Behavioral Intervention for Minority Adolescent Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01387646
First received: June 30, 2011
Last updated: July 1, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Sexually Transmitted Infection
Substance Use
Abuse
Pregnancy
Behavioral: Project IMAGE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Behavioral Intervention for Minority Adolescent Women

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Sexually transmitted infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Infection at 12 months with either chlamydia or gonorrhea


Secondary Outcome Measures:
  • Substance Use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency and type of substance use

  • Experience of abuse [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Type and frequency of experience of abuse

  • Unintended pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of unintended pregnancy


Enrollment: 562
Study Start Date: October 2004
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control Group
Participants 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
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387646

Locations
United States, Texas
San Antonio Metropolitan Health District
San Antonio, Texas, United States
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Jane D Champion, PhD The University of Texas Health Science Center at San Antonio
  More Information

No publications provided by The University of Texas Health Science Center at San Antonio

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jane Dimmitt Champion, University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01387646     History of Changes
Other Study ID Numbers: 1R01DA019180-01, 1R01DA019180-01
Study First Received: June 30, 2011
Last Updated: July 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
STI, abuse, substance use, unintended pregnancy

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 29, 2014