- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02454725
Regular HIV Testing Among At-Risk Latino Men
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Social Network
Leaders of social networks will communicate messages endorsing regular HIV testing to network members.
|
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.
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
Other Names:
|
|
Active Comparator: Comparison
HIV counseling and testing
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of HIV testing
Time Frame: Twelve months post intervention
|
Maximum number of months between two HIV tests
|
Twelve months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of HIV testing
Time Frame: Twelve months post intervention
|
Whether the participant received an HIV test every < six months during the 12-month period following study intake
|
Twelve months post intervention
|
|
HIV risk behaviors: Number of unprotected anal intercourse occasions with a non-monogamous partner
Time Frame: Twelve months post intervention
|
Number of unprotected anal intercourse occasions with a non-monogamous partner
|
Twelve months post intervention
|
|
HIV risk behaviors: Number of sexual partners
Time Frame: Twelve months post intervention
|
Number of sexual partners
|
Twelve months post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura R. Glasman, Ph.D., Medical College of Wisconsin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- PRO00020837
- R34MH100947 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Human Immunodeficiency Virus (HIV)
-
Merck Sharp & Dohme LLCWithdrawnHIV-1 | Immunodeficiency Virus Type 1, Human | Human Immunodeficiency Virus Type 1 | Human Immunodeficiency Virus 1
-
Indiana UniversityNational Institute on Aging (NIA)Enrolling by invitationHIV | Geriatric | Geriatric Assessment | HIV - Human Immunodeficiency Virus | HIV (Human Immunodeficiency Virus)United States
-
National Institute of Allergy and Infectious Diseases...CompletedHuman Immunodeficiency Virus (HIV) | Human Immunodeficiency Virus PreventionUnited States
-
RTI InternationalCenters for Disease Control and PreventionCompletedHuman Immunodeficiency Virus (HIV) PositiveUnited States
-
Bristol-Myers SquibbCompleted
-
Janssen-Cilag International NVCompletedHuman Immunodeficiency Virus (HIV) Infections | Acquired Immunodeficiency Syndrome (AIDS) VirusFrance, United Kingdom, Belgium, Germany, Spain, Switzerland, Denmark, Israel, Austria, Poland, Hungary, Sweden, Ireland
-
Merck Sharp & Dohme LLCRecruitingHuman Immunodeficiency Virus (HIV) InfectionUnited States, South Africa, Thailand, Colombia, Mexico, Russia
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID); New York University and other collaboratorsCompletedHIV (Human Immunodeficiency Virus)Swaziland
-
Columbia UniversityMinistry of Health, SwazilandCompleted
-
Bristol-Myers SquibbMedarexCompletedHuman Immunodeficiency Virus (HIV)United States
Clinical Trials on Social Network
-
Medical College of WisconsinNational Institute on Drug Abuse (NIDA)CompletedSexually Transmitted Diseases | HIVEl Salvador
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)CompletedHIV | AIDSUnited States, Russian Federation
-
Massachusetts General HospitalMbarara University of Science and TechnologyUnknown
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedOverweight and ObesityUnited States
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)CompletedHIV InfectionsBulgaria, Hungary, Russian Federation
-
Northwestern UniversityWithdrawn
-
Lisa DixonWithdrawnSchizophrenia | First Episode PsychosisUnited States
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)Completed
-
University of ChicagoUniversity of Alabama at Birmingham; Tulane University; Birmingham AIDS Outreach and other collaboratorsRecruitingHIV SeropositivityUnited States
-
City University of New YorkAlliance of Border Collaboratives; Programa CompañerosCompletedHIVMexico, United States