HIV InfectionsEnhanceNCT00231972
Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
A study testing Project Enhance and Standard prevention case management (PCM) in people with HIV Infections, run by Fenway Community Health at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Project Enhance and Standard prevention case management (PCM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Receives primary health care at Fenway Community Health
- Identifies as a man who has sex with men
- Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment
Who cannot join
- All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected
- Plans to relocate over the upcoming year
Trial locations and contacts
1 site in 1 country.
United States1 site
Fenway Community Health
Boston, Massachusetts, 02115
About this study
Official title: Enhancing HIV Prevention Among HIV Infected Men
This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.
Read the detailed description
In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.
Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
- Conditions
- HIV Infections
- Being tested
- Project Enhance, Standard prevention case management (PCM)
- Keywords
- HIV, MSM
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project EnhanceBehavioural
Also called Project Enhance Behavioral Intervention
The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
Standard prevention case management (PCM)Behavioural
Also called Project Enhance Prevention Case Management
Participants will receive standard PCM for HIV prevention.
| Study group | Role | What they receive |
|---|---|---|
| Project Enhance | Experimental | Participants will receive the risk reduction program, Project Enhance Receives: Behavioral: Project Enhance |
| Active Comparison Condition | Active comparator | Participants will receive standard prevention case management Receives: Behavioral: Standard prevention case management (PCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up
Measured: Measured at Months 3, 6, 9, and 12
Secondary outcomes (4)
Incidence of sexually transmitted diseases
Measured: Measured at Months 3, 6, 9, and 12
Higher risk-reduction self-efficacy
Measured: Measured at Months 3, 6, 9, and 12
Increased behavioral intentions to engage in safer behaviors
Measured: Measured at Months 3, 6, 9, and 12
Increased risk-reduction strategies (other than condom use)
Measured: Measured at Months 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startDec 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Kenneth Mayer, MD, Principal investigator, Fenway Community Health and Brown UniversitySteven Safren, PhD, Principal investigator, Fenway Community Health and Harvard Medical SchoolConall O'Cleirigh, PhD, Study director, Fenway Community Health and Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231972
- Sponsor's protocol ID
- R01MH068746
- Other IDs
- DAHBR 9A-ASPG, R01MH068746
- Acronym
- Enhance
- Status last verified
- Feb 2011
- First submitted
- 30 Sep 2005
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing HIV Prevention Among HIV Infected Men
- ClinicalTrials.gov ID
- NCT00231972
- Acronym / sponsor ID
- Enhance / R01MH068746
- Conditions
- HIV Infections
- Keywords
- HIV, MSM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Oct 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.
This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.
Detailed description
In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.
Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project Enhance | Experimental | Behavioral: Project EnhanceParticipants will receive the risk reduction program, Project Enhance |
| Active Comparison Condition | Active comparator | Behavioral: Standard prevention case management (PCM)Participants will receive standard prevention case management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected
- Receives primary health care at Fenway Community Health
- Identifies as a man who has sex with men
- Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment
Key exclusion criteria (2 listed)
- All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected
- Plans to relocate over the upcoming year
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 |
|---|---|---|
| Project EnhanceAlso: Project Enhance Behavioral InterventionThe behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year. | Behavioural | Project Enhance |
| Standard prevention case management (PCM)Also: Project Enhance Prevention Case ManagementParticipants will receive standard PCM for HIV prevention. | Behavioural | Active Comparison Condition |
Primary outcome
Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up
Time frame: Measured at Months 3, 6, 9, and 12
4 secondary outcomes
Incidence of sexually transmitted diseases
Time frame: Measured at Months 3, 6, 9, and 12
Higher risk-reduction self-efficacy
Time frame: Measured at Months 3, 6, 9, and 12
Increased behavioral intentions to engage in safer behaviors
Time frame: Measured at Months 3, 6, 9, and 12
Increased risk-reduction strategies (other than condom use)
Time frame: Measured at Months 3, 6, 9, and 12
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 8 Apr 2011.
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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.
Kenneth Mayer, MD principal investigator
Fenway Community Health and Brown University
Steven Safren, PhD principal investigator
Fenway Community Health and Harvard Medical School
Conall O'Cleirigh, PhD study director
Fenway Community Health and Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Enhance and Standard prevention case management (PCM) in people with HIV Infections, run by Fenway Community Health 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 2 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 8 Apr 2011. 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?
Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up (time frame: Measured at Months 3, 6, 9, and 12). 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 8 Apr 2011.