HIV InfectionsNCT00212940
Supportive Therapy for Adherence to ART(STAART)
A study testing Supportive Therapy for Adherence to ART (behavior) in people with HIV Infections, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a psycho-educational intervention can help people living with HIV handle the changes of treatment adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Supportive Therapy for Adherence to ART (behavior)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2000to Sep 2006
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- have viral load above 500 copies/ml
- not be currently on HAART
- be able to read and speak English/French
Who cannot join
- current Substance Abuse
- actively psychotic or suicidal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Patient Adherence to HIV Medications: A Prospective Intervention Study
The purpose of this study is to determine whether a psycho-educational intervention can help people living with HIV handle the changes of treatment adherence.
Read the detailed description
Participants will be randomly assigned to one of two study groups:
- Group 1: participants in this group will engage in weekly psycho-educational sessions with an HIV therapist for four weeks prior to starting their regimens. The sessions will cover topics such as becoming active in treatment care, improving coping abilities and developing skills for treatment adherence. They will also involve questionnaires and readings.
- Group 2 (the control group):participants in this group will simply receive their regular treatment regimens.
- Conditions
- HIV Infections
- Being tested
- Supportive Therapy for Adherence to ART (behavior)
- Keywords
- Treatment Naive, 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.
Supportive Therapy for Adherence to ART (behavior)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
psycho-educational intervention can help people living with HIV handle the changes of treatment adherence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2000
- Study completionSep 2006
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.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Investigators
- William Cameron, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212940
- Sponsor's protocol ID
- 1999565-01H
- Other IDs
- CIHR app# 1262000 ICE:
- Status last verified
- Jul 2007
- First submitted
- 13 Sep 2005
- Last updated
- 26 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Patient Adherence to HIV Medications: A Prospective Intervention Study
- ClinicalTrials.gov ID
- NCT00212940
- Acronym / sponsor ID
- 1999565-01H
- Conditions
- HIV Infections
- Keywords
- Treatment Naive, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Study start
- Oct 2000
- Study completion
- Sep 2006 (actual)
- First posted
- 21 Sep 2005 (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 purpose of this study is to determine whether a psycho-educational intervention can help people living with HIV handle the changes of treatment adherence.
Detailed description
Participants will be randomly assigned to one of two study groups:
- Group 1: participants in this group will engage in weekly psycho-educational sessions with an HIV therapist for four weeks prior to starting their regimens. The sessions will cover topics such as becoming active in treatment care, improving coping abilities and developing skills for treatment adherence. They will also involve questionnaires and readings.
- Group 2 (the control group):participants in this group will simply receive their regular treatment regimens.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be at least 18 years of age
- have viral load above 500 copies/ml
- not be currently on HAART
- be able to read and speak English/French
Key exclusion criteria (2 listed)
- current Substance Abuse
- actively psychotic or suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive Therapy for Adherence to ART (behavior) | Behavioural | – |
Primary outcome
psycho-educational intervention can help people living with HIV handle the changes of treatment adherence
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 26 Jul 2007.
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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.
William Cameron, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Therapy for Adherence to ART (behavior) in people with HIV Infections, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 inclusion and 2 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 26 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
psycho-educational intervention can help people living with HIV handle the changes of treatment adherence. 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 26 Jul 2007.