Status:

COMPLETED

HIV Treatment-Readiness Measure (HTRM) Validation

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Conditions:

HIV Infections

Eligibility:

All Genders

13-24 years

Brief Summary

The goal of this study is to assess the reliability of the HIV Treatment Readiness Measure (HTRM) to assist clinicians in: (1) determining whether or not youth living with HIV are ready to initiate ...

Eligibility Criteria

Inclusion

  • HIV-positive youth, 13 years 0 days to 24 years 364 days of age
  • Either HAART naïve (defined as never having taken HAART) or HAART experienced (defined as having had at least one experience taking HAART and not having taken HAART for 30 days prior to study entry)
  • Not currently on HAART, but planning to initiate HAART within the next 2 months based on provider recommendation
  • Enrolled in care at an AMTU or a collaborating site
  • Able to speak and understand English
  • Willing to provide informed consent, or assent with parental permission (if required by the site IRB) for participation in this study.

Exclusion

  • Evidence of cognitive impairment or other mental condition that limits his/her ability to complete the assessment (per PI or designee discretion)
  • Determined by the PI (or designee) to be under the influence of psychoactive agents or intoxicated at the time of assessment to a degree that would interfere with successful completion of the questionnaire
  • Visibly distraught or unstable
  • Any clinical condition that would likely interfere with the participant's ability to complete the study
  • Participants who are unable to speak English will be excluded from the initial testing of the HTRM's reliability and validity in keeping with traditional tool development strategies. If the initial study indicates that the English version of the HTRM is reliable and valid, appropriate methods will be employed to translate the instrument into Spanish and the reliability and validity will be re-examined for the Spanish version.

Key Trial Info

Start Date :

May 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00686049

Start Date

May 1 2008

End Date

January 1 2009

Last Update

February 28 2017

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Childrens Hospital of Los Angeles

Los Angeles, California, United States, 90027

2

University of California San Francisco

San Francisco, California, United States, 94117

3

Childrens National Medical Center

Washington D.C., District of Columbia, United States, 20010-2970

4

Childrens Diagnostic & Treatment Center, Inc

Fort Lauderdale, Florida, United States, 33316