Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness of Stepping Stones, an HIV-prevention education
      program, versus a brief HIV-focused intervention, in improving sexual health and preventing
      HIV infection in young residents of rural South African communities.
    

Detailed description: 
      HIV is arguably the most important problem currently facing the South African population. It
      is possible that biotechnology will eventually be able to lessen the disease's threat by
      introducing a vaccine or vaginal microbicide, but these are not expected to be available
      within the next 5 to 10 years. It is therefore extremely important to prevent HIV infection
      by modifying sexual behaviors. Voluntary counseling and testing have been shown to have an
      important impact on sexual behavior, but it is essential that other approaches to HIV
      prevention are developed and evaluated. Little research, however, has been done on behavioral
      interventions, relative to the amount of research that has been devoted to biotechnology
      development. Stepping Stones is an approach to HIV prevention that aims to improve sexual
      health through building stronger, more gender-equitable relationships with better
      communication between partners. This study will evaluate the effectiveness of the Stepping
      Stones program versus a brief HIV-focused intervention in improving sexual health and
      preventing HIV infection in young residents of rural South African communities.

      Participants in this open-label study will be randomly assigned to take part in either the
      Stepping Stones program or the brief HIV-focused intervention (control). All participants
      will first attend a baseline study visit, which will include an interview and HIV testing.
      The control intervention will entail a single 2- to 3-hour meeting among same-sex peer
      groups, and will include exercises about HIV and safer sex practices that will be drawn from
      the Stepping Stones program. Stepping Stones will entail 17 sessions with same-sex peer
      groups, and will be implemented over a period of 3 to 12 weeks. Sessions will involve
      discussions on a variety of sexual health issues, including the following topics: reflections
      on love; sexual health joys and problems; body mapping; menstruation; contraception and
      conception, including infertility; sexual problems; unwanted pregnancy; HIV; STDs; safer sex;
      gender-based violence; motivations for sexual behavior; and dealing with grief and loss. Peer
      groups will come together for 3 of the 17 meetings to build assertive communication skills by
      leading presentations on exercises from the Stepping Stones program. HIV testing will be
      performed again after 12 and 24 months to assess program effectiveness. Face-to-face
      interviews will be held at Months 6, 12, and 24 to assess the impact of the intervention on
      behavior, attitude, and beliefs.
    

Intervention name(s): Stepping Stones; stepping Stones short
Intervention type(s): Behavioral; Behavioral
Intervention description(s): a comprehensive sexual and reproductive health promotion programme lasting about 50 hours comprising 13 content sessions of about 3 hours duration and 4 meetings of peer groups; 3 hour intervention on HIV and safer sex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Behavioral Intervention; HIV; HSV2