Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332878
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2006-06-01
Brief Title:
Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
Sponsor:
Medical Research Council South Africa
Organization:
Medical Research Council South Africa
Study Overview
Official Title:
RCT of Stepping Stones Behavioural Intervention for HIV
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 diseases 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH064882 | NIH | None | None |
| DAHBR 9A-ASI | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH064882 |