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IMARA, Adapting SiHLE for Detained African American Adolescent Females
This study is not yet open for participant recruitment.
Verified by Emory University, September 2008
Sponsors and Collaborators: Emory University
Centers for Disease Control and Prevention
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00746369
  Purpose

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
HIV Infections
Behavioral: IMARA HIV Prevention Intervention
Behavioral: Nutrition and Exercise Health Promotion Intervention

MedlinePlus related topics: AIDS
U.S. FDA Resources
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

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Proportion of condom protected vaginal sex acts over the last 90 days [ Time Frame: 6 and 12 months post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV protective behaviors, such as fewer male sexual partners, over the past 90 days [ Time Frame: 6 and 12 months post-randomization ] [ Designated as safety issue: No ]

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
2: Active Comparator
Nutrition and Exercise Comparison condition
Behavioral: Nutrition and Exercise Health Promotion Intervention
Two-session, group-based comparison intervention for incarcerated female adolescents.
Intervention: Experimental
IAMRA HIV Prevention Intervention. Two-session, group based intervention for incarcerated female teens.
Behavioral: IMARA HIV Prevention Intervention
Two-session, group-based behavioral intervention for incarcerated female adolescents.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • African American
  • Ages 13-17
  • Sexually experienced
  • Incarcerated between 2 weeks and 2 months
  • Parent/guardian consent
  • Assent

Exclusion Criteria:

  • Married
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746369

Contacts
Contact: Eve S Rose, MSPH 404-727-9863 erose2@sph.emory.edu
Contact: Jessica Sales, PhD 404-727-6598 jmcderm@emory.edu

Locations
United States, Georgia
Metro Regional Youth Detention Center
Atlanta, Georgia, United States, 30316
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Ralph J. DiClemente, PhD Emory University
  More Information

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

Keywords provided by Emory University:
HIV
Prevention
Adolescents
HIV Seronegativity

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009