MedPath

HIV Treatment-Readiness Measure (HTRM) Validation

Completed
Conditions
HIV Infections
Registration Number
NCT00686049
Lead Sponsor
University of North Carolina, Chapel Hill
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 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

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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.
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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.

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To examine the factor structure and estimate the internal consistency of each factor of the HTRM.1 year
To estimate the test-retest reliability of the HTRM.Entry, Week 2
Secondary Outcome Measures
NameTimeMethod
To determine an appropriate system for scoring the HTRM.1 year
To examine the acceptability of the HTRM.Entry, Week 2

Trial Locations

Locations (15)

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

🇺🇸

Chicago, Illinois, United States

Childrens Hospital of Los Angeles

🇺🇸

Los Angeles, California, United States

University of California San Francisco

🇺🇸

San Francisco, California, United States

Childrens Diagnostic & Treatment Center, Inc

🇺🇸

Fort Lauderdale, Florida, United States

University of Miami School of Medicine

🇺🇸

Miami, Florida, United States

USF College of Medicine

🇺🇸

Tampa, Florida, United States

Childrens Memorial Hospital

🇺🇸

Chicago, Illinois, United States

University of Maryland Express Mailing Address:

🇺🇸

Baltimore, Maryland, United States

Mount Sinai Medical Center

🇺🇸

New York, New York, United States

The Childrens Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

St Jude Childrens Research Hospital

🇺🇸

Memphis, Tennessee, United States

University of Puerto Rico, Medical Sciences Campus

🇵🇷

San Juan, Puerto Rico

Childrens National Medical Center

🇺🇸

Washington, District of Columbia, United States

Tulane University Health Sciences Center

🇺🇸

New Orleans, Louisiana, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

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