Evaluating the mechanisms and long-term effects of a web-based comprehensive sexual health and media literacy education program for young adults attending community college: study protocol for a three-arm randomized controlled trial

Participants will be recruited from community college campuses located across the USA that are diverse with respect to their geographic location (e.g., rurality) as well as the racial-ethnic make-up of the student body. The program as well as the study questionnaires can be completed using a smartphone, tablet, or computer.

For students to be eligible to participate in the study, the following inclusion criteria must be met: (1) participant must be an 18- or 19-year-old community college student; (2) participants must be enrolled at one of the community college campuses from which we are recruiting for the study; (3) students must have an email address in order to receive communications about the study and must have access to a computer, tablet, or smartphone device with internet access. In addition, the study materials (e.g., questionnaires, programs) are in English; therefore, students must be able to speak and read English. Finally, no high school students who are dual enrolled in high school as well as community college classes will be eligible to participate in the study. Quotas will be used to guide enrollment and ensure that a diverse student sample with respect to race, ethnicity, and gender is recruited. Therefore, not all students who meet the eligibility criteria will be enrolled in the study.

Interested students will complete a brief eligibility survey that is located on the study recruitment website. Following completion of the web-based eligibility survey, potentially eligible students will be asked to review and endorse an online consent form which outlines the objectives of the study, describes the measures and procedure included for involvement as a participant in the project, and details the potential risks and benefits of the research. The consent form will include contact information for the PI, project director, and IRB chair, so that potential participants may contact them to ask any questions they may have about the study. Consent forms will state that participants may discontinue their participation at any time for any reason without consequences.

Not applicable. This trial does not involve collecting biological specimens.

Participants who complete Media Aware will be compared to two other groups in the study. First, the Media Aware group will be compared to a delayed intervention control group to rigorously test the short- and long-term efficacy of the program. Next, they will be compared to an active control group that receives sexual health programming without MLE content because this will provide information about the unique effects of MLE-based sexual health programming (compared to sexual health programming without MLE) on proposed mediators and outcomes.

Not applicable. There are minimal risks associated with participation in this study. If a participant experiences any discomfort, they can end their participation immediately and at any time.

Use of Media Aware and Health Aware will be monitored in an LMS. To improve adherence, automated reminders and text messages will be sent to participants if participants are not completing the intervention programs during the time provided. In addition to tracking adherence, several strategies were used during the program development process to create a program that would engage and retain the target audience. First, Media Aware was developed using an iterative process such that feedback from the target population was incorporated at multiple time points to enhance its relevance to and acceptance by young adults [10]. Health Aware was created from Media Aware and, thus, also integrates the input and feedback obtained from use of this iterative design process. Second, because web-based programs are highly acceptable to students, who often report preferring digital learning to other formats [15‐17], these sexual health education programs were designed to be completed online using responsive design, so that students can easily access programs across devices including a computer, smartphone, or tablet.

The active control group and delayed intervention control group will not have access to Media Aware during the first 12 months of the study. Additionally, only the active control group will have access to Health Aware. There are no restrictions, however, on the behavior of participants during the trial.

All primary and secondary outcomes will be assessed using online questionnaires at four timepoints: pretest, posttest, 6-month follow-up, and 12-month follow-up. Thus, while controlling for pretest scores, we will evaluate differences across groups in each of our outcomes at posttest, 6-month follow-up, and 12-month follow-up. Continuous variables measured using multiple items will be aggregated by creating scale scores based on mean values. All primary and secondary health outcomes are clinically relevant, as they are related to overall health and well-being, including STI/HIV transmission, unplanned pregnancy, relationship satisfaction, and experiences of sexual violence [18, 19]. Primary health outcomes will include relationship satisfaction, relationship violence perpetration, relationship violence victimization, identity abuse, risky sexual behaviors, condom use at last sex (anal, vaginal), condom and/or dental dam use at last oral sex, contraceptive use at last vaginal sex, and frequency of use of protection during sex (anal, vaginal, oral).

Secondary health outcomes related to relationship health and sexual violence prevention will include normative beliefs related to dating violence and gender roles, acceptance of rape myths, and efficacy and intentions to intervene as a bystander. Secondary health outcomes related to sexual health include attitudes, normative beliefs, self-efficacy, behavioral intentions, and willingness related to (1) risky sexual behaviors; (2) unprotected sex; (3) contraception/protection; and (4) sexual health communication.

