HIV Treatment-Readiness Measure (HTRM) Validation

NCT ID: NCT00686049

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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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 HAART and (2) identifying youth who may be in need of additional support services to facilitate their adherence to HAART. The current study will examine the psychometric properties of the HTRM and establish its test-retest reliability over a two week period. If the HTRM is found to be reliable, a subsequent study will examine its predictive validity.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Participants will complete two audio computer assisted self interviews on laptop computers. This study will also involve the abstraction of participants' viral load and CD4 counts from their medical charts.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M. Isabel Fernández, Ph.D.

Role: STUDY_CHAIR

Adolescent Trials Network

Locations

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Childrens Hospital of Los Angeles

Los Angeles, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Childrens Diagnostic & Treatment Center, Inc

Fort Lauderdale, Florida, United States

Site Status

University of Miami School of Medicine

Miami, Florida, United States

Site Status

USF College of Medicine

Tampa, Florida, United States

Site Status

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, United States

Site Status

Childrens Memorial Hospital

Chicago, Illinois, United States

Site Status

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

University of Maryland Express Mailing Address:

Baltimore, Maryland, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

The Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

St Jude Childrens Research Hospital

Memphis, Tennessee, United States

Site Status

University of Puerto Rico, Medical Sciences Campus

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Related Links

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http://www.atnonline.org

Adolescent Trials Network website

Other Identifiers

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ATN 065

Identifier Type: -

Identifier Source: org_study_id

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