HIV InfectionsNCT00153361
Project MIX: Behavioral Intervention to Reduce Risk Among Substance-Using MSM
A study testing Discussion Group and Video Discussion Group in people with HIV Infections, run by Gordon Mansergh at 6 sites 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 for HIV infection among non-injection, substance-using men who have sex with men (SUMSM). 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?
- Discussion Group and Video Discussion Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,686 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2002to Sep 2008
- 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 male;
- understand and read English;
- live within the metropolitan area;
- report being drunk or "buzzed" on alcohol 2 or more times or high on non-injection drugs at least once during (or two hours before) anal sex in the past six months;
- have had at least one unprotected anal sex episode in the past six months with a male partner of unknown or different HIV-status than their own (i.e., DUA)
Who cannot join
- report only marijuana, only Viagra or only marijuana and Viagra use during anal sex (current research shows that marijuana use is not associated with sexual risk behavior);
- report injecting drugs (eligible if only methamphetamine, steroids, hormones and/or prescribed medications) in the past six months;
- have known their HIV-positive status for less than six months (this is done to allow for psychological and behavioral adjustment following an initial HIV diagnosis and this time frame coincides with our screening window); these men (if they so desire) will be put on a wait list and contacted after 6 months have passed since their first HIV-positive test result;
- are currently involved in another HIV behavioral intervention study for MSM [local study site identifies a list of such studies in their community at the time of the trial];
- have a specific plan to move from the metropolitan area within the next 15 months;
- participated in the pilot phase of the project;
- other reasons that the investigators deem would make participation either detrimental to the participant or to the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The University of Illinois at Chicago
Chicago, Illinois, 60607
Howard Brown Health Center
Chicago, Illinois, 60613
Health Research Association
Hollywood, California, 90038
New York Blood Center
New York, New York, 10021
Project Achieve
New York, New York, 10024
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: Project Mix: Behavioral Intervention to Reduce Sexual Risk Behavior of Substance-Using (Non-Injection) Men Who Have Sex With Men
The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk for HIV infection among non-injection, substance-using men who have sex with men (SUMSM). The primary goal of the intervention is to reduce HIV transmission by reducing the incidence of unprotected anal sex while under the influence of alcohol and other drugs (AOD).
Read the detailed description
Men who have sex with men (MSM) continue to be the largest risk category for incident and prevalent cases of HIV and AIDS in the U.S. Studies of MSM have established an association between alcohol and other drug (AOD) use and risky sexual behaviors. Although studies have assessed and confirmed the association of AOD use and unsafe sex, few have focused specifically on reducing sexual risk of SUMSM.
Sexual risk reduction interventions for MSM identified in the published scientific literature have demonstrated that they are generally effective at reducing sexual risk behaviors among MSM. However, none of these interventions specifically targeted non-injecting SUMSM. Thus, a gap exists in prevention efforts to reduce HIV transmission among SUMSM.
The primary aim of the Project Mix overall is to develop and evaluate a practical intervention strategy that is specifically tailored to the needs of non-injecting SUMSM. The intent of the intervention is to decrease the number of unprotected anal sex partners (and acts) while under the influence of AOD and in general.
- Conditions
- HIV Infections
- Being tested
- Discussion Group, Video Discussion Group
- Keywords
- HIV Seronegativity, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discussion GroupBehavioural
Video Discussion GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral discussion sessions focused on reducing substance use and sexual risk behavior Receives: Behavioral: Discussion Group |
| Comparison | Active comparator | Video discussion on health issues unrelated to HIV prevention and substance use Receives: Behavioral: Video Discussion Group |
| Control | No intervention | Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the number of unprotected anal sex partners (and acts) while under the influence of AOD as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
Measured: 3 months
Decrease in the number of unprotected anal sex partners (and acts) as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gordon Mansergh
- Sponsor type
- US federal agency
- Collaborators
- New York Blood Center, San Francisco Department of Public Health, University of Illinois Chicago, Health Research Association
- Responsible party
- Sponsor-investigator, Gordon Mansergh, Centers for Disease Control and Prevention
- Investigators
- Gordon Mansergh, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153361
- Sponsor's protocol ID
- CDC-NCHSTP-3985
- Other IDs
- U65/CCU522209, U65/CCU922215, U65/CCU222309, U65/CCU922213
- Status last verified
- May 2024
- First submitted
- 7 Sep 2005
- Last updated
- 20 May 2024
- Results posted
- No
Publications
Mansergh G, Koblin BA, McKirnan DJ, Hudson SM, Flores SA, Wiegand RE, Purcell DW, Colfax GN; Project MIX Study Team. An intervention to reduce HIV risk behavior of substance-using men who have sex with men: a two-group randomized trial with a nonrandomized third group. PLoS Med. 2010 Aug 24;7(8):e1000329. doi: 10.1371/journal.pmed.1000329.
