HIV Prevention Among At-risk Latinos in the Heartland

November 1, 2021 updated by: Laura R. Glasman, Medical College of Wisconsin

Regular HIV Testing and HIV Prevention Among At-Risk Latino Men in the Heartland

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46222
        • Shalom Health Care Center
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • AIDS TaskForce of Greater Cleveland
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 54204
        • Sixteenth Street Community Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Standard of Care
HIV counseling and testing
Diagnostic test: HIV counseling and testing
Receive HIV testing risk assessment and advice about risk reduction and future testing.
Experimental: Standard of Care plus Network Intervention
Network intervention
Diagnostic test: HIV counseling and testing
Receive HIV testing risk assessment and advice about risk reduction and future testing.
Behavioral: Network intervention
Key individuals are trained to provide advice about regular testing and risk reduction.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Laura R Glasman, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32961
  • R01MH116787 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 HIV Infections

Clinical Trials on HIV counseling and testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe