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Clinical Trials/NCT04950686
NCT04950686CompletedNot Applicable

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

Innovation Research & Training2 sites in 1 country2,184 target enrollmentStarted: July 21, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2,184
Locations
2
Primary Endpoint
Relationship Satisfaction

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Participants will not be informed which conditions are considered intervention versus control. All measures are assessed using a web-based data collection system rather than a human outcomes assessor.

Eligibility Criteria

Ages
18 Years to 19 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Outcomes

Primary Outcomes

Relationship Satisfaction

Time Frame: 12-month follow-up

Relationship satisfaction will be assessed using 7-items (e.g., "How well does your partner meet your needs?") rated on a 5-point Likert-type scale from 1 (poorly) to 5 (extremely well); higher scores indicate greater relationship satisfaction; range = 1-5; higher scores indicate a more favorable outcome. The overall number of participants analyzed in each Arm/Group includes all participants who completed pretest. Posttest data was imputed for participants that were present at pretest but not at posttest.

Percentage of Participants With Relationship Violence Perpetration

Time Frame: 12-month follow-up

10-items (e.g., "I spoke to my partner in a hostile or mean tone of voice."); Participants were asked to rate how often these things happened with their current or ex-dating partner on a 4-point Likert-type scale from 1 (never) to 4 (often); higher scores indicate more frequent relationship violence; range = 1-4. \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

Percentage of Participants With Relationship Violence Victimization

Time Frame: 12-month follow-up

10-items (e.g., "My partner spoke to me in a hostile or mean tone of voice"); Participants were asked to rate how often these things happened with their current or ex-dating partner on a 4-point Likert-type scale from 1 (never) to 4 (often); higher scores indicate more frequent relationship violence; range = 1-4; \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

Risky Sexual Behaviors

Time Frame: 12-month follow-up

4-items (e.g., How many times have you had oral, vaginal, or anal sex with a casual partner?); Participants were asked to report how many times each behavior happened; higher scores indicate greater sexual risk taking. Responses were open-ended so while the lower limit of the range was assumed to be zero, there was no upper limit imposed on participants.

Frequency of Use of Protection During Oral Sex

Time Frame: 12-month follow-up

3-items used to calculate change in frequency of use of protection during oral sex \[e.g., "In the past month, how often did you or your partner(s) use a condom or dental dam when having oral sex?"\]; items rated on a 4-point Likert-type scale from 1 (never) to 4 (always) and averaged for analyses; higher scores indicate more frequent use of protection; Only participants who indicated they had had oral sex responded to these items.

Frequency of Condom Use During Vaginal Sex

Time Frame: 12-month follow-up

3-items used to calculate change in frequency of condom use during vaginal sex \[e.g., "In the past month, how often did you or your partner(s) use a condom when having vaginal sex?"\]; items rated on a 4-point Likert-type scale from 1 (never) to 4 (always) and averaged for analyses; higher scores indicate more frequent condom use; Only participants who indicated they had had vaginal sex responded to these items.

Percentage of Participants That Used Protection at Last Oral Sex

Time Frame: 12-month follow-up

1-item ("Did you use a condom and/or dental dam the last time you had oral sex?"); participants answered "yes" (1) or "no" (0); Only participants who indicated they had had oral sex responded to this item

Frequency of Birth Control Use

Time Frame: 12-month follow-up

3-items used to calculate change in frequency of birth control use \[e.g., "In the past month, how often did you or your partner(s) use one of the following forms of birth control? Birth control pills, The Shot (DepoProvera), The Patch, The Ring (Nuvaring), IUD (Mirena, Paragard, Skyla), The Implant (Implanon, Nexplanon), or other FDA approved methods."\]; items rated on a 4-point Likert-type scale from 1 (never) to 4 (always) and averaged for analyses; higher scores indicate more frequent birth control use; Only participants who indicated they had had vaginal sex responded to these items.

Percentage of Participants That Used Contraceptive at Last Vaginal Sex

Time Frame: posttest (4-weeks after pretest)

1-item ("Did you use any contraceptive method the last time you had vaginal sex?"); participants answered "yes" (1) or "no" (0); Only participants who indicated they had had vaginal sex responded to this item

Percentage of Participants That Used Contraceptives at Last Vaginal Sex

Time Frame: 12-month follow-up

1-item ("Did you use any contraceptive method the last time you had vaginal sex?"); participants answered "yes" (1) or "no" (0); Only participants who indicated they had had vaginal sex responded to this item

Frequency of Condom Use During Anal Sex

Time Frame: 12-month follow-up

3-items used to calculate change in frequency of condom use during anal sex \[e.g., "In the past month, how often did you or your partner(s) use a condom when having anal sex?"\]; items rated on a 4-point Likert-type scale from 1 (never) to 4 (always) and averaged for analyses; higher scores indicate more frequent condom use; Only participants who indicated they had had anal sex responded to these items.

Percentage of Participants That Used a Condom at Last Anal Sex

Time Frame: 12-month follow-up

1-item ("Did you use a condom during your last anal intercourse?"); participants answered "yes" (1) or "no" (0); Only participants who indicated they had had anal sex responded to this item

Secondary Outcomes

  • Intentions to Use a Condom(12-month follow-up)
  • Descriptive Norms of Risky Sexual Activity(12-month follow-up)
  • Media Skepticism(12-month follow-up)
  • Gender Role Norms(12-month follow-up)
  • Sex Refusal Self-efficacy(12-month follow-up)
  • Perceived Realism of Media Messages(12-month follow-up)
  • Perceived Similarity to Media Messages(12-month follow-up)
  • Intent to Intervene as Bystander(12-month follow-up)
  • Sexual Health Knowledge(12-month follow-up)
  • Attitudes Toward Contraception/Protection(12-month follow-up)
  • Attitudes Toward Risky Sexual Behaviors(12-month follow-up)
  • Attitudes Toward Unprotected Sex(12-month follow-up)
  • Attitudes Toward Communication With Partners and Medical Professionals(12-month follow-up)
  • Identification With Media(12-month follow-up)
  • Self-efficacy to Refuse Unprotected Sex(12-month follow-up)
  • Risky Sexual Behavior Intentions(12-month follow-up)
  • Intentions to Communicate With Partners and Medical Professionals About Sex(12-month follow-up)
  • Intentions to Have Unprotected Sex(12-month follow-up)
  • Rape Myth Acceptance(12-month follow-up)
  • Efficacy to Intervene as Bystander(12-month follow-up)
  • Self-efficacy to Use a Condom(12-month follow-up)
  • Self-efficacy to Communicate With Partners and Medical Professionals About Sex(12-month follow-up)
  • Injunctive Norms - Most People(12-month follow-up)
  • Descriptive Norms of Unprotected Sex(12-month follow-up)
  • Willingness to Have Unprotected Sex(12-month follow-up)
  • Willingness to Engage in Risky Sexual Behaviors(12-month follow-up)
  • Advertisement Deconstruction Skills(posttest (4-weeks after pretest))
  • Injunctive Norms - Friends(12-month follow-up)
  • Descriptive Norms - People Like me(12-month follow-up)
  • Self-efficacy to Use a Dental Dam(12 month follow-up)
  • Frequency of Communication With Sexual Partner(12-month follow-up)
  • Percentage of Participants That Communicated With a Doctor(12-month follow-up)

Investigators

Sponsor
Innovation Research & Training
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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