HORIZONS HIV Intervention
| Tracking Information | |||||
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| First Received Date ICMJE | March 5, 2008 | ||||
| Last Updated Date | June 16, 2008 | ||||
| Start Date ICMJE | April 2002 | ||||
| Primary Completion Date | August 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Proportion of condom protected vaginal sex acts over the last 60 days [ Time Frame: 6 and 12 months post-randomization ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00633906 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing [ Time Frame: 6 and 12 months post-randomization ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | HORIZONS HIV Intervention | ||||
| Official Title ICMJE | Reducing HIV Risk in Female Teens: A Tailored Approach | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Intervention ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 715 | ||||
| Completion Date | October 2005 | ||||
| Primary Completion Date | August 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 15 Years to 21 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00633906 | ||||
| Other Study ID Numbers ICMJE | MH061210 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ralph J. DiClemente, Emory University | ||||
| Study Sponsor ICMJE | Emory University | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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