HIV InfectionsUDPNCT00691041
A Network Intervention for Reducing Sexual Risk for HIV With African American Men Who Have Sex With Men (AA MSM)
A study testing Unity in Diversity in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of the study is to examine the efficacy of a network-oriented "outreach intervention" to reduce HIV and sexually transmitted infection (STI) related risk behaviors among African American men who have sex with men (AA MSM)and their social network. 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?
- Unity in Diversity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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
- Identify as a black / African American male
- Report sex with at least 2 people in past 3 months/ 1 being male
- Willingness to take HIV test or provide documentation if HIV+
- Willingness to identify and recruit friend/relative to study
Who cannot join
- Under age 18
- Identify as female or transgender
- Not identify as Black / African American
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to examine the efficacy of a network-oriented "outreach intervention" to reduce HIV and sexually transmitted infection (STI) related risk behaviors among African American men who have sex with men (AA MSM)and their social network. The hypothesis is to determine whether the new intervention is more efficacious at reducing high risk sexual behaviors than the standard normal of care provided to the public (a single session of individual HIV counseling and testing.
Read the detailed description
The intervention increases participants' personal level of knowledge and skills concerning HIV prevention and inspires participants to diffuse the information to their social network.
- Conditions
- HIV Infections
- Being tested
- Unity in Diversity
- Keywords
- HIV Prevention, Men who have sex with men, African American, Unprotected sex, HIV Seronegativity
- Medical subject headings
- HIV Infections, Homosexuality, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unity in DiversityBehavioural
HIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network Receives: Behavioral: Unity in Diversity |
| 2 | No intervention | HIV/STI counseling and testing and a single 15 minute session of resources available in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase participants knowledge of HIV/STI risks to assist with decreasing high risk sex/drug behaviors
Measured: 3 months after completing intervention
Secondary outcomes (1)
To increase participants' level of knowledge and skills concerning HIV/STI prevention and diffusing the information to their social network)
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 startAug 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.
- 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
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carl Latkin, PhD, Principal investigator, Johns Hopkins University -Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691041
- Sponsor's protocol ID
- CDC-NCHHSTP-5221
- Acronym
- UDP
- Status last verified
- Jun 2012
- First submitted
- 3 Jun 2008
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tobin KE, German D, Spikes P, Patterson J, Latkin C. A comparison of the social and sexual networks of crack-using and non-crack using African American men who have sex with men. J Urban Health. 2011 Dec;88(6):1052-62. doi: 10.1007/s11524-011-9611-4.
PubMed 21882072Latkin C, Yang C, Tobin K, Penniman T, Patterson J, Spikes P. Differences in the social networks of African American men who have sex with men only and those who have sex with men and women. Am J Public Health. 2011 Oct;101(10):e18-23. doi: 10.2105/AJPH.2011.300281. Epub 2011 Aug 18.
PubMed 21852650Latkin C, Yang C, Tobin K, Roebuck G, Spikes P, Patterson J. Social network predictors of disclosure of MSM behavior and HIV-positive serostatus among African American MSM in Baltimore, Maryland. AIDS Behav. 2012 Apr;16(3):535-42. doi: 10.1007/s10461-011-0014-z.
PubMed 21811844
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 Network Intervention for Reducing Sexual Risk for HIV With African American Men Who Have Sex With Men (AA MSM)
- ClinicalTrials.gov ID
- NCT00691041
- Acronym / sponsor ID
- UDP / CDC-NCHHSTP-5221
- Conditions
- HIV Infections
- Keywords
- HIV Prevention, Men who have sex with men, African American, Unprotected sex, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (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 the study is to examine the efficacy of a network-oriented "outreach intervention" to reduce HIV and sexually transmitted infection (STI) related risk behaviors among African American men who have sex with men (AA MSM)and their social network. The hypothesis is to determine whether the new intervention is more efficacious at reducing high risk sexual behaviors than the standard normal of care provided to the public (a single session of individual HIV counseling and testing.
Detailed description
The intervention increases participants' personal level of knowledge and skills concerning HIV prevention and inspires participants to diffuse the information to their social network.
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: Unity in DiversityHIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network |
| 2 | No intervention | –HIV/STI counseling and testing and a single 15 minute session of resources available in the community |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Identify as a black / African American male
- Report sex with at least 2 people in past 3 months/ 1 being male
- Willingness to take HIV test or provide documentation if HIV+
- Willingness to identify and recruit friend/relative to study
Key exclusion criteria (3 listed)
- Under age 18
- Identify as female or transgender
- Not identify as Black / African American
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 |
|---|---|---|
| Unity in DiversityHIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network | Behavioural | 1 |
Primary outcome
To increase participants knowledge of HIV/STI risks to assist with decreasing high risk sex/drug behaviors
Time frame: 3 months after completing intervention
1 secondary outcome
To increase participants' level of knowledge and skills concerning HIV/STI prevention and diffusing the information to their social network)
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 21882072Tobin KE, German D, Spikes P, Patterson J, Latkin C. A comparison of the social and sexual networks of crack-using and non-crack using African American men who have sex with men. J Urban Health. 2011 Dec;88(6):1052-62. doi: 10.1007/s11524-011-9611-4.
- Results publication: PubMed 21852650Latkin C, Yang C, Tobin K, Penniman T, Patterson J, Spikes P. Differences in the social networks of African American men who have sex with men only and those who have sex with men and women. Am J Public Health. 2011 Oct;101(10):e18-23. doi: 10.2105/AJPH.2011.300281. Epub 2011 Aug 18.
- Results publication: PubMed 21811844Latkin C, Yang C, Tobin K, Roebuck G, Spikes P, Patterson J. Social network predictors of disclosure of MSM behavior and HIV-positive serostatus among African American MSM in Baltimore, Maryland. AIDS Behav. 2012 Apr;16(3):535-42. doi: 10.1007/s10461-011-0014-z.
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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.
Carl Latkin, PhD principal investigator
Johns Hopkins University -Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unity in Diversity 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 4 inclusion and 3 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?
To increase participants knowledge of HIV/STI risks to assist with decreasing high risk sex/drug behaviors (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 NCT00691041, 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; AzTrials last refreshed its copy on 31 Oct 2026.