HIV Prevention Among At-risk Latinos in the Heartland

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04563715
• Other study ID #: 32961
• Secondary ID: R01MH116787
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: December 2026

Study information

• Verified date: November 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 456
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

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.

Locations

Country	Name	City	State
United States	AIDS Taskforce of Greater Cleveland	Cleveland	Ohio
United States	Shalom Health Care Center	Indianapolis	Indiana
United States	Sixteenth Street Community Health Centers	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percentage of participants who report having tested for HIV twice in the past 12 months.	Participants will complete surveys assessing HIV testing behavior.	Past 12 months
Primary	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.	Past 6 months
Primary	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.	Past 6 months
Primary	Mean percentage of participants who report having tested for HIV in the past 6 months.	Participants will complete surveys assessing HIV testing behavior.	Past 6 months