Teen PregnancyNCT04494477
Evaluation of the Impact of the IN•Clued Curriculum: An LGBTQ Sex ed Program
A study testing The IN•clued program in people with Teen Pregnancy and STD Prevention, run by Philliber Research & Evaluation at 1 site in United States.
Trial summary
The INclued program was implemented in 16 states across the US. The purpose of this study is to measure: Nine months after the end of the program and one year after the workshop, are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy, STD Prevention
- What is being tested?
- The IN•clued program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,401 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 30 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Youth participants are already in LGBTQ groups, such as gay-straight alliances in schools or local community groups or those who are recruited to attend a special event at a community-based organization or conference. Participants must be at least 14 and preferably younger than 20. Ideally, they are part of the LGBTQ community, although this is not required.
Who cannot join
- Cannot require ESL support.
Trial locations and contacts
1 site in 1 country.
United States1 site
Philliber Research & Evaluation
Accord, New York, 12404
About this study
Official title: The Evaluation of IN•Clued - Inclusive Health Care: Youth & Providers Empowered
The INclued program was implemented in 16 states across the US. The purpose of this study is to measure: Nine months after the end of the program and one year after the workshop, are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?
Read the detailed description
The IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center.
Workshops take place with LGBTQ youth groups through schools, community-based organizations, or conferences. Each segment is led by adult facilitators or trained peer educators with adult facilitator support. These peer educators are from the Planned Parenthood Teen Council peer education program. Teen Council is a unique peer education program created in 1989 by PPGNHI. It is a strong and successful peer education program that trains high school youth to become experts in delivering inclusive, comprehensive sexual health education to their peers via group and community presentations. If trained peer educators are used, they implement the intervention with the guidance and oversight of an adult facilitator.
Participants in the control condition receive a benign intervention, which like IN•clued, meets in a group setting.
Once a site or group is defined, facilitators send implementation forms to Philliber. The evaluation team reviews the information and asks any needed questions which vary by group or site. The two groups cannot differ in any significant way (e.g., gender, SES, ethnicity, or special characteristic such as pregnant and parenting participants). All decisions about final eligibility are made by the research team. If two groups or sites are similar, they are approved. If they differ in a significant way, they are not eligible for the study.
Random assignment of the groups does not technically occur until the baseline administration of the survey is completed as participants can be both added and subtracted from the group list until the time of survey administration. One facilitator at each location is informed of the outcome of random assignment before or during the administration of the baseline survey. This is done so random assignment can occur immediately after surveys are conducted as this is a one-time workshop and participants do not give assent to participate until this time.
- Conditions
- Teen Pregnancy, STD Prevention
- Being tested
- The IN•clued program
- Keywords
- LGBTQ sex education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The IN•clued programBehavioural
The INclued program as previously described.
| Study group | Role | What they receive |
|---|---|---|
| The IN•clued program | Experimental | The IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center. Receives: Behavioral: The IN•clued program |
| Control | No intervention | The youth control group receives a 10-minute presentation and a list of local sexual healthcare providers, with no indication of which providers have been trained to be more LGBTQ friendly and accepting. This 10-minute presentation is a part of a longer three-hour activity unrelated to sexual health or accessing sexual healthcare. During the three-hour session, the list of approved activities includes but is not limited to: * Films by, and for, LGBTQ youth about sexual orientation and gender identity; * Community scavenger hunts; * Poetry slams; * Discussions about relationships; and * Activities related to the appreciation of individuals' unique strengths. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?
If participants had recent (in the past three months) vaginal sex without a condom or birth control, recent oral sex without protection, or recent anal sex without a condom, they were coded as having engaged in recent unprotected or risky sexual behavior.
Measured: One year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start22 Feb 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 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 Teen PregnancyStudies 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
- Masking
- None (open label)
- Enrolment
- 1,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philliber Research & Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood of the Great Northwest and Hawaiian Islands, The Office of Adolescent Health, HHS
- Responsible party
- Principal investigator, Ashley Philliber, Philliber Research & Evaluation
- Investigators
- Ash Philliber, PhD, Principal investigator, Philliber Research & Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494477
- Sponsor's protocol ID
- PhilliberINclued
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Philliber A. The IN.clued Program: A Randomized Control Trial of an Effective Sex Education Program for Lesbian, Gay, Bisexual, Transgender, Queer, and Questioning Youths. J Adolesc Health. 2021 Oct;69(4):636-643. doi: 10.1016/j.jadohealth.2021.04.002. Epub 2021 May 14.
