HIV Treatment-Readiness Measure (HTRM) Validation

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00686049
First received: May 27, 2008
Last updated: May 15, 2014
Last verified: May 2014

May 27, 2008
May 15, 2014
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 ] [ Designated as safety issue: No ]
  • To estimate the test-retest reliability of the HTRM. [ Time Frame: Entry, Week 2 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • To examine the acceptability of the HTRM. [ Time Frame: Entry, Week 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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.

Both
13 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00686049
ATN 065
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: M. Isabel Fernández, Ph.D. Adolescent Trials Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP