Trial record 14 of 34 for:    " October 08, 2008":" November 07, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Healthy Teen Girls: HIV Risk Reduction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Angela A. Robertson, PhD, Mississippi State University
ClinicalTrials.gov Identifier:
NCT00787696
First received: November 6, 2008
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

This project assesses the efficacy of an HIV prevention program with adolescent females incarcerated in the Mississippi training school for girls. Participants in both the health education control group and the HIV prevention group will increase health knowledge as a result of their participation in the health classes while incarcerated. However, participants in the HIV prevention group will increase their condom application, assertiveness, and communication skills relative to girls in the health education only group. In addition, after release from the training school, participants in the HIV prevention group will report lower sexual risk behaviors and will have lower rates of infection with chlamydia and gonorrhea during the 12-month follow-up period than participants in the health education only group.


Condition Intervention Phase
HIV-infection/Aids
Behavioral: Cognitive-behavioral HIV/STD risk reduction
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Risk Reduction Among Young Incarcerated Females

Resource links provided by NLM:


Further study details as provided by Mississippi State University:

Primary Outcome Measures:
  • number of partners and frequency of sexual risk behaviors [ Time Frame: at 6 & 12 months ] [ Designated as safety issue: No ]
    Sexual behaviors included condom use in the 3 months prior to each assessment. Unprotected sex occasions (USOs) was calculated by subtracting the number of condom-protected vaginal and anal intercourse occasions from the total number of vaginal and anal intercourse occasions. Sex under the influence is the number of times participant reported sexual intercourse after drinking alcohol or using another drug. Safer sex was categorized as sexually abstinent or consistent condom use.

  • infection with chlamydia or gonorrhea [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reproductive health knowledge [ Time Frame: pre and post-intervention ] [ Designated as safety issue: No ]
    Assessed as the number of correct answers to 37 treu/false and multiple choice questions

  • condom application skill [ Time Frame: pre and post-intervention ] [ Designated as safety issue: No ]
    Measured by observing participants apply and remove a condom from a penile model and a 10-item checklist

  • Communication skills [ Time Frame: pre and post-intervention ] [ Designated as safety issue: No ]
    Assessed during three role-play vignettes that place the respondent in a high-risk sexual or drug use situation and asked them to respond to a series of three escalating prompts as though the situation was actually happening.

  • Perceived barriers to condom use [ Time Frame: at baseline, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    assessed using the Condom Barrier Scale (St. Lawrence, Chapdeline, et al., 1999)


Enrollment: 333
Study Start Date: September 2003
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Skills Training
intervention group received information, motivation and skills training: condom application, assertive communication & problem solving
Behavioral: Cognitive-behavioral HIV/STD risk reduction
18 60-minute group sessions plus 1 individual health and safety planning session
Active Comparator: Health Education
Comparsion group received information and motivation
Behavioral: Cognitive-behavioral HIV/STD risk reduction
18 60-minute group sessions plus 1 individual health and safety planning session

Detailed Description:

This study is a longitudinal analysis of STD/HIV exposure among adolescent female offenders in Mississippi, a population that is disproportionately African American, and at higher risk than adolescents in general due to their propensity to engage in a variety of risk-taking behaviors, earlier onset of sexual behaviors, and the greater prevalence of mental disorders, substance abuse disorders, maltreatment, and family dysfunction. Based on social cognitive theory and Fisher and Fisher's (1992) IMB (Information, Motivation, and Behavioral skills) model, we will evaluate a drug abuse related HIV risk reduction intervention and compare outcomes against a STD/HIV information and health education control condition.

Approximately 400 females committed to the state reformatory/training school for girls will be recruited for participation. The research design will consist of alternating cohort/waves of about 50 subjects each. One treatment condition will be administered at a time with a washout period between cohort/waves. Over a three year period, one half of subjects will get 18 hours of STD/HIV prevention and one half will get 18 hours of Health Education. All subjects will receive one individual counseling session designed to enhance motivation for behavioral change just prior to release from training school. Before and after the intervention, subjects' social competency skills, condom application skills, and health knowledge will be measured. Before intervention and at 6-month and 12-month follow-up, self-report measures of alcohol and drug use, condom use, sexual risk behaviors, and measures of victimization, partner risk, condom attitudes, self-efficacy, and communication related to condom use and risk reduction will be collected. Urine tests for the detection of 2 STDs (chlamydia and gonorrhea) will also be performed at admission to Columbia Training School and at 6-month and 12-month follow-up.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female, ages 13 to 17 years, committed to Columbia Training School, who provide written informed assent.

Exclusion Criteria:

  • Acute or chronic physically illness that would preclude participation as determined by facility physician; placement in maximum security unit; study participation during a prior commitment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787696

Locations
United States, Mississippi
Columbia Training School
Columbia, Mississippi, United States, 39429
Sponsors and Collaborators
Mississippi State University
Investigators
Principal Investigator: Angela A. Robertson, Ph.D. Mississippi State University
  More Information

Publications:
Responsible Party: Angela A. Robertson, PhD, Research Professor, Mississippi State University
ClinicalTrials.gov Identifier: NCT00787696     History of Changes
Other Study ID Numbers: R01DA17509-4, R01DA017509
Study First Received: November 6, 2008
Last Updated: October 19, 2011
Health Authority: United States: Federal Government

Keywords provided by Mississippi State University:
HIV prevention
female adolescent offenders
sexual risk reduction
alcohol and other drug abuse

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014