HIV InfectionsNCT00686049
HIV Treatment-Readiness Measure (HTRM) Validation
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 15 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- HIV Infections
- How many people
- 200 participants
- Where
- 15 sitesin 2 countries
- Study dates
- May 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
University of Maryland Express Mailing Address:
Baltimore, Maryland, 21201
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, 60612
Childrens Memorial Hospital
Chicago, Illinois, 60614
Childrens Diagnostic & Treatment Center, Inc
Fort Lauderdale, Florida, 33316
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105-3678
University of Miami School of Medicine
Miami, Florida, 33101
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10128
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94117
USF College of Medicine
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Childrens National Medical Center
Washington D.C., District of Columbia, 20010-2970
Puerto Rico1 site
University of Puerto Rico, Medical Sciences Campus
San Juan, 00936-5067
About this study
Official title: 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.
- Conditions
- HIV Infections
- Keywords
- HIV Treatment Readiness Measure (HTRM), Highly Active Antiretroviral Treatment (HAART), Adherence, Treatment readiness, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To examine the factor structure and estimate the internal consistency of each factor of the HTRM.
Measured: 1 year
To estimate the test-retest reliability of the HTRM.
Measured: Entry, Week 2
Secondary outcomes (2)
To determine an appropriate system for scoring the HTRM.
Measured: 1 year
To examine the acceptability of the HTRM.
Measured: Entry, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- M. Isabel Fernández, Ph.D., Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686049
- Sponsor's protocol ID
- ATN 065
- Status last verified
- Feb 2016
- First submitted
- 27 May 2008
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the HIV Treatment Readiness Measure (HTRM)
- ClinicalTrials.gov ID
- NCT00686049
- Acronym / sponsor ID
- ATN 065
- Conditions
- HIV Infections
- Keywords
- HIV Treatment Readiness Measure (HTRM), Highly Active Antiretroviral Treatment (HAART), Adherence, Treatment readiness, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To examine the factor structure and estimate the internal consistency of each factor of the HTRM.
Time frame: 1 year
To estimate the test-retest reliability of the HTRM.
Time frame: Entry, Week 2
2 secondary outcomes
To determine an appropriate system for scoring the HTRM.
Time frame: 1 year
To examine the acceptability of the HTRM.
Time frame: Entry, Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Adolescent Trials Network websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Isabel Fernández, Ph.D. study chair
Adolescent Trials Network
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the factor structure and estimate the internal consistency of each factor of the HTRM. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.