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

November 6, 2008
October 19, 2011
September 2003
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • number of partners and sexual risk behaviors [ Time Frame: at 6 & 12 months ] [ Designated as safety issue: No ]
  • infection with chlamydia or gonorrhea [ Time Frame: one year ] [ Designated as safety issue: No ]
  • alcohol and other drug use [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00787696 on ClinicalTrials.gov Archive Site
  • 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)
  • reproductive health knowledge [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
  • condom application skill [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
  • social competency skills [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Healthy Teen Girls: HIV Risk Reduction
HIV Risk Reduction Among Young Incarcerated Females

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV-infection/Aids
Behavioral: Cognitive-behavioral HIV/STD risk reduction
18 60-minute group sessions plus 1 individual health and safety planning session
  • Experimental: Skills Training
    intervention group received information, motivation and skills training: condom application, assertive communication & problem solving
    Intervention: Behavioral: Cognitive-behavioral HIV/STD risk reduction
  • Active Comparator: Health Education
    Comparsion group received information and motivation
    Intervention: Behavioral: Cognitive-behavioral HIV/STD risk reduction
Robertson AA, St Lawrence J, Morse DT, Baird-Thomas C, Liew H, Gresham K. The Healthy Teen Girls project: comparison of health education and STD risk reduction intervention for incarcerated adolescent females. Health Educ Behav. 2011 Jun;38(3):241-50. doi: 10.1177/1090198110372332. Epub 2011 Mar 10. Erratum in: Health Educ Behav. 2011 Aug;38(4):423. Robertson, Angela R [corrected to Robertson, Angela A].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
333
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Female
13 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00787696
R01DA17509-4, R01DA017509
No
Angela A. Robertson, PhD, Mississippi State University
Mississippi State University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Angela A. Robertson, Ph.D. Mississippi State University
Mississippi State University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP