Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161343
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2005-09-08
Brief Title:
Maintaining HIV Prevention Gains in Female Adolescents
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
Status:
COMPLETED
Status Verified Date:
2009-04
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:
In this study an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females Study design
randomized controlled study
participants 640 girls aged 15-19 years old
length of follow-up 1 year after the intervention is completed
Study hypothesis The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by
lower incidence of STIs at 6 and 12 months as compared to baseline
decreased incidence of risky sexual behaviors
increased knowledge of the level of risk of certain behaviors
increased knowledge of safer sexual behaviors that can prevention HIV infection
increased motivation to reduce sexual risk
increased behavioral skills to reduce risk of HIV infection
randomized controlled study
participants 640 girls aged 15-19 years old
length of follow-up 1 year after the intervention is completed
Study hypothesis The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by
lower incidence of STIs at 6 and 12 months as compared to baseline
decreased incidence of risky sexual behaviors
increased knowledge of the level of risk of certain behaviors
increased knowledge of safer sexual behaviors that can prevention HIV infection
increased motivation to reduce sexual risk
increased behavioral skills to reduce risk of HIV infection
Detailed Description:
Adolescence is the only age category where the number of females infected with HIV outnumber the number of males Despite these data only three randomized controlled trials have evaluated the efficacy of a gender-specific HIV-risk reduction program for adolescent females The proposed research aims to address this gap in HIV prevention science and will evaluate the short and longer-term efficacy of a HIV-prevention intervention for adolescent girls We will recruit 640 adolescent females aged 15 to 19 years from family planning clinics and randomly assign them to one of two conditions a an HIV-risk reduction intervention based on the Information-Motivation-Behavioral Skills IMB model Fisher Fisher 1992 or b a structurally equivalent health promotion control group CTL both supplemented by booster sessions at 3 and 6 months At a short-term 3-month follow-up we hypothesize that IMB participants will increase HIV-related knowledge motivation and behavioral skills and decrease the frequency of risky sexual practices relative to CTL participants We will reassess all participants at 6 and 12 months to evaluate the longer-term efficacy of the interventions At these longer-term follow-ups we hypothesize that IMB participants will demonstrate higher levels of HIV knowledge motivation and behavioral skills decreased risky sexual practices and decreased rates of STDs Chlamydia gonorrhea relative to the CTL participants The final aim of the proposed research is to determine whether the constructs in the Information-Motivation-Behavioral Skills IMB Model Fisher Fisher 1992 can account for variability in HIV-related behavior We hypothesize that preventive behavior at 6 and 12 months will be a function of a participants HIV-related information motivation and behavioral skills at the 3-month follow-up and that information and motivation will be partially mediated by behavioral skills to influence the initiation and maintenance of HIV preventive behavior The long-term intent of the proposed research is to develop a risk reduction program that can be used by community-based health organizations to reduce the risk of HIV infection among adolescent females
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