Maintaining HIV Prevention Gains in Female Adolescents
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ClinicalTrials.gov Identifier: NCT00161343 |
Recruitment Status
:
Completed
First Posted
: September 12, 2005
Last Update Posted
: September 6, 2012
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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 |
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 |
---|---|
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
|
- 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 ]
- - score on assessments of information, motivation, and behavioral skills to reduce risk for HIV [ Time Frame: baseline, 3, 6, & 12 months ]

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Ages Eligible for Study: | 15 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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