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HIV Prevention Among At-risk Latinos in the Heartland

NCT ID: NCT04563715

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV Latinos Networks Men who have sex with men Transgender USA Midwest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of Care

HIV counseling and testing

Group Type ACTIVE_COMPARATOR

HIV counseling and testing

Intervention Type DIAGNOSTIC_TEST

Receive HIV testing risk assessment and advice about risk reduction and future testing.

Standard of Care plus Network Intervention

Network intervention

Group Type EXPERIMENTAL

HIV counseling and testing

Intervention Type DIAGNOSTIC_TEST

Receive HIV testing risk assessment and advice about risk reduction and future testing.

Network intervention

Intervention Type BEHAVIORAL

Key individuals are trained to provide advice about regular testing and risk reduction.

Interventions

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HIV counseling and testing

Receive HIV testing risk assessment and advice about risk reduction and future testing.

Intervention Type DIAGNOSTIC_TEST

Network intervention

Key individuals are trained to provide advice about regular testing and risk reduction.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Exclusion Criteria

* Cis-gender female.
* Did not have sex with men or identify as homosexual or bisexual.
* Cannot provide consent.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Laura R. Glasman

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura R Glasman

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Shalom Health Care Center

Indianapolis, Indiana, United States

Site Status

AIDS Taskforce of Greater Cleveland

Cleveland, Ohio, United States

Site Status

Sixteenth Street Community Health Centers

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH116787

Identifier Type: NIH

Identifier Source: secondary_id

View Link

32961

Identifier Type: -

Identifier Source: org_study_id