Clinical trial NCT06132672: Medical Mistrust Among Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men (HLMSM)
Official title: Identifying and Addressing Historical and Structural Drivers of Medical Mistrust Among Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Hispanic/Latino gay
bisexual men
HIV prevention
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Recruit, enroll, and collect baseline data from 144 Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men (HLMSM), including 16 Community-Based Peer Navigators (known as Navigators) and their social network members (n=8 unique social network members per leader). Navigators (coupled with their social networks) will be randomly assigned to intervention (n=8 Navigators; n=64 social network members) or delayed-intervention (n=8 Navigators; n=64 social network members) groups. Navigators in the intervention group will be trained and supported for 12 months of implementation across years 3 and 4; those in the delayed-intervention group will be trained in year 5
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is an urgent need to address HIV inequities and disparities in the US, particularly within vulnerable communities such as Hispanic/Latino gay, bisexual, and other men who have sex with men (HLMSM).

Detailed description: Medical mistrust is associated with HIV disparities among HLMSM because mistrust may result in delayed or reduced use of needed HIV prevention (e.g., HIV testing and Pre-exposure prophylaxis (PrEP) uptake) and care (e.g., AntiretroViral Therapy \[ART\]) services.

While advances have been made to increase the use of HIV prevention and care services, profound disparities persist, and a need remains for increased understanding of the multilevel drivers of medical mistrust and for effective interventions to address these drivers among HLMSM in the US.

This research proposes a mixed-method study that includes rigorous qualitative and quantitative methods to better understand the drivers of medical mistrust among Spanish-speaking, English-speaking, and bilingual (including Spanish and English, or an indigenous language and Spanish and/or English) HLMSM. This study also proposes to refine and test a multilevel intervention designed to address medical mistrust and increase the use of needed HIV prevention and care services among diverse HLMSM in Mecklenburg County, NC, a jurisdiction prioritized by the Ending the HIV Epidemic in the US (EHE) initiative.

Eligibility criteria: Inclusion Criteria:

* reside in Mecklenburg County, NC
* identify as Hispanic/Latino
* be ≥18 years of age
* speak English and Spanish
* report identifying as male and having had sex with at least 1 man in the past 6 months
* provide informed consent

Exclusion Criteria:

* less than 18 years of age
* female

Primary outcomes:
measure: Change in Rate of medical mistrust
timeFrame: baseline to post-intervention up to 18 months
measure: Change in Rate of Human Immunodeficiency Virus (HIV) testing
timeFrame: baseline to post-intervention up to 18 months
measure: Change in Rate of pre-exposure prophylaxis (PrEP) uptake
timeFrame: baseline to post-intervention up to 18 months
measure: Change in the amount of use of HIV care services
timeFrame: baseline to post-intervention up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott D Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
References: