Clinical trial NCT00787696: Healthy Teen Girls: HIV Risk Reduction
Official title: HIV Risk Reduction Among Young Incarcerated Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV-infection/Aids
Keywords: HIV prevention
female adolescent offenders
sexual risk reduction
alcohol and other drug abuse
Lead sponsor: Mississippi State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-11-07
Enrollment: 333
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: number of partners and frequency of sexual risk behaviors
timeFrame: at 6 & 12 months
measure: infection with chlamydia or gonorrhea
timeFrame: one year
Secondary outcomes:
measure: reproductive health knowledge
timeFrame: pre and post-intervention
measure: condom application skill
timeFrame: pre and post-intervention
measure: Communication skills
timeFrame: pre and post-intervention
measure: Perceived barriers to condom use
timeFrame: at baseline, 6 and 12 month follow-up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Columbia Training School
state: Mississippi
Study officials:
affiliation: Mississippi State University
name: Angela A. Robertson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.