Clinical trial NCT00686049: HIV Treatment-Readiness Measure (HTRM) Validation
Official title: Validation of the HIV Treatment Readiness Measure (HTRM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV Treatment Readiness Measure (HTRM)
Highly Active Antiretroviral Treatment (HAART)
Adherence
Treatment readiness
HIV
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2008-05-29
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To examine the factor structure and estimate the internal consistency of each factor of the HTRM.
timeFrame: 1 year
measure: To estimate the test-retest reliability of the HTRM.
timeFrame: Entry, Week 2
Secondary outcomes:
measure: To determine an appropriate system for scoring the HTRM.
timeFrame: 1 year
measure: To examine the acceptability of the HTRM.
timeFrame: Entry, Week 2
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Childrens Diagnostic & Treatment Center, Inc
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: USF College of Medicine
state: Florida
city: Chicago
country: United States
facility: Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
state: Illinois
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Express Mailing Address:
state: Maryland
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: The Childrens Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St Jude Childrens Research Hospital
state: Tennessee
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus
Study officials:
affiliation: Adolescent Trials Network
name: M. Isabel Fernández, Ph.D.
role: STUDY_CHAIR
References: