Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council, South Africa
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00332878
First received: June 1, 2006
Last updated: December 6, 2007
Last verified: December 2007

June 1, 2006
December 6, 2007
March 2003
Not Provided
HIV sero-incidence [ Time Frame: 24 months post-baseline ] [ Designated as safety issue: No ]
Measured at Months 12 and 24: HIV sero-incidence
Complete list of historical versions of study NCT00332878 on ClinicalTrials.gov Archive Site
  • HSV-2 sero-incidence [ Time Frame: 24 months post-baseline ] [ Designated as safety issue: No ]
  • correct condom use at last sex, number of partners, transactional sex, intimate partner violence, any casual partner, [ Time Frame: 12 months and 24 months post-baseline ] [ Designated as safety issue: No ]
  • Measured between Months 6 and 8, and at Months 12 and 24: HSV-2 sero-incidence
  • Gender-based violence
  • Condom use
  • Partner numbers
  • Transactional sex
  • Gender attitudes
  • Communication
Not Provided
Not Provided
 
Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
RCT of Stepping Stones Behavioural Intervention for HIV

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Stepping Stones
    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
  • Behavioral: stepping Stones short
    3 hour intervention on HIV and safer sex
  • Experimental: 1
    Stepping Stones
    Intervention: Behavioral: Stepping Stones
  • Active Comparator: 2
    A 3 hour intervention on HIV and safer sex
    Intervention: Behavioral: stepping Stones short

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2801
April 2006
Not Provided

Inclusion Criteria:

  • Resident of the village in which individual is studying (i.e., not a migrant scholar)
  • Mature enough to understand the study and the consent process

Exclusion Criteria:

  • N/A
Both
16 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00332878
R01 MH64882, DAHBR 9A-ASI
Yes
Prof Rachel Jewkes, Medical Research Council
National Institute of Mental Health (NIMH)
Medical Research Council, South Africa
Principal Investigator: Rachel K. Jewkes, MBBS MSc MD Medical Research Council, South Africa
National Institute of Mental Health (NIMH)
December 2007

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