Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
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ClinicalTrials.gov Identifier: NCT00332878 |
Recruitment Status :
Completed
First Posted : June 2, 2006
Last Update Posted : January 26, 2015
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Behavioral: Stepping Stones Behavioral: stepping Stones short | Phase 3 |
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 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 |
Actual Primary Completion Date : | April 2006 |
Actual Study Completion Date : | April 2006 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Stepping Stones
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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
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Behavioral: stepping Stones short
3 hour intervention on HIV and safer sex |
- HIV sero-incidence [ Time Frame: 24 months post-baseline ]
- HSV-2 sero-incidence [ Time Frame: 24 months post-baseline ]
- 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 ]

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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:
- N/A

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 |
Principal Investigator: | Rachel K. Jewkes, MBBS MSc MD | Medical Research Council, South Africa |
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 |
Other Study ID Numbers: |
R01MH064882 ( U.S. NIH Grant/Contract ) R01MH064882 ( U.S. NIH Grant/Contract ) DAHBR 9A-ASI |
First Posted: | June 2, 2006 Key Record Dates |
Last Update Posted: | January 26, 2015 |
Last Verified: | January 2015 |
Behavioral Intervention HIV HSV2 |
Infection 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 |