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Maintaining HIV Prevention Gains in Female Adolescents

Primary Purpose

HIV Infection, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Health Improvement Project for Teens on HIV Prevention
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV, Prevention Intervention, Female, Adolescents, STD, HIV Seronegativity

Eligibility Criteria

15 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model

Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model

Outcomes

Primary Outcome Measures

rates of STIs
computer-assisted survey results
- score on self-report of frequency of risky sexual and substance use behaviors

Secondary Outcome Measures

- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV

Full Information

First Posted
September 8, 2005
Last Updated
September 4, 2012
Sponsor
University of Rochester
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00161343
Brief Title
Maintaining HIV Prevention Gains in Female Adolescents
Official Title
Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Sexually Transmitted Diseases
Keywords
HIV, Prevention Intervention, Female, Adolescents, STD, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model
Intervention Type
Behavioral
Intervention Name(s)
Health Improvement Project for Teens on HIV Prevention
Other Intervention Name(s)
HIP Teens
Intervention Description
Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
Primary Outcome Measure Information:
Title
rates of STIs
Time Frame
Baseline, 6 and 12 months
Title
computer-assisted survey results
Time Frame
baseline, 1 week, 3, 6, & 12 months
Title
- score on self-report of frequency of risky sexual and substance use behaviors
Time Frame
baseline, 1 week, 3, 6, & 12 months
Secondary Outcome Measure Information:
Title
- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV
Time Frame
baseline, 3, 6, & 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne C. Morrison-Beedy, Ph.D., RN
Organizational Affiliation
University of Rochester School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester School of Nursing
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16052902
Citation
Morrison-Beedy D, Aronowitz T, Dyne J, Mkandawire L, Murphy C, Martin J. The nurse clinician as research participant recruiter: experience from a longitudinal intervention study. J N Y State Nurses Assoc. 2001 Fall-Winter;32(2):9-13.
Results Reference
background
PubMed Identifier
15625713
Citation
Morrison-Beedy D, Carey MP, Kowalski J, Tu X. Group-based HIV risk reduction intervention for adolescent girls: evidence of feasibility and efficacy. Res Nurs Health. 2005 Feb;28(1):3-15. doi: 10.1002/nur.20056.
Results Reference
background
PubMed Identifier
12570188
Citation
Morrison-Beedy D, Carey MP, Aronowitz T. Psychosocial correlates of HIV risk behavior in adolescent girls. J Obstet Gynecol Neonatal Nurs. 2003 Jan-Feb;32(1):94-101. doi: 10.1177/0884217502239806.
Results Reference
background
PubMed Identifier
11994826
Citation
Morrison-Beedy D, Carey MP, Aronowitz T, Mkandawire L, Dyne J. An HIV risk-reduction intervention in an adolescent correctional facility: lessons learned. Appl Nurs Res. 2002 May;15(2):97-101. doi: 10.1053/apnr.2002.29530.
Results Reference
background
PubMed Identifier
11828857
Citation
Morrison-Beedy D, Carey MP, Aronowitz T, Mkandawire L, Dyne J. Adolescents' input on the development of an HIV risk reduction intervention. J Assoc Nurses AIDS Care. 2002 Jan-Feb;13(1):21-7. doi: 10.1016/S1055-3290(06)60238-0.
Results Reference
background
PubMed Identifier
24476350
Citation
Morrison-Beedy D, Crean HF, Passmore D, Carey MP. Risk reduction strategies used by urban adolescent girls in an HIV prevention trial. Curr HIV Res. 2013 Oct;11(7):559-69. doi: 10.2174/1570162x12666140129110129.
Results Reference
derived
PubMed Identifier
23299011
Citation
Morrison-Beedy D, Jones SH, Xia Y, Tu X, Crean HF, Carey MP. Reducing sexual risk behavior in adolescent girls: results from a randomized controlled trial. J Adolesc Health. 2013 Mar;52(3):314-21. doi: 10.1016/j.jadohealth.2012.07.005. Epub 2012 Aug 28.
Results Reference
derived

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Maintaining HIV Prevention Gains in Female Adolescents

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