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

N/A

Recruiting

Led By Kirk L von Sternberg, Ph.D.

Research Sponsored by Baylor University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female adolescents between 14-19 years of age, of any race, who are at risk of substance-exposed pregnancy and HIV/STI will be eligible. Specifically, they must report the following behaviors within the last 3 months: sexual intercourse with a male, inconsistent/ineffective condom use, inconsistent/ineffective contraception use

Be younger than 65 years old

Must not have

Do not speak or read/write in English

Unable to meet study requirements, including follow-up assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an intervention called CHOICES-TEEN can reduce the risk of substance-exposed pregnancy and HIV/STI among high-risk female youth involved with the juvenile justice system.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no direct medical side effects as this is an educational intervention. However, participants may experience discomfort discussing personal habits or feel stress when trying to change behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot speak or read/write in English.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HIV

Change in risk of alcohol-exposed pregnancy (AEP) as measured by self-reported daily standard drinks, vaginal sex, and use of contraception on the Timeline Followback calendar.

Change in risk of marijuana-exposed pregnancy (MEP) as measured by self-reported marijuana use, vaginal sex, and use of contraception on the Timeline Followback calendar.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CHOICES-TEENExperimental Treatment1 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 EducationActive Control1 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.

0 / 3Eligibility criteria met