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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific program, called CHOICES-TEEN, can help young women involved with the juvenile justice system reduce their risk of substance-exposed pregnancy and STIs like HIV. The program focuses on reducing alcohol use, encouraging marijuana cessation, and increasing condom and contraception use. Participants will attend sessions that include motivational interviewing and cognitive-behavioral techniques. Young women who have had sexual intercourse with a male and have used condoms and contraception inconsistently in the past three months may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to significant changes in health programs for young women.

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 prior data suggests that the CHOICES-TEEN intervention is safe for high-risk female youth?

Research has shown that programs like CHOICES-TEEN successfully reduce risky behaviors leading to teen pregnancy, HIV, and STDs. These programs aim to increase teens' knowledge about safe practices and improve decision-making skills, proving effective in lowering the chances of engaging in risky behaviors.

While specific safety data for CHOICES-TEEN is unavailable, similar programs using motivational interviewing and cognitive-behavioral techniques are generally well-received. These methods are usually considered safe because they focus on counseling and education rather than medical treatment. Reports have not indicated negative effects from these educational programs, suggesting that CHOICES-TEEN is likely a safe choice for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHOICES-TEEN program because it combines Motivational Interviewing (MI) and cognitive-behavioral approaches to address risky behaviors like alcohol and marijuana use and poor contraceptive practices. Unlike standard education programs, which might focus solely on information delivery, this approach actively enhances motivation for change and is personalized through counseling sessions. The blend of in-person and Telehealth sessions offers flexibility, potentially increasing accessibility and engagement among teens. This method aims not just to educate but to empower teens to make healthier choices, potentially reducing the risk of STIs and substance-exposed pregnancies.

What evidence suggests that the CHOICES-TEEN intervention could be effective for preventing substance-exposed pregnancy and STIs?

Research has shown that the CHOICES-TEEN program, an intervention in this trial, can reduce the risk of pregnancy and HIV/STI in young women at high risk. In one study, 52% of participants demonstrated a lower risk of HIV/STI just one month after completing the program. This program employs Motivational Interviewing, a counseling method that encourages behavior change, along with cognitive-behavioral techniques to guide participants in making safer choices about alcohol, marijuana, and birth control. Overall, early results suggest that CHOICES-TEEN effectively reduces risky behaviors and enhances decision-making skills among young people in the juvenile justice system. ^{6 7 8 9 10}

Who Is on the Research Team?

Kirk L von Sternberg, Ph.D.

Principal Investigator

University of Texas at Austin

Danielle E Parrish, Ph.D.

Principal Investigator

Baylor University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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.

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/search/14EACF0B4B8AC6D57598B8961CAA4A01A2FFCEB861BF/project-details/10402834

Project Details - NIH RePORTER Therefore, the overall objective of this study is to test the efficacy of CHOICES-TEEN (CT) for reducing the risks of SEP and HIV/STI in young women involved in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6824550/

Reducing Substance-Exposed Pregnancy and HIV among ... All 22 participants that received the intervention were at HIV/STI risk at the baseline. Fifty-two percent were at reduced risk at 1-month and 28.6% were at ...

3. sites.utexas.edu sites.utexas.edu/hbrt-test-4/choices-teen/

CHOICES-TEEN This study aims to test the efficacy of CHOICES-TEEN (CT), a preventative intervention centered around the use of Motivational Interviewing (MI), for reducing ...

4. researchgate.net researchgate.net/publication/325902627_CHOICES-TEEN_Reducing_Substance-Exposed_Pregnancy_and_HIV_among_Juvenile_Justice_Adolescent_Females

Reducing Substance-Exposed Pregnancy and HIV among ... The preconception counseling model tested in the CDC funded Project CHOICES efficacy trial to reduce the risk of an alcohol-exposed pregnancy ( ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03633149

Choices4Health: Intervention to Prevent Substance- ... This is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11889277/

Safer Choices: Reducing Teen Pregnancy, HIV, and STDs Conclusions: The Safer Choices program was effective in reducing important risk behaviors for HIV, other STDs, and pregnancy and in enhancing most psychosocial ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1913682/

Safer choices: reducing teen pregnancy, HIV, and STDs CONCLUSIONS: The Safer Choices program was effective in reducing important risk behaviors for HIV, other STDs, and pregnancy and in enhancing most psychosocial ...

8. opa.hhs.gov opa.hhs.gov/sites/default/files/2022-09/mpc-teen-pregnancy-prevention-program.pdf

Making Proud Choices! - An Evidence-Based Teen Pregnancy ... The purpose of this review is to identify programs that improve knowledge about STIs and effective methods of contraception, reduce risky sexual ...

9. journals.sagepub.com journals.sagepub.com/doi/10.1093/phr/116.S1.82

Safer Choices: Reducing Teen Pregnancy, HIV, and STDs The Safer Choices program was effective in reducing important risk behaviors for HIV, other STDs, and pregnancy and in enhancing most psychosocial determinants ...

10. etr.org etr.org/ebi/programs/safer-choices/

Safer Choices - Program Success Center Safer Choices is a 2-year, multi-component STD, HIV, and teen pregnancy prevention program for high school students. The program aims to reduce the frequency of ...