HIVPhase 2NCT00164320
Project TEAM: Teaching HIV Prevention in the HIV Clinic
A Phase 2 study testing TEAM in people with HIV, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this study is to determine if the TEAM prevention intervention delivered by a physician and an HIV-positive counselor is effective. It is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- TEAM
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to May 2006
- Phase
- Phase 2
- 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
- Adult, Older adult
Who may be able to join
- 1) 18 years or older, 2) HIV-infected, 3) Sexually active, 3)Receiving HIV primary care at participating clinic, 4) Can communicate in English or Spanish, 5) No previous enrollment in the TEAM study or intervention.
Who cannot join
- 1) Participation in a similar study run by the TEAM PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami School of Medicine
Miami, Florida, 33136
About this study
The purpose of this study is to determine if the TEAM prevention intervention delivered by a physician and an HIV-positive counselor is effective. It is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition.
- Conditions
- HIV
- Being tested
- TEAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAMBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported unprotected (without condoms)anal or vaginal sex with HIV-negative or unknown-status persons.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Dogan Eroglu, PhD., Study director, Centers for Disease Control and PreventionLisa Metsch, PhD., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164320
- Sponsor's protocol ID
- CDC-NCHSTP-3699
- Other IDs
- R18/CCR420971-01
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project TEAM: Teaching HIV Prevention in the HIV Clinic
- ClinicalTrials.gov ID
- NCT00164320
- Acronym / sponsor ID
- CDC-NCHSTP-3699
- Conditions
- HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- May 2004
- Study completion
- May 2006
- First posted
- 14 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 if the TEAM prevention intervention delivered by a physician and an HIV-positive counselor is effective. It is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) 18 years or older, 2) HIV-infected, 3) Sexually active, 3)Receiving HIV primary care at participating clinic, 4) Can communicate in English or Spanish, 5) No previous enrollment in the TEAM study or intervention.
Key exclusion criteria (1 listed)
- 1) Participation in a similar study run by the TEAM PI.
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 |
|---|---|---|
| TEAM | Behavioural | – |
Primary outcome
Self-reported unprotected (without condoms)anal or vaginal sex with HIV-negative or unknown-status persons.
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 14 Sep 2005.
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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.
Dogan Eroglu, PhD. study director
Centers for Disease Control and Prevention
Lisa Metsch, PhD. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TEAM in people with HIV, run by Centers for Disease Control and Prevention at 1 site in United States.
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 1 inclusion and 1 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 14 Sep 2005. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Self-reported unprotected (without condoms)anal or vaginal sex with HIV-negative or unknown-status persons.. 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 14 Sep 2005.