HIV InfectionsNCT00691496
A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
A study testing Behavioral intervention to reduce sexual risk among African-American men who have sex with men in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk 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?
- Behavioral intervention to reduce sexual risk among African-American men who have sex with men
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Nov 2009
- 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
None listed.
Who cannot join
- Participated in pilot
- Identify as transgender
- Plan to move before end of study
- Refuse HIV testing at baseline or identified as a newly diagnosed HIV through testing at the baseline
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk among African-American men who have sex with men (MSM).
- Conditions
- HIV Infections
- Being tested
- Behavioral intervention to reduce sexual risk among African-American men who have sex with men
- Keywords
- HIV Prevention, African-American, gay, bisexual, intervention trial, HIV Seronegativity
- Medical subject headings
- HIV Infections, Homosexuality, Bisexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral intervention to reduce sexual risk among African-American men who have sex with menBehavioural
5 week intervention to increase skill level of participants with talking to their social networks and sexual partners about reducing high risk sexual behaviors while preparing a healthy meal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receives HIV testing and counseling and 5 week intervention Receives: Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with men |
| 2 | No intervention | Receives only HIV Testing and Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary goal of the intervention is to reduce HIV transmission or acquisition by reducing the frequency of unprotected anal intercourse among African-American MSM.
Measured: 3 months after completing intervention
Secondary outcomes (1)
Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners.
Measured: 3 months after completing the intervention
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 startMay 2008
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- New York Blood Center, The New York Academy of Medicine
- Responsible party
- Sponsor
- Investigators
- Beryl Koblin, PhD, Principal investigator, New York Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691496
- Sponsor's protocol ID
- CDC-NCHHSTP-5157
- Status last verified
- Jun 2012
- First submitted
- 3 Jun 2008
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Koblin BA, Bonner S, Powell B, Metralexis P, Egan JE, Patterson J, Xu G, Hoover DR, Goodman K, Chin J, Tieu HV, Spikes P. A randomized trial of a behavioral intervention for black MSM: the DiSH study. AIDS. 2012 Feb 20;26(4):483-8. doi: 10.1097/QAD.0b013e32834f9833.
PubMed 22156967Tieu HV, Spikes P, Patterson J, Bonner S, Egan JE, Goodman K, Stewart K, Frye V, Xu G, Hoover DR, Koblin BA. Sociodemographic and risk behavior characteristics associated with unprotected sex with women among black men who have sex with men and women in New York City. AIDS Care. 2012;24(9):1111-9. doi: 10.1080/09540121.2012.672723. Epub 2012 Apr 25.
PubMed 22533637Tieu HV, Xu G, Bonner S, Spikes P, Egan JE, Goodman K, Stewart K, Koblin BA. Sexual partner characteristics, serodiscordant/serostatus unknown unprotected anal intercourse and disclosure among human immunodeficiency virus-infected and uninfected black men who have sex with men in New York City. Sex Transm Dis. 2011 Jun;38(6):548-54. doi: 10.1097/OLQ.0b013e318203e2d7.
PubMed 21217419
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00691496
- Acronym / sponsor ID
- CDC-NCHHSTP-5157
- Conditions
- HIV Infections
- Keywords
- HIV Prevention, African-American, gay, bisexual, intervention trial, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- New York Blood Center, The New York Academy of Medicine
- Study start
- May 2008
- Primary completion
- Oct 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 purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk 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 | Experimental | Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with menReceives HIV testing and counseling and 5 week intervention |
| 2 | No intervention | –Receives only HIV Testing and Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Participated in pilot
- Identify as transgender
- Plan to move before end of study
- Refuse HIV testing at baseline or identified as a newly diagnosed HIV through testing at the baseline
- Under 18 years of age
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 |
|---|---|---|
| Behavioral intervention to reduce sexual risk among African-American men who have sex with men5 week intervention to increase skill level of participants with talking to their social networks and sexual partners about reducing high risk sexual behaviors while preparing a healthy meal | Behavioural | 1 |
Primary outcome
The primary goal of the intervention is to reduce HIV transmission or acquisition by reducing the frequency of unprotected anal intercourse among African-American MSM.
Time frame: 3 months after completing intervention
1 secondary outcome
Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners.
Time frame: 3 months after completing the intervention
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 13 Jun 2012.
- Results publication: PubMed 22156967Koblin BA, Bonner S, Powell B, Metralexis P, Egan JE, Patterson J, Xu G, Hoover DR, Goodman K, Chin J, Tieu HV, Spikes P. A randomized trial of a behavioral intervention for black MSM: the DiSH study. AIDS. 2012 Feb 20;26(4):483-8. doi: 10.1097/QAD.0b013e32834f9833.
- Results publication: PubMed 22533637Tieu HV, Spikes P, Patterson J, Bonner S, Egan JE, Goodman K, Stewart K, Frye V, Xu G, Hoover DR, Koblin BA. Sociodemographic and risk behavior characteristics associated with unprotected sex with women among black men who have sex with men and women in New York City. AIDS Care. 2012;24(9):1111-9. doi: 10.1080/09540121.2012.672723. Epub 2012 Apr 25.
- Results publication: PubMed 21217419Tieu HV, Xu G, Bonner S, Spikes P, Egan JE, Goodman K, Stewart K, Koblin BA. Sexual partner characteristics, serodiscordant/serostatus unknown unprotected anal intercourse and disclosure among human immunodeficiency virus-infected and uninfected black men who have sex with men in New York City. Sex Transm Dis. 2011 Jun;38(6):548-54. doi: 10.1097/OLQ.0b013e318203e2d7.
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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.
Beryl Koblin, PhD principal investigator
New York Blood Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral intervention to reduce sexual risk among African-American men who have sex with men 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 0 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 13 Jun 2012. 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?
The primary goal of the intervention is to reduce HIV transmission or acquisition by reducing the frequency of unprotected anal intercourse among African-American MSM. (time frame: 3 months after completing intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00691496, which also lists 3 linked publications.
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 13 Jun 2012.