NCT00746369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 19, 2013

Status Verified

May 1, 2013

Enrollment Period

3.8 years

First QC Date

September 3, 2008

Last Update Submit

November 18, 2013

Conditions

HIV Infections

Keywords

HIVPreventionAdolescentsHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

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

    3 and 6 months post-randomization

Secondary Outcomes (1)

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

    3 and 6 months post-randomization

Study Arms (2)

2

NO INTERVENTION

Intervention

EXPERIMENTAL

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

Behavioral: IMARA HIV Prevention Intervention

Interventions

IMARA HIV Prevention InterventionBEHAVIORAL

Three individual sessions- behavioral intervention for incarcerated female adolescents.

Intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Female
  • African American
  • Ages 13-17
  • Sexually experienced
  • Incarcerated at least 2 days and released to a non-restrictive setting
  • Parent/guardian consent
  • Assent

You may not qualify if:

  • Married
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metro Regional Youth Detention Center

Atlanta, Georgia, 30316, United States

Location

Related 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.

    PMID: 20488969BACKGROUND

  • 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.

    PMID: 21368023BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Ralph J. DiClemente, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 4, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 19, 2013

Record last verified: 2013-05

Locations

US(1)