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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02009046
Acronym
SEI
Enrollment
1909
Registered
2013-12-11
Start date
2011-09-30
Completion date
2014-05-31
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Sexually Transmitted Diseases

Keywords

Adolescent, Sex education, Sexuality education, Sexually transmitted diseases, Pregnancy, Sexual behavior, Sexuality, Relationship rights, Gender norms, Human rights, Intervention studies, Parent intervention, Peer intervention

Brief summary

This study examines the effectiveness of the Sexuality Education Initiative (SEI), a comprehensive, multi-component, rights-based sexuality education program developed and implemented by Planned Parenthood Los Angeles for high school students. The primary goal of the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive, rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy component, (3) a parent education component, and (4) clinical services linkages. It is hypothesized that the 12-session classroom curriculum is more effective than a 3-session control sex education curriculum. It is also hypothesized that the full SEI package (all four components) is more effective than the control condition (control curriculum and clinical services only).

Detailed description

This study examines the effectiveness of the Sexuality Education Initiative (SEI), a comprehensive, multi-component, rights-based sexuality education program developed and implemented by Planned Parenthood Los Angeles for high school students. The primary goal of the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive, rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy component, (3) a parent education component, and (4) clinical services linkages. * The 12-session gender-sensitive, rights-based 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. * The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as school-wide resources to their peers, organize health events at school, and refer students to school-based clinic services. * The parent education component consists of a series of sessions for parents, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. * The in-school clinical services component provides clinic without walls health services on campus, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also trains teachers and school staff to distribute condoms to students as needed. The evaluation design involves two levels of randomization: First, all schools are randomized into one of two conditions: receiving all three SEI school wide components (peer, parent, clinical services) or receiving only one of these three school wide components (clinical services). Schools are randomized within matched pairs of demographically similar schools. Second, within each school, classrooms are randomized into one of two conditions: a basic 3-session sex education curriculum (control) or the 12-session SEI curriculum (intervention). Thus, all participating 9th grade students will receive at least three sexuality education curriculum sessions and access to on-site clinic services. The primary research questions for the evaluation are: 1. Is the 12-session SEI gender-sensitive, rights-based sexuality education curriculum more effective than a 3-session comparison curriculum in reducing risk of unwanted pregnancy and sexually transmitted infections (STIs) among high school students? 2. Is the full comprehensive program (all four components as a package) more effective than the two-component comparison condition (only the 3-session comparison curriculum and the clinical services linkages) in reducing risk of teen pregnancies and STIs? The first hypothesis is that the 12-session SEI gender-sensitive, rights-based curriculum is more effective than the 3-session comparison curriculum in improving sexual health outcomes (as defined in section 7) among program participants one year after participation in the program. The second hypothesis is that the full SEI program (all four components as a package) is more effective than the comparison condition (only the 3-session comparison curriculum and the clinical services linkages) in improving sexual health outcomes one year after participation. In addition to addressing these questions using the designated primary and secondary outcomes, this study will examine changes in the following short-term outcomes that measure critical concepts being addressed by the curriculum and serve as the hypothesized mediators in the SEI theory of change: * Attitudes about rights in sexual relationships * Communication about relationships, rights and sexuality with partners * Communication about relationships, rights and sexuality with parents/ guardians * Access to accurate information about sexuality and sexual health * Knowledge about sex, sexuality and sexual risk protection * Self-efficacy to assert sexual limits and manage risky situations * Intentions to protect self from sexual risk * Awareness of sexual and reproductive health services

Interventions

BEHAVIORALSEI 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.

BEHAVIORALControl 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.

BEHAVIORALSEI Curriculum + 3 School Components

Participants receive SEI classroom curriculum and all three school wide components. The peer education/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. The clinical services linkages includes 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.

BEHAVIORALControl Curriculum + 1 School Component

Participants receive control classroom curriculum and one of the three school wide components, the clinical services linkages. This component includes 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.

