Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
RCT of Stepping Stones Behavioural Intervention for HIV
2 other identifiers
interventional
2,801
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Mar 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedJanuary 26, 2015
January 1, 2015
3.1 years
June 1, 2006
January 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV sero-incidence
24 months post-baseline
Secondary Outcomes (2)
HSV-2 sero-incidence
24 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
Study Arms (2)
1
EXPERIMENTALStepping Stones
2
ACTIVE COMPARATORA 3 hour intervention on HIV and safer sex
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Various villages in South Africa
Mthatha, Eastern Cape, South Africa
Related Publications (2)
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.
PMID: 16398750BACKGROUNDJewkes 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.
PMID: 18687720DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel K. Jewkes, MBBS MSc MD
Medical Research Council, South Africa
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Administrator
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 2, 2006
Study Start
March 1, 2003
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
January 26, 2015
Record last verified: 2015-01