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Completed

NCT Number: NCT00332878

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

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.

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Key information

Age range

16 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Various villages in South Africa

Mthatha, Eastern Cape, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stepping Stones

Behavioral

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

stepping Stones short

Behavioral

3 hour intervention on HIV and safer sex

Primary outcomes

  1. HIV sero-incidence

    Time frame: 24 months post-baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical Research Council, South Africa

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

RCT of Stepping Stones Behavioural Intervention for HIV

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jun 2, 2006
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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