Clinical trial NCT04563715: HIV Prevention Among At-risk Latinos in the Heartland
Official title: Regular HIV Testing and HIV Prevention Among At-Risk Latino Men in the Heartland
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Latinos
Networks
Men who have sex with men
Transgender
USA Midwest
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-09-24
Enrollment: 456
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean percentage of participants who report having tested for HIV twice in the past 12 months.
timeFrame: Past 12 months
measure: Mean percentage of PrEP-eligible participants who report having consulted with a provider about PrEP.
timeFrame: Past 6 months
measure: Mean percentage of participants who report having had unprotected sex with a casual partner.
timeFrame: Past 6 months
measure: Mean percentage of participants who report having tested for HIV in the past 6 months.
timeFrame: Past 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Shalom Health Care Center
state: Indiana
city: Cleveland
country: United States
facility: AIDS Taskforce of Greater Cleveland
state: Ohio
city: Milwaukee
country: United States
facility: Sixteenth Street Community Health Centers
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Laura R Glasman
role: PRINCIPAL_INVESTIGATOR
References: