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Healthy Teen Girls: HIV Risk Reduction

M

Mississippi State University

Status and phase

Completed
Phase 2
Phase 1

Conditions

HIV-infection/Aids

Treatments

Behavioral: Cognitive-behavioral HIV/STD risk reduction

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00787696
R01DA17509-4
R01DA017509 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

333 patients

Sex

Female

Ages

13 to 18 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

333 participants in 2 patient groups

Skills Training
Experimental group
Description:
intervention group received information, motivation and skills training: condom application, assertive communication \& problem solving
Treatment:
Behavioral: Cognitive-behavioral HIV/STD risk reduction
Health Education
Active Comparator group
Description:
Comparsion group received information and motivation
Treatment:
Behavioral: Cognitive-behavioral HIV/STD risk reduction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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