SexYMHPNCT01118416
Risk Reduction Intervention for Vulnerable Young Adult Males
A study of Sex and Substance Use, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The primary aim of this study is to test a brief 4-session risk reduction intervention, based on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and sexual risk taking behaviors among non-treatment seeking young men who have sex with men (YMSM) in NYC. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sex, Substance Use, HIV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2011
- 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 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 5 days of drug use (cocaine, ketamine, ecstasy, methamphetamine, or GHB) in the past 90 days;
- At least 1 instance of unprotected anal sex in the past 90 days;
- Biological male;
- HIV-negative;
- Residential stability;
- Ability to communicate in written English.
Who cannot join
- Unstable, serious psychiatric symptoms;
- Currently suicidal/homicidal;
- Evidence of gross cognitive impairment;
- Reports current enrollment in a drug or HIV related intervention or research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, 10018
About this study
The primary aim of this study is to test a brief 4-session risk reduction intervention, based on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and sexual risk taking behaviors among non-treatment seeking young men who have sex with men (YMSM) in NYC.
Read the detailed description
This study is a randomized clinical trial. A sample of 300 non-treatment seeking YMSM (ages 18-24) who report risky sex and club drug use in the past 90 days are being enrolled using active and passive community-based recruitment strategies in NYC. After baseline assessment, participants are being randomly assigned to one of two study arms: a Brief Risk Reduction Intervention Condition - a four session MET intervention piloted for feasibility and acceptability among YMSM, designed to increase readiness to change club drug use and unprotected sex; or an Education Comparison Condition - four sessions of facilitated education regarding the effects of club drugs and unprotected sex. Participants undergo follow-up assessments 3, 6, 9, and 12 months after baseline.
- Conditions
- Sex, Substance Use, HIV
- Being tested
- HIV prevention intervention randomized control trial
- Keywords
- sexual risk, substance use, HIV, prevention, intervention, Motivational Enhancement Therapy, young men who have sex with men
- Medical subject headings
- Coitus, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV prevention intervention randomized control trialBehavioural
Substance using HIV-negative young MSM who engage in sexual risk are randomized to either a motivational interviewing or an education condition to reduce sexual risk and drug use.
| Study group | Role | What they receive |
|---|---|---|
| intervention condition | Experimental | Participants randomized to the intervention condition will undergo 4 one-hour sessions of motivational interviewing (MI), during which their sexual risk taking and substance use patterns will be discussed with a trained counselor with the goal of reducing instances of unprotected anal sex and substance use. Receives: Behavioral: HIV prevention intervention randomized control trial |
| Education condition | Active comparator | Participants randomized to the education condition will undergo 4 one-hour sessions during which they will view video segments and discuss sexual risk taking and substance use with a health educator, with the goal of reducing instances of unprotected anal sex and substance use by making informed decisions. Receives: Behavioral: HIV prevention intervention randomized control trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual risk
Participants in the MET condition will report greater reductions in the number of unprotected anal intercourse acts and in the proportion of days of club drug use than those in the education comparison condition at the end of the intervention period (3 months) and will maintain greater reductions in the number of unprotected anal intercourse acts and the proportion of days of club drug use than those in the education comparison condition at the three follow-up assessments (6, 9, and 12 months).
Measured: every three months over the course of a year
Secondary outcomes (1)
motivation to change club drug use and unsafe sex over 12 months
The following factors assessed at baseline will predict club drug use and unsafe sex over the 12-month outcome period: baseline severity of club drug use, baseline severity of other substance use, motivation, decisional balance, and self-efficacy.
Measured: every three months over the course of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJun 2006
- Primary completionSep 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexStudies 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
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey T. Parsons, Hunter College of City University of New York
- Investigators
- Jeffrey T Parsons, PhD, Principal investigator, Hunter College of CUNY and Center for HIV/AIDS Educational Studies and Training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118416
- Sponsor's protocol ID
- R01DA020366
- Acronym
- YMHP
- Status last verified
- May 2013
- First submitted
- 5 May 2010
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Reduction Intervention for Vulnerable Young Adult Males
- ClinicalTrials.gov ID
- NCT01118416
- Acronym / sponsor ID
- YMHP / R01DA020366
- Conditions
- Sex, Substance Use, HIV
- Keywords
- sexual risk, substance use, HIV, prevention, intervention, Motivational Enhancement Therapy, young men who have sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 May 2010 (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 primary aim of this study is to test a brief 4-session risk reduction intervention, based on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and sexual risk taking behaviors among non-treatment seeking young men who have sex with men (YMSM) in NYC.
Detailed description
This study is a randomized clinical trial. A sample of 300 non-treatment seeking YMSM (ages 18-24) who report risky sex and club drug use in the past 90 days are being enrolled using active and passive community-based recruitment strategies in NYC. After baseline assessment, participants are being randomly assigned to one of two study arms: a Brief Risk Reduction Intervention Condition - a four session MET intervention piloted for feasibility and acceptability among YMSM, designed to increase readiness to change club drug use and unprotected sex; or an Education Comparison Condition - four sessions of facilitated education regarding the effects of club drugs and unprotected sex. Participants undergo follow-up assessments 3, 6, 9, and 12 months after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention condition | Experimental | Behavioral: HIV prevention intervention randomized control trialParticipants randomized to the intervention condition will undergo 4 one-hour sessions of motivational interviewing (MI), during which their sexual risk taking and substance use patterns will be discussed with a trained counselor with the goal of reducing instances of unprotected anal sex and substance use. |
| Education condition | Active comparator | Behavioral: HIV prevention intervention randomized control trialParticipants randomized to the education condition will undergo 4 one-hour sessions during which they will view video segments and discuss sexual risk taking and substance use with a health educator, with the goal of reducing instances of unprotected anal sex and substance use by making informed decisions. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- At least 5 days of drug use (cocaine, ketamine, ecstasy, methamphetamine, or GHB) in the past 90 days;
- At least 1 instance of unprotected anal sex in the past 90 days;
- Biological male;
- HIV-negative;
- Residential stability;
Key exclusion criteria (4 listed)
- Unstable, serious psychiatric symptoms;
- Currently suicidal/homicidal;
- Evidence of gross cognitive impairment;
- Reports current enrollment in a drug or HIV related intervention or research 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 |
|---|---|---|
| HIV prevention intervention randomized control trialSubstance using HIV-negative young MSM who engage in sexual risk are randomized to either a motivational interviewing or an education condition to reduce sexual risk and drug use. | Behavioural | Education condition, intervention condition |
Primary outcome
Sexual risk
Time frame: every three months over the course of a year
Participants in the MET condition will report greater reductions in the number of unprotected anal intercourse acts and in the proportion of days of club drug use than those in the education comparison condition at the end of the intervention period (3 months) and will maintain greater reductions in the number of unprotected anal intercourse acts and the proportion of days of club drug use than those in the education comparison condition at the three follow-up assessments (6, 9, and 12 months).
1 secondary outcome
motivation to change club drug use and unsafe sex over 12 months
Time frame: every three months over the course of a year
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 3 Jun 2013.
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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.
Jeffrey T Parsons, PhD principal investigator
Hunter College of CUNY and Center for HIV/AIDS Educational Studies and Training
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sex and Substance Use, run by Hunter College of City University of New York 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 6 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 3 Jun 2013. 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?
Sexual risk (time frame: every three months over the course of a year). 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 3 Jun 2013.