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HIV Treatment-Readiness Measure (HTRM) Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00686049
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : February 28, 2017
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease
HIV Infections

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the HIV Treatment Readiness Measure (HTRM)
Study Start Date : May 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.

Primary Outcome Measures :
  1. To examine the factor structure and estimate the internal consistency of each factor of the HTRM. [ Time Frame: 1 year ]
  2. To estimate the test-retest reliability of the HTRM. [ Time Frame: Entry, Week 2 ]

Secondary Outcome Measures :
  1. To determine an appropriate system for scoring the HTRM. [ Time Frame: 1 year ]
  2. To examine the acceptability of the HTRM. [ Time Frame: Entry, Week 2 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00686049

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United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of California San Francisco
San Francisco, California, United States, 94117
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Childrens Diagnostic & Treatment Center, Inc
Fort Lauderdale, Florida, United States, 33316
University of Miami School of Medicine
Miami, Florida, United States, 33101
USF College of Medicine
Tampa, Florida, United States, 33606
United States, Illinois
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, United States, 60612
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Express Mailing Address:
Baltimore, Maryland, United States, 21201
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center
New York, New York, United States, 10128
United States, Pennsylvania
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105-3678
Puerto Rico
University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
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Study Chair: M. Isabel Fernández, Ph.D. Adolescent Trials Network

Additional Information:
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT00686049     History of Changes
Other Study ID Numbers: ATN 065
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2016

Keywords provided by University of North Carolina, Chapel Hill:
HIV Treatment Readiness Measure (HTRM)
Highly Active Antiretroviral Treatment (HAART)
Treatment readiness

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases