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

NCT ID: NCT00332878

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2801 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2006-04-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Stepping Stones

Group Type: EXPERIMENTAL

Stepping Stones

Intervention Type: 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

2

A 3 hour intervention on HIV and safer sex

Group Type: ACTIVE_COMPARATOR

stepping Stones short

Intervention Type: BEHAVIORAL

3 hour intervention on HIV and safer sex

Interventions

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

Intervention Type: BEHAVIORAL

stepping Stones short

3 hour intervention on HIV and safer sex

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role: lead

Responsible Party

Tasnim Mohsam

Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel K. Jewkes, MBBS MSc MD

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council, South Africa

Locations

Various villages in South Africa

Mthatha, Eastern Cape, South Africa

Countries

South Africa

References

Jewkes R, Nduna M, Levin J, Jama N, Dunkle K, Khuzwayo N, Koss M, Puren A, Wood K, Duvvury N. A cluster randomized-controlled trial to determine the effectiveness of Stepping Stones in preventing HIV infections and promoting safer sexual behaviour amongst youth in the rural Eastern Cape, South Africa: trial design, methods and baseline findings. Trop Med Int Health. 2006 Jan;11(1):3-16. doi: 10.1111/j.1365-3156.2005.01530.x.

Reference Type: BACKGROUND

PMID: 16398750 (View on PubMed)

Jewkes R, Nduna M, Levin J, Jama N, Dunkle K, Puren A, Duvvury N. Impact of stepping stones on incidence of HIV and HSV-2 and sexual behaviour in rural South Africa: cluster randomised controlled trial. BMJ. 2008 Aug 7;337:a506. doi: 10.1136/bmj.a506.

Reference Type: DERIVED

PMID: 18687720 (View on PubMed)

Other Identifiers

R01MH064882

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR 9A-ASI

Identifier Type: -

Identifier Source: secondary_id

R01MH064882

Identifier Type: NIH

Identifier Source: org_study_id

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