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Sponsors and Collaborators: |
Emory University Centers for Disease Control and Prevention |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00746369 |
The IMARA Program will test the efficacy of a multi-session HIV Prevention program, adapted from an existing program(SiHLE), for incarcerated African American adolescent females.
Condition | Intervention |
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HIV Infections |
Behavioral: IMARA HIV Prevention Intervention Behavioral: Nutrition and Exercise Health Promotion Intervention |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | IMARA, Adapting SiHLE for Detained African American Adolescent Females |
Estimated Enrollment: | 350 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Nutrition and Exercise Comparison condition
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Behavioral: Nutrition and Exercise Health Promotion Intervention
Two-session, group-based comparison intervention for incarcerated female adolescents.
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Intervention: Experimental
IAMRA HIV Prevention Intervention. Two-session, group based intervention for incarcerated female teens.
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Behavioral: IMARA HIV Prevention Intervention
Two-session, group-based behavioral intervention for incarcerated female adolescents.
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African American adolescent females in youth detention centers are at high risk for HIV infection. There are, however, no evidence-based interventions (EBI) for this vulnerable population. The aim of this project is to develop and test a culturally and gender-appropriate sexual health education program designed to promote HIV preventive sexual behaviors among African American adolescent females in youth detention centers. The study will be conducted in four stages: (1) adaptation of SiHLE intervention; (2) pilot adapted intervention; (3) revisions to adapted intervention, measures, and implementation; and (4) implementation and evaluation.
We will work closely with the Metro Regional Youth Detention Center (RYDC), in Atlanta, Georgia for all four stages of the project. The first stage, adaptation of SiHLE intervention, will be implemented using data collected from a prior study and with use of Community and Teen Advisory Boards (CAB and TAB). The pilot intervention will be completed with 20 participants from Metro RYDC and will test recruitment and retention strategies, the adapted intervention, and all measures. Revisions will be made based on findings from the pilot. For stage four, implementation and evaluation, we propose to recruit 350 unmarried African American adolescent females, 13-17 years of age, from Metro RYDC. While at the Metro RYDC, adolescents will be invited to participate in the proposed study. All adolescents will be required to have verbal informed parental/guardian consent and complete signed assent forms. Adolescents who are eligible and willing to participate in the project will complete an initial survey conducted on a computer(ACASI). The survey is designed to assess adolescents' sexual risk and preventive behaviors. After they complete the survey, adolescents will then be assigned, by chance alone, to receive either the adapted SiHLE intervention or a time-equivalent health promotion condition. All adolescents will complete 2 group sessions implemented by an African American health educator and co-facilitated by a trained African American peer educator.
As we anticipate the participants will be released prior to the follow-up assessment, adolescents will come to a central community site to complete follow-up interviews at 6 and 12-months after completing their initial survey. In addition, both groups will attend a 2-hour booster session at the 6 month follow-up designed to reinforce concepts presented in the initial group sessions. We will compare the new adapted SiHLE intervention, IMARA, to the general health education program in its ability to maintain or enhance adolescents' use of HIV prevention behaviors. If successful, the findings could have important implications for HIV prevention in this vulnerable population.
Ages Eligible for Study: | 13 Years to 17 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eve S Rose, MSPH | 404-727-9863 | erose2@sph.emory.edu |
Contact: Jessica Sales, PhD | 404-727-6598 | jmcderm@emory.edu |
United States, Georgia | |
Metro Regional Youth Detention Center | |
Atlanta, Georgia, United States, 30316 |
Principal Investigator: | Ralph J. DiClemente, PhD | Emory University |
Responsible Party: | Emory University ( Ralph J. DiClemente ) |
Study ID Numbers: | 5UR6PS000679 |
Study First Received: | September 3, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00746369 |
Health Authority: | United States: Institutional Review Board |
HIV Prevention Adolescents HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |