Clinical trial NCT04950686: Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students
Official title: The Community College Health Study: A Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Sexual Assault
Violence, Domestic
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-06
Enrollment: 2184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Community college students are an underserved and at-risk population in terms of their sexual and relationship health. This is a three-arm randomized control trial to evaluate the long-term efficacy of a web-based sexual and relationship health promotion program among U.S. community college students (expected N = 2010) and explore the mechanisms underlying the program efficacy.

Detailed description: Community college students are an underserved and at-risk population in terms of their sexual and relationship health. One promising avenue for improving sexual decision making among this population is media literacy education (MLE). Though studies show MLE is an effective approach to sexual health promotion there is a need to better understand the mechanisms by which MLE programs impact health outcomes. The ultimate goals of this study are to 1) advance theoretical frameworks of media literacy to better understand the underlying mechanisms that lead to sexual health behavior change and 2) enhance the sexual and relationship health of community college students by identifying successful methods of health promotion and strategies to implement health programs at community colleges. This study is a three-arm randomized control trial (RCT) with 2010 community college students (ages 18-19) from 30 colleges across the U.S. All components of this study (i.e., interventions, surveys) are web-based.

Participating students will be randomized to one of three conditions: 1) students who receive a sexual health program grounded in MLE (Media Aware); 2) students who receive a sexual health program with no MLE; and 3) a wait-list control group. Participants will complete pretest, posttest, 6-month follow-up, and 12-month follow-up surveys to examine changes across the three groups in our primary outcomes (e.g., risky sexual behavior) and secondary outcomes (e.g., sexual health knowledge, rape myth acceptance, perceived realism of media messages).

Eligibility criteria: Inclusion Criteria:

* Students must be 18 or 19 years of age.
* Students must attend one of the community colleges from which this study is recruiting participants.
* Students must have an email address to receive study communication.
* Students must have access to a computer, tablet, or phone device with internet access as the questionnaires and programs are web-based.
* Students must be able to speak and read English because the study materials (e.g., questionnaires, programs) are in English.

Exclusion Criteria:

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Primary outcomes:
measure: Relationship satisfaction
timeFrame: posttest (4-weeks after pretest)
measure: Relationship satisfaction
timeFrame: 6-month follow-up
measure: Relationship satisfaction
timeFrame: 12-month follow-up
measure: Relationship violence perpetration
timeFrame: posttest (4-weeks after pretest)
measure: Relationship violence perpetration
timeFrame: 6-month follow-up
measure: Relationship violence perpetration
timeFrame: 12-month follow-up
measure: Relationship violence victimization
timeFrame: posttest (4-weeks after pretest)
measure: Relationship violence victimization
timeFrame: 6-month follow-up
measure: Relationship violence victimization
timeFrame: 12-month follow-up
measure: Identity abuse
timeFrame: posttest (4-weeks after pretest)
measure: Identity abuse
timeFrame: 6-month follow-up
measure: Identity abuse
timeFrame: 12-month follow-up
measure: Risky sexual behaviors
timeFrame: posttest (4-weeks after pretest)
measure: Risky sexual behaviors
timeFrame: 6-month follow-up
measure: Risky sexual behaviors
timeFrame: 12-month follow-up
measure: Use of protection at last oral sex
timeFrame: posttest (4-weeks after pretest)
measure: Use of protection at last oral sex
timeFrame: 6-month follow-up
measure: Use of protection at last oral sex
timeFrame: 12-month follow-up
measure: Frequency of use of protection during oral sex
timeFrame: posttest (4-weeks after pretest)
measure: Frequency of use of protection during oral sex
timeFrame: 6-month follow-up
measure: Frequency of use of protection during oral sex
timeFrame: 12-month follow-up
measure: Frequency of condom use during vaginal sex
timeFrame: posttest (4-weeks after pretest)
measure: Frequency of condom use during vaginal sex
timeFrame: 6-month follow-up
measure: Frequency of condom use during vaginal sex
timeFrame: 12-month follow-up
measure: Frequency of birth control use
timeFrame: posttest (4-weeks after pretest)
measure: Frequency of birth control use
timeFrame: 6-month follow-up
measure: Frequency of birth control use
timeFrame: 12-month follow-up
measure: Contraceptive use at last vaginal sex
timeFrame: posttest (4-weeks after pretest)
measure: Contraceptive use at last vaginal sex
timeFrame: 6-month follow-up
measure: Contraceptive use at last vaginal sex
timeFrame: 12-month follow-up
measure: Frequency of condom use during anal sex
timeFrame: posttest (4-weeks after pretest)
measure: Frequency of condom use during anal sex
timeFrame: 6-month follow-up
measure: Frequency of condom use during anal sex
timeFrame: 12-month follow-up
measure: Condom use at last anal sex
timeFrame: posttest (4-weeks after pretest)
measure: Condom use at last anal sex
timeFrame: 6-month follow-up
measure: Condom use at last anal sex
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Perceived media message completeness
timeFrame: posttest (4-weeks after pretest)
measure: Perceived media message completeness
timeFrame: 6-month follow-up
measure: Perceived media message completeness
timeFrame: 12-month follow-up
measure: Cognitive elaboration of advertisement
timeFrame: posttest (4-weeks after pretest)
measure: Cognitive elaboration of advertisement
timeFrame: 6-month follow-up
measure: Cognitive elaboration of advertisement
timeFrame: 12-month follow-up
measure: Perceived realism of media messages
timeFrame: posttest (4-weeks after pretest)
measure: Perceived realism of media messages
timeFrame: 6-month follow-up
measure: Perceived realism of media messages
timeFrame: 12-month follow-up
measure: Perceived similarity to media messages
timeFrame: posttest (4-weeks after pretest)
measure: Perceived similarity to media messages
timeFrame: 6-month follow-up
measure: Perceived similarity to media messages
timeFrame: 12-month follow-up
measure: Identification with media
timeFrame: posttest (4-weeks after pretest)
measure: Identification with media
timeFrame: 6-month follow-up
measure: Identification with media
timeFrame: 12-month follow-up
measure: Media skepticism
timeFrame: posttest (4-weeks after pretest)
measure: Media skepticism
timeFrame: 6-month follow-up
measure: Media skepticism
timeFrame: 12-month follow-up
measure: Dating violence norms
timeFrame: posttest (4-weeks after pretest)
measure: Dating violence norms
timeFrame: 6-month follow-up
measure: Dating violence norms
timeFrame: 12-month follow-up
measure: Gender role norms
timeFrame: posttest (4-weeks after pretest)
measure: Gender role norms
timeFrame: 6-month follow-up
measure: Gender role norms
timeFrame: 12-month follow-up
measure: Rape myth acceptance
timeFrame: posttest (4-weeks after pretest)
measure: Rape myth acceptance
timeFrame: 6-month follow-up
measure: Rape myth acceptance
timeFrame: 12-month follow-up
measure: Efficacy to intervene as bystander
timeFrame: posttest (4-weeks after pretest)
measure: Efficacy to intervene as bystander
timeFrame: 6-month follow-up
measure: Efficacy to intervene as bystander
timeFrame: 12-month follow-up
measure: Intent to intervene as bystander
timeFrame: posttest (4-weeks after pretest)
measure: Intent to intervene as bystander
timeFrame: 6-month follow-up
measure: Intent to intervene as bystander
timeFrame: 12-month follow-up
measure: Sexual health knowledge
timeFrame: posttest (4-weeks after pretest)
measure: Sexual health knowledge
timeFrame: 6-month follow-up
measure: Sexual health knowledge
timeFrame: 12-month follow-up
measure: Attitudes toward risky sexual behaviors
timeFrame: posttest (4-weeks after pretest)
measure: Attitudes toward risky sexual behaviors
timeFrame: 6-month follow-up
measure: Attitudes toward risky sexual behaviors
timeFrame: 12-month follow-up
measure: Attitudes toward unprotected sex
timeFrame: posttest (4-weeks after pretest)
measure: Attitudes toward unprotected sex
timeFrame: 6-month follow-up
measure: Attitudes toward unprotected sex
timeFrame: 12-month follow-up
measure: Attitudes toward contraception/protection
timeFrame: posttest (4-weeks after pretest)
measure: Attitudes toward contraception/protection
timeFrame: 6-month follow-up
measure: Attitudes toward contraception/protection
timeFrame: 12-month follow-up
measure: Attitudes toward communication with partners and medical professionals
timeFrame: posttest (4-weeks after pretest)
measure: Attitudes toward communication with partners and medical professionals
timeFrame: 6-month follow-up
measure: Attitudes toward communication with partners and medical professionals
timeFrame: 12-month follow-up
measure: Descriptive norms of unprotected sex
timeFrame: posttest (4-weeks after pretest)
measure: Descriptive norms of unprotected sex
timeFrame: 6-month follow-up
measure: Descriptive norms of unprotected sex
timeFrame: 12-month follow-up
measure: Descriptive norms of risky sexual activity
timeFrame: posttest (4-weeks after pretest)
measure: Descriptive norms of risky sexual activity
timeFrame: 6-month follow-up
measure: Descriptive norms of risky sexual activity
timeFrame: 12-month follow-up
measure: Sex refusal self-efficacy
timeFrame: posttest (4-weeks after pretest)
measure: Sex refusal self-efficacy
timeFrame: 6-month follow-up
measure: Sex refusal self-efficacy
timeFrame: 12-month follow-up
measure: Self-efficacy to refuse unprotected sex
timeFrame: posttest (4-weeks after pretest)
measure: Self-efficacy to refuse unprotected sex
timeFrame: 6-month follow-up
measure: Self-efficacy to refuse unprotected sex
timeFrame: 12-month follow-up
measure: Self-efficacy to use protection
timeFrame: posttest (4-weeks after pretest)
measure: Self-efficacy to use protection
timeFrame: 6-month follow-up
measure: Self-efficacy to use protection
timeFrame: 12-month follow-up
measure: Self-efficacy to communicate with partners and medical professionals about sex
timeFrame: posttest (4-weeks after pretest)
measure: Self-efficacy to communicate with partners and medical professionals about sex
timeFrame: 6-month follow-up
measure: Self-efficacy to communicate with partners and medical professionals about sex
timeFrame: 12-month follow-up
measure: Risky sexual behavior intentions
timeFrame: posttest (4-weeks after pretest)
measure: Risky sexual behavior intentions
timeFrame: 6-month follow-up
measure: Risky sexual behavior intentions
timeFrame: 12-month follow-up
measure: Intentions to have unprotected sex
timeFrame: posttest (4-weeks after pretest)
measure: Intentions to have unprotected sex
timeFrame: 6-month follow-up
measure: Intentions to have unprotected sex
timeFrame: 12-month follow-up
measure: Intentions to use protection/contraception
timeFrame: posttest (4-weeks after pretest)
measure: Intentions to use protection/contraception
timeFrame: 6-month follow-up
measure: Intentions to use protection/contraception
timeFrame: 12-month follow-up
measure: Intentions to communicate with partners and medical professionals about sex
timeFrame: posttest (4-weeks after pretest)
measure: Intentions to communicate with partners and medical professionals about sex
timeFrame: 6-month follow-up
measure: Intentions to communicate with partners and medical professionals about sex
timeFrame: 12-month follow-up
measure: Willingness to have unprotected sex
timeFrame: posttest (4-weeks after pretest)
measure: Willingness to have unprotected sex
timeFrame: 6-month follow-up
measure: Willingness to have unprotected sex
timeFrame: 12-month follow-up
measure: Willingness to engage in risky sexual behaviors
timeFrame: posttest (4-weeks after pretest)
measure: Willingness to engage in risky sexual behaviors
timeFrame: 6-month follow-up
measure: Willingness to engage in risky sexual behaviors
timeFrame: 12-month follow-up
measure: Advertisement deconstruction skills
timeFrame: posttest (4-weeks after pretest)
measure: Advertisement deconstruction skills
timeFrame: 6-month follow-up
measure: Advertisement deconstruction skills
timeFrame: 12-month follow-up
measure: Injunctive norms - most people
timeFrame: posttest (4-weeks after pretest)
measure: Injunctive norms - most people
timeFrame: 6-month follow-up
measure: Injunctive norms - most people
timeFrame: 12-month follow-up
measure: Injunctive norms - friends
timeFrame: posttest (4-weeks after pretest)
measure: Injunctive norms - friends
timeFrame: 6-month follow-up
measure: Injunctive norms - friends
timeFrame: 12-month follow-up
measure: Descriptive norms - people like me
timeFrame: posttest (4-weeks after pretest)
measure: Descriptive norms - people like me
timeFrame: 6-month follow-up
measure: Descriptive norms - people like me
timeFrame: 12-month follow-up
measure: Frequency of communication with sexual partner
timeFrame: posttest (4-weeks after pretest)
measure: Frequency of communication with sexual partner
timeFrame: 6-month follow-up
measure: Frequency of communication with sexual partner
timeFrame: 12-month follow-up
measure: Frequency of communication with doctor
timeFrame: posttest (4-weeks after pretest)
measure: Frequency of communication with doctor
timeFrame: 6-month follow-up
measure: Frequency of communication with doctor
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: innovation Research and Training
state: North Carolina
Study officials:
affiliation: innovation Research and Training
name: Tracy M Scull, PhD
role: PRINCIPAL_INVESTIGATOR
References: