Maintaining HIV Prevention Gains in Female Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dianne Morrison-Beedy, University of Rochester
ClinicalTrials.gov Identifier:
NCT00161343
First received: September 8, 2005
Last updated: September 4, 2012
Last verified: April 2009
  Purpose

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

Condition Intervention Phase
HIV Infection
Sexually Transmitted Diseases
Behavioral: Health Improvement Project for Teens on HIV Prevention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • rates of STIs [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • computer-assisted survey results [ Time Frame: baseline, 1 week, 3, 6, & 12 months ] [ Designated as safety issue: No ]
  • - score on self-report of frequency of risky sexual and substance use behaviors [ Time Frame: baseline, 1 week, 3, 6, & 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - score on assessments of information, motivation, and behavioral skills to reduce risk for HIV [ Time Frame: baseline, 3, 6, & 12 months ] [ Designated as safety issue: No ]

Enrollment: 640
Study Start Date: December 2004
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Other Name: HIP Teens
Placebo Comparator: 2
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
Other Name: HIP Teens

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.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161343

Locations
United States, New York
University of Rochester School of Nursing
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Dianne C. Morrison-Beedy, Ph.D., RN University of Rochester School of Nursing
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dianne Morrison-Beedy, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00161343     History of Changes
Other Study ID Numbers: R01-NR-008194
Study First Received: September 8, 2005
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
HIV
Prevention Intervention
Female
Adolescents
STD
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Immune System Diseases
Immunologic Deficiency Syndromes
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014