Skip to main content
OpenTrials
Completed

NCT Number: NCT00746369

IMARA, Adapting SiHLE for Detained African American Adolescent Females

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Metro Regional Youth Detention Center

Atlanta, Georgia, 30316, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMARA HIV Prevention Intervention

Behavioral

Three individual sessions- behavioral intervention for incarcerated female adolescents.

Primary outcomes

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

    Time frame: 3 and 6 months post-randomization

Secondary outcomes

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

    Time frame: 3 and 6 months post-randomization

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Acronym: IMARA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 4, 2008
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.