Sexual BehaviorNCT03533192
Replication of Evidence-based Programs
A study testing It's Your Game...Keep it Real in people with Sexual Behavior, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this school-level randomized intervention trial is to evaluate the It's Your Game…Keep It Real program, an evidence-based teen pregnancy, HIV, and STI prevention program, among 2,000 students from 20 middle schools in 10 participating school districts in Harris County and surrounding areas. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- It's Your Game...Keep it Real
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,588 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- enrolled in 7th grade at a participating school in fall 2012
- did not have limited capabilities or special needs as determined by the school
- spoke English well enough to understand the survey questions if they were read aloud.
Who cannot join
- -did not meet inclusion criteria
About this study
Official title: Teenage Pregnancy Prevention: Replication of Evidence-based Programs
The purpose of this school-level randomized intervention trial is to evaluate the It's Your Game…Keep It Real program, an evidence-based teen pregnancy, HIV, and STI prevention program, among 2,000 students from 20 middle schools in 10 participating school districts in Harris County and surrounding areas. An audio computer-assisted self interview (A-CASI) assessment was used to assess demographic characteristics, psychosocial factors, sexual behaviors, and program exposure at three data collection points. Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.
Read the detailed description
Program Implemented: It's Your Game…Keep It Real (IYG) consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). The intervention was provided to the same 7th and 8th graders over a two-year period (i.e., the same students receive up to 24 lessons over two years). The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models. The lessons were delivered according to the schedule that worked best for schools (for example, twice a week, once a week, or daily) within a school semester. The lessons were delivered by trained teachers during regular classroom time and were taught during a variety of subject areas (for example, physical education/health, social studies, and science). Teachers implementing the lessons were required to attend training in order to teach the 7th- and 8th-grade lessons.
Sample: This sample included students at 20 schools from selected school districts throughout the greater Houston, Texas, area that agreed to participate in the study and that served 7th and 8th grades. Student inclusion criteria required that students not face language barriers or require educational accommodations that would preclude them from participation in the survey data collection process. Data collection staff, blind to school study condition, recruited 7th-grade students attending eligible classes across the 20 middle schools participating in the randomized controlled trial. A mix of census and sampling was used when securing consent for participation. In schools with 250 or fewer 7th-grade students, consents were distributed to all students. For schools with 7th-grade enrollments of more than 250, classes were sampled randomly and consents were distributed to 180 students. The study included one cohort and followed students from 7th through 9th grades. The final enrolled sample size was 2,588 students for whom parental consent and student assent were obtained.
Setting: The study sites included 20 urban middle schools, in Harris County, Texas. The program was implemented in 10 intervention schools by trained facilitators. Most facilitators in both 7th and 8th grades were physical education teachers.
Data Collection: Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.
Data Analysis: Impact data were analyzed using multilevel regression due to the nested nature of the study design (students within schools).
- Conditions
- Sexual Behavior
- Being tested
- It's Your Game...Keep it Real
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It's Your Game...Keep it RealBehavioural
It's Your Game...Keep it Real consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). In each grade, the curriculum integrates group-based classroom activities with personalized journaling and individually tailored computer-based activities. A life-skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal rules regarding risk behaviors, detect signs or situations that might challenge these rules, and use refusal skills and other tactics to protect these rules. The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models.
| Study group | Role | What they receive |
|---|---|---|
| Receipt of It's Your Game...Keep it Real | Experimental | It's Your Game...Keep it Real is an HIV, STI, and teen pregnancy prevention program Receives: Behavioral: It's Your Game...Keep it Real |
| Usual care | No intervention | Students received their regular health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of vaginal or oral sex
The variable is a yes/no measure of whether a person has ever had vaginal OR oral sex. The measure is created from the following items on the survey:
- "Have you ever had sexual intercourse?" (defined in survey as penis in vagina)
- "Have you ever had oral sex?" Participants who respond yes they have had sexual intercourse OR yes they have had oral sex are coded as 1 for yes; those who respond no they have not had sexual intercourse AND no they have not had oral sex are coded as 0 for no.
Measured: 12 months after the program ends
Secondary outcomes (38)
Initiation of vaginal intercourse
The variable is a yes/no measure of whether a person has ever had vaginal intercourse. The measure is based on the following item on the survey:
- "Have you ever had sexual intercourse?" (defined in survey as penis in vagina) Respondents who respond yes they have had sexual intercourse are coded as 1 for yes and those who respond no they have not had vaginal intercourse are coded as 0 for no.
