Maintaining HIV Prevention Gains in Female Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents

Conditions
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HIV Infection, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Health Improvement Project for Teens on HIV Prevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model | Behavioral: Health Improvement Project for Teens on HIV Prevention<br>* Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls<br>* Other names: HIP Teens;|
| Placebo Comparator: 2<br>Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model | Behavioral: Health Improvement Project for Teens on HIV Prevention<br>* Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls<br>* Other names: HIP Teens;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - score on assessments of information, motivation, and behavioral skills to reduce risk for HIV |  | baseline, 3, 6, & 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Prevention Intervention, Female, Adolescents, STD, HIV Seronegativity