HIV InfectionPhase 2NCT01327898
Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
A Phase 2 study testing empowerment theory-based small group discussion and individual resilience counseling in people with HIV Infection and Substance Abuse, run by Nova Southeastern University at 2 sites in United States.
Trial summary
The specific aims of the 5-year study are to: 1) describe the nature and extent of substance use and sexual risk behaviors in a sample of 500 sexually active, substance using, not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- HIV Infection, Substance Abuse
- What is being tested?
- empowerment theory-based small group discussion and individual resilience counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Jul 2014
- Phase
- Phase 2
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- ongoing substance use and ongoing unprotected anal intercourse with men
Who cannot join
- past twelve month participation in HIV prevention intervention or drug treatment; no current working telephone number and residential address; no intention to remain in in South Florida for next 12 months; newly diagnosed with HIV infection in the past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NSU Research Center
Miami Beach, Florida, 33139
NSU Research Center
Wilton Manors, Florida, 33305
About this study
The specific aims of the 5-year study are to: 1) describe the nature and extent of substance use and sexual risk behaviors in a sample of 500 sexually active, substance using, not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft. Lauderdale); 2) identify the independent covariates of baseline substance abuse and sexual risks; 3) evaluate, through random assignment of participants, the relative effectiveness of two intervention conditions in reducing sexual risks and substance use, as measured at 3-, 6-, and 12-month follow-up assessments: a) an innovative five-session risk reduction intervention derived from psychological empowerment theory titled Project GOAL; and, b) an enhanced community standard-of-care HIV counseling Comparison Condition.
Read the detailed description
Although recent meta-analyses of the HIV prevention intervention literature have demonstrated that behavioral interventions reduce sexual risk-taking among men who have sex with men (MSM), interventions for not-in-treatment substance using MSM are lacking. Consequently, and based upon overwhelming evidence that substance use is a primary driver of HIV infection among urban MSM, public health authorities have identified the development of efficacious interventions for substance using MSM as a concern of the highest priority. The proposed study aims to test a new intervention based upon psychological empowerment theory that, in preliminary field tests, produced high levels of acceptability and participation, as well as large reductions in sexual risks and substance use, among a sample of ethnically-diverse, high risk, substance using, HIV+ and -negative MSM. The intervention to be tested is based upon a theory of MSM health risk behaviors that posits that urban gay "fast lane" subcultures present risk environments - including lack of integration with the larger society, normative hypersexuality and substance use, homophobia, sexual competitiveness, and an emphasis on entertainment and escapism - that become problematic for a sizable minority of MSM who live in them.
The proposed project responds directly to the calls by public health authorities for the development of efficacious risk reduction interventions for substance using MSM. South Florida consistently ranks in the top three MSAs nationwide in HIV and AIDS incidence and prevalence. South Florida is also a well-known migration point for MSM of extraordinarily diverse backgrounds with high rates of non-injection drug use. This setting provides an excellent context for testing an innovative intervention among high risk substance using MSM who are in need of HIV prevention services.
- Conditions
- HIV Infection, Substance Abuse
- Being tested
- empowerment theory-based small group discussion, individual resilience counseling
- Keywords
- MSM, HIV/AIDS, sexual risk, substance use
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empowerment theory-based small group discussionBehavioural
four small group discussion sessions followed by one individual counseling session
individual resilience counselingBehavioural
one individual resilience counseling session
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | empowerment theory-based small group discussion Receives: Behavioral: empowerment theory-based small group discussion |
| 2 | Active comparator | single session individual resilience counseling Receives: Behavioral: individual resilience counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
unprotected anal intercourse events outside of primary relationships
Measured: 3 months
unprotected anal intercourse events outside of primary relationships
Measured: 6 months
unprotected anal intercourse events outside of primary relationships
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startNov 2008
- Primary completionDec 2011
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steven Kurtz, Ph.D., Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327898
- Sponsor's protocol ID
- DESPR DA024579
- Status last verified
- Jul 2014
- First submitted
- 30 Mar 2011
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
- ClinicalTrials.gov ID
- NCT01327898
- Acronym / sponsor ID
- DESPR DA024579
- Conditions
- HIV Infection, Substance Abuse
- Keywords
- MSM, HIV/AIDS, sexual risk, substance use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Apr 2011 (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 specific aims of the 5-year study are to: 1) describe the nature and extent of substance use and sexual risk behaviors in a sample of 500 sexually active, substance using, not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft. Lauderdale); 2) identify the independent covariates of baseline substance abuse and sexual risks; 3) evaluate, through random assignment of participants, the relative effectiveness of two intervention conditions in reducing sexual risks and substance use, as measured at 3-, 6-, and 12-month follow-up assessments: a) an innovative five-session risk reduction intervention derived from psychological empowerment theory titled Project GOAL; and, b) an enhanced community standard-of-care HIV counseling Comparison Condition.
Detailed description
Although recent meta-analyses of the HIV prevention intervention literature have demonstrated that behavioral interventions reduce sexual risk-taking among men who have sex with men (MSM), interventions for not-in-treatment substance using MSM are lacking. Consequently, and based upon overwhelming evidence that substance use is a primary driver of HIV infection among urban MSM, public health authorities have identified the development of efficacious interventions for substance using MSM as a concern of the highest priority. The proposed study aims to test a new intervention based upon psychological empowerment theory that, in preliminary field tests, produced high levels of acceptability and participation, as well as large reductions in sexual risks and substance use, among a sample of ethnically-diverse, high risk, substance using, HIV+ and -negative MSM. The intervention to be tested is based upon a theory of MSM health risk behaviors that posits that urban gay "fast lane" subcultures present risk environments - including lack of integration with the larger society, normative hypersexuality and substance use, homophobia, sexual competitiveness, and an emphasis on entertainment and escapism - that become problematic for a sizable minority of MSM who live in them.
The proposed project responds directly to the calls by public health authorities for the development of efficacious risk reduction interventions for substance using MSM. South Florida consistently ranks in the top three MSAs nationwide in HIV and AIDS incidence and prevalence. South Florida is also a well-known migration point for MSM of extraordinarily diverse backgrounds with high rates of non-injection drug use. This setting provides an excellent context for testing an innovative intervention among high risk substance using MSM who are in need of HIV prevention services.
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: empowerment theory-based small group discussionempowerment theory-based small group discussion |
| 2 | Active comparator | Behavioral: individual resilience counselingsingle session individual resilience counseling |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ongoing substance use and ongoing unprotected anal intercourse with men
Key exclusion criteria (1 listed)
- past twelve month participation in HIV prevention intervention or drug treatment; no current working telephone number and residential address; no intention to remain in in South Florida for next 12 months; newly diagnosed with HIV infection in the past 6 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 |
|---|---|---|
| empowerment theory-based small group discussionfour small group discussion sessions followed by one individual counseling session | Behavioural | 1 |
| individual resilience counselingone individual resilience counseling session | Behavioural | 2 |
Primary outcome
unprotected anal intercourse events outside of primary relationships
Time frame: 3 months
unprotected anal intercourse events outside of primary relationships
Time frame: 6 months
unprotected anal intercourse events outside of primary relationships
Time frame: 12 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 25 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing empowerment theory-based small group discussion and individual resilience counseling in people with HIV Infection and Substance Abuse, run by Nova Southeastern University at 2 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 1 inclusion and 1 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 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this 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.
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?
unprotected anal intercourse events outside of primary relationships (time frame: 3 months). The study lists 3 primary outcomes in all. 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 25 Jul 2014.