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.

Study Overview

• Status: Completed
• Conditions: HIV-infection/Aids
• Intervention / Treatment: Behavioral: Cognitive-behavioral HIV/STD risk reduction

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.

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Columbia, Mississippi, United States, 39429
      • Columbia Training School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
infection with chlamydia or gonorrhea		one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reproductive health knowledge	Assessed as the number of correct answers to 37 treu/false and multiple choice questions	pre and post-intervention
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
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
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

Collaborators and Investigators

• Sponsor: Mississippi State University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Angela A. Robertson, Ph.D., Mississippi State University

Publications and helpful links

General Publications

• 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].

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 7, 2008

Study Record Updates

• Last Update Posted (Estimate): October 20, 2011
• Last Update Submitted That Met QC Criteria: October 19, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: HIV prevention; female adolescent offenders; sexual risk reduction; alcohol and other drug abuse
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01DA17509-4; R01DA017509 (U.S. NIH Grant/Contract)