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View Clinical Trial (Medical Research Study)
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Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men - NCT00951249-90038 (Clinical Trial 351342)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy351342.aspx
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| City: |
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Los Angeles |
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State:
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CA |
| Zip Code: |
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90038 |
| Conditions: |
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HIV Infections |
| Purpose: |
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It has been estimated that black men who have sex with men (MSM) account for one quarter of
all new HIV infections in the US annually, yet little prevention work has been directed
towards this population. The purpose of this study is to research and potentially design a
new and better way to try and slow the spread of HIV among black MSM.
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| Study summary: |
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In the US, men who have sex with men (MSM) comprise the largest proportion of new HIV
infections, with black MSM being infected at significantly higher rates. Differences in
sexual-risk behaviors and substance use do not explain the disproportionate HIV rates by
race among MSM. The most likely explanations are low frequency of HIV testing, high HIV
prevalence within sexual networks, high prevalence of other sexual transmitted infections
(STIs), and barriers to health care access and HIV/STI treatment. These result in later
diagnoses of HIV-infected men, more frequent STIs, and fewer HIV-infected men having access
to care.
The purpose of this study is to gather information on the achievability and acceptability of
the following interventions:
A.) Referral of up to five sexual partners by index participants for enrollment into the
study B.) Counseling and testing for HIV C.) Counseling and testing for other STIs D.)
Counseling and referral for care offered to participants for issues such as substance use
and mental health.
E.) Engagement with peer health care system navigators (PHNs) to facilitate uptake of health
care and other services.
These interventions are designed to impact several factors related to the HIV epidemic among
black MSM. At the individual level, the interventions will address personal risk factors for
either acquiring or transmitting HIV, including identifying undiagnosed HIV or STI
infections, and helping participants to reduce risk-behaviors, such as those influenced by
drugs and alcohol. The interventions are also designed to have an impact at the population
level. If successful, they will lower the viral load in HIV-infected men by identifying
those who qualify for HIV treatment and intervening to increase treatment and access to
healthcare. Overall, the study investigators propose that by lowering both the proportion of
men with undiagnosed HIV infection and those with chronic, untreated infection, the rates of
HIV transmission will be reduced among the black MSM population. This is a feasibility
study, designed to provide estimates about the potential effectiveness of these
interventions. These estimates will then be used to determine whether a large-scale trial of
the interventions would be successful.
Approximately 2418 total participants will be enrolled into the study at six different
sites. Participants will be enrolled in one of two ways: either directly from the community,
or referred by other participants (sexual network partners). The total duration of the study
will be two years. This includes 12 months for participant accrual and 12 months of
follow-up for each participant. All participants will have an enrollment visit, during which
he will complete a questionnaire covering topics such as sexual risk behaviors, drug and/or
alcohol use, current and prior engagement with the health care system, barriers to HIV care,
unmet service needs, frequented venues, attitudes about race, sexual history, research, and
health care. Participants will also be asked to enumerate 5 social and 10 sexual network
members (age, race, HIV status), information which will be used to better understand the
characteristics of black MSM social and sexual networks.
Participants will be offered HIV and STI testing and counseling. Those with reactive HIV
rapid test results will have HIV infection confirmed by Western blot and will have a CD4
cell count and viral load test performed. Counselors will provide post-test HIV participants
counseling to those who have had HIV rapid test performed and will schedule all participants
to return to the clinic approximately two weeks later to receive additional test results.
The counselor will also discuss the participant's engagement in health care, and will
determine the participant's health and lesser service needs. The counselor will also inquire
about homophobic or partner violence and provide any care referrals if needed. Additionally,
risk reduction counseling will be provided.
Study participation will end after the initial visit for three groups of participants. These
groups include those who have: A.) an HIV-positive diagnosis prior to screening for this
study and are either in care (have seen a health care provider for HIV-related care in the
last six months)or who have unprotected sex only with HIV-infected partners. B.)
HIV-uninfected participants enrolled after the site's 200 person cap for this category, and
C.) participants who refuse HIV testing after the site's fist 20 participants in this
category have been enrolled. Participants who fall into the categories listed above will
provide only baseline cross-sectional data.
All other participants will then have the counselor explain about peer health care system
navigation and introduce the participant to the PHN. The PHN will meet with the participant
and schedule an initial discussion, unless the participant does not have any need for the
navigation, in which case the PHN will plan to call after a few weeks to check for any
emerging needs. The PHN will interact with the participant on a schedule that is independent
of the study visit schedule and is determined by the participant's needs. The PHN's role
will be to help the participant overcome his barriers to health care through a number of
activities.
Follow-up visits are scheduled infrequently, so participants may be contacted periodically
between visits to stay in touch and provide updated locator information. Visits will include
the completion of a questionnaire, HIV testing for those who were not infected at the prior
visit, with confirmation and follow-up tests if necessary. A viral load test will be
performed for HIV-infected participants at the time of diagnoses and again at 52 weeks. All
participants will receive STI counseling and testing at 26 and 52 weeks. Participants will
receive counseling to include risk reduction counseling and pre- and post- test counseling,
as needed. Participants will also be counseled for issues such as mental health and
substance use and referred for care as appropriate. Participants will be asked to report any
STI or HIV diagnoses they receive between visits and to provide documentation of diagnoses.
Plasma specimens for testing will also be collected from all participants at all visits.
In order to collect additional information on the black MSM population, interviews and focus
groups will also be a component in this study. Focus group meetings will be approximately
1.5 to 2 hours long and will be conducted at locations that allow for privacy and
confidentiality. Interviews will last for between 60 to 90 minutes and will be conducted
with individual participants. Interviews will be audio recorded and transcribed. |
| Criteria: |
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Inclusion Criteria:
- Willing and able to provide informed consent
- Black, African American, Caribbean Black, or multiethnic Black
- At least one instance of unprotected anal intercourse (UAI) with a man in the past
six months
- Residing in the metropolitan area and do not plan to move away during the time of
study participation
Exclusion Criteria:
- Co-enrollment in any other HIV interventional research study or have been enrolled in
an HIV vaccine trial in which they were either in the active arm or do not know the
arm in which they were enrolled.
- Would be enrolled as a community-recruited participant in a category that has already
reached its enrollment cap
- Any medical, psychiatric, or social condition, or occupational or other
responsibility that, in the judgment of the investigator, would make participation in
the study unsafe, complicate interpretation of study outcome data, or otherwise
interfere with achieving the study objectives |
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| Study is available at: |
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UCLA Vine Street CRS
Los Angeles, CA 90038
United States
Primary Contact:
Christopher Hucks-Ortiz, MPH
Email: Chortiz@ucla.edu
Phone: 323-461-3107 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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