Measured: 12 months after the program ends
Initiation of oral sex
The variable is a yes/no measure of whether a person has ever had oral sex. The measure is based on the following item on the survey:
- "Have you ever had oral sex?" Respondents who respond yes they have had oral sex are coded as 1 for yes and those who respond no they have not had oral sex are coded as 0 for no.
Measured: 12 months after the program ends
Participation in vaginal sex without a condom
The variable is a yes/no measure of whether a person participated in vaginal sex without a condom. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Participation in vaginal sex without an effective method of birth control
The variable is a yes/no measure of whether a person participated in vaginal sex without an effective method of birth control. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Use of Condom at last sex
The variable is a yes/no measure of whether a person reported using a condom the last time they had vaginal sex. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Use of effective method of birth control at last sex
The variable is a yes/no measure of whether a person reported using an effective method of birth control the last time they had vaginal sex. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Percent of youth who report having vaginal sex 2 or more times in the past 3 months
This variable is the percent of youth who reported having vaginal sex 2 or more times versus 1 time during the past 3 months. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Percent of youth who report having oral sex 2 or more times in the past 3 months
This variable is the percent of youth who reported having oral sex 2 or more times versus 1 time during the past 3 months. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Percent of youth who report having vaginal sex with 2 or more partners in the past 3 months
This variable is the percent of youth who reported having vaginal sex with 2 or more partners versus 1 partner during the last 3 months. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Percent of youth who report having oral sex with 2 or more partners in the past 3 months
This variable is the percent of youth who reported having oral sex with 2 or more partners versus 1 partner during the last 3 months. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Percent of youth who report using drugs or alcohol before vaginal sex at least 1 time in the past 3 months
This variable is the percent of youth who reported using drugs or alcohol before vaginal sex 1 time versus 0 times in the last 3 months. It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
Percent of youth who report using drugs or alcohol before oral sex at least 1 time in the past 3 months
This variable is the percent of youth who reported using drugs or alcohol before oral sex 1 time versus 0 times in the last 3 months.It is only calculated for youth who reported having had sex in the past 3 months.
Measured: past 3 months
General condom knowledge
This variable provides a mean score for general condom knowledge as measured by Coyle et al. (2014). Higher scores indicated greater condom knowledge. 6 items; yes, no, or not sure response format
Measured: Past year
General HIV/STI knowledge
This variable provides a mean score for general HIV/STI knowledge as measured by Coyle et al. (1999). Higher scores indicated greater HIV/STI knowledge. 4 items; true, false, or not sure response format
Measured: Past year
Knowledge of signs and symptoms of STIs
This variable provides a mean score for knowledge of signs and symptoms of STIs as measured by Coyle et al. (1999). Higher scores indicated greater knowledge of the signs and symptoms of STIs. 7 items; yes/no response format
Measured: Past year
General beliefs about waiting to have sex
This variable provides a mean score for general beliefs about waiting to have sex as measured by Borawski et al. (2005). Higher scores reflect more positive beliefs about waiting to have sex; 4 items; 4-point scale (strongly disagree to strongly agree response format)
Measured: Past year
Beliefs about waiting until marriage to have sex
This variable provides a mean score for beliefs about waiting until marriage to have sex as measured using items adapted from the Texas A\&M High School Youth Survey and Teen Activities and Attitudes Survey; Higher scores reflect more positive beliefs about waiting until marriage to have sex; 3 items; 4-point scale (strongly disagree to strongly agree) response format
Measured: Past year
Reasons to not have sex
This variable provides a mean score for the number of reasons participants provide for not having sex as measured by Coyle et al., 2004. A higher score reflects more reasons for not having sex. 10 items; Yes/No response format
Measured: Past year
General beliefs about condoms
This variable provides a mean score for general beliefs about condoms as measured by the Case Western Health Promotion Study. A higher score reflects more positive beliefs about condoms. 3 items; 4-point scale (strongly disagree to strongly agree) response format
Measured: Past year
Perceived friends beliefs about waiting to have sex
This variable provides a mean score for perceived friends beliefs about waiting to have sex as measured by Coyle et al., 2004. A higher score reflects students as being more likely to perceive their friends as having more negative attitudes towards waiting to have sex. 4 items; 4-point scale (strongly disagree to strongly agree) response format.
