Maintaining HIV Prevention Gains in Female Adolescents

NCT00161343 | Completed Phase 2 DMC

• 1 other identifier: R01NR008194
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infection; Sexually Transmitted Diseases

Keywords

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

Outcome Measures

Primary Outcomes (3)

• rates of STIs

  Baseline, 6 and 12 months

• computer-assisted survey results

  baseline, 1 week, 3, 6, & 12 months

• - score on self-report of frequency of risky sexual and substance use behaviors

  baseline, 1 week, 3, 6, & 12 months

Secondary Outcomes (1)

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

  baseline, 3, 6, & 12 months

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Health Improvement Project for Teens on HIV Prevention

2

PLACEBO COMPARATOR

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

Behavioral: Health Improvement Project for Teens on HIV Prevention

Interventions

Health Improvement Project for Teens on HIV Prevention BEHAVIORAL

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

Also known as: HIP Teens

1; 2

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Sexually active in the past 3 months
• Available for follow-up contacts over the next 13 months
• English speaking

You may not qualify if:

• Pregnant, or had a baby in the last 3 months
• Married or living with a partner

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Rochester School of Nursing

Rochester, New York, 14642, United States

Location

Related Publications (7)

• 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.

  PMID: 16052902 BACKGROUND

• 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.

  PMID: 15625713 BACKGROUND

• 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.

  PMID: 12570188 BACKGROUND

• 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.

  PMID: 11994826 BACKGROUND

• 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.

  PMID: 11828857 BACKGROUND

• 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.

  PMID: 24476350 DERIVED

• 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.

  PMID: 23299011 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dianne C. Morrison-Beedy, Ph.D., RN

  University of Rochester School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 6, 2012

Record last verified: 2009-04

Locations

US (1)