Clinical trial NCT00161343: Maintaining HIV Prevention Gains in Female Adolescents
Official title: Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
Sexually Transmitted Diseases
Keywords: HIV
Prevention Intervention
Female
Adolescents
STD
HIV Seronegativity
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-09-12
Enrollment: 640
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: rates of STIs
timeFrame: Baseline, 6 and 12 months
measure: computer-assisted survey results
timeFrame: baseline, 1 week, 3, 6, & 12 months
measure: - score on self-report of frequency of risky sexual and substance use behaviors
timeFrame: baseline, 1 week, 3, 6, & 12 months
Secondary outcomes:
measure: - score on assessments of information, motivation, and behavioral skills to reduce risk for HIV
timeFrame: baseline, 3, 6, & 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester School of Nursing
state: New York
Study officials:
affiliation: University of Rochester School of Nursing
name: Dianne C. Morrison-Beedy, Ph.D., RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1002/nur.20056.
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. doi: 10.1177/0884217502239806.
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. doi: 10.1053/apnr.2002.29530.
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. doi: 10.1016/S1055-3290(06)60238-0.
citation: 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.
citation: 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.