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Regular HIV Testing Among At-Risk Latino Men

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Social Network
Comparison
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) focused on measuring HIV Testing, Latino

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • self-report as a Latino man who has sex with men (LMSM);
  • living in the Milwaukee area;
  • willing and able to provide consent for participation;

Additional Inclusion Criteria for Social Network Seeds:

  • more than 70% of social network members are LMSM
  • more than 50% of LMSM social network members are at risk for HIV

Exclusion Criteria:

  • Female
  • 17 years of age or younger
  • Unable to provide consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Social Network

    Comparison

    Arm Description

    Leaders of social networks will communicate messages endorsing regular HIV testing to network members.

    HIV counseling and testing

    Outcomes

    Primary Outcome Measures

    Frequency of HIV testing
    Maximum number of months between two HIV tests

    Secondary Outcome Measures

    Frequency of HIV testing
    Whether the participant received an HIV test every < six months during the 12-month period following study intake
    HIV risk behaviors: Number of unprotected anal intercourse occasions with a non-monogamous partner
    Number of unprotected anal intercourse occasions with a non-monogamous partner
    HIV risk behaviors: Number of sexual partners
    Number of sexual partners

    Full Information

    First Posted
    April 20, 2015
    Last Updated
    January 31, 2019
    Sponsor
    Medical College of Wisconsin
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02454725
    Brief Title
    Regular HIV Testing Among At-Risk Latino Men
    Official Title
    Regular HIV Testing Among At-Risk Latino Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    June 1, 2018 (Actual)
    Study Completion Date
    June 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical College of Wisconsin
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Early HIV diagnosis followed by linkage to treatment soon after HIV infection can reduce mortality and prevent new HIV infections. To obtain the full benefit of early HIV diagnosis, the US Centers for Disease Control and Prevention suggest that high risk groups get tested for HIV regularly, every three to six months. This study will examine the feasibility of a strategy to promote regular HIV testing and HIV risk reduction among Latino men at risk for HIV which, if successful, will help to identify Latino men unaware of their HIV status, benefitting them and the society.
    Detailed Description
    In the US, the HIV epidemic largely affects clusters of interconnected persons with high HIV prevalence and undiagnosed HIV infections that must be reached to reduce incidence. Latino men who have sex with men (LMSM) are overrepresented in these clusters. Following African Americans, LMSM have the highest HIV incidence rate and are the next most likely to be unaware of their HIV infection. Between 2005 and 2008, nearly one-quarter of the HIV positive LMSM were unaware of the infection. High HIV prevalence in LMSM networks and lack of strategies to promote regular HIV testing may explain why many LMSM are not benefiting from early diagnosis. Many LMSM face social and legal challenges that hinder their access to healthcare services and outreach. They often have little understanding of HIV treatments, experience discrimination, and hold mistaken assumptions about HIV risk, including beliefs that motivate them to seek sexual partners within their high prevalence in-group as a form of preventing infection. A social network approach can address the demands of engaging LMSM in regular HIV screening and reduce their collective risk. LMSM often rely on other LMSM who are sources of advice and referrals and who partially shield them from the double jeopardy of being a sexual and ethnic minority. Network interventions can capitalize on these relationships to promote access to resources and foster norms that reward regular testing and encourage collective safety. This project uses social networks to promote regular HIV testing and risk reduction among LMSM. Rather than delivering risk reduction messages and opportunities for HIV testing, the intervention will penetrate networks of LMSM through well positioned members. Unlike strategies that target personal networks or social groups within venues, the intervention will recruit three-ring networks of interconnected LMSM and isolate their ties. Three recruitment rings will help to find less visible LMSM; and isolating their ties will identify who can reach them. In addition to informing and motivating their peers to reduce risk, key network members will be trained to be links to prevention resources, deliver tailored prompts to HIV testing, and support peers' testing behaviors to encourage repetition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus (HIV)
    Keywords
    HIV Testing, Latino

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    107 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Social Network
    Arm Type
    Experimental
    Arm Description
    Leaders of social networks will communicate messages endorsing regular HIV testing to network members.
    Arm Title
    Comparison
    Arm Type
    Active Comparator
    Arm Description
    HIV counseling and testing
    Intervention Type
    Behavioral
    Intervention Name(s)
    Social Network
    Intervention Description
    Leaders of social networks will undergo small group training to develop skills to convey information effectively and deliver messages endorsing regular HIV testing to members of their social networks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Comparison
    Other Intervention Name(s)
    HIV Counseling and Testing
    Intervention Description
    All participants will receive HIV counseling and rapid testing following the Wisconsin Department of Health guidelines. Sexually active men who receive a negative test result will be told that they should be HIV-tested every three to six months, unless they have a monogamous HIV negative partner
    Primary Outcome Measure Information:
    Title
    Frequency of HIV testing
    Description
    Maximum number of months between two HIV tests
    Time Frame
    Twelve months post intervention
    Secondary Outcome Measure Information:
    Title
    Frequency of HIV testing
    Description
    Whether the participant received an HIV test every < six months during the 12-month period following study intake
    Time Frame
    Twelve months post intervention
    Title
    HIV risk behaviors: Number of unprotected anal intercourse occasions with a non-monogamous partner
    Description
    Number of unprotected anal intercourse occasions with a non-monogamous partner
    Time Frame
    Twelve months post intervention
    Title
    HIV risk behaviors: Number of sexual partners
    Description
    Number of sexual partners
    Time Frame
    Twelve months post intervention

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: self-report as a Latino man who has sex with men (LMSM); living in the Milwaukee area; willing and able to provide consent for participation; Additional Inclusion Criteria for Social Network Seeds: more than 70% of social network members are LMSM more than 50% of LMSM social network members are at risk for HIV Exclusion Criteria: Female 17 years of age or younger Unable to provide consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura R. Glasman, Ph.D.
    Organizational Affiliation
    Medical College of Wisconsin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Regular HIV Testing Among At-Risk Latino Men

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