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IMARA, Adapting SiHLE for Detained African American Adolescent Females (IMARA)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMARA HIV Prevention Intervention
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Prevention, Adolescents, HIV Seronegativity

Eligibility Criteria

13 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Metro Regional Youth Detention Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2

Intervention

Arm Description

IMARA HIV Prevention Intervention. Three individual sessions for incarcerated female teens.

Outcomes

Primary Outcome Measures

Proportion of condom protected vaginal sex acts over the last 90 days

Secondary Outcome Measures

Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing

Full Information

First Posted
September 3, 2008
Last Updated
November 18, 2013
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00746369
Brief Title
IMARA, Adapting SiHLE for Detained African American Adolescent Females
Acronym
IMARA
Official Title
IMARA, Adapting SiHLE for Detained African American Adolescent Females
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Prevention, Adolescents, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
IMARA HIV Prevention Intervention. Three individual sessions for incarcerated female teens.
Intervention Type
Behavioral
Intervention Name(s)
IMARA HIV Prevention Intervention
Intervention Description
Three individual sessions- behavioral intervention for incarcerated female adolescents.
Primary Outcome Measure Information:
Title
Proportion of condom protected vaginal sex acts over the last 90 days
Time Frame
3 and 6 months post-randomization
Secondary Outcome Measure Information:
Title
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing
Time Frame
3 and 6 months post-randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph J. DiClemente, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metro Regional Youth Detention Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30316
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20488969
Citation
Latham TP, Sales JM, Boyce LS, Renfro TL, Wingood GM, DiClemente RJ, Rose E. Application of ADAPT-ITT: adapting an evidence-based HIV prevention intervention for incarcerated African American adolescent females. Health Promot Pract. 2010 May;11(3 Suppl):53S-60S. doi: 10.1177/1524839910361433.
Results Reference
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PubMed Identifier
21368023
Citation
Latham TP, Sales JM, Renfro TL, Boyce LS, Rose E, Murray CC, Wingood GM, DiClemente RJ. Employing a teen advisory board to adapt an evidence-based HIV/STD intervention for incarcerated African-American adolescent women. Health Educ Res. 2012 Oct;27(5):895-903. doi: 10.1093/her/cyr003. Epub 2011 Mar 2.
Results Reference
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IMARA, Adapting SiHLE for Detained African American Adolescent Females

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