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Completed

NCT Number: NCT00787696

Healthy Teen Girls: HIV Risk Reduction

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.

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Key information

Conditions

HIV-infection/Aids Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Columbia Training School

Columbia, Mississippi, 39429, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral HIV/STD risk reduction

Behavioral

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

Primary outcomes

  1. number of partners and frequency of sexual risk behaviors

    Time frame: at 6 & 12 months

    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.

  2. infection with chlamydia or gonorrhea

    Time frame: one year

Secondary outcomes

  1. reproductive health knowledge

    Time frame: pre and post-intervention

    Assessed as the number of correct answers to 37 treu/false and multiple choice questions

  2. condom application skill

    Time frame: pre and post-intervention

    Measured by observing participants apply and remove a condom from a penile model and a 10-item checklist

  3. Communication skills

    Time frame: pre and post-intervention

    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.

  4. Perceived barriers to condom use

    Time frame: at baseline, 6 and 12 month follow-up

    assessed using the Condom Barrier Scale (St. Lawrence, Chapdeline, et al., 1999)

Sponsors and collaborators

Lead sponsor

Mississippi State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

HIV Risk Reduction Among Young Incarcerated Females

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Nov 7, 2008
Registry last updated
Oct 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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