Maintaining HIV Prevention Gains in Female Adolescents

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
HIV Infection; Sexually Transmitted Diseases	Behavioral: Health Improvement Project for Teens on HIV Prevention	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	640 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
Study Start Date :	December 2004
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	August 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	15 Years to 19 Years (Child, Adult)
Sexes 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

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Locations

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

Sponsors and Collaborators

University of Rochester

National Institute of Nursing Research (NINR)

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Dianne Morrison-Beedy, Professor, University of Rochester
ClinicalTrials.gov Identifier:	NCT00161343 History of Changes
Other Study ID Numbers:	R01NR008194 ( U.S. NIH Grant/Contract )
First Posted:	September 12, 2005
Last Update Posted:	September 6, 2012
Last Verified:	April 2009

Keywords provided by Dianne Morrison-Beedy, University of Rochester:

HIV; Prevention Intervention; Female	Adolescents; STD; HIV Seronegativity

Additional relevant MeSH terms:

Genital Diseases, Female; HIV Infections; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections	Virus Diseases; Sexually Transmitted Diseases, Viral; Immunologic Deficiency Syndromes; Immune System Diseases; Infection; Genital Diseases, Male