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Healthy Teen Girls: HIV Risk Reduction

Primary Purpose

HIV-infection/Aids

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral HIV/STD risk reduction
Sponsored by
Mississippi State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV-infection/Aids focused on measuring HIV prevention, female adolescent offenders, sexual risk reduction, alcohol and other drug abuse

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia Training School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Skills Training

Health Education

Arm Description

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

Comparsion group received information and motivation

Outcomes

Primary Outcome Measures

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.
infection with chlamydia or gonorrhea

Secondary Outcome Measures

reproductive health knowledge
Assessed as the number of correct answers to 37 treu/false and multiple choice questions
condom application skill
Measured by observing participants apply and remove a condom from a penile model and a 10-item checklist
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.
Perceived barriers to condom use
assessed using the Condom Barrier Scale (St. Lawrence, Chapdeline, et al., 1999)

Full Information

First Posted
November 6, 2008
Last Updated
October 19, 2011
Sponsor
Mississippi State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00787696
Brief Title
Healthy Teen Girls: HIV Risk Reduction
Official Title
HIV Risk Reduction Among Young Incarcerated Females
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mississippi State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-infection/Aids
Keywords
HIV prevention, female adolescent offenders, sexual risk reduction, alcohol and other drug abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skills Training
Arm Type
Experimental
Arm Description
intervention group received information, motivation and skills training: condom application, assertive communication & problem solving
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Comparsion group received information and motivation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral HIV/STD risk reduction
Intervention Description
18 60-minute group sessions plus 1 individual health and safety planning session
Primary Outcome Measure Information:
Title
number of partners and frequency of sexual risk behaviors
Description
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.
Time Frame
at 6 & 12 months
Title
infection with chlamydia or gonorrhea
Time Frame
one year
Secondary Outcome Measure Information:
Title
reproductive health knowledge
Description
Assessed as the number of correct answers to 37 treu/false and multiple choice questions
Time Frame
pre and post-intervention
Title
condom application skill
Description
Measured by observing participants apply and remove a condom from a penile model and a 10-item checklist
Time Frame
pre and post-intervention
Title
Communication skills
Description
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.
Time Frame
pre and post-intervention
Title
Perceived barriers to condom use
Description
assessed using the Condom Barrier Scale (St. Lawrence, Chapdeline, et al., 1999)
Time Frame
at baseline, 6 and 12 month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela A. Robertson, Ph.D.
Organizational Affiliation
Mississippi State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Training School
City
Columbia
State/Province
Mississippi
ZIP/Postal Code
39429
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21393623
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. Erratum In: Health Educ Behav. 2011 Aug;38(4):423. Robertson, Angela R [corrected to Robertson, Angela A].
Results Reference
result

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Healthy Teen Girls: HIV Risk Reduction

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