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

HIV Infections Clinical Trial

Official title:

RCT of Stepping Stones Behavioural Intervention for HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332878
• Other study ID #: R01MH064882
• Secondary ID: R01MH064882DAHBR
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2006
• Last updated: January 22, 2015
• Start date: March 2003
• Est. completion date: April 2006

Study information

• Verified date: January 2015
• Source: Medical Research Council, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2801
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 23 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

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
• stepping Stones short
3 hour intervention on HIV and safer sex

Locations

Country	Name	City	State
South Africa	Various villages in South Africa	Mthatha	Eastern Cape

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council, South Africa	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV sero-incidence		24 months post-baseline	No
Secondary	HSV-2 sero-incidence		24 months post-baseline	No
Secondary	correct condom use at last sex, number of partners, transactional sex, intimate partner violence, any casual partner,		12 months and 24 months post-baseline	No