HIV Treatment-Readiness Measure (HTRM) Validation

HIV Infections Clinical Trial

Official title:

Validation of the HIV Treatment Readiness Measure (HTRM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686049
• Other study ID #: ATN 065
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: February 27, 2017
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, Medical Sciences Campus	San Juan
United States	University of Maryland Express Mailing Address:	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Childrens Memorial Hospital	Chicago	Illinois
United States	Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital	Chicago	Illinois
United States	Childrens Diagnostic & Treatment Center, Inc	Fort Lauderdale	Florida
United States	Childrens Hospital of Los Angeles	Los Angeles	California
United States	St Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Miami School of Medicine	Miami	Florida
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	The Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California San Francisco	San Francisco	California
United States	USF College of Medicine	Tampa	Florida
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the factor structure and estimate the internal consistency of each factor of the HTRM.		1 year
Primary	To estimate the test-retest reliability of the HTRM.		Entry, Week 2
Secondary	To determine an appropriate system for scoring the HTRM.		1 year
Secondary	To examine the acceptability of the HTRM.		Entry, Week 2

External Links

•   Adolescent Trials Network website