxiety developed by ISA Group. Each of four program modules is ≈30 minutes involving videos and interactive and didactic activities. Thus, it approximates RealConsent® in format and duration."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
C l e a r s e l e c t i o n Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Participants were encouraged to complete their assigned program within a week by offering a $10 incentive for completing a brief acceptability survey following each program module."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
C l e a r s e l e c t i o n Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As the program was self-paced and accessed via the web using a computer or mobile phone, the only interaction that occurred with participants was the email with the link and instructions on how to access their assigned program. Also, if they had technical difficulties, interactions to solve the issue would occur via email. Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Progress through intervention modules was monitored. Email reminders were sent to participants to complete the program within a week. Also, following the completion of each module, we would send participants a link to a brief, survey for which they received $10 for completing. [41] Behaviorally specific language was used to describe the unwanted sexual experience outcomes and tactics. Types of unwanted sexual behavior assessed included sexual contact (e.g., fondling) and attempted or completed penetration (oral, vaginal, or anal). The tactics included two forms of verbal coercion including (1) telling lies, verbal threats, making promises known to be untrue, or using verbal pressure and (2) showing displeasure, criticizing, or getting angry; incapacitation (i.e., taking advantage when the participant was "too drunk or out of it" to stop what was happening); and two forms of physical force including (1) threatening physical force and (2) use of physical force. Participants were asked how often each sexual experience was obtained by each tactic with response options ranging from 0 (never) to 3 (three or more times). At baseline, "in the past 12 months" was used as the time reference and at 6-months follow-up, "since viewing the web-based program" was the time reference. Sexual victimization was analyzed in two ways as recommended by Davis et al [42] and which takes into consideration the severity of the assault (e.g., "fondling" vs. "completed vaginal rape") and also the tactic used (e.g., "alcohol incapacitated" vs. "physical force") in addition to the frequency. The combined outcomes separated tactics scale (COSTS) was measured as a continuous construct with a range of 0-63 where six severity ranks were used. For the rape outcomes that had the same tactic (e.g., "attempted rape by force" and "completed rape by force"), each was given the same severity rank. Each severity score was multiplied by the frequency and then summed. The separated outcomes separated tactics (SOTS) was measured as a continuous construct with a range of 0-135 where each outcome by each tactic was ranked by severity from 1 (sexual contact with verbal coercion) to 9 (completed rape by force) and then multiplied by the frequency. [42] Secondary Outcomes Alcohol Protective Behaviors. Alcohol protective behaviors were assessed with 15 items from the Protective Behavioral Strategies Survey,[43] with answer choices ranging on a 5point scale (1) Always to (5) Never. Participants were asked while using alcohol or "partying" whether they engaged in alcohol-related protective behaviors (e.g., "determine not to exceed a set number of drinks," "avoid mixing different types of alcohol," and "know where your drink had been at all times"). For the current study, the scale showed adequate reliability (α =.86). Items were summed for a total score for engaging in protective behaviors.
Dating Risk Behaviors. Dating risk behaviors were assessed using the Dating Behavior Survey, which consists of 15 items assessing the situational variables including alcohol use that have been found to be related to acquaintance rape.
[44] Participants indicated how often they engaged in situational behaviors that would put them at risk (e.g., On the first few dates..., "I consume alcohol or drugs," or " my partner and I do things that allow us to spend time alone together"). Answer choices ranged on a 5-point scale (1) Never to (5) Always. For the current study, reliability was adequate (α =.71). Responses were summed for a total score for risk-related dating behavior. Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No interim analyses were performed. As this was to evaluate a behavioral intervention, there were no stopping guidelines.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study SAS statistical software was used to generate the stratified, block randomization sequence to ensure equal numbers between treatment and control groups and proportionate numbers from each of the three universities. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Stratified block randomization was implemented via Redcap to randomly assign participants to either RealConsent® or to an attention-matched placebo condition called Stress and Mood Management (Isagroup.com)." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The stratified randomization sequence was uploaded to RedCap, which was used to randomize each participant by the study project director.
11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study biostatistician generated the random allocation sequence. Participants enrolled in the study online. Once enrolled, participants completed the online baseline assessment, then the study project director used RedCap to access the sequence and randomize each participant.

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any). Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Potential participants were blinded to study hypotheses and told that the purpose of the study was to "examine the effectiveness of a 3-hour web-based program for incoming female freshmen." In addition, they were informed that they would be randomized to view one of two different web-based programs. Each program covers topics related to college women's mental and physical health and safety. In addition, the online assessment included additional measures directly related to the comparator program such as stress level, anxiety, and mood. The biostatistician was also blinded in that study condition was assigned either "a" or "b" in all data files.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator". Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Potential participants were blinded to study hypotheses and told that the purpose of the study was to "examine the effectiveness of a 3-hour web-based program for incoming female freshmen." In addition, they were informed that they would be randomized to view one of two different web-based programs. Each program covers topics related to college women's mental and physical health and safety. In addition, the online assessment included additional measures directly related to the comparator program such as stress level, anxiety, and mood. As we did not interact directly with participants, we do not know for certain if they knew which program or if their assigned program was the program of interest.
Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Both interventions were web-based, involved some degree of interactivity, and were approximately 3 hours in duration. Yes, "Analyses were performed on prespecified hypotheses for the primary outcome variable of sexual violence victimization using an intent-to-treat protocol in which participants were analyzed according to their assigned study conditions.[47] Additional analyses were also performed on several secondary outcomes including alcohol protective behaviors, dating risk behaviors and alcohol misuse using an intent-to-treat protocol. Statisticians were blinded to which group ("a" or "b") was the experimental condition. An additional secondary outcome, bystander behavior, was also analyzed using a "dosage" protocol versus an intentto-treat protocol. Participants who had completed 100% of the RealConsent program were compared to the control group participants plus those participants who had completed <100% of the program. Dosage was used to test for effects on bystander behavior as intervention content specific to bystander behavior was in the last module of the program.
Descriptive statistics were created for all study measures, with mean and standard deviation for continuous variables and frequency distribution for categorical variables. Comparisons were conducted of baseline findings across study characteristics and outcomes to determine if participants that completed the intervention were similar to those who did not. A substantial number of participants were expected to report not having an experience of sexual victimization, to not have engaged in bystander behavior, and/or not having previously consumed alcohol. To account for these zero occurrences, a comparison of the mean occurrence for each outcome across the baseline and 6-month follow-up time points was accomplished with a two-stage modeling process using zero-inflated regression models. In the first stage, a logistic regression model was used to model occurrence or not for each outcome, and in the second stage a Poisson or gamma regression model was used to model each outcome for those that had at least one occurrence. Sexual victimization and most of the alcohol consumption measurements were count outcomes and modeled with the Poisson distribution. The alcohol protective and dating risk behaviors scales were both continuous and reasonably symmetric. A multilevel model in the form of a general linear mixed model was used. The bystander behavior scale was skewed and assessed with logistic regression; heavy drinking outcomes were continuous and skewed and were modeled with a gamma distribution. Participants were assessed at baseline and at 6-months follow-up. Repeated measurements on each participant results in within-subject correlation. This was accounted for by estimating each zero inflated model with population averaged effects using a marginal model and generalized estimating equations. Each zero-inflated marginal model included fixed effects to control for study site, race, ethnicity, place of living, relationship status, sexual orientation, engagement in athletics, job status, ever drank alcohol, time, study condition. A time by study condition interaction term was included in each model to assess and test for intervention effectiveness. The interaction term quantifies the relative change in the outcome over time across study conditions. Intervention effects were estimated with odds ratios for logistic models, incidence rate ratios for Poisson models, and regression coefficients for gamma models. The SAS Software system was used for all statistical analyses." 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Subgroup analyses were not performed. All models were adjusted for fixed effects: time, race/ethnicity, place of living, relationship status, sexual orientation, engagement in athletics, job status, ever drank alcohol, and ever on a date. Does your paper address subitem X26-i?

X26-i) Comment on ethics committee approval
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "This study was approved by the Georgia State University's Institutional Review Board (H19033)." Does your paper address subitem X26-ii?

x26-ii) Outline informed consent procedures
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "If individuals met eligibility criteria, they were then redirected to another online survey to complete the informed consent form and electronically provide their consent to participate." The following was provided to potential participants during the informed consent procedure: "The purpose of this study is to examine the effectiveness of a 3-hour web-based program for incoming female freshmen. If you decide to take part, you will take part in an online study. Participating in this study calls for about 5.5 hours of your time over the next six months. The study will involve: • Completing a 45-minute online survey • viewing a 4-part web-based program at your own pace (total time of program = 3 hours) • Completing a 10-minute survey following each of the 4 parts • Completing a second 45-minute online survey 6 months later • The online survey will be on personal information (age, race, ethnicity, etc.), attitudes, health behaviors, dating behaviors, experiences of sexual violence, and perceptions of risk. • The brief 10-minute surveys will ask your opinion on the program content. • You will be randomized to view one of two different web-based programs. Each program covers topics related to female freshmen's mental and physical health and safety.
"Please check this box if you have read this section on the procedures of the research study."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) C l e a r s e l e c t i o n Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As part of the informed consent process, participants were told: IV. Risks: There is the possibility that taking part in this study may cause you to be nervous or stressed when answering some of the questions or viewing the program; you do not have to answer any questions you do not want to answer in the survey. Also, if you feel too anxious or stressed, you will be provided with the Principal Investigator's phone number. If you need or want to talk to a trained therapist, you will be provided a toll-free 800-hotline number for you to call. You will also be given local university resources for you to contact.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 59/82 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "The recruitment process (See Figure 2) resulted in 4,473 first-year women college students who were screened for eligibility. Of those, 2,327 were not eligible, 349 did not undergo the informed consent process, 8 declined to participate, 908 did not enroll for other reasons. N=881 consented, completed baseline and were then randomized. At six-months, a total of 161 participants (18.3%) were lost to follow-up. Chi-square results indicated there was not differential attrition: 85 of 444 (18.9%) in the RealConsent condition versus 76 of 437 (17.4%) in the placebo comparison condition (P=.83).
