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HIV Prevention Among At-risk Latinos in the Heartland

Primary Purpose

HIV Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV counseling and testing
Network intervention
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Latinos, Networks, Men who have sex with men, Transgender, USA Midwest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Latinx men who have sex with men or transgender women 18 or more years of age.
  • Lives in the Milwaukee, Cleveland or Indianapolis area.
  • Can provide informed consent.
  • Additional inclusion criteria for networks: 80% or more of the network is of Latinx descent.

Exclusion Criteria:

  • Cis-gender female.
  • Did not have sex with men or identify as homosexual or bisexual.
  • Cannot provide consent.

Sites / Locations

  • Shalom Health Care Center
  • AIDS Taskforce of Greater Cleveland
  • Sixteenth Street Community Health Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Standard of Care plus Network Intervention

Arm Description

HIV counseling and testing

Network intervention

Outcomes

Primary Outcome Measures

Mean percentage of participants who report having tested for HIV twice in the past 12 months.
Participants will complete surveys assessing HIV testing behavior.
Mean percentage of PrEP-eligible participants who report having consulted with a provider about PrEP.
Participants will complete surveys in which they will report whether they consulted with a provider about PrEP.
Mean percentage of participants who report having had unprotected sex with a casual partner.
Participants will complete surveys in which they will report whether they had unprotected sex with a casual partner.
Mean percentage of participants who report having tested for HIV in the past 6 months.
Participants will complete surveys assessing HIV testing behavior.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2020
Last Updated
November 1, 2021
Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04563715
Brief Title
HIV Prevention Among At-risk Latinos in the Heartland
Official Title
Regular HIV Testing and HIV Prevention Among At-Risk Latino Men in the Heartland
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a randomized controlled trial that evaluates the efficacy of a network intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three mid sized Midwestern cities.
Detailed Description
To benefit from early HIV diagnosis, the CDC suggests that groups at higher HIV risk get tested regularly. The study will evaluate the efficacy of an intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three midsized Midwestern cities. The intervention uses the relationships that permeate networks of LMSMT by training well-positioned members to encourage a collective response to the epidemic and to disseminate HIV testing and prevention messages and resources within the network. Thus, we will (a) recruit 36 friendship networks of LMSMT in Milwaukee, Cleveland, and Indianapolis (N ≈ 432); (b) test them for HIV and recommend that they test regularly; (c) invite key members of 18 randomly selected networks to a 4-session training to promote regular HIV testing and prevention in their networks; (d) conduct chart reviews to verify regular testing and PrEP visits and assess regular testing, PrEP visits, and risk behavior and mediators at 6, 12 and 18-month follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Latinos, Networks, Men who have sex with men, Transgender, USA Midwest

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
HIV counseling and testing
Arm Title
Standard of Care plus Network Intervention
Arm Type
Experimental
Arm Description
Network intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
HIV counseling and testing
Intervention Description
Receive HIV testing risk assessment and advice about risk reduction and future testing.
Intervention Type
Behavioral
Intervention Name(s)
Network intervention
Intervention Description
Key individuals are trained to provide advice about regular testing and risk reduction.
Primary Outcome Measure Information:
Title
Mean percentage of participants who report having tested for HIV twice in the past 12 months.
Description
Participants will complete surveys assessing HIV testing behavior.
Time Frame
Past 12 months
Title
Mean percentage of PrEP-eligible participants who report having consulted with a provider about PrEP.
Description
Participants will complete surveys in which they will report whether they consulted with a provider about PrEP.
Time Frame
Past 6 months
Title
Mean percentage of participants who report having had unprotected sex with a casual partner.
Description
Participants will complete surveys in which they will report whether they had unprotected sex with a casual partner.
Time Frame
Past 6 months
Title
Mean percentage of participants who report having tested for HIV in the past 6 months.
Description
Participants will complete surveys assessing HIV testing behavior.
Time Frame
Past 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male gender at birth
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Latinx men who have sex with men or transgender women 18 or more years of age. Lives in the Milwaukee, Cleveland or Indianapolis area. Can provide informed consent. Additional inclusion criteria for networks: 80% or more of the network is of Latinx descent. Exclusion Criteria: Cis-gender female. Did not have sex with men or identify as homosexual or bisexual. Cannot provide consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura R Glasman
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalom Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
Facility Name
AIDS Taskforce of Greater Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Sixteenth Street Community Health Centers
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
54204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HIV Prevention Among At-risk Latinos in the Heartland

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