Trial Outcomes & Findings for Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students (NCT NCT02009046)

Results Overview

Between-arm difference in percent of youth who report engaging in recent sexual intercourse but not using birth control and/or condoms

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1909 participants

Primary outcome timeframe

1 year

Results posted on

2018-11-29

Participant Flow

In Year 1 (2011-12), eight schools participated. Following the first year, one matched pair of schools dropped out due to school administration changes and a new matched pair of schools with similar student characteristics was added for Year 2 (2012-13). Thus, ten schools participated in intervention delivery over the study period.

1909 participants were enrolled.

Participant milestones

Participant milestones
Measure	SEI Classroom Curriculum Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.
Overall Study STARTED	1025	884
Overall Study SEI Curriculum Only	461	0
Overall Study SEI Curriculum + 3 SchoolWide Components	544	0
Overall Study Ctrl Curriculum Only	0	456
Overall Study Ctrl Curriculm +1 SchoolWide Component	0	428
Overall Study COMPLETED	769	678
Overall Study NOT COMPLETED	256	206

Reasons for withdrawal

Reasons for withdrawal
Measure	SEI Classroom Curriculum Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.
Overall Study Lost to Follow-up	256	206

Baseline Characteristics

Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SEI Classroom Curriculum n=1025 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=884 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	Total n=1909 Participants Total of all reporting groups
Age, Categorical <=18 years	1025 Participants n=5 Participants	884 Participants n=7 Participants	1909 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.15 years STANDARD_DEVIATION .60 • n=5 Participants	14.16 years STANDARD_DEVIATION .55 • n=7 Participants	14.15 years STANDARD_DEVIATION .60 • n=5 Participants
Sex: Female, Male Female	518 Participants n=5 Participants	448 Participants n=7 Participants	966 Participants n=5 Participants
Sex: Female, Male Male	507 Participants n=5 Participants	436 Participants n=7 Participants	943 Participants n=5 Participants
Region of Enrollment United States	1025 participants n=5 Participants	884 participants n=7 Participants	2881 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report engaging in recent sexual intercourse but not using birth control and/or condoms

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants With Pregnancy Risk	11.8 percentage of participants	11.1 percentage of participants	10.2 percentage of participants	10.8 percentage of participants

PRIMARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report engaging in recent vaginal, anal and/or oral sexual intercourse but not using condoms

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants With Sexually Transmitted Infection (STI) Risk	12.8 percentage of participants	13.4 percentage of participants	11.0 percentage of participants	13.8 percentage of participants

PRIMARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report having more than one recent vaginal, anal and/or oral sexual partner

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants With Multiple Sexual Partners	4.3 percentage of participants	5.6 percentage of participants	2.9 percentage of participants	5.8 percentage of participants

PRIMARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report ever using sexual and reproductive health services

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants Who Ever Used Sexual and Reproductive Health Services	27.7 percentage of participants	21.7 percentage of participants	28.9 percentage of participants	16.0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report ever engaging in vaginal and/or anal sexual intercourse

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants Who Ever Had Sex	31.2 percentage of participants	28.6 percentage of participants	30.2 percentage of participants	26.7 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report ever engaging in oral sexual intercourse

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants Who Ever Had Oral Sex	22.2 percentage of participants	22.6 percentage of participants	21.3 percentage of participants	23.9 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report engaging in vaginal and/or anal sexual intercourse during the last 3 months

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=3 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants With Recent Sexual Activity	18.2 percentage of participants	16.7 percentage of participants	16.0 percentage of participants	16.4 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report engaging in oral sexual intercourse in the last 3 months

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants With Recent Oral Sex Activity	10.7 percentage of participants	13.0 percentage of participants	9.3 percentage of participants	14.2 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report using a condom the last time they had sexual intercourse

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants Who Used Condom at Last Sex	59.8 percentage of participants	58.9 percentage of participants	60.9 percentage of participants	57.9 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report using birth control and/or condoms the last time they had sexual intercourse

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants Who Used Contraceptive at Last Sex	64.2 percentage of participants	68.1 percentage of participants	65.6 percentage of participants	64.9 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: 412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.

Between-arm difference in percent of youth who report currently having a condom with them (e.g., in a pocket, purse or backpack)

Outcome measures

Outcome measures
Measure	SEI Classroom Curriculum n=769 Participants Participants receive the SEI classroom curriculum. SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.	Control Classroom Curriculum n=678 Participants Participants receive the control classroom curriculum. Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.	SEI Curriculum + 3 School Wide Components n=412 Participants Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). 3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.	Control Curriculum + 1 School Wide Component n=329 Participants Participants receive control curriculum and one of the three school wide components (clinical services linkages). 1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
Percent of Participants Who Currently Have Condom	18.4 percentage of participants	10.4 percentage of participants	20.3 percentage of participants	9.3 percentage of participants

Adverse Events

SEI Classroom Curriculum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Classroom Curriculum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SEI Curriculum + 3 School Wide Components

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Curriculum + 1 School Wide Component

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Norman A. Constantine, Ph.D.

PHI

Phone: 925-284-8118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place