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "The recruitment process (See Figure 2) resulted in 4,473 first-year women college students who were screened for eligibility. Of those, 2,327 were not eligible, 349 did not undergo the informed consent process, 8 declined to participate, 908 did not enroll for other reasons. N=881 consented, completed baseline and were then randomized. At six-months, a total of 161 participants (18.3%) were lost to follow-up. Chi-square results indicated there was not differential attrition: Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Figure 2 in the manuscript is the CONSORT study flowchart with attrition by group and also dosage of the intervention components by group shown. Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Active recruitment began in October 2018 and ended in February 2019." Participants were asked to complete a follow-up survey six months following the baseline survey.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" C l e a r s e l e c t i o n Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There were not any secular events affecting the trial during the study period. Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The trial ended following the completion of the 6-month follow-up and was not stopped early.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
C l e a r s e l e c t i o n Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, each of the N"s for each stage of the recruitment process, follow-up, and completion of intervention modules are presented in the CONSORT study flowchart.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
C l e a r s e l e c t i o n Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Analyses were performed on prespecified hypotheses for the primary outcome variable of sexual violence victimization using an intent-to-treat protocol in which participants were analyzed according to their assigned study conditions.[47] Additional analyses were also performed on several secondary outcomes including alcohol protective behaviors, dating risk behaviors and alcohol misuse using an intent-to-treat protocol. Statisticians were blinded to which group ("a" or "b") was the experimental condition. An additional secondary outcome, bystander behavior, was also analyzed using a "dosage" protocol versus an intentto-treat protocol. Participants who had completed 100% of the RealConsent program were compared to the control group participants plus those participants who had completed <100% of the program. Dosage was used to test for effects on bystander behavior as intervention content specific to bystander behavior was in the last module of the program." Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, for each primary and secondary outcome analyzed, results are presented for each group with corresponding estimated effect size, i.e., odds ratios for logistic models, incidence rate ratios for Poisson models, and regression coefficients for gamma models, and their corresponding 95% CI.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [ 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, the paper reports dosage received for each intervention and attrition.
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, we present relative effect sizes for binary outcomes. The study's primary objective is to reduce risk of sexual violence victimization while the secondary outcomes are reducing hazardous drinking and increasing protective behaviors; thus, absolute effect sizes are not relevant as we are not examining the presence or absence of a disease outcome.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Results are presented for pre-specified adjusted analyses. No other analyses were performed.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
C l e a r s e l e c t i o n Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study For one secondary outcome, bystander behavior, analyses were performed using dosage as the content for this outcome was in the last module of the intervention. Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "This study is the first comprehensive SV risk reduction program specific to women that incorporates entertainment-education media into web-based and mobile technologies, is theoretically and empirically informed, embodies proven behavior change techniques, includes alcohol education as a central component, and integrates bystander education as well as self-defense training-all factors associated with SV risk reduction. The results from this RCT demonstrate significant changes in both primary and secondary outcomes among a racially diverse sample of first-year women college students. Among participants who had experienced any SV, RealConsent participants reported less exposure to SV (primary outcome) than control group participants (P<.001). This result suggests that RealConsent is effective for participants who are most at risk. Although we did not find significant results for our zero-inflated logistic model, which compared no exposure to SV to any exposure to SV by condition, we can speculate possible reasons for this null finding. Does your paper address subitem 22-ii?

22-ii) Highlight unanswered new questions, suggest future research
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The Discussion section highlights future research stemming from the results.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "Our trial had several limitations. First, our trial was conducted with first-year college women recruited from three universities located in the southeastern United States. Future research should test RealConsent among college women matriculated at universities located in other geographical areas of the United States. Second, although not extreme, we experienced some loss to follow-up in terms of completion of the respective web-based programs and follow-up survey. It is unclear what the potential reasons were for this loss to follow-up; however, previous research has shown that attrition in web-based trials may be higher than in-person trials. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "First, our trial was conducted with first-year college women recruited from three universities located in the southeastern United States. Future research should test RealConsent® among college women matriculated at universities located in other geographical areas of the United States." Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
C l e a r s e l e c t i o n Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study About the CONSORT EHEALTH checklist X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
C l e a r s e l e c t i o n Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, "LFS and AMS-M are the developers of RealConsent, but neither derived financial income from the web-based program." As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
I made minor changes to the abstract.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * I spend approximately 4 hours completing this checklist.
As a result of using this checklist, do you think your manuscript has improved? * STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary le.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you!