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Ensayos clínicos

Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men

Patrocinador(es) del estudio: HIV Prevention Trials Network
Números de identificación: NCT00951249, HPTN 061
  • Concluido

Propósito del estudio

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.

Afección:
Infecciones por el VIH

Detalles del estudio

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 allowIn 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

Criterios de inclusión

    :
    • 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

Criterios de exclusión

    :
    • 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

Centros de estudio/contactos

California

    UCLA Vine Street CRS, Los Angeles, California, 90038, United States

    San Francisco Vaccine and Prevention CRS, San Francisco, California, 94102, United States

District of Columbia

    George Washington University, Washington, District of Columbia, 20037, United States

Georgia

    The Ponce de Leon Ctr. CRS, Atlanta, Georgia, 30308, United States

    Hope Clinic of the Emory Vaccine Center CRS, Decatur, Georgia, 30030, United States

Massachusetts

    The Fenway Institute, Boston, Massachusetts, 02115, United States

New York

    Harlem Hospital Center/Columbia University CRS, New York, New York, 10032, United States

    NY Blood Ctr./Union Square CRS, New York, New York, 10003, United States

Actualizado: 14 de mayo del 2010

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