Maintaining HIV Prevention Gains in Female Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dianne Morrison-Beedy, University of Rochester
ClinicalTrials.gov Identifier:
NCT00161343
First received: September 8, 2005
Last updated: September 4, 2012
Last verified: April 2009

September 8, 2005
September 4, 2012
December 2004
August 2009   (final data collection date for primary outcome measure)
  • rates of STIs [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • computer-assisted survey results [ Time Frame: baseline, 1 week, 3, 6, & 12 months ] [ Designated as safety issue: No ]
  • - score on self-report of frequency of risky sexual and substance use behaviors [ Time Frame: baseline, 1 week, 3, 6, & 12 months ] [ Designated as safety issue: No ]
  • rates of STIs at baseline, 6 months and 12 months
  • computer-assisted survey results:
  • - score on self-report of frequency of risky sexual and substance use behaviors
Complete list of historical versions of study NCT00161343 on ClinicalTrials.gov Archive Site
- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV [ Time Frame: baseline, 3, 6, & 12 months ] [ Designated as safety issue: No ]
- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV
Not Provided
Not Provided
 
Maintaining HIV Prevention Gains in Female Adolescents
Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents

In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:

  • randomized, controlled study
  • participants: 640 girls aged 15-19 years old
  • length of follow-up: 1 year after the intervention is completed

Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:

  • lower incidence of STI's at 6 and 12 months, as compared to baseline
  • decreased incidence of risky sexual behaviors
  • increased knowledge of the level of risk of certain behaviors
  • increased knowledge of safer sexual behaviors that can prevention HIV infection
  • increased motivation to reduce sexual risk
  • increased behavioral skills to reduce risk of HIV infection

Adolescence is the only age category where the number of females infected with HIV outnumber the number of males. Despite these data, only three randomized controlled trials have evaluated the efficacy of a gender-specific HIV-risk reduction program for adolescent females. The proposed research aims to address this gap in HIV prevention science, and will evaluate the short and longer-term efficacy of a HIV-prevention intervention for adolescent girls. We will recruit 640 adolescent females aged 15 to 19 years from family planning clinics and randomly assign them to one of two conditions: (a) an HIV-risk reduction intervention based on the Information-Motivation-Behavioral Skills (IMB) model (Fisher & Fisher, 1992) or (b) a structurally equivalent health promotion control group (CTL) both supplemented by booster sessions at 3 and 6 months. At a short-term (3-month) follow-up, we hypothesize that IMB participants will increase HIV-related knowledge, motivation, and behavioral skills, and decrease the frequency of risky sexual practices relative to CTL participants. We will reassess all participants at 6 and 12 months to evaluate the longer-term efficacy of the interventions. At these longer-term follow-ups, we hypothesize that IMB participants will demonstrate higher levels of HIV knowledge, motivation, and behavioral skills; decreased risky sexual practices; and decreased rates of STDs (Chlamydia, gonorrhea) relative to the CTL participants. The final aim of the proposed research is to determine whether the constructs in the Information-Motivation-Behavioral Skills (IMB) Model (Fisher & Fisher, 1992), can account for variability in HIV-related behavior. We hypothesize that preventive behavior at 6 and 12 months will be a function of a participant's HIV-related information, motivation, and behavioral skills at the 3-month follow-up, and that information and motivation will be partially mediated by behavioral skills to influence the initiation and maintenance of HIV preventive behavior. The long-term intent of the proposed research is to develop a risk reduction program that can be used by community-based health organizations to reduce the risk of HIV infection among adolescent females.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infection
  • Sexually Transmitted Diseases
Behavioral: Health Improvement Project for Teens on HIV Prevention
Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
Other Name: HIP Teens
  • Experimental: 1
    Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model
    Intervention: Behavioral: Health Improvement Project for Teens on HIV Prevention
  • Placebo Comparator: 2
    Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model
    Intervention: Behavioral: Health Improvement Project for Teens on HIV Prevention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
640
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 15-19 years old
  • Sexually active in the past 3 months
  • Available for follow-up contacts over the next 13 months
  • English speaking

Exclusion Criteria:

  • Pregnant, or had a baby in the last 3 months
  • Married or living with a partner
Female
15 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161343
R01-NR-008194
Yes
Dianne Morrison-Beedy, University of Rochester
University of Rochester
National Institute of Nursing Research (NINR)
Principal Investigator: Dianne C. Morrison-Beedy, Ph.D., RN University of Rochester School of Nursing
University of Rochester
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP