Lack of Knowledge About Condoms and Birth ControlNCT04027010
An Evaluation of Virtual Student Health Center Among Incarcerated Juvenile Offenders
A study testing "Healthy U" tablet application in people with Lack of Knowledge About Condoms and Birth Control and Adolescent Sexual Intercourse, run by WestEd at 2 sites in United States.
Trial summary
WestEd and its partners Efficacity and the Oregon Youth Authority (OYA), are conducting a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U, for youthful male offenders. Read more about this study
- Who is it for?
- Ages 14 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lack of Knowledge About Condoms and Birth Control, Adolescent Sexual Intercourse, Sexual Intercourse Without a Condom or Birth Control
- What is being tested?
- "Healthy U" tablet application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2017to 1 May 2020
- 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 14 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male
- Aged 14-19
- OYA commits
- Have the cognitive ability to complete the baseline and follow-up surveys
- Need to be within 30-90 days of release
Who cannot join
- Female
- Outside of age criteria
- Oregon Department of Corrections commits
- Does not have the cognitive ability to complete the baseline and follow-up surveys
- Not within 30-90 days of release
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WestEd
Los Alamitos, California, 90720
WestEd
Woburn, Massachusetts, 01801
About this study
Official title: A Randomized Controlled Trial of Virtual Student Health Center Among Incarcerated Juvenile Offenders
WestEd and its partners Efficacity and the Oregon Youth Authority (OYA), are conducting a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U, for youthful male offenders. This study involves male teenagers (age 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The innovative, non-curricular, technology-based intervention, Healthy U, is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. The purpose of this study is to test this intervention on a population of young men incarcerated at the OYA who will soon be released into the community. The intervention is tailored to this population by updating the design, videos, and examples to best reflect the youth in the study, and OYA staff are being trained to facilitate the self-guided intervention.
Read the detailed description
WestEd and its partners, Efficacity and the Oregon Youth Authority (OYA), were funded by the Department of Health and Human Services (DHHS) to conduct a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U (formally known as Virtual Student Health Center), for youthful male offenders to test the impact of this innovative, non-curricular, technology-based intervention, that is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. Healthy U was designed to give adolescents and teens the tools they need to reduce their risk of unintended pregnancy and sexually transmitted diseases (STDs), including HIV, using a low-cost, transportable platform that is user-friendly for youth (and staff to oversee). In this project, we take the innovative Healthy U intervention and modify its implementation for juveniles in custody of a correctional facility.
This study involved male teenagers (ages 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The findings from this study are intended to contribute to research on both teen pregnancy and crime prevention. Teen parents and their children are at greater risk for subsequent criminal offending, and the children of teen parents also have greater risk of child abuse and neglect victimization. The current knowledge base suggests that youth exposed to the juvenile justice system have sex more often with more partners at a younger age and without protection (Bryan, Rocheleau, Robbins, \& Hutchinson, 2005). This randomized study was designed to contribute to our understanding of what works with this population and to strengthen our knowledge base around developing and implementing technology-based interventions in a juvenile correctional environment.
- Conditions
- Lack of Knowledge About Condoms and Birth Control, Adolescent Sexual Intercourse, Sexual Intercourse Without a Condom or Birth Control, Unplanned Pregnancies
- Being tested
- "Healthy U" tablet application
- Keywords
- juvenile justice, male-focused intervention, unplanned teen fatherhood, technology-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Healthy U" tablet applicationOther
Also called Virtual Student Health Center
There are seven modules in Healthy U: Puberty, Birth Control, Teen Pregnancy, HIV, STDs, Healthy Relationships, and Condom Negotiation. Each module has six sections: Introduction and Review, Narrative Teen Portrait, Information Film, Activity/Game, Dramatic Film, and Imagination Challenge. The Introduction and Review has videos lasting 1-2 minutes where the Healthy U "host" introduces each module. In the Narrative Teen Portrait for each module, a different teen discusses their experience with the topic for 1-3 minutes. The Information Film lasts 5-18 minutes per module and provides factual information. For each module, the Activity/Game includes multiple choice, true/false, or other games. The Dramatic Film lasts 5-17 minutes for each module and shows a fictional account of a teen experiencing the topic. Finally, the Imagination Challenge asks the youth to imagine a scenario, such as going to a health clinic to obtain free condoms.
| Study group | Role | What they receive |
|---|---|---|
| "Healthy U" tablet application | Experimental | Healthy U is a self-administered intervention implemented through a tablet app with interactive learning experiences, including videos, digital games, quizzes, and role-plays. Healthy U takes youth 3-4 hours to complete. The goals of Healthy U are to: 1) Increase male youth's perception of vulnerability to unplanned fatherhood, STDs and HIV; 2) Increase male youth's self-efficacy for negotiating condom use with their partners; 3) Increase male youth's self-efficacy for using condoms correctly and consistently every time they have sex; and 4) Increase male youth's engagement with goals and dreams for their future. Receives: Other: "Healthy U" tablet application |
| Treatment as usual | No intervention | The counterfactual condition for the study is a business-as-usual condition. OYA does not provide much programming to youth in its facilities related to sexual health and pregnancy prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual intercourse
The outcome was based on four survey items. Youth who responded "no" to the first item: "Have you ever had sexual intercourse?" were coded as "0". Youth who responded "no" to the second item: "Have you been out of a close custody OYA facility any time in the past three months?" were also coded as "0". Youth who responded "no" to the third item: "During the last 3 months, did you have sexual intercourse, even once?" were also coded as "0". Youth who responded "yes" to the first three items and provided a valid response greater than zero to the fourth item: "In the last 3 months (include only the time you were outside of a close custody OYA facility), how many TIMES did you have sexual inter-course?" were coded as the value they entered.
