HIV Treatment-Readiness Measure (HTRM) Validation
This study has been completed.
Sponsor:
Westat
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT00686049
First received: May 27, 2008
Last updated: February 29, 2016
Last verified: February 2016
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Purpose
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 |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validation of the HIV Treatment Readiness Measure (HTRM) |
Resource links provided by NLM:
Further study details as provided by Westat:
Primary Outcome Measures:
- To examine the factor structure and estimate the internal consistency of each factor of the HTRM. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To estimate the test-retest reliability of the HTRM. [ Time Frame: Entry, Week 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine an appropriate system for scoring the HTRM. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To examine the acceptability of the HTRM. [ Time Frame: Entry, Week 2 ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | May 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 13 Years to 24 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| 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.
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686049
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686049
Locations
| 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
Westat
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
| Study Chair: | M. Isabel Fernández, Ph.D. | Adolescent Trials Network |
More Information
Additional Information:
| Responsible Party: | Westat |
| ClinicalTrials.gov Identifier: | NCT00686049 History of Changes |
| Other Study ID Numbers: | ATN 065 |
| Study First Received: | May 27, 2008 |
| Last Updated: | February 29, 2016 |
| Health Authority: | United States: Federal Government |
Keywords provided by Westat:
|
HIV Treatment Readiness Measure (HTRM) Highly Active Antiretroviral Treatment (HAART) Adherence Treatment readiness HIV |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016