HIV Treatment-Readiness Measure (HTRM) Validation

Study Overview
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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.

Official Title
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Validation of the HIV Treatment Readiness Measure (HTRM)

Conditions
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HIV Infections

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine an appropriate system for scoring the HTRM. |  | 1 year | 
| To examine the acceptability of the HTRM. |  | Entry, Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV Treatment Readiness Measure (HTRM), Highly Active Antiretroviral Treatment (HAART), Adherence, Treatment readiness