HIV Treatment-Readiness Measure (HTRM) Validation

February 27, 2017 updated by: University of North Carolina, Chapel Hill

Validation of the HIV Treatment Readiness Measure (HTRM)

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.

Study Overview

Status

Completed

Conditions

HIV Infections

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - San Juan, Puerto Rico, 00936-5067
    - University of Puerto Rico, Medical Sciences Campus
United States
- California
  - Los Angeles, California, United States, 90027
    - Childrens Hospital of Los Angeles
  - San Francisco, California, United States, 94117
    - University of California San Francisco
- District of Columbia
  - Washington, District of Columbia, United States, 20010-2970
    - Childrens National Medical Center
- Florida
  - Fort Lauderdale, Florida, United States, 33316
    - Childrens Diagnostic & Treatment Center, Inc
  - Miami, Florida, United States, 33101
    - University of Miami School of Medicine
  - Tampa, Florida, United States, 33606
    - USF College of Medicine
- Illinois
  - Chicago, Illinois, United States, 60614
    - Childrens Memorial Hospital
  - Chicago, Illinois, United States, 60612
    - Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Health Sciences Center
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland Express Mailing Address:
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center
  - New York, New York, United States, 10128
    - Mount Sinai Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - The Childrens Hospital of Philadelphia
- Tennessee
  - Memphis, Tennessee, United States, 38105-3678
    - St Jude Childrens Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators

Study Chair: M. Isabel Fernández, Ph.D., Adolescent Trials Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Adolescent Trials Network website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)