Sexual AbstinencePREISNCT04180358
Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project
A study testing Native STAND and Regular Health/Physical Education Curriculum in people with Sexual Abstinence and Responsible Sex, run by Capacity Builders Inc. at 1 site in United States.
Trial summary
Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native Students Together Against Negative Decisions (Native STAND) which aims to reduce pregnancies, births, and sexually transmitted infections (STI's) including HIV/AIDS among high-risk youth populations by implementing culturally sensitive… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Abstinence, Responsible Sex
- What is being tested?
- Native STAND and Regular Health/Physical Education Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 834 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2017to 29 Sep 2021
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages of 14-18
- In grades 9-11
- Provide parental consent and participant assent to participate in the study
- Students in the first two groups will be allowed to participate in the intervention if they are enrolled in the classroom that will be receiving the intervention
- Students in the third group will be allowed to participate in the intervention only if they were part of the study's intervention group
Who cannot join
- Not have previously participated in any of the following past CBI Teen Pregnancy
- Prevention programs:
- New Mexico's Department of Health - Wyman's Teen Outreach Program
- Success with Adolescent Goals, inclusive of the Above the Waist Curriculum
- Students in 12th grade
- Study participants from previous cohorts
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Capacity Builders Inc.
Farmington, New Mexico, 87401
Lois Ritter, 505-326-4245 ext. 148, l.ritter@capacitybuilders.info
Lois Ritter
About this study
Official title: Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project Effectively Educating Navajo Youth on the Prevention of Adolescent Pregnancy, Sexually Transmitted Infections, and HIV/AIDS
Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native Students Together Against Negative Decisions (Native STAND) which aims to reduce pregnancies, births, and sexually transmitted infections (STI's) including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. The study has two hypotheses: (1) Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e. oral, vaginal and anal) in the last 3 months as compared to students assigned to the comparison group, measured at 12 month and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up); (2) Do students assigned to the Youth Builders program have a greater change of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group, measured at 12 and 18 months after random assignment? (No sexual activity or use contraception if engage in sex at 12 month and 18 month follow up.
Read the detailed description
Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native STAND, recruiting Navajo youth in grades 9-11 and between the ages 14-18 who attend school in the Consolidated School District in New Mexico. Using the Theory of Reasoned Action as a theoretical framework, the curriculum will be administered in classrooms over 27 sessions lasting 45 minutes. The curriculum will entail lessons conducted in either Physical Education or Health Classes and youth will be randomly assigned to two groups by the local program evaluator. Youth will be required to obtain signed consent and assent forms prior to participating in the intervention program. Youth will complete pre and post surveys to measure program outcomes. Random assignment will be conducted for the impact and comparison groups by being placed into a pool; students will be blindly pulled to become the impact group. Groups will be stratified to ensure balance between treatment and comparison groups. Quarterly evaluation reports (QERs) and an annual evaluation report will be provided to the Action Team for review.
Capacity Builder's Inc. (CBI) Youth Builders PREIS program seeks to test a modification of the Native STAND curriculum in Northwest New Mexico with at least 834 Navajo teens and 3 cohorts. The curriculum is intended to reduce pregnancies, births, and STI's including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. Additional curriculum of adulthood preparation subjects will increase participant knowledge in the areas of: healthy relationships, adolescent development, communication skills, healthy life skills. Youth Builders will be delivered within the traditional school day, embedded into regularly scheduled learning time. Presented once each week for 27 weeks over a 36-week school year, Youth Builders will reach students where they are, overcoming many challenges associated with retention. The project will support a Randomized Controlled Experimental Design. CBI will create valuable resources to support Youth Builders replication nationwide, including a comprehensive Youth Builders Blueprint, describing all action steps taken to achieve goals and objectives. In addition to action steps, the Youth Builders Blueprint will include: program curriculum; curricular map; training materials; sample parent consent forms; sample referral procedures / policies; staff training schedules; sample partnership agreements; Action Team meeting minutes,QERs, and annual evaluation reports The Youth Builders Blueprint will be available in both print and online format, and will be widely disseminated throughout the CBI network of non-profit agencies, Tribes, and school districts across the United States. Conference presentation will be ongoing at state and national conferences.
- Conditions
- Sexual Abstinence, Responsible Sex
- Being tested
- Native STAND, Regular Health/Physical Education Curriculum
- Keywords
- Navajo, Sex, Abstain, Culture, Random, Control, Trial, PREIS
- Medical subject headings
- Sexual Abstinence, Safe Sex, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native STANDBehavioural
Native STAND is a comprehensive sexual health curriculum for Native high school students that focuses on sexually transmitted infections, HIV/AIDS, and teen pregnancy prevention, while also covering drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Sessions will be conducted in regular Physical Education and/or Health Education classes during classroom/school hours.