PubMed 33994311
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of IN•Clued - Inclusive Health Care: Youth & Providers Empowered
- ClinicalTrials.gov ID
- NCT04494477
- Acronym / sponsor ID
- PhilliberINclued
- Conditions
- Teen Pregnancy, STD Prevention
- Keywords
- LGBTQ sex education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,401 participants (actual)
- Lead sponsor
- Philliber Research & EvaluationUniversity, hospital or other
- Collaborators
- Planned Parenthood of the Great Northwest and Hawaiian Islands, The Office of Adolescent Health, HHS
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 31 Jul 2020 (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 INclued program was implemented in 16 states across the US. The purpose of this study is to measure: Nine months after the end of the program and one year after the workshop, are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?
Detailed description
The IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center.
Workshops take place with LGBTQ youth groups through schools, community-based organizations, or conferences. Each segment is led by adult facilitators or trained peer educators with adult facilitator support. These peer educators are from the Planned Parenthood Teen Council peer education program. Teen Council is a unique peer education program created in 1989 by PPGNHI. It is a strong and successful peer education program that trains high school youth to become experts in delivering inclusive, comprehensive sexual health education to their peers via group and community presentations. If trained peer educators are used, they implement the intervention with the guidance and oversight of an adult facilitator.
Participants in the control condition receive a benign intervention, which like IN•clued, meets in a group setting.
Once a site or group is defined, facilitators send implementation forms to Philliber. The evaluation team reviews the information and asks any needed questions which vary by group or site. The two groups cannot differ in any significant way (e.g., gender, SES, ethnicity, or special characteristic such as pregnant and parenting participants). All decisions about final eligibility are made by the research team. If two groups or sites are similar, they are approved. If they differ in a significant way, they are not eligible for the study.
Random assignment of the groups does not technically occur until the baseline administration of the survey is completed as participants can be both added and subtracted from the group list until the time of survey administration. One facilitator at each location is informed of the outcome of random assignment before or during the administration of the baseline survey. This is done so random assignment can occur immediately after surveys are conducted as this is a one-time workshop and participants do not give assent to participate until this time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The IN•clued program | Experimental | Behavioral: The IN•clued programThe IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center. |
| Control | No intervention | –The youth control group receives a 10-minute presentation and a list of local sexual healthcare providers, with no indication of which providers have been trained to be more LGBTQ friendly and accepting. This 10-minute presentation is a part of a longer three-hour activity unrelated to sexual health or accessing sexual healthcare. During the three-hour session, the list of approved activities includes but is not limited to: * Films by, and for, LGBTQ youth about sexual orientation and gender identity; * Community scavenger hunts; * Poetry slams; * Discussions about relationships; and * Activities related to the appreciation of individuals' unique strengths. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Youth participants are already in LGBTQ groups, such as gay-straight alliances in schools or local community groups or those who are recruited to attend a special event at a community-based organization or conference. Participants must be at least 14 and preferably younger than 20. Ideally, they are part of the LGBTQ community, although this is not required.
Key exclusion criteria (1 listed)
- Cannot require ESL support.
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 |
|---|---|---|
| The IN•clued programThe INclued program as previously described. | Behavioural | The IN•clued program |
Primary outcome
Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?
Time frame: One year after baseline
If participants had recent (in the past three months) vaginal sex without a condom or birth control, recent oral sex without protection, or recent anal sex without a condom, they were coded as having engaged in recent unprotected or risky sexual behavior.
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 31 Jul 2020.
- Derived from this study: PubMed 33994311Philliber A. The IN.clued Program: A Randomized Control Trial of an Effective Sex Education Program for Lesbian, Gay, Bisexual, Transgender, Queer, and Questioning Youths. J Adolesc Health. 2021 Oct;69(4):636-643. doi: 10.1016/j.jadohealth.2021.04.002. Epub 2021 May 14.
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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.
Ash Philliber, PhD principal investigator
Philliber Research & Evaluation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The IN•clued program in people with Teen Pregnancy and STD Prevention, run by Philliber Research & Evaluation at 1 site 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 1 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants? (time frame: One year after baseline). 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 NCT04494477, 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 31 Jul 2020.