Maintaining HIV Prevention Gains in Female Adolescents

September 4, 2012 updated by: Dianne Morrison-Beedy, University of Rochester

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

640

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • HIP Teens

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Dianne C. Morrison-Beedy, Ph.D., RN, University of Rochester School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR008194 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infection

Clinical Trials on Health Improvement Project for Teens on HIV Prevention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe