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Sponsors and Collaborators: |
Emory University National Institutes of Health (NIH) |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00633906 |
The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.
Condition | Intervention |
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HIV Infections Sexually Transmitted Diseases |
Behavioral: HORIZONS HIV Intervention Behavioral: enhanced standard-of-care |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Reducing HIV Risk in Female Teens: A Tailored Approach |
Enrollment: | 715 |
Study Start Date: | April 2002 |
Study Completion Date: | October 2005 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
HORIZONS HIV Intervention. Two-session, group-based interactive intervention.
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Behavioral: HORIZONS HIV Intervention
Two-session, group-based interactive HIV prevention intervention
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2: Active Comparator
Enhanced standard-of-care session. One hour, video-based and brief discussion.
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Behavioral: enhanced standard-of-care
1 hour group session consisting of an HIV prevention video, a question and answer session with an African American woman health educator, and participation in a group discussion about how to avoid acquiring HIV.
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African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV interventions can significantly reduce HIV-associated sexual risk behaviors among this vulnerable population. The Horizons HIV intervention was developed for African-American female adolescents attending reproductive health clinics in Atlanta, GA. The specific objectives were:
715 participants, ages 15-21, were recruited and enrolled at a large urban county health department, a teen clinic in a public hospital and a reproductive health clinic in the Atlanta area. After a computer interview assessing adolescents' sexual risk and preventive behaviors, and STD testing (Chlamydia and gonorrhea), participants were randomized to one of 2 conditions: the HORIZONS Intervention or the Standard-of-care counseling group. Two trained female health educators lead the 2-session HORIZONS intervention which addressed gender and ethnic pride issues, STD/HIV knowledge, assertive partner communication and refusal skills, and role-play practice. Social Cognitive Theory (SCT) and the Theory of Gender and Power were complementary theoretical frameworks guiding the design and implementation of the HIV intervention. To supplement this group intervention, four phone contacts delivered by the original health educator were conducted during the follow-up period. The supplemental contacts reinforced workshop materials with an individually tailored plan for each participant. The control group received tracking calls only. Follow-up assessments identical to the baseline were conducted at 6 and 12-months post-randomization.
Ages Eligible for Study: | 15 Years to 21 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Fulton County Department of Health and Wellness | |
Atlanta, Georgia, United States, 30303 | |
Grady Teen Clinic | |
Atlanta, Georgia, United States, 30303 | |
Planned Parenthood of GA | |
Atlanta, Georgia, United States, 30303 |
Principal Investigator: | Ralph J DiClemente, PhD | Emory University |
Responsible Party: | Emory University ( Ralph J. DiClemente ) |
Study ID Numbers: | MH061210 |
Study First Received: | March 5, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00633906 History of Changes |
Health Authority: | United States: Institutional Review Board |
HIV Sexually Transmitted diseases Adolescents Prevention HIV Seronegativity |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Genital Diseases, Male |
Immunologic Deficiency Syndromes Genital Diseases, Female Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |