Maintaining HIV Prevention Gains in Female Adolescents

HIV Infection Clinical Trial

Official title:

Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161343
• Other study ID #: R01NR008194
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: September 4, 2012
• Start date: December 2004
• Est. completion date: August 2009

Study information

• Verified date: April 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection
• Sexually Transmitted Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester School of Nursing	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rates of STIs		Baseline, 6 and 12 months	No
Primary	computer-assisted survey results		baseline, 1 week, 3, 6, & 12 months	No
Primary	- score on self-report of frequency of risky sexual and substance use behaviors		baseline, 1 week, 3, 6, & 12 months	No
Secondary	- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV		baseline, 3, 6, & 12 months	No

External Links

•   Principal Investigator's Faculty Website