HIV InfectionsNCT00712088
Project ICARE: Intervening for Community Awareness, Respect, & Empowerment
A study testing Project ICARE and HCT in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This project will test the efficacy of a behavioral intervention to reduce sexual risk for HIV infection among African American Men who Have Sex with Men (MSM). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Project ICARE and HCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older;
- Self-identify as African American
- Understand and read English;
- Live within the Chicago area;
- Report at least two (male or female) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.
Who cannot join
- Have been diagnosed with HIV within the past three months (to allow for psychological and behavioral adjustment following an initial HIV diagnosis);
- Have a specific plan to move from the Chicago area within the next nine months;
- Report active injection drug use other than hormones or steroids.
- Participated in the intervention video or the pilot phase of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project ICARE: Intervening for Community Awareness, Respect, & Empowerment - Behavioral Intervention to Reduce Sexual Risk Behavior of African American Men Who Have Sex With Men
This project will test the efficacy of a behavioral intervention to reduce sexual risk for HIV infection among African American Men who Have Sex with Men (MSM).
- Conditions
- HIV Infections
- Being tested
- Project ICARE, HCT
- Keywords
- HIV, Unsafe Sex, High Risk Sex, HIV Prevention, African-American, gay, bisexual, intervention trial
- Medical subject headings
- HIV Infections, Unsafe Sex, Homosexuality, Bisexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ICAREBehavioural
Also called Intervening for Community Awareness, Respect, & Empowerment
Group-level intervention (Project ICARE)
HCTBehavioural
Offer of HIV counseling and testing
| Study group | Role | What they receive |
|---|---|---|
| 1: Group Intervention | Experimental | Group level intervention Receives: Behavioral: Project ICARE |
| 2: HCT | Active comparator | Offer of HIV counseling and testing Receives: Behavioral: HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected Sex
Measured: past three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2010
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Howard Brown Health Center, University of Illinois Chicago, South Side Help Center, Chicago Department of Public Health
- Investigators
- David McKirnan, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712088
- Sponsor's protocol ID
- CDC-NCHHSTP-5159
- Status last verified
- Mar 2010
- First submitted
- 3 Jun 2008
- Last updated
- 11 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ICARE: Intervening for Community Awareness, Respect, & Empowerment - Behavioral Intervention to Reduce Sexual Risk Behavior of African American Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00712088
- Acronym / sponsor ID
- CDC-NCHHSTP-5159
- Conditions
- HIV Infections
- Keywords
- HIV, Unsafe Sex, High Risk Sex, HIV Prevention, African-American, gay, bisexual, intervention trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Howard Brown Health Center, University of Illinois Chicago, South Side Help Center, Chicago Department of Public Health
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Jul 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.
This project will test the efficacy of a behavioral intervention to reduce sexual risk for HIV infection among African American Men who Have Sex with Men (MSM).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Group Intervention | Experimental | Behavioral: Project ICAREGroup level intervention |
| 2: HCT | Active comparator | Behavioral: HCTOffer of HIV counseling and testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older;
- Self-identify as African American
- Understand and read English;
- Live within the Chicago area;
- Report at least two (male or female) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.
Key exclusion criteria (4 listed)
- Have been diagnosed with HIV within the past three months (to allow for psychological and behavioral adjustment following an initial HIV diagnosis);
- Have a specific plan to move from the Chicago area within the next nine months;
- Report active injection drug use other than hormones or steroids.
- Participated in the intervention video or the pilot phase of this study.
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 |
|---|---|---|
| Project ICAREAlso: Intervening for Community Awareness, Respect, & EmpowermentGroup-level intervention (Project ICARE) | Behavioural | 1: Group Intervention |
| HCTOffer of HIV counseling and testing | Behavioural | 2: HCT |
Primary outcome
Unprotected Sex
Time frame: past three months
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 11 Mar 2010.
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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.
David McKirnan, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project ICARE and HCT in people with HIV Infections, 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 5 inclusion and 4 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 11 Mar 2010. 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.
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?
Unprotected Sex (time frame: past three months). 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 11 Mar 2010.