HIV Treatment-Readiness Measure (HTRM) Validation

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00686049

ATN 065

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 13 to 24 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Study Group

Description:

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.