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Enrolling by Invitation

NCT Number: NCT04563715

HIV Prevention Among At-risk Latinos 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.

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Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shalom Health Care Center, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIV counseling and testing

Diagnostic Test

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

Network intervention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Sep 24, 2020
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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