Measured: Past year
Perceived norms about sex (I)
This variable provides a mean score that reflects a student's perception regarding how many teens who had sex wished they had waited until they were older (as measured by Coyle et al., 2004). A higher score means that a student perceived that more teens who had had sex wished they had waited until they were older; 1 item; 4-point scale (strongly disagree to strongly agree) response format
Measured: Past year
Perceived norms about sex (II)
This variable provides a mean score that reflects a student's perception regarding how many other teens their age are having sex (as measured by Coyle et al., 2004). A higher score means that students perceived that many other teens their age were having sex; 1 item; 4-point scale (strongly disagree to strongly agree) response format
Measured: Past year
Perceived friends sexual behaviors (I)
This variable provides a mean score that reflects a student's perception regarding how many of their friends have a boyfriend/girlfriend (as measured by Coyle et al., 2004). A higher score means that students perceived that many of their friends have a boyfriend/girlfriend; 1 item; 5-point scale (none to all) response format
Measured: Past year
Perceived friends sexual behaviors (II)
This variable provides a mean score that reflects a student's perception regarding how many of their friends have had sex (as measured by Coyle et al., 2004). A higher score means that students perceived that many of their friends have had sex; 1 item; 5-point scale (none to all) response format
Measured: Past year
Perceived friends' beliefs about condoms
This variable provides a mean score for perceived friends' beliefs about condoms as measured by the Case Western Health Promotion Study. A higher score reflects that students perceived their friends has having more positive beliefs about condoms. 3 items; 4-point scale (strongly disagree to strongly agree) response format
Measured: Past year
Perceived self-efficacy to refrain from having sex
This variable provides a mean score for perceived self-efficacy to refrain from having sex (as measured by Coyle et al., 2004). A higher score reflects higher perceived self-efficacy to refrain from having sex. 6 items; 4 point scale (definitely could not to definitely could) response format
Measured: Past year
Perceived self-efficacy to negotiate the use of condoms with a partner
This variable provides a mean score for perceived self-efficacy to negotiate the use of condoms with a partner as measured by Coyle et al., 2004. A higher score reflects greater self-efficacy. 2 items; 4-point scale (definitely could not to definitely could) response format
Measured: Past year
Perceived self-efficacy to obtain and correctly use condoms
This variable provides a mean score for perceived self-efficacy to obtain and correctly use condoms as measured by Coyle et al., 2004. A higher score reflects greater self-efficacy. 3 items; 4-point scale (definitely could not to definitely could) response format
Measured: Past year
Personal limits regarding sex
This variable provides a mean score for how one feels about how far he/she would go sexually and be able to communicate it to their partner as measured by Borawski et al., 2005. A higher score reflects that person would have higher perceived personal limits regarding sex. 1 item; 4-point scale (I have never really thought about how far I will go sexually to I know how far I would go sexually and I could tell a partner what I would do or not do)
Measured: Past year
Personal limits regarding condoms
This variable provides a mean score for how one feels what he/she thinks about condom use and whether they could communicate it to a partner as measured by Borawski et al., 2005. A higher score reflects that person would have higher perceived personal limits regarding condoms. 1 item; 4-point scale (I have never really thought about using condoms to I know whether or not I would use condoms and I could tell my partner)
Measured: Past year
Communication with parents about sex
This variable provides a mean score for parental communication about sex as measured by Ball et al., 2004 and Miller et al., 1998. A higher score reflects greater communication with parents. 6 items; 3-point scale (we've never talked about it to we've talked about it lots of times)
Measured: Past year
Exposure to risky situations
This variable provides a mean score for student exposure to risky situations as measured by Borawski et al., 2005 and Coyle et al., 2004. A higher score reflects more exposure to risky situations (e.g., gone to someone's house when an adult was not there). 5 items; 5-point scale (never to 6 times or more) response format
Measured: Past 3 months
Intentions to have sex in the next year
This variable provides a mean score for student intentions to have sex in the next year if they have the chance as measured by Tortolero et al., 2010. A higher score reflects greater intentions to have sex in the next year. 1 item; 4-point scale (yes, definitely to no, definitely not) response format
Measured: Past year
Intentions to remain abstinent until the end of high school
This variable provides a mean score for student intentions remain abstinent until the end of high school as measured by the Case Western Health Promotion Study. A higher score reflects greater intentions to remain abstinent. 1 item; 4-point scale (yes, definitely to no, definitely not)
Measured: Past year
Intentions to remain abstinent until marriage
This variable provides a mean score for student intentions to remain abstinent until marriage as measured by the Case Western Health Promotion Study. A higher score reflects greater intentions to remain abstinent until marriage. 1 item; 4-point scale (yes, definitely to no, definitely not)
Measured: Past year
Intentions to use a condom if have sex in the next year
