Expired Study
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Rochester, New York 14642


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


Study summary:

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.


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


Study is Available At:


Original ID:

R01-NR-008194


NCT ID:

NCT00161343


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

15 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Rochester


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

640


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:December 2004
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:August 2009
Primary Completion Type:Actual
Verification Date:April 2009
Last Changed Date:September 4, 2012
First Received Date:September 8, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV
Time Frame:baseline, 3, 6, & 12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:- score on self-report of frequency of risky sexual and substance use behaviors
Time Frame:baseline, 1 week, 3, 6, & 12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:computer-assisted survey results
Time Frame:baseline, 1 week, 3, 6, & 12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:rates of STIs
Time Frame:Baseline, 6 and 12 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Health Improvement Project for Teens on HIV Preven
Description:Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
Arm Name:1
Other Name:HIP Teens

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model
Study Arm Type:Experimental
Arm Name:1
Description:Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Rochester
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Nursing Research (NINR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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. Review.
PMID:16052902
Reference Type:Reference
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.
PMID:15625713
Reference Type:Reference
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.
PMID:12570188
Reference Type:Reference
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.
PMID:11994826
Reference Type:Reference
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.
PMID:11828857

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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