Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Rochester National Institute of Nursing Research (NINR) |
---|---|
Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00161343 |
In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:
Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:
Condition | Intervention | Phase |
---|---|---|
HIV Infection Sexually Transmitted Diseases |
Behavioral: Health Improvement Project for Teens on HIV Prevention |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents |
Estimated Enrollment: | 640 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model
|
Behavioral: Health Improvement Project for Teens on HIV Prevention
Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
|
2: Placebo Comparator
Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model
|
Behavioral: Health Improvement Project for Teens on HIV Prevention
Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
|
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.
Ages Eligible for Study: | 15 Years to 19 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester School of Nursing | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Dianne C. Morrison-Beedy, Ph.D., RN | University of Rochester School of Nursing |
Responsible Party: | University of Rochester School of Nursing ( Dianne Morrison-Beedy, PhD, RN, WHNP-BC, FNAP, FAAN ) |
Study ID Numbers: | R01-NR-008194 |
Study First Received: | September 8, 2005 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00161343 History of Changes |
Health Authority: | United States: Institutional Review Board |
HIV Prevention Intervention Female |
Adolescents STD HIV Seronegativity |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Benzocaine Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Genital Diseases, Male |
Immunologic Deficiency Syndromes Genital Diseases, Female Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |