HIV Treatment-Readiness Measure (HTRM) Validation
Validation of the HIV Treatment Readiness Measure (HTRM)
1 other identifier
observational
200
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFebruary 28, 2017
February 1, 2016
8 months
May 27, 2008
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
To determine an appropriate system for scoring the HTRM.
1 year
To examine the acceptability of the HTRM.
Entry, Week 2
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Childrens Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California San Francisco
San Francisco, California, 94117, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Childrens Diagnostic & Treatment Center, Inc
Fort Lauderdale, Florida, 33316, United States
University of Miami School of Medicine
Miami, Florida, 33101, United States
USF College of Medicine
Tampa, Florida, 33606, United States
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland Express Mailing Address:
Baltimore, Maryland, 21201, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105-3678, United States
University of Puerto Rico, Medical Sciences Campus
San Juan, 00936-5067, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
M. Isabel Fernández, Ph.D.
Adolescent Trials Network
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
February 28, 2017
Record last verified: 2016-02