This variable provides a mean score for student intentions to use a condom if they have sex in the next year as measured by Tortolero et al., 2010. A higher score reflects greater intentions to use a condom; 1 item; 4-point scale (yes, definitely to no, definitely not)
Measured: Past year
Intentions to use effective birth control if have sex in the next year
This variable provides a mean score for student intentions to use effective birth control if they have sex in the next year as measured by Tortolero et al., 2010. A higher score reflects greater intentions to use effective birth control; 1 item; 4-point scale (yes, definitely to no, definitely not)
Measured: Past year
Intentions to get tested for HIV/STI if think at risk
This variable provides a mean score for student intentions to get tested for HIV/STI if they think they are at risk as measured by the Safer Choices survey. A higher score reflects greater intentions to get tested; 1 item; 4-point scale (yes, definitely to no, definitely not)
Measured: Past year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,588 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ETR Associates, The Office of Adolescent Health, HHS
- Responsible party
- Principal investigator, Melissa Peskin, The University of Texas Health Science Center, Houston
- Investigators
- Susan T Emery, PhD, Principal investigator, UT School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533192
- Sponsor's protocol ID
- HSC-SPH-10-0455
- Status last verified
- May 2018
- First submitted
- 23 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peskin MF, Coyle KK, Anderson PM, Laris BA, Glassman JR, Franks HM, Thiel MA, Potter SC, Unti T, Edwards S, Johnson-Baker K, Cuccaro PM, Diamond P, Markham CM, Shegog R, Baumler ER, Gabay EK, Emery ST. Replication of It's Your Game...Keep It Real! in Southeast Texas. J Prim Prev. 2019 Jun;40(3):297-323. doi: 10.1007/s10935-019-00549-0.
PubMed 31028508
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teenage Pregnancy Prevention: Replication of Evidence-based Programs
- ClinicalTrials.gov ID
- NCT03533192
- Acronym / sponsor ID
- HSC-SPH-10-0455
- Conditions
- Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,588 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- ETR Associates, The Office of Adolescent Health, HHS
- Study start
- Sep 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this school-level randomized intervention trial is to evaluate the It's Your Game…Keep It Real program, an evidence-based teen pregnancy, HIV, and STI prevention program, among 2,000 students from 20 middle schools in 10 participating school districts in Harris County and surrounding areas. An audio computer-assisted self interview (A-CASI) assessment was used to assess demographic characteristics, psychosocial factors, sexual behaviors, and program exposure at three data collection points. Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.
Detailed description
Program Implemented: It's Your Game…Keep It Real (IYG) consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). The intervention was provided to the same 7th and 8th graders over a two-year period (i.e., the same students receive up to 24 lessons over two years). The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models. The lessons were delivered according to the schedule that worked best for schools (for example, twice a week, once a week, or daily) within a school semester. The lessons were delivered by trained teachers during regular classroom time and were taught during a variety of subject areas (for example, physical education/health, social studies, and science). Teachers implementing the lessons were required to attend training in order to teach the 7th- and 8th-grade lessons.
Sample: This sample included students at 20 schools from selected school districts throughout the greater Houston, Texas, area that agreed to participate in the study and that served 7th and 8th grades. Student inclusion criteria required that students not face language barriers or require educational accommodations that would preclude them from participation in the survey data collection process. Data collection staff, blind to school study condition, recruited 7th-grade students attending eligible classes across the 20 middle schools participating in the randomized controlled trial. A mix of census and sampling was used when securing consent for participation. In schools with 250 or fewer 7th-grade students, consents were distributed to all students. For schools with 7th-grade enrollments of more than 250, classes were sampled randomly and consents were distributed to 180 students. The study included one cohort and followed students from 7th through 9th grades. The final enrolled sample size was 2,588 students for whom parental consent and student assent were obtained.
Setting: The study sites included 20 urban middle schools, in Harris County, Texas. The program was implemented in 10 intervention schools by trained facilitators. Most facilitators in both 7th and 8th grades were physical education teachers.
Data Collection: Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.
Data Analysis: Impact data were analyzed using multilevel regression due to the nested nature of the study design (students within schools).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receipt of It's Your Game...Keep it Real | Experimental | Behavioral: It's Your Game...Keep it RealIt's Your Game...Keep it Real is an HIV, STI, and teen pregnancy prevention program |
| Usual care | No intervention | –Students received their regular health education. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- enrolled in 7th grade at a participating school in fall 2012
- did not have limited capabilities or special needs as determined by the school
- spoke English well enough to understand the survey questions if they were read aloud.
