Healthy Teen Girls: HIV Risk Reduction

NCT00787696 | Completed Phase 1

• 2 other identifiers: R01DA17509-4R01DA017509
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-infection/Aids

Keywords

HIV prevention; female adolescent offenders; sexual risk reduction; alcohol and other drug abuse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• reproductive health knowledge

  pre and post-intervention

• condom application skill

  pre and post-intervention

• Communication skills

  pre and post-intervention

• Perceived barriers to condom use

  at baseline, 6 and 12 month follow-up

Study Arms (2)

Skills Training

EXPERIMENTAL

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

Behavioral: Cognitive-behavioral HIV/STD risk reduction

Health Education

ACTIVE COMPARATOR

Comparsion group received information and motivation

Behavioral: Cognitive-behavioral HIV/STD risk reduction

Interventions

Cognitive-behavioral HIV/STD risk reduction BEHAVIORAL

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

Health Education; Skills Training

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female, ages 13 to 17 years, committed to Columbia Training School, who provide written informed assent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mississippi State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia Training School

Columbia, Mississippi, 39429, United States

Location

Related Publications (1)

• 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.

  PMID: 21393623 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Angela A. Robertson, Ph.D.

  Mississippi State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: September 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: October 20, 2011

Record last verified: 2011-10

Locations

US (1)