HIV Prevention Among At-risk Latinos in the Heartland

Not Applicable

• Conditions: HIV Infections
• Interventions: Diagnostic Test: HIV counseling and testing; Behavioral: Network intervention

• Registration Number: NCT04563715
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-24
• Study Start: 2020-11-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-03
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 456

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	HIV counseling and testing	HIV counseling and testing
Standard of Care plus Network Intervention	HIV counseling and testing	Network intervention
Standard of Care plus Network Intervention	Network intervention	Network intervention

Primary Outcome Measures

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

Trial Locations

Locations (3)

AIDS Taskforce of Greater Cleveland; 🇺🇸 Cleveland, Ohio, United States

Shalom Health Care Center; 🇺🇸 Indianapolis, Indiana, United States

Sixteenth Street Community Health Centers; 🇺🇸 Milwaukee, Wisconsin, United States