Health and Life Skills Education for Preventing STIs and Substance-Exposed Pregnancy

Overseen By Danielle E Parrish, Ph.D.

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Baylor University

Disqualifiers: Severe cognitive, psychiatric impairment, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment CHOICES-TEEN for preventing STIs and substance-exposed pregnancy?

The Safer Choices program, which is similar to CHOICES-TEEN, has been shown to reduce risky sexual behaviors and increase protective behaviors among high school students, such as increased condom use and improved communication about sexual health. Additionally, Project CHOICES, which targets alcohol and contraceptive behaviors, has been effective in reducing the risk of alcohol-exposed pregnancies, suggesting that similar approaches in CHOICES-TEEN could be beneficial. ^{1 2 3 4 5}

Is the Health and Life Skills Education program safe for humans?

The Safer Choices program, which is similar to Health and Life Skills Education, has been implemented in schools and involves activities with students, parents, and community members. It focuses on reducing risky behaviors and increasing protective behaviors among teens, suggesting it is generally safe for human participants. ^{1 2 4 6 7}

How is the CHOICES-TEEN treatment different from other treatments for preventing STIs and substance-exposed pregnancy?

CHOICES-TEEN is unique because it combines health and life skills education specifically tailored for teens to prevent sexually transmitted infections (STIs) and substance-exposed pregnancies, focusing on educational interventions rather than medication or traditional medical treatments. ^{1 2 6 8 9}

What is the purpose of this trial?

This randomized controlled trial will: 1) Test the efficacy of the CHOICES-TEEN (CT) intervention compared with an Attentional Control (AC) condition on reducing the risk of substance-exposed pregnancy (SEP) and HIV/STI among high-risk female youth involved with the juvenile justice system by reducing alcohol use, increasing marijuana cessation, reducing risk of pregnancy, and increasing condom use; 2) Test the efficacy of CT, compared to AC, on increasing cognitive self-regulation abilities; 3) Test proposed intervention mediators/mechanisms of action for CT overall and by race/ethnicity; and 4) Test the moderating effect of initial readiness to change on risk of SEP and risk of HIV/STI.

Research Team

Danielle E Parrish, Ph.D.

Principal Investigator

Baylor University

Kirk L von Sternberg, Ph.D.

Principal Investigator

University of Texas at Austin

Eligibility Criteria

This trial is for female teens aged 14-17 involved with the juvenile justice system, at risk of pregnancy and HIV/STI due to alcohol use, marijuana use, and unprotected sex. They must be able to follow the study plan and speak/read English.

Inclusion Criteria

I am a female aged 14-19 at risk of pregnancy or HIV/STI due to recent unprotected sex.

Exclusion Criteria

Severe cognitive and/or psychiatric impairment that precludes cooperation with study protocol, per judgement of the interventionist or research staff

I cannot speak or read/write in English.

I can attend all required study visits and follow-up assessments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the CHOICES-TEEN intervention or Health and Life Skills Education over four sessions, including one in-person and three Telehealth sessions.

4 weeks

1 visit (in-person), 3 visits (virtual)

Follow-up

Participants are monitored for changes in risk of SEP, HIV/STI, and cognitive self-regulation abilities at 3-, 6-, and 9-month intervals.

9 months

3 visits (virtual)

Data Analysis

Data analysis using generalized linear mixed and structural equation modeling to evaluate treatment effects and mediators.

Treatment Details

Interventions

• CHOICES-TEEN
• Health and Life Skills Education

Trial Overview The CHOICES-TEEN (CT) program aims to reduce substance-exposed pregnancies and HIV/STI risks by promoting sobriety from alcohol and marijuana, safe sex practices, and better decision-making compared to a standard health education program.

Participant Groups

Group I: CHOICES-TEEN Experimental Treatment 1 Intervention

This is a four session session utilizing Motivational Interviewing (MI) and cognitive-behavioral approaches to enhance motivation for change in one or more primary behaviors: alcohol, marijuana, and condom/contraceptive use. The intervention is delivered by a trained master's level counselor and an Adolescent Medicine Specialist using one in-person session, and three Telehealth sessions.

Group II: Health and Life Skills Education Active Control 1 Intervention

This four session life skills education program provides detailed information on time management, sleep, nutrition and exercise, and financial management. This program is delivered in person for the first session and then by Telehealth platform.

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Findings from Research

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]

The Safer Choices program, evaluated over 31 months with 3869 ninth-grade students, significantly improved condom use and reduced unprotected intercourse, demonstrating its effectiveness in lowering sexual risk behaviors.

While the program enhanced several psychosocial factors related to safe sex, it did not significantly affect the rates of sexual initiation among students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer choices: reducing teen pregnancy, HIV, and STDs. Coyle, K., Basen-Engquist, K., Kirby, D., et al.[2022]

Project CHOICES is an effective intervention designed to reduce the risk of alcohol-exposed pregnancy by addressing both alcohol consumption and contraceptive use among women visiting STD clinics.

The program utilizes motivational interviewing and personalized feedback, aligning with CDC strategies to integrate services and improve health outcomes for women at high risk of heavy alcohol use and ineffective contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel integration effort to reduce the risk for alcohol-exposed pregnancy among women attending urban STD clinics. Hutton, HE., Chander, G., Green, PP., et al.[2021]

The Safer Choices program, evaluated in a randomized trial with 3,869 ninth-grade students across 20 schools, significantly improved 9 out of 13 psychosocial factors related to safe sex practices, such as knowledge and self-efficacy regarding condom use.

The program effectively reduced risky sexual behaviors, including a decrease in unprotected intercourse and an increase in condom and contraceptive use at last intercourse, demonstrating its efficacy in promoting safer sexual practices among high school youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term impact of safer choices: a multicomponent, school-based HIV, other STD, and pregnancy prevention program. Coyle, K., Basen-Engquist, K., Kirby, D., et al.[2022]

Adolescent clinics that provide medical care and condoms can improve knowledge but do not significantly change risky behaviors, highlighting the need for more comprehensive programs.

A survey of 46 teenage males entering a new clinic revealed that they value medical care and free condoms, but also expressed interest in job-related services and support groups, indicating a desire for a broader range of health and support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Need for services in a new urban teenage clinic for men. Levine, DA.[2018]

A study identified that busy schedules and competing priorities are significant barriers for school administrators in participating in research on condom education, with superintendents and principals citing time constraints and lack of interest as key reasons for opting out.

The findings suggest that gaining administrative approval for human sexuality research in schools is difficult, indicating a need for more effective communication strategies, such as phone calls, to engage school leaders in these important educational initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to Human Sexuality Education Survey Research Among Vermont Public School Administrators. Blaisdell, AJ., Olsen, LK.[2020]

School nurses can enhance teens' access to sexual health information by collaborating with various stakeholders, including teachers, counselors, and families, which helps reduce risks associated with unprotected or forced sexual intercourse.

Open communication between teens and health professionals is crucial for empowering young people to make informed decisions about their sexual health and to seek care when necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the role of the school nurse in sexual health education? Jackson, V.[2017]

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]

The Safer Choices 2 program targets high-risk students in alternative high schools, with a study cohort of 711 out of 940 initially enrolled students, highlighting the need for effective HIV, STI, and pregnancy prevention interventions in this demographic.

Baseline data revealed that a significant portion of students were sexually active, with 55.4% reporting unprotected intercourse, indicating a critical need for targeted educational and preventive measures to address their high-risk behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer choices 2: rationale, design issues, and baseline results in evaluating school-based health promotion for alternative school students. Tortolero, SR., Markham, CM., Addy, RC., et al.[2018]

References

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

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

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

Safer choices: reducing teen pregnancy, HIV, and STDs. [2022]

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

A novel integration effort to reduce the risk for alcohol-exposed pregnancy among women attending urban STD clinics. [2021]

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

Short-term impact of safer choices: a multicomponent, school-based HIV, other STD, and pregnancy prevention program. [2022]

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

Need for services in a new urban teenage clinic for men. [2018]

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

Barriers to Human Sexuality Education Survey Research Among Vermont Public School Administrators. [2020]

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

What is the role of the school nurse in sexual health education? [2017]

8. France pubmed.ncbi.nlm.nih.gov

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

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

Safer choices 2: rationale, design issues, and baseline results in evaluating school-based health promotion for alternative school students. [2018]