Key exclusion criteria (1 listed)
- -did not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It's Your Game...Keep it RealIt's Your Game...Keep it Real consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). In each grade, the curriculum integrates group-based classroom activities with personalized journaling and individually tailored computer-based activities. A life-skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal rules regarding risk behaviors, detect signs or situations that might challenge these rules, and use refusal skills and other tactics to protect these rules. The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models. | Behavioural | Receipt of It's Your Game...Keep it Real |
Primary outcome
Initiation of vaginal or oral sex
Time frame: 12 months after the program ends
The variable is a yes/no measure of whether a person has ever had vaginal OR oral sex. The measure is created from the following items on the survey: * "Have you ever had sexual intercourse?" (defined in survey as penis in vagina) * "Have you ever had oral sex?" Participants who respond yes they have had sexual intercourse OR yes they have had oral sex are coded as 1 for yes; those who respond no they have not had sexual intercourse AND no they have not had oral sex are coded as 0 for no.
38 secondary outcomes
Initiation of vaginal intercourse
Time frame: 12 months after the program ends
Initiation of oral sex
Time frame: 12 months after the program ends
Participation in vaginal sex without a condom
Time frame: past 3 months
Participation in vaginal sex without an effective method of birth control
Time frame: past 3 months
Use of Condom at last sex
Time frame: past 3 months
Use of effective method of birth control at last sex
Time frame: past 3 months
Percent of youth who report having vaginal sex 2 or more times in the past 3 months
Time frame: past 3 months
Percent of youth who report having oral sex 2 or more times in the past 3 months
Time frame: past 3 months
Percent of youth who report having vaginal sex with 2 or more partners in the past 3 months
Time frame: past 3 months
Percent of youth who report having oral sex with 2 or more partners in the past 3 months
Time frame: past 3 months
Percent of youth who report using drugs or alcohol before vaginal sex at least 1 time in the past 3 months
Time frame: past 3 months
Percent of youth who report using drugs or alcohol before oral sex at least 1 time in the past 3 months
Time frame: past 3 months
General condom knowledge
Time frame: Past year
General HIV/STI knowledge
Time frame: Past year
Knowledge of signs and symptoms of STIs
Time frame: Past year
General beliefs about waiting to have sex
Time frame: Past year
Beliefs about waiting until marriage to have sex
Time frame: Past year
Reasons to not have sex
Time frame: Past year
General beliefs about condoms
Time frame: Past year
Perceived friends beliefs about waiting to have sex
Time frame: Past year
Perceived norms about sex (I)
Time frame: Past year
Perceived norms about sex (II)
Time frame: Past year
Perceived friends sexual behaviors (I)
Time frame: Past year
Perceived friends sexual behaviors (II)
Time frame: Past year
Perceived friends' beliefs about condoms
Time frame: Past year
Perceived self-efficacy to refrain from having sex
Time frame: Past year
Perceived self-efficacy to negotiate the use of condoms with a partner
Time frame: Past year
Perceived self-efficacy to obtain and correctly use condoms
Time frame: Past year
Personal limits regarding sex
Time frame: Past year
Personal limits regarding condoms
Time frame: Past year
Communication with parents about sex
Time frame: Past year
Exposure to risky situations
Time frame: Past 3 months
Intentions to have sex in the next year
Time frame: Past year
Intentions to remain abstinent until the end of high school
Time frame: Past year
Intentions to remain abstinent until marriage
Time frame: Past year
Intentions to use a condom if have sex in the next year
Time frame: Past year
Intentions to use effective birth control if have sex in the next year
Time frame: Past year
Intentions to get tested for HIV/STI if think at risk
Time frame: Past year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Derived from this study: PubMed 31028508Peskin MF, Coyle KK, Anderson PM, Laris BA, Glassman JR, Franks HM, Thiel MA, Potter SC, Unti T, Edwards S, Johnson-Baker K, Cuccaro PM, Diamond P, Markham CM, Shegog R, Baumler ER, Gabay EK, Emery ST. Replication of It's Your Game...Keep It Real! in Southeast Texas. J Prim Prev. 2019 Jun;40(3):297-323. doi: 10.1007/s10935-019-00549-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan T Emery, PhD principal investigator
UT School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing It's Your Game...Keep it Real in people with Sexual Behavior, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of vaginal or oral sex (time frame: 12 months after the program ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.