Measured: 6 months after the baseline survey
Secondary outcomes (3)
Sexual intercourse without a condom
The outcome was created by subtracting the sexual intercourse outcome from the following measure based on four items. Youth who responded "no" to the first item: "Have you ever had sexual intercourse?" were coded as "0". Youth who responded "no" to the second item: "Have you been out of a close custody OYA facility any time in the past three months?" were also coded as "0". Youth who responded "no" to the third item: "During the last 3 months, did you have sexual intercourse, even once?" were also coded as "0". Youth who responded "yes" to the first three items and provided a valid response greater than zero to the fourth item: "In the last 3 months (include only the time you were outside of a close custody OYA facility), how many TIMES did you or your partner use a condom when you had sexual inter-course?" were coded as the value they entered. Youth who responded "none" to the fourth item were coded as "0".
Measured: 6 months after the baseline survey
Sexual intercourse without any methods of birth control
The outcome was based on four survey items. Youth who responded "no" to the first item: "Have you ever had sexual intercourse?" were coded as "0". Youth who responded "no" to the second item: "Have you been out of a close custody OYA facility any time in the past three months?" were also coded as "0". Youth who responded "no" to the third item: "During the last 3 months, did you have sexual intercourse, even once?" were also coded as "0". Youth who responded "yes" to the first three items and provided a valid response greater than zero to the fourth item: "In the last 3 months (include only the time you were outside of a close custody OYA facility), how many times did you have sexual intercourse without you or your partner using any methods of birth control (that is, you didn't use a condom or any other type of birth control shown in the blue box above)?" were coded as the value they entered. Youth who responded "none" to the fourth item were coded as "0".
Measured: 6 months after the baseline survey
Subsequent pregnancies of female partners
The outcome was created by subtracting the number of pregnancies reported at baseline from the number of pregnancies reported at the 6-month follow-up. At both time points, the measure was based on three questions. Youth who responded "no" to the first item: "Have you ever had sexual intercourse?" were coded as "0". Youth who responded "no" or "don't know" to the second item: "To the best of your knowledge, have you ever gotten someone pregnant, even if no child was born?" were also coded as "0". Youth who responded "yes" to the first two items and provided a valid response greater than zero to the third item: "To the best of your knowledge, how many times have you gotten someone pregnant?" were coded as the value they entered.
Measured: 6 months after the baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Feb 2017
- Primary completion1 May 2020
- Study completion1 May 2020
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 Lack of Knowledge About Condoms and Birth ControlStudies of the same condition, open and under way.
- 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
- Model description
- The treatment condition involves participation in a teen pregnancy prevention program, Healthy U (formally known as Virtual Student Health Center). The comparison condition for the study is treatment as usual.
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- WestEd
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Youth Authority, Efficacity, The Office of Adolescent Health, HHS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027010
- Sponsor's protocol ID
- 8169
- Status last verified
- Aug 2022
- First submitted
- 17 Jul 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bryan A, Rocheleau CA, Robbins RN, Hutchinson KE. Condom use among high-risk adolescents: testing the influence of alcohol use on the relationship of cognitive correlates of behavior. Health Psychol. 2005 Mar;24(2):133-42. doi: 10.1037/0278-6133.24.2.133.
PubMed 15755227
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Virtual Student Health Center Among Incarcerated Juvenile Offenders
- ClinicalTrials.gov ID
- NCT04027010
- Acronym / sponsor ID
- 8169
- Conditions
- Lack of Knowledge About Condoms and Birth Control, Adolescent Sexual Intercourse, Sexual Intercourse Without a Condom or Birth Control, Unplanned Pregnancies
- Keywords
- juvenile justice, male-focused intervention, unplanned teen fatherhood, technology-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- WestEdUniversity, hospital or other
- Collaborators
- Oregon Youth Authority, Efficacity, The Office of Adolescent Health, HHS
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 19 Jul 2019 (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.
WestEd and its partners Efficacity and the Oregon Youth Authority (OYA), are conducting a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U, for youthful male offenders. This study involves male teenagers (age 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The innovative, non-curricular, technology-based intervention, Healthy U, is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. The purpose of this study is to test this intervention on a population of young men incarcerated at the OYA who will soon be released into the community. The intervention is tailored to this population by updating the design, videos, and examples to best reflect the youth in the study, and OYA staff are being trained to facilitate the self-guided intervention.