PubMed 20811491
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Mix: Behavioral Intervention to Reduce Sexual Risk Behavior of Substance-Using (Non-Injection) Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00153361
- Acronym / sponsor ID
- CDC-NCHSTP-3985
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,686 participants (actual)
- Lead sponsor
- Gordon ManserghUS federal agency
- Collaborators
- New York Blood Center, San Francisco Department of Public Health, University of Illinois Chicago, Health Research Association
- Study start
- Oct 2002
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 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 project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk for HIV infection among non-injection, substance-using men who have sex with men (SUMSM). The primary goal of the intervention is to reduce HIV transmission by reducing the incidence of unprotected anal sex while under the influence of alcohol and other drugs (AOD).
Detailed description
Men who have sex with men (MSM) continue to be the largest risk category for incident and prevalent cases of HIV and AIDS in the U.S. Studies of MSM have established an association between alcohol and other drug (AOD) use and risky sexual behaviors. Although studies have assessed and confirmed the association of AOD use and unsafe sex, few have focused specifically on reducing sexual risk of SUMSM.
Sexual risk reduction interventions for MSM identified in the published scientific literature have demonstrated that they are generally effective at reducing sexual risk behaviors among MSM. However, none of these interventions specifically targeted non-injecting SUMSM. Thus, a gap exists in prevention efforts to reduce HIV transmission among SUMSM.
The primary aim of the Project Mix overall is to develop and evaluate a practical intervention strategy that is specifically tailored to the needs of non-injecting SUMSM. The intent of the intervention is to decrease the number of unprotected anal sex partners (and acts) while under the influence of AOD and in general.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Discussion GroupBehavioral discussion sessions focused on reducing substance use and sexual risk behavior |
| Comparison | Active comparator | Behavioral: Video Discussion GroupVideo discussion on health issues unrelated to HIV prevention and substance use |
| Control | No intervention | –Waitlist control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be 18 years of age or older;
- self-identify as male;
- understand and read English;
- live within the metropolitan area;
- report being drunk or "buzzed" on alcohol 2 or more times or high on non-injection drugs at least once during (or two hours before) anal sex in the past six months;
Key exclusion criteria (7 listed)
- report only marijuana, only Viagra or only marijuana and Viagra use during anal sex (current research shows that marijuana use is not associated with sexual risk behavior);
- report injecting drugs (eligible if only methamphetamine, steroids, hormones and/or prescribed medications) in the past six months;
- have known their HIV-positive status for less than six months (this is done to allow for psychological and behavioral adjustment following an initial HIV diagnosis and this time frame coincides with our screening window); these men (if they so desire) will be put on a wait list and contacted after 6 months have passed since their first HIV-positive test result;
- are currently involved in another HIV behavioral intervention study for MSM [local study site identifies a list of such studies in their community at the time of the trial];
- have a specific plan to move from the metropolitan area within the next 15 months;
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 |
|---|---|---|
| Discussion Group | Behavioural | Intervention |
| Video Discussion Group | Behavioural | Comparison |
Primary outcome
Decrease in the number of unprotected anal sex partners (and acts) while under the influence of AOD as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
Time frame: 3 months
Decrease in the number of unprotected anal sex partners (and acts) as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
Time frame: 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 20 May 2024.
- Derived from this study: PubMed 20811491Mansergh G, Koblin BA, McKirnan DJ, Hudson SM, Flores SA, Wiegand RE, Purcell DW, Colfax GN; Project MIX Study Team. An intervention to reduce HIV risk behavior of substance-using men who have sex with men: a two-group randomized trial with a nonrandomized third group. PLoS Med. 2010 Aug 24;7(8):e1000329. doi: 10.1371/journal.pmed.1000329.
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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.
Gordon Mansergh, PhD principal investigator
Centers for Disease Control and Prevention
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion Group and Video Discussion Group in people with HIV Infections, run by Gordon Mansergh at 6 sites 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 6 inclusion and 7 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 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Decrease in the number of unprotected anal sex partners (and acts) while under the influence of AOD as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT00153361, which also lists 1 linked publication.
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 20 May 2024.