HIV InfectionsPhase 2/3NCT00690690
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
A Phase 2/3 study testing Video (group-delivered video-based intervention) and HCT in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The overall goal of this study is to develop and evaluate a brief, video-based, group-level intervention designed to reduce sexual risk taking among culturally diverse English- and Spanish-speaking Latino men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Video (group-delivered video-based intervention) and HCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Nov 2009
- Phase
- Phase 2/3
- 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 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18 - 49
- Self-identify as Latino or Hispanic
- Speak English and/or Spanish
- Reside in NYC and not plan to move in the next 3 months
- Have had 2 or more sex partners in the last 3 months
- Have had at least 1 male sex partner in the last 3 months
- Have engaged in unprotected anal intercourse with at least one male partner in the last 3 months
- Be HIV negative or not know their status
Who cannot join
- Participated in a program (research or non-research) during the past 6 months where they have received HIV prevention education (e.g. an in-person or online group session, workshop, support group).
- Report being HIV-positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Education Development Center, Inc.
New York, New York, 10014
About this study
The overall goal of this study is to develop and evaluate a brief, video-based, group-level intervention designed to reduce sexual risk taking among culturally diverse English- and Spanish-speaking Latino men who have sex with men (MSM).
- Conditions
- HIV Infections
- Being tested
- Video (group-delivered video-based intervention), HCT
- Keywords
- HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, unsafe sex, high risk sex
- Medical subject headings
- HIV Infections, Unsafe Sex, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video (group-delivered video-based intervention)Behavioural
group-delivered video-based intervention
HCTBehavioural
Offer of HIV counseling and testing
| Study group | Role | What they receive |
|---|---|---|
| video | Experimental | Not described Receives: Behavioral: Video (group-delivered video-based intervention) |
| 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.
Sexual risk behavior
Measured: past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2009
- Study completionNov 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.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Education Development Center, Inc., Callen-Lorde Community Health Center, Hispanic AIDS Forum, Inc.
- Investigators
- Lydia O'Donnell, PhD, Principal investigator, Education Development Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690690
- Sponsor's protocol ID
- CDC-NCHHSTP-5142
- Status last verified
- Mar 2010
- First submitted
- 3 Jun 2008
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
- ClinicalTrials.gov ID
- NCT00690690
- Acronym / sponsor ID
- CDC-NCHHSTP-5142
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, unsafe sex, high risk sex
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Education Development Center, Inc., Callen-Lorde Community Health Center, Hispanic AIDS Forum, Inc.
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Jun 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 overall goal of this study is to develop and evaluate a brief, video-based, group-level intervention designed to reduce sexual risk taking among culturally diverse English- and Spanish-speaking Latino 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 |
|---|---|---|
| video | Experimental | Behavioral: Video (group-delivered video-based intervention) |
| HCT | Active comparator | Behavioral: HCTOffer of HIV counseling and testing |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be between the ages of 18 - 49
- Self-identify as Latino or Hispanic
- Speak English and/or Spanish
- Reside in NYC and not plan to move in the next 3 months
- Have had 2 or more sex partners in the last 3 months
Key exclusion criteria (2 listed)
- Participated in a program (research or non-research) during the past 6 months where they have received HIV prevention education (e.g. an in-person or online group session, workshop, support group).
- Report being HIV-positive
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 |
|---|---|---|
| Video (group-delivered video-based intervention)group-delivered video-based intervention | Behavioural | video |
| HCTOffer of HIV counseling and testing | Behavioural | HCT |
Primary outcome
Sexual risk behavior
Time frame: past 3 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 9 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.
Lydia O'Donnell, PhD principal investigator
Education Development Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Video (group-delivered video-based intervention) 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 8 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 9 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Sexual risk behavior (time frame: past 3 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 9 Mar 2010.