Sponsors

University of Southern California
CollaboratorOTHER
Planned Parenthood Los Angeles
CollaboratorUNKNOWN
Ford Foundation
CollaboratorOTHER
Public Health Institute, California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
13 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* 9th grade student at a participating high school in East or South Los Angeles * Written parent/guardian consent and student assent to participate

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Percent of Participants With Pregnancy Risk1 yearBetween-arm difference in percent of youth who report engaging in recent sexual intercourse but not using birth control and/or condoms
Percent of Participants With Sexually Transmitted Infection (STI) Risk1 yearBetween-arm difference in percent of youth who report engaging in recent vaginal, anal and/or oral sexual intercourse but not using condoms
Percent of Participants With Multiple Sexual Partners1 yearBetween-arm difference in percent of youth who report having more than one recent vaginal, anal and/or oral sexual partner
Percent of Participants Who Ever Used Sexual and Reproductive Health Services1 yearBetween-arm difference in percent of youth who report ever using sexual and reproductive health services

Secondary

MeasureTime frameDescription
Percent of Participants Who Used Condom at Last Sex1 yearBetween-arm difference in percent of youth who report using a condom the last time they had sexual intercourse
Percent of Participants Who Ever Had Sex1 yearBetween-arm difference in percent of youth who report ever engaging in vaginal and/or anal sexual intercourse
Percent of Participants Who Currently Have Condom1 yearBetween-arm difference in percent of youth who report currently having a condom with them (e.g., in a pocket, purse or backpack)
Percent of Participants Who Used Contraceptive at Last Sex1 yearBetween-arm difference in percent of youth who report using birth control and/or condoms the last time they had sexual intercourse
Percent of Participants Who Ever Had Oral Sex1 yearBetween-arm difference in percent of youth who report ever engaging in oral sexual intercourse
Percent of Participants With Recent Sexual Activity1 yearBetween-arm difference in percent of youth who report engaging in vaginal and/or anal sexual intercourse during the last 3 months
Percent of Participants With Recent Oral Sex Activity1 yearBetween-arm difference in percent of youth who report engaging in oral sexual intercourse in the last 3 months

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

1909 participants were enrolled.

Participants by arm

ArmCount
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.
1,025
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.
884
Total1,909

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up256206

Baseline characteristics

CharacteristicControl Classroom CurriculumSEI Classroom CurriculumTotal
Age, Categorical
<=18 years
884 Participants1025 Participants1909 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous14.16 years
STANDARD_DEVIATION 0.55
14.15 years
STANDARD_DEVIATION 0.6
14.15 years
STANDARD_DEVIATION 0.6
Region of Enrollment
United States
884 participants1025 participants2881 participants
Sex: Female, Male
Female
448 Participants518 Participants966 Participants
Sex: Female, Male
Male
436 Participants507 Participants943 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1,0250 / 8840 / 5440 / 428
other
Total, other adverse events
0 / 1,0250 / 8840 / 5440 / 428
serious
Total, serious adverse events
0 / 1,0250 / 8840 / 5440 / 428

Outcome results

Primary

Percent of Participants Who Ever Used Sexual and Reproductive Health Services

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants Who Ever Used Sexual and Reproductive Health Services27.7 percentage of participants
Control Classroom CurriculumPercent of Participants Who Ever Used Sexual and Reproductive Health Services21.7 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants Who Ever Used Sexual and Reproductive Health Services28.9 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants Who Ever Used Sexual and Reproductive Health Services16.0 percentage of participants
p-value: 0.021895% CI: [1.05, 1.78]Regression, Logistic
p-value: 0.021195% CI: [1.09, 2.75]Regression, Logistic
Primary

Percent of Participants With Multiple Sexual Partners

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants With Multiple Sexual Partners4.3 percentage of participants
Control Classroom CurriculumPercent of Participants With Multiple Sexual Partners5.6 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants With Multiple Sexual Partners2.9 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants With Multiple Sexual Partners5.8 percentage of participants
p-value: 0.100695% CI: [0.35, 1.1]Regression, Logistic
p-value: 0.211795% CI: [0.16, 1.53]Regression, Logistic
Primary

Percent of Participants With Pregnancy Risk

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants With Pregnancy Risk11.8 percentage of participants
Control Classroom CurriculumPercent of Participants With Pregnancy Risk11.1 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants With Pregnancy Risk10.2 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants With Pregnancy Risk10.8 percentage of participants
p-value: 0.64395% CI: [0.75, 1.6]Regression, Logistic
p-value: 0.371895% CI: [0.39, 1.44]Regression, Logistic
Primary

Percent of Participants With Sexually Transmitted Infection (STI) Risk

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants With Sexually Transmitted Infection (STI) Risk12.8 percentage of participants
Control Classroom CurriculumPercent of Participants With Sexually Transmitted Infection (STI) Risk13.4 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants With Sexually Transmitted Infection (STI) Risk11.0 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants With Sexually Transmitted Infection (STI) Risk13.8 percentage of participants
p-value: 0.808395% CI: [0.67, 1.37]Regression, Logistic
p-value: 0.108395% CI: [0.32, 1.13]Regression, Logistic
Secondary

Percent of Participants Who Currently Have Condom

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants Who Currently Have Condom18.4 percentage of participants
Control Classroom CurriculumPercent of Participants Who Currently Have Condom10.4 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants Who Currently Have Condom20.3 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants Who Currently Have Condom9.3 percentage of participants
p-value: 0.000295% CI: [1.39, 2.8]Regression, Logistic
p-value: 0.00395% CI: [1.44, 5.09]Regression, Logistic
Secondary

Percent of Participants Who Ever Had Oral Sex

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants Who Ever Had Oral Sex22.2 percentage of participants
Control Classroom CurriculumPercent of Participants Who Ever Had Oral Sex22.6 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants Who Ever Had Oral Sex21.3 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants Who Ever Had Oral Sex23.9 percentage of participants
p-value: 0.810295% CI: [0.75, 1.44]Regression, Logistic
p-value: 0.295695% CI: [0.39, 1.34]Regression, Logistic
Secondary

Percent of Participants Who Ever Had Sex

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants Who Ever Had Sex31.2 percentage of participants
Control Classroom CurriculumPercent of Participants Who Ever Had Sex28.6 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants Who Ever Had Sex30.2 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants Who Ever Had Sex26.7 percentage of participants
p-value: 0.176395% CI: [0.9, 1.73]Regression, Logistic
p-value: 0.586995% CI: [0.45, 1.58]Regression, Logistic
Secondary

Percent of Participants Who Used Condom at Last Sex

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants Who Used Condom at Last Sex59.8 percentage of participants
Control Classroom CurriculumPercent of Participants Who Used Condom at Last Sex58.9 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants Who Used Condom at Last Sex60.9 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants Who Used Condom at Last Sex57.9 percentage of participants
p-value: 0.908595% CI: [0.54, 2.01]Regression, Logistic
p-value: 0.805995% CI: [0.36, 3.62]Regression, Logistic
Secondary

Percent of Participants Who Used Contraceptive at Last Sex

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants Who Used Contraceptive at Last Sex64.2 percentage of participants
Control Classroom CurriculumPercent of Participants Who Used Contraceptive at Last Sex68.1 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants Who Used Contraceptive at Last Sex65.6 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants Who Used Contraceptive at Last Sex64.9 percentage of participants
p-value: 0.686195% CI: [0.44, 1.71]Regression, Logistic
p-value: 0.9973Regression, Logistic
Secondary

Percent of Participants With Recent Oral Sex Activity

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants With Recent Oral Sex Activity10.7 percentage of participants
Control Classroom CurriculumPercent of Participants With Recent Oral Sex Activity13.0 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants With Recent Oral Sex Activity9.3 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants With Recent Oral Sex Activity14.2 percentage of participants
p-value: 0.133595% CI: [0.52, 1.09]Regression, Logistic
p-value: 0.074195% CI: [0.29, 1.06]Regression, Logistic
Secondary

Percent of Participants With Recent Sexual Activity

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

Time frame: 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.

ArmMeasureValue (NUMBER)
SEI Classroom CurriculumPercent of Participants With Recent Sexual Activity18.2 percentage of participants
Control Classroom CurriculumPercent of Participants With Recent Sexual Activity16.7 percentage of participants
SEI Curriculum + 3 School Wide ComponentsPercent of Participants With Recent Sexual Activity16.0 percentage of participants
Control Curriculum + 1 School Wide ComponentPercent of Participants With Recent Sexual Activity16.4 percentage of participants
p-value: 0.464595% CI: [0.82, 1.56]Regression, Logistic
p-value: 0.380995% CI: [0.43, 1.4]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026