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Completed

NCT Number: NCT02009046

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

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).

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Key information

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood Los Angeles

Los Angeles, California, 90007, United States

About this study

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:

  • 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?
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SEI Classroom Curriculum

Behavioral

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

Behavioral

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 Components

Behavioral

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.

Control Curriculum + 1 School Component

Behavioral

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.

Primary outcomes

  1. Percent of Participants With Pregnancy Risk

    Time frame: 1 year

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

  2. Percent of Participants With Sexually Transmitted Infection (STI) Risk

    Time frame: 1 year

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

  3. Percent of Participants With Multiple Sexual Partners

    Time frame: 1 year

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

  4. Percent of Participants Who Ever Used Sexual and Reproductive Health Services

    Time frame: 1 year

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

Secondary outcomes

  1. Percent of Participants Who Ever Had Sex

    Time frame: 1 year

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

  2. Percent of Participants Who Ever Had Oral Sex

    Time frame: 1 year

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

  3. Percent of Participants With Recent Sexual Activity

    Time frame: 1 year

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

  4. Percent of Participants With Recent Oral Sex Activity

    Time frame: 1 year

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

  5. Percent of Participants Who Used Condom at Last Sex

    Time frame: 1 year

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

  6. Percent of Participants Who Used Contraceptive at Last Sex

    Time frame: 1 year

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

  7. Percent of Participants Who Currently Have Condom

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Public Health Institute, California

Other

Collaborators

  • Ford Foundation
  • Planned Parenthood Los Angeles
  • University of Southern California

Registry information

Acronym: SEI

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2013
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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