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Healthy Teen Girls: HIV Risk Reduction

NCT ID: NCT00787696

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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HIV-infection/Aids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Skills Training

intervention group received information, motivation and skills training: condom application, assertive communication \& problem solving

Group Type EXPERIMENTAL

Cognitive-behavioral HIV/STD risk reduction

Intervention Type BEHAVIORAL

18 60-minute group sessions plus 1 individual health and safety planning session

Health Education

Comparsion group received information and motivation

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral HIV/STD risk reduction

Intervention Type BEHAVIORAL

18 60-minute group sessions plus 1 individual health and safety planning session

Interventions

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Cognitive-behavioral HIV/STD risk reduction

18 60-minute group sessions plus 1 individual health and safety planning session

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Mississippi State University

OTHER

Sponsor Role lead

Responsible Party

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Angela A. Robertson, PhD

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela A. Robertson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mississippi State University

Locations

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Columbia Training School

Columbia, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21393623 (View on PubMed)

Other Identifiers

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R01DA017509

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA17509-4

Identifier Type: -

Identifier Source: org_study_id