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
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) focused on measuring HIV Testing, Latino
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
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
NCT ID
NCT02454725
First Posted
April 20, 2015
Last Updated
January 31, 2019
Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Mental Health (NIMH)
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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