Maintaining HIV Prevention Gains in Female Adolescents
Condition: HIV Infection; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Health Improvement Project for Teens on HIV Prevention
Intervention type(s): Behavioral
Intervention description(s): Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
Other intervention name(s): HIP Teens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Prevention Intervention; Female; Adolescents; STD; HIV Seronegativity