Behavioral Intervention for Minority Adolescent Women

Summary

The purpose of this Stage II clinical trial is to test the efficacy of a culturally sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging contraceptive use. Its primary goal is to expand risk-reduction interventions created in previous studies to further increase intervention efficacy for this particularly vulnerable, high-risk group. An adolescent intervention has been created and pilot tested in developmental studies. Results indicated reductions in substance use, risk behaviors, unintended pregnancy, STI and abuse without reports of adverse outcomes. Specific aims of the current study include: 1) To obtain a more in-depth understanding of configurations of psychosocial and situational factors associated with high-risk sexual behavior, substance use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this group; 3) To evaluate the effects of the adolescent intervention model versus enhanced counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and STI/HIV at 6 and 12 months follow-up. Participants will include a convenience sample of 600 Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or physical abuse and current STI.

Conditions

• Sexually Transmitted Infection
• Substance Use
• Abuse
• Pregnancy

Interventions

BEHAVIORAL

Project IMAGE

Participants in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention. The intervention will include 2 workshops, 5 support groups sessions and 2 individual counseling sessions. They will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Jane D Champion, PhD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-10-31

Primary Completion

2009-04-30

Completion

2009-04-30

Countries

• United States

Study Locations