Secondary outcomes related to media-related cognitions and behaviors assess whether participants have the skills necessary to critically analyze media messages—skills which are related to health decisions and behaviors [20]. These include perceived media message completeness, cognitive elaboration, perceived realism of media messages, perceived similarity to media messages, identification with media messages, media skepticism, and media deconstruction skills.

Upon enrollment, participants will receive an email and/or text indicating that they have been enrolled in the study, and provided with a link to access the pretest questionnaire (which will use a unique identifier in place of names, for confidentiality). Upon completion of the pretest questionnaire, participants will receive a second email. The content of the second email will depend upon the participants’ condition. Participants on campuses assigned to the intervention group will received an email link to the Media Aware program. Participants on campuses in the active control group will receive an email containing a link to the Health Aware program. Both of these groups will be told they will have 2 weeks to complete the program and complete the Student Feedback Questionnaire (SFQ). The SFQ is administered following completion of the assigned program (see “Measures” section for more information about the SFQ). Participants on campuses assigned to the delayed intervention control group will receive an email stating that the next step will be the completion of a second questionnaire in 4 weeks (the posttest). Email links for each questionnaire will be sent to all participants at the appropriate times, based upon the completion date of the pretest questionnaire: the posttest questionnaire will be administered 4 weeks after the pretest; the first follow-up questionnaire will be administered 6 months after the pretest; the second follow-up questionnaire will be administered 12 months after the pretest. After the delayed intervention control participants complete the 12-month follow-up questionnaire, they will receive an email that will include a link to access the Media Aware program, and they will be asked to complete the program and SFQ. This participant timeline is also shown in Fig. 1.

We expect to recruit approximately 2010 young adults who are attending community college to participate in this study. We plan to recruit approximately 67 students on each of 30 different community college campuses as participants. Optimal Design [21] was used to determine that there would need to be 40 participating students from each college in the final sample for the proposed group randomized trial. Based on a previous evaluation of Media Aware [10], the following values were input to determine the final targeted sample size: (1) a small effect size (.28); (2) ICC for campus effects = .02; (3) α = .05; (4) power = .80; and (5) 10 campuses per condition. The effect size used in this power analysis was the smallest effect size detected in a previous evaluation of Media Aware with community college students (for one of the secondary outcomes: willingness to have unprotected sex). The ICC used in this power analysis is the one detected in the previous evaluation. With an estimated attrition rate of 40% between pretest and 12-month follow-up, it was determined that 2010 students were needed to complete the pretest in order to achieve the final sample size. However, we intend to multiply impute missing data to retain our original sample size. Finally, while it is our goal to recruit 67 students from each of 30 campuses, there are practical considerations related to the community-based nature of this study (e.g., social distancing policies, limited number of eligible students on a campus, campus dropout) that may impact our final number of colleges and size of our student sample.

Prior to beginning student recruitment, project researchers will meet with personnel (i.e., administrators, faculty, or staff) at community colleges across the USA to discuss the project and its requirements. Community college campuses that agree to make the opportunity to participate available to their students will be included in the study. Efforts will be made to ensure the campuses that are included are diverse with respect to rurality and the racial-ethnic composition of the student body.

It is expected that we will conduct a rolling enrollment of participants over the course of a 2-year recruitment period. Students will be recruited through use of a variety of print and digital methods. During student recruitment, college personnel may also be asked to assist the research team with disseminating study recruitment materials to students. Individualized recruitment plans will be made for use on each college campus—these will often be based upon suggestions from campus administrators. Some methods that may be used include distribution of digital recruitment materials via emails, listservs, or college-specific courseware such as Blackboard, or social media [22]. Print recruitment materials, such as flyers, posters, and tent-cards, may be posted around campus and distributed to students at tabling events. Recruitment materials will direct students to the study website, where they can learn more about the study, find study team contact information, and complete an online screener. If a student passes the screener, they will be directed to an online study consent form.

Not all eligible students who complete the consent form will be enrolled in the study. To ensure a diverse sample with respect to race-ethnicity, we will attempt to sample students from each campus within strata, so that the composition of the study sample on each campus might reflect the composition of the campus race-ethnicity demographic characteristics. Thus, our goal is to recruit a final sample for each campus that is composed of approximately the same percentage of minority students that are enrolled in the college as well as approximately an equal number of male and female students (acknowledging that a proportion of the sample will identify as gender non-binary and be eligible for participation).