We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00332878
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Stepping Stones Behavioral: stepping Stones short Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2801 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RCT of Stepping Stones Behavioural Intervention for HIV
Study Start Date : March 2003
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Stepping Stones
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
Active Comparator: 2
A 3 hour intervention on HIV and safer sex
Behavioral: stepping Stones short
3 hour intervention on HIV and safer sex

Outcome Measures

Primary Outcome Measures :
  1. HIV sero-incidence [ Time Frame: 24 months post-baseline ]

Secondary Outcome Measures :
  1. HSV-2 sero-incidence [ Time Frame: 24 months post-baseline ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332878

South Africa
Various villages in South Africa
Mthatha, Eastern Cape, South Africa
Sponsors and Collaborators
Medical Research Council, South Africa
National Institute of Mental Health (NIMH)
Principal Investigator: Rachel K. Jewkes, MBBS MSc MD Medical Research Council, South Africa
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tasnim Mohsam, Administrator, Medical Research Council, South Africa
ClinicalTrials.gov Identifier: NCT00332878     History of Changes
Other Study ID Numbers: R01MH064882 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Tasnim Mohsam, Medical Research Council, South Africa:
Behavioral Intervention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases