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

RCT of Stepping Stones Behavioural Intervention for HIV

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00332878
Enrollment
2801
Registered
2006-06-02
Start date
2003-03-31
Completion date
2006-04-30
Last updated
2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Behavioral Intervention, HIV, HSV2

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.

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.

Interventions

BEHAVIORALStepping 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

BEHAVIORALstepping Stones short

3 hour intervention on HIV and safer sex

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Medical Research Council, South Africa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 23 Years
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

Design outcomes

Primary

MeasureTime frame
HIV sero-incidence24 months post-baseline

Secondary

MeasureTime frame
HSV-2 sero-incidence24 months post-baseline
correct condom use at last sex, number of partners, transactional sex, intimate partner violence, any casual partner,12 months and 24 months post-baseline

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026