Maintaining HIV Prevention Gains in Female Adolescents
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| ClinicalTrials.gov Identifier: NCT00161343 |
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Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : September 6, 2012
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Sponsor:
University of Rochester
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Dianne Morrison-Beedy, University of Rochester
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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 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model
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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 |
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Placebo Comparator: 2
Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model
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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 |
Primary Outcome Measures :
- rates of STIs [ Time Frame: Baseline, 6 and 12 months ]
- computer-assisted survey results [ Time Frame: baseline, 1 week, 3, 6, & 12 months ]
- - 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 :
- - score on assessments of information, motivation, and behavioral skills to reduce risk for HIV [ Time Frame: baseline, 3, 6, & 12 months ]
Information from the National Library of Medicine
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161343
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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| Last Update Posted: | September 6, 2012 |
| Last Verified: | April 2009 |
Keywords provided by Dianne Morrison-Beedy, University of Rochester:
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HIV Prevention Intervention Female |
Adolescents STD HIV Seronegativity |
Additional relevant MeSH terms:
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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 |