Regular Health/Physical Education CurriculumBehavioural
General health and physical education curriculum provided by New Mexico's Public Education Department.
| Study group | Role | What they receive |
|---|---|---|
| Impact group | Experimental | The impact group will receive the interventions in the classrooms Receives: Behavioral: Native STAND |
| Comparison group | Placebo comparator | Comparison group will not receive the intervention Receives: Behavioral: Regular Health/Physical Education Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstaining from sexual activity
Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e. oral, vaginal and anal) in the last 3 months compared to students assigned to the comparison group at 12 month follow up and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up?
Measured: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Abstaining from sex or practicing safe sex
Do students assigned to the Youth Builders program have a greater chance of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group at 12 month follow up and 18 month follow up? (No sexual activity or use contraception if engage in sex at 12 and 18 month follow up)?
Measured: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Secondary outcomes (3)
Positive impact on participants' assertive communication/negotiation skills
To what degree does the Youth Builders curriculum have a positive impact on participants' assertive communication/negotiation skills?
Measured: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Positive impact on the peer to peer communication/discussing expectations habits of participants
To what degree does the Youth Builders curriculum have a positive impact on the peer to peer communication/discussing expectations habits of participants?
Measured: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Positive impact on the family communication/discussing expectations habits of participants
To what degree does the Youth Builders curriculum have a positive impact on the family communication/discussing expectations habits of participants?
Measured: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start24 Oct 2017
- Primary completion1 Feb 2021 (estimated)
- Study completion29 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AbstinenceStudies 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
- CBI will implement the Youth Builders PREIS Native STAND curriculum, a comprehensive sexual health curriculum designed for Native high school students that focuses on STI's, HIV/AIDS, and teen pregnancy prevention and covers drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Youth Build will enroll 834 youth in 3 cohorts with 42 clusters of 20 students, each who will be randomly assigned to an impact or a comparison group. Students will complete pre and post survey questionnaires and be provided incentives to maintain program participation. The program will have 4 staff: Project Director, Project Coordinator, and 2 Prevention Educations responsible for collecting data and tracking progress as well as implementing the curriculum
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 834 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capacity Builders Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Mathematica Policy Research, Inc., Family and Youth Services Bureau
- Responsible party
- Sponsor
- Investigators
- Lois Ritter, Principal investigator, Capacity Builders Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180358
- Sponsor's protocol ID
- 90AP2687-01-00
- Other IDs
- 90AP2687-00
- Acronym
- PREIS
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project Effectively Educating Navajo Youth on the Prevention of Adolescent Pregnancy, Sexually Transmitted Infections, and HIV/AIDS
- ClinicalTrials.gov ID
- NCT04180358
- Acronym / sponsor ID
- PREIS / 90AP2687-01-00
- Conditions
- Sexual Abstinence, Responsible Sex
- Keywords
- Navajo, Sex, Abstain, Culture, Random, Control, Trial, PREIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 834 participants (estimated)
- Lead sponsor
- Capacity Builders Inc.University, hospital or other
- Collaborators
- Mathematica Policy Research, Inc., Family and Youth Services Bureau
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 29 Sep 2021 (estimated)
- First posted
- 27 Nov 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.
Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native Students Together Against Negative Decisions (Native STAND) which aims to reduce pregnancies, births, and sexually transmitted infections (STI's) including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. The study has two hypotheses: (1) Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e. oral, vaginal and anal) in the last 3 months as compared to students assigned to the comparison group, measured at 12 month and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up); (2) Do students assigned to the Youth Builders program have a greater change of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group, measured at 12 and 18 months after random assignment? (No sexual activity or use contraception if engage in sex at 12 month and 18 month follow up.
Detailed description
Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native STAND, recruiting Navajo youth in grades 9-11 and between the ages 14-18 who attend school in the Consolidated School District in New Mexico. Using the Theory of Reasoned Action as a theoretical framework, the curriculum will be administered in classrooms over 27 sessions lasting 45 minutes. The curriculum will entail lessons conducted in either Physical Education or Health Classes and youth will be randomly assigned to two groups by the local program evaluator. Youth will be required to obtain signed consent and assent forms prior to participating in the intervention program. Youth will complete pre and post surveys to measure program outcomes. Random assignment will be conducted for the impact and comparison groups by being placed into a pool; students will be blindly pulled to become the impact group. Groups will be stratified to ensure balance between treatment and comparison groups. Quarterly evaluation reports (QERs) and an annual evaluation report will be provided to the Action Team for review.
