Maintaining HIV Prevention Gains in Female Adolescents

Phase 2

Completed

• Conditions: HIV Infection; Sexually Transmitted Diseases
• Interventions: Behavioral: Health Improvement Project for Teens on HIV Prevention

• Registration Number: NCT00161343
• Lead Sponsor: University of Rochester

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 STI's 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 participant's 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 Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2009-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 640

Inclusion Criteria

• 15-19 years old
• Sexually active in the past 3 months
• Available for follow-up contacts over the next 13 months
• English speaking

Exclusion Criteria

• Pregnant, or had a baby in the last 3 months
• Married or living with a partner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Health Improvement Project for Teens on HIV Prevention	Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model
2	Health Improvement Project for Teens on HIV Prevention	Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model

Primary Outcome Measures

Name	Time	Method
- score on self-report of frequency of risky sexual and substance use behaviors	baseline, 1 week, 3, 6, & 12 months
rates of STIs	Baseline, 6 and 12 months
computer-assisted survey results	baseline, 1 week, 3, 6, & 12 months

Secondary Outcome Measures

Name	Time	Method
- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV	baseline, 3, 6, & 12 months

Trial Locations

Locations (1)

University of Rochester School of Nursing; 🇺🇸 Rochester, New York, United States