Healthy Teen Girls: HIV Risk Reduction

HIV-infection/Aids Clinical Trial

Official title:

HIV Risk Reduction Among Young Incarcerated Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787696
• Other study ID #: R01DA17509-4
• Secondary ID: R01DA017509
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 6, 2008
• Last updated: October 19, 2011
• Start date: September 2003
• Est. completion date: December 2009

Study information

• Verified date: October 2011
• Source: Mississippi State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV-infection/Aids

Intervention

Behavioral:
• Cognitive-behavioral HIV/STD risk reduction
18 60-minute group sessions plus 1 individual health and safety planning session

Locations

Country	Name	City	State
United States	Columbia Training School	Columbia	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Mississippi State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of partners and frequency of sexual risk behaviors	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.	at 6 & 12 months	No
Primary	infection with chlamydia or gonorrhea		one year	No
Secondary	reproductive health knowledge	Assessed as the number of correct answers to 37 treu/false and multiple choice questions	pre and post-intervention	No
Secondary	condom application skill	Measured by observing participants apply and remove a condom from a penile model and a 10-item checklist	pre and post-intervention	No
Secondary	Communication skills	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.	pre and post-intervention	No
Secondary	Perceived barriers to condom use	assessed using the Condom Barrier Scale (St. Lawrence, Chapdeline, et al., 1999)	at baseline, 6 and 12 month follow-up	No