Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men
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|ClinicalTrials.gov Identifier: NCT00951249|
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : May 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Referral of Partners Behavioral: Screening for STIs and counseling Behavioral: Peer health care system navigators Behavioral: Enhanced counseling||Not Applicable|
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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 other 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 diagnosis 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1553 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of a Community-Level, Multi-Component Intervention for Black Men Who Have Sex With Men|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
HIV-infected and uninfected black MSM
Behavioral: Referral of Partners
Referral of up to five sexual partners by index participants for enrollment into the studyBehavioral: Screening for STIs and counseling
Identification of STIs and treatment or referral for treatment, if applicableBehavioral: Peer health care system navigators
HIV/STI treatment and other medical and social servicesBehavioral: Enhanced counseling
Counseling and referral for care offered to participants for issues such as substance use and mental health
- Number of participants enrolled at each city [ Time Frame: At 52 Weeks ]
- Proportion of participants who agree to HIV testing [ Time Frame: Throughout study ]
- Proportion of participants who agree to STI testing [ Time Frame: Throughout study ]
- Proportion of participants who use PHN [ Time Frame: Throughout study ]
- Proportion of participants who are newly diagnosed with HIV at enrollment [ Time Frame: At Study Entry ]
- Increase in condom use [ Time Frame: Study Entry to Week 52 ]
- Decrease in viral load among HIV-infected participants who initiate HAART during their study participation [ Time Frame: At Week 52 ]
- Decrease in STI [ Time Frame: At Study Entry to Week 52 ]
- Number of participants with recent HIV infection [ Time Frame: At Study Entry ]
- Number of participants with acute HIV infection [ Time Frame: At Week 52 ]
- Number of seroconversions during follow-up among those who are HIV-uninfected [ Time Frame: At Follow-up ]
- Number of sex partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Number of sero-discordant or sero-unknown partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Type and frequency of anal intercourse [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Level of condom use [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Partner change rate [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- As individually self-reported by participants: network size, composition, density, multiplexity, durability, and homogeneity [ Time Frame: Throughout study ]
- Overlap of participant's sexual network with his social network [ Time Frame: Throughout study ]
- Attitudes of black MSM toward other prevention interventions [ Time Frame: Throughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951249
|United States, California|
|UCLA Vine Street CRS|
|Los Angeles, California, United States, 90038|
|San Francisco Vaccine and Prevention CRS|
|San Francisco, California, United States, 94102|
|United States, District of Columbia|
|George Washington University|
|Washington, District of Columbia, United States, 20037|
|United States, Georgia|
|The Ponce de Leon Ctr. CRS|
|Atlanta, Georgia, United States, 30308|
|Hope Clinic of the Emory Vaccine Center CRS|
|Decatur, Georgia, United States, 30030|
|United States, Massachusetts|
|The Fenway Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|NY Blood Ctr./Union Square CRS|
|New York, New York, United States, 10003|
|Harlem Hospital Center/Columbia University CRS|
|New York, New York, United States, 10032|
|Study Chair:||Beryl Koblin, PhD||New York Blood Center|
|Study Chair:||Kenneth Mayer, MD||Fenway Community Health Center|
|Study Chair:||Darrell P. Wheeler, PhD, MPH, ACSW||School of Social Work, Hunter College|