IMARA, Adapting SiHLE for Detained African American Adolescent Females

HIV Infections Clinical Trial

— IMARA  

Official title:

IMARA, Adapting SiHLE for Detained African American Adolescent Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746369
• Other study ID #: IRB00005355
• Secondary ID: 5UR6PS000679
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: November 18, 2013
• Start date: October 2008
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• IMARA HIV Prevention Intervention
Three individual sessions- behavioral intervention for incarcerated female adolescents.

Locations

Country	Name	City	State
United States	Metro Regional Youth Detention Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of condom protected vaginal sex acts over the last 90 days		3 and 6 months post-randomization	No
Secondary	Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing		3 and 6 months post-randomization	No