Teen Talk Program for Sexual Health Education

(TTHSR Trial)

Overseen By Pamela J Drake, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: ETR Associates

Disqualifiers: Under 16, Over 19, Insufficient English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

1120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties. The Teen Talk High School Refresher (TTHSR) is a sexual health education "booster" program for older high school students attending school in rural communities that was designed to help address this situation. Though there is preliminary evidence of the program's effectiveness, it has not yet been rigorously evaluated with a randomized controlled trial. TTHSR is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Most students this age will have received prior SHE. TTHSR is a 5-hour "booster" intervention, delivered during late high school, intended to enhance the effectiveness of previous SHE. The study's primary research question is: What is the impact at 6-months post baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days? The study's secondary research questions are: * What is the impact at 6-months post baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers, peers, and partners about their sexual health? * What is the impact at 6-months post-baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services? * What is the impact at 12-months post-baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely, as the study focuses on sexual health education rather than medical treatment.

Is the Teen Talk Program for Sexual Health Education safe for participants?

The Teen Talk Program, evaluated under different names like HEART and Teen Council, has been found to be safe and well-received by adolescents. Participants reported improvements in sexual health knowledge and communication skills, with no safety concerns noted in the studies. ^{1 2 3 4 5}

How is the Teen Talk High School Refresher (TTHSR) treatment different from other sexual health education treatments?

The Teen Talk High School Refresher (TTHSR) is unique because it focuses on refreshing and reinforcing sexual health education specifically for high school students, potentially using peer-led approaches and interactive tools to enhance engagement and retention of information, unlike traditional methods that may not emphasize these aspects. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Teen Talk High School Refresher (TTHSR)?

The HEART program, a similar online sexual health education initiative, showed positive results in improving sexual communication, condom use intentions, and knowledge about HIV/STDs among high school students. This suggests that programs like TTHSR could also be effective in promoting sexual health education. ^{1 5 11 12 13}

Who Is on the Research Team?

Pamela J Drake, PhD

Principal Investigator

ETR Associates

Are You a Good Fit for This Trial?

The trial is for high school students aged 16 to 19 in rural areas, specifically those in the 11th and 12th grades who have sufficient English skills. Participants will be from schools that choose a class or group mostly comprising these grades to take part in the study for two years.

Inclusion Criteria

My school is participating in a study for 2 years and has chosen a group I'm in.

I am part of a specific group identified by my school.

I can speak and understand English well enough to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (in-person)

Intervention

Students receive the Teen Talk High School Refresher, a 5-session SHE 'booster' program

5 hours

5 sessions (in-person)

6-Month Follow-up

Participants are surveyed to assess the impact of the intervention on sexual health behaviors and self-efficacy

6 months post-baseline

Survey (in-person or online)

12-Month Follow-up

Participants are surveyed to assess long-term impact of the intervention on sexual health behaviors

12 months post-baseline

Survey (in-person or online)

What Are the Treatments Tested in This Trial?

Interventions

• Teen Talk High School Refresher (TTHSR)

Trial Overview The Teen Talk High School Refresher (TTHSR) program is being tested against standard sexual health education. It's a 'booster' intervention designed to reinforce safe sex practices and prevent unintended pregnancies and STIs among older high school students.

How Is the Trial Designed?

Group I: TTHSR Intervention Experimental Treatment 1 Intervention

Intervention: Students in schools in this group will receive the Teen Talk High School Refresher, a 5-session SHE "booster" program

Group II: Comparison Active Control 1 Intervention

"Business-as-usual" control: Students in schools in this group will receive their school's normal classroom teaching

Who Is Running the Clinical Trial?

ETR Associates

Lead Sponsor

Trials

14

Recruited

12,900+

Published Research Related to This Trial

The Safer Choices intervention is a comprehensive program aimed at reducing risky sexual behaviors among high school students to prevent HIV, STDs, and pregnancy, involving multiple stakeholders like school staff, parents, and community members.

The program includes various components such as curriculum development, peer education, and parent education, all designed to create a supportive school environment and promote protective behaviors among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer Choices: a multicomponent school-based HIV/STD and pregnancy prevention program for adolescents. Coyle, K., Kirby, D., Parcel, G., et al.[2004]

A systematic review highlights the importance of integrating comprehensive health education for adolescents regarding contraception, STI prevention, and HPV vaccination during initial consultations, emphasizing the need for open dialogue and informed choices.

Contraceptive counseling should prioritize the use of condoms alongside regular contraceptive methods to effectively prevent STIs and unplanned pregnancies, while also considering the specific needs and health conditions of teenage patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contraception for adolescent : CNGOF Contraception guidelines]. Pienkowski, C., Cartault, A.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Brief Online Sexual Health Program for Adolescents: A Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Youth United Through Health Education: community-level, peer-led outreach to increase awareness and improve noninvasive sexually transmitted infection screening in urban African American youth. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Brief Online Sexual Health Program for Adolescents. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Partnering with public schools: a resident-driven reproductive health education initiative. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Reaching High-Need Youth Populations With Evidence-Based Sexual Health Education in California. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

ProjectHeartforGirls.com: Development of a Web-Based HIV/STD Prevention Program for Adolescent Girls Emphasizing Sexual Communication Skills. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the impact of the Teen Council peer education program on youth development. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safer Choices: a multicomponent school-based HIV/STD and pregnancy prevention program for adolescents. [2004]

9. France pubmed.ncbi.nlm.nih.gov

[Contraception for adolescent : CNGOF Contraception guidelines]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Assessment of a Novel Interactive Website to Inform Adolescent and Young Adult Decision-Making about Contraception. [2023]

11. Spain pubmed.ncbi.nlm.nih.gov

Sexual education in school context: the efficience of a training intervention. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Effects of a school-based sexuality education program on peer educators: the Teen PEP model. [2021]

13. England pubmed.ncbi.nlm.nih.gov

What was retained? The assessment of the training for the peer trainers' course on short and long term basis. [2023]