Capacity Builder's Inc. (CBI) Youth Builders PREIS program seeks to test a modification of the Native STAND curriculum in Northwest New Mexico with at least 834 Navajo teens and 3 cohorts. The curriculum is intended to reduce pregnancies, births, and STI's including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. Additional curriculum of adulthood preparation subjects will increase participant knowledge in the areas of: healthy relationships, adolescent development, communication skills, healthy life skills. Youth Builders will be delivered within the traditional school day, embedded into regularly scheduled learning time. Presented once each week for 27 weeks over a 36-week school year, Youth Builders will reach students where they are, overcoming many challenges associated with retention. The project will support a Randomized Controlled Experimental Design. CBI will create valuable resources to support Youth Builders replication nationwide, including a comprehensive Youth Builders Blueprint, describing all action steps taken to achieve goals and objectives. In addition to action steps, the Youth Builders Blueprint will include: program curriculum; curricular map; training materials; sample parent consent forms; sample referral procedures / policies; staff training schedules; sample partnership agreements; Action Team meeting minutes,QERs, and annual evaluation reports The Youth Builders Blueprint will be available in both print and online format, and will be widely disseminated throughout the CBI network of non-profit agencies, Tribes, and school districts across the United States. Conference presentation will be ongoing at state and national conferences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- CBI will implement the Youth Builders PREIS Native STAND curriculum, a comprehensive sexual health curriculum designed for Native high school students that focuses on STI's, HIV/AIDS, and teen pregnancy prevention and covers drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Youth Build will enroll 834 youth in 3 cohorts with 42 clusters of 20 students, each who will be randomly assigned to an impact or a comparison group. Students will complete pre and post survey questionnaires and be provided incentives to maintain program participation. The program will have 4 staff: Project Director, Project Coordinator, and 2 Prevention Educations responsible for collecting data and tracking progress as well as implementing the curriculum
| Arm | Type | Receives |
|---|---|---|
| Impact group | Experimental | Behavioral: Native STANDThe impact group will receive the interventions in the classrooms |
| Comparison group | Placebo comparator | Behavioral: Regular Health/Physical Education CurriculumComparison group will not receive the intervention |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Between the ages of 14-18
- In grades 9-11
- Provide parental consent and participant assent to participate in the study
- Students in the first two groups will be allowed to participate in the intervention if they are enrolled in the classroom that will be receiving the intervention
- Students in the third group will be allowed to participate in the intervention only if they were part of the study's intervention group
Key exclusion criteria (6 listed)
- Not have previously participated in any of the following past CBI Teen Pregnancy
- New Mexico's Department of Health - Wyman's Teen Outreach Program
- Success with Adolescent Goals, inclusive of the Above the Waist Curriculum
- Students in 12th grade
- Study participants from previous cohorts
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 |
|---|---|---|
| Native STANDNative STAND is a comprehensive sexual health curriculum for Native high school students that focuses on sexually transmitted infections, HIV/AIDS, and teen pregnancy prevention, while also covering drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Sessions will be conducted in regular Physical Education and/or Health Education classes during classroom/school hours. | Behavioural | Impact group |
| Regular Health/Physical Education CurriculumGeneral health and physical education curriculum provided by New Mexico's Public Education Department. | Behavioural | Comparison group |
Primary outcome
Abstaining from sexual activity
Time frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e. oral, vaginal and anal) in the last 3 months compared to students assigned to the comparison group at 12 month follow up and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up?
Abstaining from sex or practicing safe sex
Time frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Do students assigned to the Youth Builders program have a greater chance of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group at 12 month follow up and 18 month follow up? (No sexual activity or use contraception if engage in sex at 12 and 18 month follow up)?
3 secondary outcomes
Positive impact on participants' assertive communication/negotiation skills
Time frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Positive impact on the peer to peer communication/discussing expectations habits of participants
Time frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Positive impact on the family communication/discussing expectations habits of participants
Time frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Healthy Native YouthLink provided by the sponsor.
- Native STAND (Students Together Against Negative Decisions)Link provided by the sponsor.
- Capacity BuildersLink provided by the sponsor.
- Navajo Nation Human Research Review BoardLink provided by the sponsor.
- 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.
Lois Ritter principal investigator
Capacity Builders Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native STAND and Regular Health/Physical Education Curriculum in people with Sexual Abstinence and Responsible Sex, run by Capacity Builders Inc. 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristen Rivas, MS Ed, LADC (775-690-5992, orivasconsulting@charter.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstaining from sexual activity (time frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2019.