Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Stepping Stones
stepping Stones short
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Behavioral Intervention, HIV, HSV2
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
Sites / Locations
- Various villages in South Africa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Stepping Stones
A 3 hour intervention on HIV and safer sex
Outcomes
Primary Outcome Measures
HIV sero-incidence
Secondary Outcome Measures
HSV-2 sero-incidence
correct condom use at last sex, number of partners, transactional sex, intimate partner violence, any casual partner,
Full Information
NCT ID
NCT00332878
First Posted
June 1, 2006
Last Updated
January 22, 2015
Sponsor
Medical Research Council, South Africa
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00332878
Brief Title
Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
Official Title
RCT of Stepping Stones Behavioural Intervention for HIV
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council, South Africa
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Behavioral Intervention, HIV, HSV2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2801 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Stepping Stones
Arm Title
2
Arm Type
Active Comparator
Arm Description
A 3 hour intervention on HIV and safer sex
Intervention Type
Behavioral
Intervention Name(s)
Stepping Stones
Intervention Description
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
Intervention Name(s)
stepping Stones short
Intervention Description
3 hour intervention on HIV and safer sex
Primary Outcome Measure Information:
Title
HIV sero-incidence
Time Frame
24 months post-baseline
Secondary Outcome Measure Information:
Title
HSV-2 sero-incidence
Time Frame
24 months post-baseline
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel K. Jewkes, MBBS MSc MD
Organizational Affiliation
Medical Research Council, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Various villages in South Africa
City
Mthatha
State/Province
Eastern Cape
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
16398750
Citation
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.
Results Reference
background
PubMed Identifier
18687720
Citation
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.
Results Reference
derived
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Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
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