Family-based HIV Prevention for Adolescent Girls
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This is an exploratory/developmental study to support the early phases of development and
      evaluation of a family-based HIV prevention program for adolescent girls prior to a
      full-scale trial. Research on the new intervention will include evaluating the feasibility,
      tolerability, and acceptability of the intervention, and allow us to obtain the preliminary
      data needed as a pre-requisite to a larger-scale intervention study.

      Adolescent females and their mother/guardian will be randomized to either: a family-based
      risk reduction intervention; or a no-treatment control group condition. Participants in both
      conditions will be assessed at baseline, immediate post-intervention, and at 3- and 6-month
      follow-ups. A subset of families (12 adolescents and 12 mothers) will participate in a
      qualitative interview following the 6-month follow-up, in which information will be obtained
      on participant perception of procedures and intervention content, and whether they have
      utilized skills taught following the end of the project.
    

Detailed description: 
      Participants will be involved with the study and follow up for a total of 32 to 36 weeks.

      68-84 female adolescents and their mother/guardian (total N = 136-168).

      African American or mixed race, sexually active female adolescents age 15 to 19 who are at
      risk for HIV infection and their mother/guardian

      The adolescent participant and her mother/guardian will be randomized to either a
      family-based risk reduction intervention or a no-treatment control group condition.

      Participants in both conditions will be assessed at baseline, immediate post-intervention,
      and at 3- and 6-month follow-ups. A subset of 24 participants from the intervention condition
      (12 adolescents and 12 mothers) will participate in a qualitative interview following the
      6-month follow-up, in which information will be obtained on participant perception of
      procedures and intervention content, and whether they have utilized skills taught following
      the end of the project.

      Interviewers will collect participant data from the baseline and follow-up behavioral
      interviews using a Computer Assisted Personal Interviewing (CAPI) method on a portable
      computer.
    

Intervention name(s): Family-Based Risk Reduction Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention module topics include five modules and each module is 2 hours in length. The intervention will focus on the elements critical to HIV risk behavior change. These include: risk education (practical understanding of factors responsible for risk and behavior changes needed to reduce risk); threat personalization (accurate appraisal of personal risk based on behavior); self-efficacy (belief that one can implement risk reduction behavior changes and that if changes are made they will have protective value); skills acquisition (e.g., condom use, safer sex guidance, negotiation); cognitive problem-solving skills; and reinforcement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV prevention; HIV Seronegativity; HIV negative