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

NCT04950686 | Completed Results DMC

• 2 other identifiers: CCHealthStudy-R01-20-007R01HD099134
• Study Type: interventional
• Target: 2,184
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Behavior; Sexual Assault; Violence, Domestic

Outcome Measures

Primary Outcomes (33)

• Relationship Satisfaction

  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.

  posttest (4-weeks after pretest)

• Relationship Satisfaction

  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.

  6-month follow-up

• Relationship Satisfaction

  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.

  12-month follow-up

• Percentage of Participants With Relationship Violence Perpetration

  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. \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

  posttest (4-weeks after pretest)

• Percentage of Participants With Relationship Violence Perpetration

  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. \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

  6-month follow-up

• Percentage of Participants With Relationship Violence Perpetration

  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. \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

  12-month follow-up

• Percentage of Participants With Relationship Violence Victimization

  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; \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

  posttest (4-weeks after pretest)

• Percentage of Participants With Relationship Violence Victimization

  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; \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

  6-month follow-up

• Percentage of Participants With Relationship Violence Victimization

  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; \[Given lack of variability, this measure was dichotomized so 0 equals no violence and 1 equals any violence.\]

  12-month follow-up

• Risky Sexual Behaviors

  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.

  posttest (4-weeks after pretest)

• Risky Sexual Behaviors

  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.

  6-month follow-up

• Risky Sexual Behaviors

  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.

  12-month follow-up

• Percentage of Participants That Used Protection at Last Oral Sex

  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

  posttest (4-weeks after pretest)

• Percentage of Participants That Used Protection at Last Oral Sex

  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

  6-month follow-up

• Percentage of Participants That Used Protection at Last Oral Sex

  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

  12-month follow-up

• Frequency of Use of Protection During Oral Sex

  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.

  posttest (4-weeks after pretest)

• Frequency of Use of Protection During Oral Sex

  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.

  6-month follow-up

• Frequency of Use of Protection During Oral Sex

  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.

  12-month follow-up

• Frequency of Condom Use During Vaginal Sex

  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.

  posttest (4-weeks after pretest)

• Frequency of Condom Use During Vaginal Sex

  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.

  6-month follow-up

• Frequency of Condom Use During Vaginal Sex

  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.

  12-month follow-up

• Frequency of Birth Control Use

  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.

  posttest (4-weeks after pretest)

• Frequency of Birth Control Use

  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.

  6-month follow-up

• Frequency of Birth Control Use

  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.

  12-month follow-up

• Percentage of Participants That Used Contraceptive at Last Vaginal Sex

  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

  posttest (4-weeks after pretest)

• Percentage of Participants That Used Contraceptives at Last Vaginal Sex

  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

  6-month follow-up

• Percentage of Participants That Used Contraceptives at Last Vaginal Sex

  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

  12-month follow-up

• Frequency of Condom Use During Anal Sex

  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.

  posttest (4-weeks after pretest)

• Frequency of Condom Use During Anal Sex

  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.

  6-month follow-up

• Frequency of Condom Use During Anal Sex

  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.

  12-month follow-up

• Percentage of Participants That Used a Condom at Last Anal Sex

  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

  posttest (4-weeks after pretest)

• Percentage of Participants That Used a Condom at Last Anal Sex

  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

  6-month follow-up

• Percentage of Participants That Used a Condom at Last Anal Sex

  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

  12-month follow-up

Secondary Outcomes (94)

• Perceived Realism of Media Messages

  posttest (4-weeks after pretest)

• Perceived Realism of Media Messages

  6-month follow-up

• Perceived Realism of Media Messages

  12-month follow-up

• Perceived Similarity to Media Messages

  posttest (4-weeks after pretest)

• Perceived Similarity to Media Messages

  6-month follow-up

Study Arms (3)

Intervention - Media Aware for Young Adults

EXPERIMENTAL

This arm will receive Media Aware for Young Adults between the pretest and posttest questionnaire. Media Aware for Young Adults is a web-based sexual and relationship health promotion program that uses a media literacy education (MLE) approach. The program is self-paced and includes four modules.

Behavioral: Media Aware for Young Adults

Active Control - Health Aware for Young Adults

ACTIVE COMPARATOR

This arm will receive Health Aware for Young Adults in between the pretest and posttest questionnaire. Health Aware for Young Adults is a web-based sexual and relationship health promotion program. The program contains the same health content as Media Aware for Young Adults but without the media literacy education components. The program is self-paced and includes four modules.

Behavioral: Health Aware for Young Adults

Delayed Intervention Control

NO INTERVENTION

Participants in this condition will not receive a sexual or relationship health promotion program until after the 12-month follow-up survey. After that survey is complete, they will receive access to the Media Aware for Young Adults program.

Interventions

Media Aware for Young Adults BEHAVIORAL

Media Aware for Young Adults is a web-based sexual and relationship health promotion program designed for young adults that uses a media literacy education (MLE) approach.

Intervention - Media Aware for Young Adults

Health Aware for Young Adults BEHAVIORAL

Media Aware for Young Adults is a web-based sexual and relationship health promotion program designed for young adults.

Active Control - Health Aware for Young Adults

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Innovation Research & Training: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

innovation Research and Training

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Tracy Scull, PhD
• Organization: innovation Research and Training

tscull@irtinc.us

9194937700

Study Officials

• Tracy M Scull, PhD

  innovation Research and Training

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: July 6, 2021
• Study Start: July 21, 2021
• Primary Completion: March 24, 2024
• Study Completion: March 24, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)