Skip to main content
OpenTrials
Completed

NCT Number: NCT01387646

Behavioral Intervention for Minority Adolescent Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sexually Transmitted Infection Abuse Chemically-Induced Disorders Communicable Diseases Disease Attributes Genital Diseases Infections Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Sexually Transmitted Diseases Substance Use Substance-Related Disorders Urogenital Diseases

Age range

14 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

San Antonio Metropolitan Health District

San Antonio, Texas, United States

About this study

African-and Mexican-American adolescent women with a current STI and history of abuse will be identified at public health and STI clinics within the San Antonio Metropolitan Health District system. Women who agree to participate and give informed consent will be randomized into the intervention or control arm. Women in the control arm will be interviewed at baseline, be given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and will receive abuse and enhanced clinical counseling. Women 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. Women in the intervention arm will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline. All women in the study will be followed over one year, with follow-up interviews including an inquiry about any Adverse Events (AEs) or Serious Adverse Events (SAEs), and a targeted physical exams and contraception counseling at 6 and 12 months. During the study period, women will be encouraged to return to the study clinic for problem visits if they suspect they have been infected with a STI or require contraception or abuse counseling. All analyses of intervention effects will be performed on an intent-to-treat basis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 14-18 years, Mexican-or African-American female with a history of STI or abuse seeking health care through the San Antonio Metropolitan Health District.

Exclusion criteria

  • No history of STI or abuse

Treatment and study plan

Project IMAGE

Behavioral

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.

Primary outcomes

  1. Sexually transmitted infection

    Time frame: 12 months

    Infection at 12 months with either chlamydia or gonorrhea

Secondary outcomes

  1. Substance Use

    Time frame: 12 months

    Frequency and type of substance use

  2. Experience of abuse

    Time frame: 12 months

    Type and frequency of experience of abuse

  3. Unintended pregnancy

    Time frame: 12 months

    Frequency of unintended pregnancy

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2011
Registry last updated
Jul 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.