Detailed description
WestEd and its partners, Efficacity and the Oregon Youth Authority (OYA), were funded by the Department of Health and Human Services (DHHS) to conduct a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U (formally known as Virtual Student Health Center), for youthful male offenders to test the impact of this innovative, non-curricular, technology-based intervention, that is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. Healthy U was designed to give adolescents and teens the tools they need to reduce their risk of unintended pregnancy and sexually transmitted diseases (STDs), including HIV, using a low-cost, transportable platform that is user-friendly for youth (and staff to oversee). In this project, we take the innovative Healthy U intervention and modify its implementation for juveniles in custody of a correctional facility.
This study involved male teenagers (ages 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The findings from this study are intended to contribute to research on both teen pregnancy and crime prevention. Teen parents and their children are at greater risk for subsequent criminal offending, and the children of teen parents also have greater risk of child abuse and neglect victimization. The current knowledge base suggests that youth exposed to the juvenile justice system have sex more often with more partners at a younger age and without protection (Bryan, Rocheleau, Robbins, \& Hutchinson, 2005). This randomized study was designed to contribute to our understanding of what works with this population and to strengthen our knowledge base around developing and implementing technology-based interventions in a juvenile correctional environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment condition involves participation in a teen pregnancy prevention program, Healthy U (formally known as Virtual Student Health Center). The comparison condition for the study is treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| "Healthy U" tablet application | Experimental | Other: "Healthy U" tablet applicationHealthy U is a self-administered intervention implemented through a tablet app with interactive learning experiences, including videos, digital games, quizzes, and role-plays. Healthy U takes youth 3-4 hours to complete. The goals of Healthy U are to: 1) Increase male youth's perception of vulnerability to unplanned fatherhood, STDs and HIV; 2) Increase male youth's self-efficacy for negotiating condom use with their partners; 3) Increase male youth's self-efficacy for using condoms correctly and consistently every time they have sex; and 4) Increase male youth's engagement with goals and dreams for their future. |
| Treatment as usual | No intervention | –The counterfactual condition for the study is a business-as-usual condition. OYA does not provide much programming to youth in its facilities related to sexual health and pregnancy prevention. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male
- Aged 14-19
- OYA commits
- Have the cognitive ability to complete the baseline and follow-up surveys
- Need to be within 30-90 days of release
Key exclusion criteria (5 listed)
- Female
- Outside of age criteria
- Oregon Department of Corrections commits
- Does not have the cognitive ability to complete the baseline and follow-up surveys
- Not within 30-90 days of release
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 |
|---|---|---|
| "Healthy U" tablet applicationAlso: Virtual Student Health CenterThere are seven modules in Healthy U: Puberty, Birth Control, Teen Pregnancy, HIV, STDs, Healthy Relationships, and Condom Negotiation. Each module has six sections: Introduction and Review, Narrative Teen Portrait, Information Film, Activity/Game, Dramatic Film, and Imagination Challenge. The Introduction and Review has videos lasting 1-2 minutes where the Healthy U "host" introduces each module. In the Narrative Teen Portrait for each module, a different teen discusses their experience with the topic for 1-3 minutes. The Information Film lasts 5-18 minutes per module and provides factual information. For each module, the Activity/Game includes multiple choice, true/false, or other games. The Dramatic Film lasts 5-17 minutes for each module and shows a fictional account of a teen experiencing the topic. Finally, the Imagination Challenge asks the youth to imagine a scenario, such as going to a health clinic to obtain free condoms. | Other | "Healthy U" tablet application |
Primary outcome
Sexual intercourse
Time frame: 6 months after the baseline survey
The outcome was based on four survey items. Youth who responded "no" to the first item: "Have you ever had sexual intercourse?" were coded as "0". Youth who responded "no" to the second item: "Have you been out of a close custody OYA facility any time in the past three months?" were also coded as "0". Youth who responded "no" to the third item: "During the last 3 months, did you have sexual intercourse, even once?" were also coded as "0". Youth who responded "yes" to the first three items and provided a valid response greater than zero to the fourth item: "In the last 3 months (include only the time you were outside of a close custody OYA facility), how many TIMES did you have sexual inter-course?" were coded as the value they entered.
3 secondary outcomes
Sexual intercourse without a condom
Time frame: 6 months after the baseline survey
Sexual intercourse without any methods of birth control
Time frame: 6 months after the baseline survey
Subsequent pregnancies of female partners
Time frame: 6 months after the baseline survey
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 10 Aug 2022.
- Background: PubMed 15755227Bryan A, Rocheleau CA, Robbins RN, Hutchinson KE. Condom use among high-risk adolescents: testing the influence of alcohol use on the relationship of cognitive correlates of behavior. Health Psychol. 2005 Mar;24(2):133-42. doi: 10.1037/0278-6133.24.2.133.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Healthy U" tablet application in people with Lack of Knowledge About Condoms and Birth Control and Adolescent Sexual Intercourse, run by WestEd at 2 sites in United States.
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 5 inclusion and 5 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Sexual intercourse (time frame: 6 months after the baseline survey). 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 NCT04027010, 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 10 Aug 2022.