IMARA, Adapting SiHLE for Detained African American Adolescent Females

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University
ClinicalTrials.gov Identifier:
NCT00746369
First received: September 3, 2008
Last updated: November 18, 2013
Last verified: May 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IMARA, Adapting SiHLE for Detained African American Adolescent Females

Resource links provided by NLM:


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: 3 and 6 months post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing [ Time Frame: 3 and 6 months post-randomization ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: October 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Experimental: Intervention
IMARA HIV Prevention Intervention. Three individual sessions for incarcerated female teens.
Behavioral: IMARA HIV Prevention Intervention
Three individual sessions- 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 the control condition. All adolescents will complete 3 individual sessions implemented by an African American health 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 3 and 6-months after completing their initial survey. We will also obtain a self-collected vaginal swab specimen to test for chlamydia and gonorrhea. We will compare the new adapted SiHLE intervention, IMARA, to the control condition 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 at least 2 days and released to a non-restrictive setting
  • Parent/guardian consent
  • Assent

Exclusion Criteria:

  • Married
  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746369

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

Publications:
Responsible Party: Ralph J. DiClemente, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00746369     History of Changes
Other Study ID Numbers: IRB00005355, 5UR6PS000679
Study First Received: September 3, 2008
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
HIV
Prevention
Adolescents
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014