Behavioral Intervention for Minority Adolescent Women

NCT01387646 | Completed Phase 2 DMC

• 1 other identifier: 1R01DA019180-01
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

STI, abuse, substance use, unintended pregnancy

Outcome Measures

Primary Outcomes (1)

• Sexually transmitted infection

  Infection at 12 months with either chlamydia or gonorrhea

  12 months

Secondary Outcomes (3)

• Substance Use

  12 months

• Experience of abuse

  12 months

• Unintended pregnancy

  12 months

Study Arms (1)

Control Group

OTHER

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

Interventions

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.

Control Group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• No history of STI or abuse

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

San Antonio Metropolitan Health District

San Antonio, Texas, United States

Location

Related Publications (3)

• Collins JL, Owen DC, Champion JD. The Meaning of Weight: A Big Way of Life for Rural Mexican-American Adolescent Men and Caregivers. Public Health Nurs. 2016 Sep;33(5):421-9. doi: 10.1111/phn.12263. Epub 2016 Apr 14.

  PMID: 27079291 DERIVED

• Collins JL, Champion JD. Assessment of mobile device and SMS Use for Diet and Exercise Information Among Rural Mexican-American adolescents. J Pediatr Nurs. 2014 Nov-Dec;29(6):493-502. doi: 10.1016/j.pedn.2014.03.020. Epub 2014 Mar 15.

  PMID: 24704179 DERIVED

• Dimmitt Champion J, Harlin B, Collins JL. Sexual risk behavior and STI health literacy among ethnic minority adolescent women. Appl Nurs Res. 2013 Nov;26(4):204-9. doi: 10.1016/j.apnr.2013.06.003. Epub 2013 Jul 15.

  PMID: 23867137 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jane D Champion, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 4, 2011
• Study Start: October 1, 2004
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 4, 2011

Record last verified: 2011-06

Locations

US (1)