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HIV Treatment-Readiness Measure (HTRM) Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00686049
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):

May 27, 2008
May 29, 2008
February 28, 2017
May 2008
January 2009   (Final data collection date for primary outcome measure)
  • To examine the factor structure and estimate the internal consistency of each factor of the HTRM. [ Time Frame: 1 year ]
  • To estimate the test-retest reliability of the HTRM. [ Time Frame: Entry, Week 2 ]
Same as current
Complete list of historical versions of study NCT00686049 on ClinicalTrials.gov Archive Site
  • To determine an appropriate system for scoring the HTRM. [ Time Frame: 1 year ]
  • To examine the acceptability of the HTRM. [ Time Frame: Entry, Week 2 ]
Same as current
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HIV Treatment-Readiness Measure (HTRM) Validation
Validation of the HIV Treatment Readiness Measure (HTRM)

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.

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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
HIV-infected, English speaking youth between 13 and 24 years of age who are enrolled in care at an AMTU or collaborating site, not currently on HAART but planning to initiate HAART within the next two months.
HIV Infections
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
13 Years to 24 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
ATN 065
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University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: M. Isabel Fernández, Ph.D. Adolescent Trials Network
University of North Carolina, Chapel Hill
February 2016