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Maintaining HIV Prevention Gains in Female Adolescents

NCT ID: NCT00161343

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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HIV Infection Sexually Transmitted Diseases

Keywords

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HIV Prevention Intervention Female Adolescents STD HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Health Improvement Project for Teens on HIV Prevention

Intervention Type BEHAVIORAL

Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls

2

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

Group Type PLACEBO_COMPARATOR

Health Improvement Project for Teens on HIV Prevention

Intervention Type BEHAVIORAL

Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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HIP Teens

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Dianne Morrison-Beedy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dianne C. Morrison-Beedy, Ph.D., RN

Role: PRINCIPAL_INVESTIGATOR

University of Rochester School of Nursing

Locations

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University of Rochester School of Nursing

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16052902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15625713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12570188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11994826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11828857 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24476350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23299011 (View on PubMed)

Other Identifiers

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R01NR008194

Identifier Type: NIH

Identifier Source: org_study_id

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